Trial Outcomes & Findings for Randomized Controlled Trial of Group Prevention Coaching (NCT NCT01838226)
NCT ID: NCT01838226
Last Updated: 2023-07-27
Results Overview
The primary outcome will be 10-year risk of fatal coronary event or non-fatal MI 6 months after enrollment, as measured by Framingham Risk Score. Scores range from 0 - 100, as this is a percentage of risk. Higher scores are worse, as they represent higher risk.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
401 participants
Primary outcome timeframe
6 months
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Group Prevention Clinics
A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction).
|
Treatment as Usual Control
Usual VA care
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
199
|
|
Overall Study
COMPLETED
|
126
|
128
|
|
Overall Study
NOT COMPLETED
|
76
|
71
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Controlled Trial of Group Prevention Coaching
Baseline characteristics by cohort
| Measure |
Group Prevention Clinics
n=202 Participants
A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Each group will consist of 10 patients. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction).
|
Treatment as Usual Control
n=199 Participants
Usual VA care
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
361 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
195 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
390 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
|
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
|
60 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
246 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
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
202 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Framingham Risk Score
|
28.9 percent risk of event
STANDARD_DEVIATION 15.2 • n=5 Participants
|
29.5 percent risk of event
STANDARD_DEVIATION 17.2 • n=7 Participants
|
29.2 percent risk of event
STANDARD_DEVIATION 16.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary outcome will be 10-year risk of fatal coronary event or non-fatal MI 6 months after enrollment, as measured by Framingham Risk Score. Scores range from 0 - 100, as this is a percentage of risk. Higher scores are worse, as they represent higher risk.
Outcome measures
| Measure |
Group Prevention Clinics
n=202 Participants
A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction).
|
Treatment as Usual Control
n=199 Participants
Usual VA care
|
|---|---|---|
|
Risk of Fatal Coronary Event or Non-fatal MI
|
27.0 percent risk of major cv event in 10 yrs
Standard Deviation 17.2
|
26.3 percent risk of major cv event in 10 yrs
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: 6 monthsMeasure of self-efficacy. Scored from 0-100, with 100 being higher self-efficacy and a better outcome.
Outcome measures
| Measure |
Group Prevention Clinics
n=202 Participants
A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction).
|
Treatment as Usual Control
n=199 Participants
Usual VA care
|
|---|---|---|
|
Patient Activation Measure
|
62.1 units on a scale
Standard Deviation 11.5
|
62.6 units on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 12 monthThe primary outcome will be 10-year risk of fatal coronary event or non-fatal MI 12 months after enrollment, as measured by Framingham Risk Score. Scores range from 0 - 100, as this is a percentage of risk. Higher scores are worse, as they represent higher risk.
Outcome measures
| Measure |
Group Prevention Clinics
n=202 Participants
A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction).
|
Treatment as Usual Control
n=199 Participants
Usual VA care
|
|---|---|---|
|
Risk of Fatal Coronary Event or Non-fatal MI
|
25.7 percent risk of cv event in 10 years
Standard Deviation 15.4
|
28.2 percent risk of cv event in 10 years
Standard Deviation 16.8
|
Adverse Events
Group Prevention Clinics
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Treatment as Usual Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group Prevention Clinics
n=202 participants at risk
A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction).
|
Treatment as Usual Control
n=199 participants at risk
Usual VA care
|
|---|---|---|
|
Cardiac disorders
death
|
0.50%
1/202 • Number of events 1 • 12 months
Adverse events were assessed without regard to specific adverse event terms.
|
0.00%
0/199 • 12 months
Adverse events were assessed without regard to specific adverse event terms.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place