Trial Outcomes & Findings for A Patient-Spouse Intervention for Self-Managing High Cholesterol (NCT NCT00321789)
NCT ID: NCT00321789
Last Updated: 2015-04-24
Results Overview
assessed with non-fasting blood test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
255 participants
Primary outcome timeframe
11-month follow-up
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
Intervention
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
128
|
|
Overall Study
COMPLETED
|
112
|
112
|
|
Overall Study
NOT COMPLETED
|
15
|
16
|
Reasons for withdrawal
| Measure |
Intervention
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Protocol Violation
|
5
|
3
|
Baseline Characteristics
A Patient-Spouse Intervention for Self-Managing High Cholesterol
Baseline characteristics by cohort
| Measure |
Intervention
n=127 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=128 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Missed at least one dose of cholesterol medication in previous 30 days at baseline
missed at least one dose
|
31 participants
n=5 Participants
|
28 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Missed at least one dose of cholesterol medication in previous 30 days at baseline
did not miss at least one dose
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
35 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=5 Participants
|
128 participants
n=7 Participants
|
255 participants
n=5 Participants
|
|
Education
8th grade or less
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Education
some high school
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Education
high school degree or equivalent
|
26 participants
n=5 Participants
|
20 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Education
some college or vocational training, no degree
|
34 participants
n=5 Participants
|
35 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Education
Associate's degree
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Education
Bachelor's degree
|
19 participants
n=5 Participants
|
28 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Education
Graduate or professional degree
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Education
not reported
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Employment status
working full time
|
46 participants
n=5 Participants
|
58 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Employment status
working part time
|
19 participants
n=5 Participants
|
10 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Employment status
unemployed, searching for work
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Employment status
unemployed, not searching for work
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Employment status
retired
|
43 participants
n=5 Participants
|
47 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Employment status
disabled
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Employment status
not reported
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
High risk for cardiovascular event based on Framingham score
high risk
|
25 participants
n=5 Participants
|
19 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
High risk for cardiovascular event based on Framingham score
low or moderate risk
|
102 participants
n=5 Participants
|
109 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
number of participants who met goal for low-density lipoprotein cholesterol at baseline
met goal
|
45 participants
n=5 Participants
|
62 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
number of participants who met goal for low-density lipoprotein cholesterol at baseline
did not meet goal
|
82 participants
n=5 Participants
|
66 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
number of participants prescribed cholesterol medication at baseline
taking cholesterol medication
|
62 participants
n=5 Participants
|
57 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
number of participants prescribed cholesterol medication at baseline
not taking cholesterol medication
|
65 participants
n=5 Participants
|
71 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Missed at least one dose of cholesterol medication in previous 30 days at baseline
not relevant (not taking medication)
|
65 participants
n=5 Participants
|
71 participants
n=7 Participants
|
136 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 11-month follow-upassessed with non-fasting blood test
Outcome measures
| Measure |
Intervention
n=127 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=128 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Low-density Lipoprotein Cholesterol
|
123.6 mg/dL
Standard Deviation 25.6
|
115.3 mg/dL
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: 11-month follow-upSelf-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
Outcome measures
| Measure |
Intervention
n=115 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=109 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Caloric Intake
|
1175.3 kcal/day
Standard Deviation 578.8
|
1253.9 kcal/day
Standard Deviation 575.0
|
SECONDARY outcome
Timeframe: 11-month follow-upSelf-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
Outcome measures
| Measure |
Intervention
n=115 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=109 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Saturated Fat (Grams/Day)
|
15.1 grams per day
Standard Deviation 8.9
|
17.4 grams per day
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 11-month follow-upSelf-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
Outcome measures
| Measure |
Intervention
n=115 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=109 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Total Fat (Grams/Day)
|
46.5 grams per day
Standard Deviation 25.6
|
54.2 grams per day
Standard Deviation 31.1
|
SECONDARY outcome
Timeframe: 11-month follow-upSelf-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
Outcome measures
| Measure |
Intervention
n=115 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=109 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Cholesterol Intake
|
152.1 milligrams per day
Standard Deviation 97.4
|
175.5 milligrams per day
Standard Deviation 117.1
|
SECONDARY outcome
Timeframe: 11-month follow-upSelf-reported, assessed via Block Brief Food Frequency Questionnaire.
Outcome measures
| Measure |
Intervention
n=115 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=109 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Fiber Intake
|
13.2 grams per day
Standard Deviation 6.3
|
11.9 grams per day
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 11-month follow-upSelf-reported via Community Health Activities Model Program for Seniors questionnaire.
Outcome measures
| Measure |
Intervention
n=127 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=128 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Frequency of Moderate Intensity Physical Activity
|
10 times per week
Interval 6.0 to 14.0
|
10 times per week
Interval 4.0 to 16.0
|
SECONDARY outcome
Timeframe: 11-month follow-upSelf-reported via Community Health Activities Model Program for Seniors questionnaire.
Outcome measures
| Measure |
Intervention
n=127 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=128 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Duration of Moderate Intensity Physical Activity
|
7.3 hours per week
Interval 3.9 to 10.8
|
7.8 hours per week
Interval 3.5 to 12.3
|
SECONDARY outcome
Timeframe: 11-month follow-upSelf-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
Outcome measures
| Measure |
Intervention
n=115 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=109 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Total Fat (%)
|
35.4 percentage of calories
Standard Deviation 7.3
|
38.2 percentage of calories
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: 11-month follow-upSelf-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
Outcome measures
| Measure |
Intervention
n=115 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=109 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Saturated Fat (%)
|
11.4 percentage of calories
Standard Deviation 2.8
|
12.3 percentage of calories
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 11-month follow-upAssessed via non-fasting blood test. Goal is determined by 2003 National Cholesterol Education Program guidelines. Goal could be 160mg/dL for low risk (no coronary heart disease (CHD), 0-1 risk factor); 130 mg/dL for medium risk (no CHD, at least 2 risk factors); or 100 mg/dL for high risk (CHD and risk equivalents including diabetes, atherosclerotic disease, and multiple risk factors that confer a 10-year risk for CHD \>20% per Framingham score).
Outcome measures
| Measure |
Intervention
n=127 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=128 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Number of Participants With Goal LDL-C
|
57 participants
|
62 participants
|
SECONDARY outcome
Timeframe: 11-month follow-upThis was assessed via electronic medical record abstraction. Results could not be modeled statistically due to missing data/small cell sizes (i.e., not all participants had a prescription for medication because this was not an inclusion criterion).
Outcome measures
| Measure |
Intervention
n=127 Participants
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=128 Participants
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
Number of Participants Prescribed Cholesterol Medication
|
56 participants
|
56 participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=127 participants at risk
Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
|
Usual Care
n=128 participants at risk
Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
|
|---|---|---|
|
General disorders
death
|
0.00%
0/127 • 11 months
|
0.78%
1/128 • 11 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place