Trial Outcomes & Findings for Positive Psychology for Acute Coronary Syndrome Patients (NCT NCT03122184)
NCT ID: NCT03122184
Last Updated: 2020-05-14
Results Overview
Feasibility will be measured by examining the number of completed exercises.
COMPLETED
NA
69 participants
24 weeks
2020-05-14
Participant Flow
69 participants enrolled in the study but 22 either withdrew their consent or failed to attend their first in-person visit before randomization. Forty-seven individuals were randomized to a treatment condition.
Participant milestones
| Measure |
Positive Psychology + Motivational Interviewing
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Positive Psychology + Motivational Interviewing
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Terminated due to cognitive problem
|
1
|
0
|
Baseline Characteristics
Positive Psychology for Acute Coronary Syndrome Patients
Baseline characteristics by cohort
| Measure |
Positive Psychology + Motivational Interviewing
n=24 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=23 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Medication Adherence
|
95 percentage of time
STANDARD_DEVIATION 18 • n=5 Participants
|
98 percentage of time
STANDARD_DEVIATION 4 • n=7 Participants
|
97 percentage of time
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Dietary Adherence
|
54.8 score on a scale
STANDARD_DEVIATION 27.4 • n=5 Participants
|
55.4 score on a scale
STANDARD_DEVIATION 32.2 • n=7 Participants
|
55.1 score on a scale
STANDARD_DEVIATION 29.5 • n=5 Participants
|
|
Positive Affect
|
28.5 score on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
33.3 score on a scale
STANDARD_DEVIATION 6.3 • n=7 Participants
|
30.9 score on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Trait Optimism
|
16.1 score on a scale
STANDARD_DEVIATION 5.7 • n=5 Participants
|
16.5 score on a scale
STANDARD_DEVIATION 4.6 • n=7 Participants
|
16.3 score on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
State Optimisim
|
25.8 score on a scale
STANDARD_DEVIATION 6.9 • n=5 Participants
|
28.0 score on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
26.9 score on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
HADS-A Score
|
5.5 score on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
5.2 score on a scale
STANDARD_DEVIATION 4.0 • n=7 Participants
|
5.3 score on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
HADS-D Score
|
4.0 score on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
3.5 score on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
3.7 score on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Physical Function
|
37.3 score on a scale
STANDARD_DEVIATION 13.3 • n=5 Participants
|
43.2 score on a scale
STANDARD_DEVIATION 13.9 • n=7 Participants
|
40.2 score on a scale
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
SF-12 Scores (Physical)
|
37.0 score on a scale
STANDARD_DEVIATION 7.0 • n=5 Participants
|
40.0 score on a scale
STANDARD_DEVIATION 9.0 • n=7 Participants
|
38.3 score on a scale
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
SF-12 Scores (Mental)
|
46.9 score on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
49.3 score on a scale
STANDARD_DEVIATION 8.0 • n=7 Participants
|
48.1 score on a scale
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Adherence to Health Behaviors
|
9.9 score on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
11.1 score on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
10.5 score on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Cardiac Symptoms
|
9.2 score on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
8.5 score on a scale
STANDARD_DEVIATION 5.3 • n=7 Participants
|
8.9 score on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Physical Activity
|
2439.7 MET-minutes per week
STANDARD_DEVIATION 5067.6 • n=5 Participants
|
1809.8 MET-minutes per week
STANDARD_DEVIATION 2266.8 • n=7 Participants
|
2131.5 MET-minutes per week
STANDARD_DEVIATION 3924.2 • n=5 Participants
|
|
Perceived Stress
|
5.7 score on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
5.7 score on a scale
STANDARD_DEVIATION 2.7 • n=7 Participants
|
5.7 score on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksFeasibility will be measured by examining the number of completed exercises.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=24 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Feasibility of the PP-MI Based Health Behavior Intervention
|
10.0 exercises completed
Standard Deviation 3.9
|
—
|
PRIMARY outcome
Timeframe: Weeks 1-12Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=24 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Acceptability of the PP-MI Exercises: Utility Score
Utility of the PP component
|
8.0 units on a scale
Standard Deviation 2.3
|
—
|
|
Acceptability of the PP-MI Exercises: Utility Score
Utility of the MI component
|
8.2 units on a scale
Standard Deviation 2.2
|
—
|
PRIMARY outcome
Timeframe: Weeks 1-12Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=24 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Acceptability of the PP-MI Exercises: Ease Score
Ease of the PP component
|
8.3 units on a scale
Standard Deviation 2.3
|
—
|
|
Acceptability of the PP-MI Exercises: Ease Score
Ease of the MI component
|
8.1 units on a scale
Standard Deviation 2.4
|
—
|
SECONDARY outcome
Timeframe: MVPA at 12 weeks and 24 weeksPopulation: Not everyone provided follow-up data at both time points.
ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=18 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=16 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Minutes of Moderate to Vigorous Physical Activity (Actigraph)
MVPA at 12-week
|
33.0 minutes/day
Standard Deviation 19.0
|
23.2 minutes/day
Standard Deviation 26.2
|
|
Minutes of Moderate to Vigorous Physical Activity (Actigraph)
MVPA at 24-week
|
34.6 minutes/day
Standard Deviation 22.9
|
18.1 minutes/day
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Change in score from Baseline to 12 weeks, 24 weeksPopulation: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher score indicates greater levels of medication adherence.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=21 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in Medication Adherence
12 weeks
|
5 percentage of time
Standard Deviation 2.2
|
5 percentage of time
Standard Deviation 2.2
|
|
Change in Medication Adherence
24 weeks
|
0 percentage of time
Standard Deviation 0
|
-6 percentage of time
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Change in score from Baseline to 12 weeks, 24 weeksPopulation: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone who provided data at both time points.
Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat. Minimum= 0; Maximum= 216. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate lower levels of dietary adherence.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=21 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=21 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in Dietary Adherence
12 weeks
|
-2.8 score on a scale
Standard Deviation 31.2
|
-17.6 score on a scale
Standard Deviation 21.5
|
|
Change in Dietary Adherence
24 weeks
|
2.1 score on a scale
Standard Deviation 33.8
|
-7.7 score on a scale
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: Change in score from Baseline to 12 weeks, 24 weeksPopulation: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=20 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in Positive Affect
12 weeks
|
8.8 score on a scale
Standard Deviation 6.0
|
4.9 score on a scale
Standard Deviation 6.5
|
|
Change in Positive Affect
24 weeks
|
9.5 score on a scale
Standard Deviation 6.8
|
2.2 score on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Change in score from baseline to 12 week, 24 weekPopulation: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of optimism.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=20 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in Trait Optimism
12 weeks
|
2.2 score on a scale
Standard Deviation 3.8
|
2.0 score on a scale
Standard Deviation 5.3
|
|
Change in Trait Optimism
24 weeks
|
1.7 score on a scale
Standard Deviation 5.9
|
2.8 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Change of score from Baseline to 12 weeks, 24 weeksPopulation: Not all participants provided data at all follow-up points.
Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation. Minimum:7, Maximum:35. The higher number indicates a greater level of optimism. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=19 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in State Optimism
Change in SOM at 12 weeks
|
5.3 score on a scale
Standard Deviation 6.5
|
-.1 score on a scale
Standard Deviation 6.8
|
|
Change in State Optimism
Change in SOM at 24 weeks
|
6.0 score on a scale
Standard Deviation 7.1
|
.6 score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Change in score from Baseline to 12 week, 24 weekPopulation: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of anxiety.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=19 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Changes in HADS-A Scores
12 weeks
|
-2.8 score on a scale
Standard Deviation 3.3
|
-1.3 score on a scale
Standard Deviation 2.8
|
|
Changes in HADS-A Scores
24 weeks
|
-2.3 score on a scale
Standard Deviation 3.8
|
-1.9 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Change in score from Baseline to 12 week, 24 weekPopulation: We will use a random effects regression model with a random intercept for each participant.
The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression).
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=19 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in HADS-D Scores
12 weeks
|
-1.8 score on a scale
Standard Deviation 2.8
|
.5 score on a scale
Standard Deviation 2.5
|
|
Change in HADS-D Scores
24 weeks
|
-1.5 score on a scale
Standard Deviation 3.3
|
-0.8 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Change of score from Baseline to 12 week, 24 weekPopulation: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity. Minimum: 0, Maximum: 58.2. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of functional capacity.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=20 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in Physical Function
12 weeks
|
9.7 score on a scale
Standard Error 11.7
|
4.4 score on a scale
Standard Error 13.3
|
|
Change in Physical Function
24 weeks
|
14.1 score on a scale
Standard Error 13.0
|
4.9 score on a scale
Standard Error 10.8
|
SECONDARY outcome
Timeframe: Change of score from Baseline to 12 week, 24 weekPopulation: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=19 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in SF-12 Scores (Physical)
12 weeks
|
8.0 score on a scale
Standard Deviation 8.0
|
7.2 score on a scale
Standard Deviation 8.3
|
|
Change in SF-12 Scores (Physical)
24 weeks
|
12.3 score on a scale
Standard Deviation 7.4
|
6.8 score on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Change of score from baseline to 12 and 24 weeks.Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=19 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in SF-12 Scores (Mental)
12 week
|
8.8 score on a scale
Standard Deviation 8.7
|
1.3 score on a scale
Standard Deviation 5.8
|
|
Change in SF-12 Scores (Mental)
24 week
|
6.3 score on a scale
Standard Deviation 7.9
|
2.6 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Change of score from Baseline to 12 week, 24 weekPopulation: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score. (Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate better adherence to health behaviors.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=21 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=21 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in Adherence to Health Behaviors
12 weeks
|
4.9 score on a scale
Standard Deviation 3.1
|
3.5 score on a scale
Standard Deviation 2.7
|
|
Change in Adherence to Health Behaviors
24 weeks
|
4.4 score on a scale
Standard Deviation 2.9
|
3.3 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Change of score from Baseline to 12 week, 24 weekPopulation: Not all participants provided data at all follow-up points.
Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients. Minimum: 0, Maximum: 30. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of cardiac symptoms.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=19 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in Cardiac Symptoms
12 weeks
|
-6.6 score on a scale
Standard Deviation 3.7
|
-4.8 score on a scale
Standard Deviation 4.4
|
|
Change in Cardiac Symptoms
24 weeks
|
-6.6 score on a scale
Standard Deviation 4.6
|
-5.1 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Change of score from Baseline to 12 week, 24 weekPopulation: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure asseses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=21 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=20 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in Physical Activity
12 weeks
|
649.5 MET-minutes per week
Standard Deviation 1857.1
|
159.9 MET-minutes per week
Standard Deviation 4244.6
|
|
Change in Physical Activity
24 weeks
|
-359.4 MET-minutes per week
Standard Deviation 1671.7
|
-171.1 MET-minutes per week
Standard Deviation 2014.0
|
SECONDARY outcome
Timeframe: Change of score from Baseline to 12 week, 24 weekPopulation: Not all participants provided data at all follow-up points.
Measured by the Perceived Stress Scale (PSS-4) measure. Minimum: 0, Maximum: 16. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress.
Outcome measures
| Measure |
Positive Psychology + Motivational Interviewing
n=20 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=19 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
Change in Perceived Stress
24 weeks
|
-2.3 score on a scale
Standard Deviation 3.0
|
-2.5 score on a scale
Standard Deviation 2.9
|
|
Change in Perceived Stress
12 weeks
|
-2.8 score on a scale
Standard Deviation 3.0
|
-1.4 score on a scale
Standard Deviation 3.1
|
Adverse Events
Positive Psychology + Motivational Interviewing
Motivational Interviewing Health Education
Serious adverse events
| Measure |
Positive Psychology + Motivational Interviewing
n=24 participants at risk
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=23 participants at risk
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
General disorders
Unexpected chest and back pain
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
Cardiac disorders
Unexpected Coronary Artery Syndrome
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
8.7%
2/23 • Number of events 2 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected aneurysm
|
0.00%
0/24 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
Cardiac disorders
Unexpected NSTEMI
|
0.00%
0/24 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected hospital admission due to alt ms
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected fever
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
Cardiac disorders
Unexpected hypotension
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected sepsis
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected GI bleed
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected calculus of gallbladder
|
0.00%
0/24 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected melena
|
0.00%
0/24 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected mass
|
0.00%
0/24 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected rectal bleeding
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Lymphoma
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected A-FIB
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected Carpal Tunnel Syndrome
|
0.00%
0/24 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 2 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
Eye disorders
Unexpected eye damage
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected blood in stool
|
0.00%
0/24 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected malignant neoplasm of colon
|
0.00%
0/24 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
Other adverse events
| Measure |
Positive Psychology + Motivational Interviewing
n=24 participants at risk
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
|
Motivational Interviewing Health Education
n=23 participants at risk
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
|
|---|---|---|
|
General disorders
Allergic reaction
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Stomach cramps and vomiting
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Throat swelling
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
0.00%
0/23 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Abdominal pain
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
13.0%
3/23 • Number of events 5 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
Cardiac disorders
Chest pain
|
8.3%
2/24 • Number of events 2 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 2 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
Cardiac disorders
Chest discomfort
|
4.2%
1/24 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 2 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
|
General disorders
Unexpected balance issues
|
0.00%
0/24 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
4.3%
1/23 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place