Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease (VHPI)

Representational Telehealth Nursing Intervention for Veterans With CHD

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.

Study Overview

• Status: Completed
• Conditions: Heart Disease
• Intervention / Treatment: Behavioral: Motivational Interview

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52246-2208
      • Iowa City VA Health Care System, Iowa City, IA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Usual Care; For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36v Physical Function Scale	Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge
SF-36v Role Limitations Due to Physical Health Scale	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.	Change from baseline to 3-months post hospital discharge
SF-36v Role Limitations Due to Emotional Problems Scale	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.	Change from baseline to 3-months post hospital discharge
SF-36v Energy-Fatigue Scale	Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge
SF-36v Emotional Well-Being Scale	Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge
SF-36v Social Functioning Scale	Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge
SF-36v Pain Scale	Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge
SF-36v General Health Scale	General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Physical Limitations Scale	Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Angina Stability Scale	Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Angina Frequency Scale	Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Treatment Satisfaction Scale	Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Disease Perception Scale	Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.	Change from baseline to 3-months post hospital discharge

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Iowa
• Investigators: Principal Investigator: Mark W Vander Weg, PhD MS BA, Iowa City VA Health Care System, Iowa City, IA

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2012
• Primary Completion (Actual): June 30, 2012
• Study Completion (Actual): October 31, 2012

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: March 26, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: myocardial infarction (MI); coronary heart disease (CHD); acute coronary syndromes (ACS)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: PPO 09-283; 200910778 (Other Identifier: University of Iowa)