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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01566214
First received: March 19, 2012
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Heart Disease
Behavioral: Motivational Interview
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Representational Telehealth Nursing Intervention for Veterans With CHD

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Change in health-related quality of life (SF-36V Health Survey) [ Time Frame: Change from baseline to 3-months post hospital discharge ] [ Designated as safety issue: No ]
    36-item self-report measure of health-related quality of life designed specifically for Veterans.

  • Change in cardiac quality of life (Seattle Angina Questionnaire) [ Time Frame: Change from baseline to 3-months post hospital discharge ] [ Designated as safety issue: No ]
    11-item self-report measure to assess cardiac quality of life


Secondary Outcome Measures:
  • Change in disease attributions (MIHART semi-structured interview) [ Time Frame: Change from baseline to 3-months post hospital discharge ] [ Designated as safety issue: No ]
    Semi-structured interview to assess participants' adaptive and non-adaptive attributions regarding the causes of their MI/acute coronary syndrome.

  • Change in illness representations (Illness Perception Questionnaire - Revised) [ Time Frame: Change from baseline to 3-months post hospital discharge ] [ Designated as safety issue: No ]
    42-item self-report measure of participants' non-attributional components of their illness representations.


Enrollment: 14
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566214

Locations
United States, Iowa
Iowa City VA Health Care System
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Mark Vander Weg, PhD VA Health Care System/University of Iowa
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01566214     History of Changes
Other Study ID Numbers: 200910778-MVW
Study First Received: March 19, 2012
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
coronary heart disease (CHD)
myocardial infarction (MI)
acute coronary syndromes (ACS)

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014