NCT01566214: VHPI

Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease

Completed Phase 2 Results posted Last updated 24 December 2018

What this trial tests

Phase 2 trial testing Motivational Interview in Heart Disease in 12 participants. Completed in 31 October 2012.

Timeline

30 April 2012

Primary endpoint
30 June 2012

31 October 2012

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	30 April 2012
Primary completion	30 June 2012
Estimated completion	31 October 2012
Sites	1 location across United States

Drugs / interventions tested

• Motivational Interview

Conditions studied

• Heart Disease — all drugs for Heart Disease →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

SF-36v Physical Function Scale Primary · Change from baseline to 3-months post hospital discharge

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

Group	Value	95% CI
Motivational Interview	-6.67	± 7.64
Usual Care	13.33	± 12.52

SF-36v Role Limitations Due to Physical Health Scale Primary · 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.

Group	Value	95% CI
Motivational Interview	-22.92	± 35.54
Usual Care	9.38	± 36.39

SF-36v Role Limitations Due to Emotional Problems Scale Primary · 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.

Group	Value	95% CI
Motivational Interview	-27.78	± 25.46
Usual Care	5.56	± 13.61

SF-36v Energy-Fatigue Scale Primary · 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.

Group	Value	95% CI
Motivational Interview	-5.00	± 42.65
Usual Care	1.67	± 23.49

SF-36v Emotional Well-Being Scale Primary · 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.

Group	Value	95% CI
Motivational Interview	-14.67	± 37.86
Usual Care	-2.00	± 7.90

SF-36v Social Functioning Scale Primary · 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.

Group	Value	95% CI
Motivational Interview	-16.67	± 40.18
Usual Care	-10.42	± 18.40

SF-36v Pain Scale Primary · 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.

Group	Value	95% CI
Motivational Interview	-5.00	± 13.23
Usual Care	14.17	± 13.10

SF-36v General Health Scale Primary · 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.

Group	Value	95% CI
Motivational Interview	-5.00	± 18.03
Usual Care	4.17	± 17.15

Seattle Angina Questionnaire Physical Limitations Scale Primary · 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.

Group	Value	95% CI
Motivational Interview	-5.93	± 8.98
Usual Care	3.33	± 30.43

Seattle Angina Questionnaire Angina Stability Scale Primary · Change from baseline to 3-months post hospital discharge

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

Group	Value	95% CI
Motivational Interview	25.00	± 66.14
Usual Care	-12.50	± 17.68

Seattle Angina Questionnaire Angina Frequency Scale Primary · 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.

Group	Value	95% CI
Motivational Interview	20.00	± 43.59
Usual Care	16.67	± 22.51

Seattle Angina Questionnaire Treatment Satisfaction Scale Primary · 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.

Group	Value	95% CI
Motivational Interview	-3.92	± 33.45
Usual Care	7.84	± 10.95

Sponsor's own description

The purpose of this research study is to survey patients to learn about their beliefs and behaviors related to the management of heart disease and to discuss options for making healthy lifestyle changes. From the information the investigators get from patients, the investigators hope to develop better methods for taking care of patients who have heart disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Telemedicine and the assessment of clinician time: a scoping review.
   Kidholm K, Jensen LK, Johansson M, Montori VM. · · 2023 · cited 16× · PMID 38099431 · DOI 10.1017/s0266462323002830
2. The Mental Health-Acute Coronary Syndrome Continuum: Bidirectional Pathophysiological Links and Clinical Implications.
   Herlaș-Pop A, Radu AF, Radu A, Bungau GS, et al · · 2026 · PMID 41892853 · DOI 10.3390/medsci14010138