Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease

Phase 2

Completed

• Conditions: Heart Disease
• Interventions: Behavioral: Motivational Interview

• Registration Number: NCT01566214
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

Coronary heart disease (CHD) is a significant health threat among veterans. Compared to their civilian counterparts, veterans experience greater disability, reinfarction, and mortality following myocardial infarction (MI) and other acute coronary syndromes (ACS). High rates of hypertension, diabetes, and cardiac risk behaviors (e.g., smoking) and low socioeconomic status (SES) further increase veterans' CHD-related morbidity and mortality. The proposed pilot project will establish the feasibility of a telehealth nursing intervention for veterans with CHD who are recovering from MI/ACS. The Veterans Heart Attack Representations Telehealth (Vet-HART) intervention is designed to promote adaptive conceptual change in veterans' beliefs (common sense models or representations) about CHD etiology and self-management and facilitate health behavior changes (e.g., smoking cessation, medication adherence, diet management, and increased physical activity). The long-term goal of this research program is to improve veterans' quality of life (QoL) and reduce their CHD-related morbidity/mortality. The proposed project is the requisite next step in attaining that goal.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-29
• Study Start: 2012-04-30
• Primary Completion: 2012-06-30
• Study Completion: 2012-10-31
• Status Verified: 2018-06
• Results First Submitted: 2018-06-12
• Results First Submitted QC: 2018-06-12
• Last Update Submitted: 2018-06-12
• Results First Posted: 2018-12-24
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Admission to an inpatient medicine unit for MI, ACS, and coronary angiography
• Age

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Exclusion Criteria

• Altered mental status
• Language barriers
• Dementia or Cognitive Impairment
• Diagnostic Study
• Resident in long-term care facility prior to the present admission
• Planned discharge to a skilled or intermediate care facility or hospice
• Lack of access to a functioning phone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motivational Interview	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.

Primary Outcome Measures

Name	Time	Method
SF-36v Role Limitations Due to Physical Health Scale	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.
SF-36v Role Limitations Due to Emotional Problems Scale	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.
SF-36v Pain Scale	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.
Seattle Angina Questionnaire Angina Stability Scale	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.
SF-36v Physical Function Scale	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.
SF-36v Energy-Fatigue Scale	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.
Seattle Angina Questionnaire Physical Limitations Scale	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.
SF-36v Emotional Well-Being Scale	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.
Seattle Angina Questionnaire Disease Perception Scale	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.
SF-36v Social Functioning Scale	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.
SF-36v General Health Scale	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.
Seattle Angina Questionnaire Angina Frequency Scale	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.
Seattle Angina Questionnaire Treatment Satisfaction Scale	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.

Trial Locations

Locations (1)

Iowa City VA Health Care System, Iowa City, IA; 🇺🇸 Iowa City, Iowa, United States