Trial Outcomes & Findings for Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease (NCT NCT01566214)

NCT ID: NCT01566214

Last Updated: 2018-12-24

Results Overview

Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: Change from baseline to 3-months post hospital discharge
• Results posted on: 2018-12-24

Participant Flow

Participant milestones

Measure	Motivational Interview For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Overall Study STARTED	6	6
Overall Study COMPLETED	3	6
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Motivational Interview For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Overall Study Lost to Follow-up	3	0

Baseline Characteristics

Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease

Baseline characteristics by cohort

Measure	Motivational Interview n=6 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.	Total n=12 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Age, Continuous	68.33 Years STANDARD_DEVIATION 11.98 • n=5 Participants	65.67 Years STANDARD_DEVIATION 8.64 • n=7 Participants	67.00 Years STANDARD_DEVIATION 10.05 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 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

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Population: Participants who completed the SF-36v at baseline, 1 month, and 3 months.

Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
SF-36v Physical Function Scale	-6.67 units on a scale Standard Deviation 7.64	13.33 units on a scale Standard Deviation 12.52

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Role Limitations Due to Physical Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
SF-36v Role Limitations Due to Physical Health Scale	-22.92 units on a scale Standard Deviation 35.54	9.38 units on a scale Standard Deviation 36.39

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Role Limitations Due to Emotional Problems Scale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
SF-36v Role Limitations Due to Emotional Problems Scale	-27.78 units on a scale Standard Deviation 25.46	5.56 units on a scale Standard Deviation 13.61

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
SF-36v Energy-Fatigue Scale	-5.00 units on a scale Standard Deviation 42.65	1.67 units on a scale Standard Deviation 23.49

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
SF-36v Emotional Well-Being Scale	-14.67 units on a scale Standard Deviation 37.86	-2.00 units on a scale Standard Deviation 7.90

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
SF-36v Social Functioning Scale	-16.67 units on a scale Standard Deviation 40.18	-10.42 units on a scale Standard Deviation 18.40

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
SF-36v Pain Scale	-5.00 units on a scale Standard Deviation 13.23	14.17 units on a scale Standard Deviation 13.10

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
SF-36v General Health Scale	-5.00 units on a scale Standard Deviation 18.03	4.17 units on a scale Standard Deviation 17.15

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Seattle Angina Questionnaire Physical Limitations Scale	-5.93 units on a scale Standard Deviation 8.98	3.33 units on a scale Standard Deviation 30.43

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Population: Note that because 4 participants in the Usual Care group reported that they did not experience chest pain in the prior four weeks, their responses could not be included in the analysis, as the scale measures changes in the severity of chest pain. Therefore, only 2 participants in the Usual Care group contributed to the analysis.

Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=2 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Seattle Angina Questionnaire Angina Stability Scale	25.00 units on a scale Standard Deviation 66.14	-12.50 units on a scale Standard Deviation 17.68

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Seattle Angina Questionnaire Angina Frequency Scale	20.00 units on a scale Standard Deviation 43.59	16.67 units on a scale Standard Deviation 22.51

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Seattle Angina Questionnaire Treatment Satisfaction Scale	-3.92 units on a scale Standard Deviation 33.45	7.84 units on a scale Standard Deviation 10.95

PRIMARY outcome

Timeframe: Change from baseline to 3-months post hospital discharge

Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Outcome measures

Measure	Motivational Interview n=3 Participants For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Usual Care n=6 Participants For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Seattle Angina Questionnaire Disease Perception Scale	13.89 units on a scale Standard Deviation 9.62	9.72 units on a scale Standard Deviation 17.01

Adverse Events

Motivational Interview

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Vander Weg

Iowa City VA Health Care System

Phone: 319-338-0581

Email: mark.vanderweg@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place