Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease

Heart Disease Clinical Trial

— VHPI  

Official title:

Representational Telehealth Nursing Intervention for Veterans With CHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566214
• Other study ID #: PPO 09-283
• Secondary ID: 200910778
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2012
• Est. completion date: October 31, 2012

Study information

• Verified date: June 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 31, 2012
• Est. primary completion date: June 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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