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Completed

NCT Number: NCT01566214

Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease

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.

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Key information

Conditions

Heart Disease Acute Coronary Syndrome Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational interview

Behavioral

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 outcomes

  1. SF-36v Physical Function Scale

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. SF-36v Energy-Fatigue Scale

    Time frame: 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.

  5. SF-36v Emotional Well-Being Scale

    Time frame: 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.

  6. SF-36v Social Functioning Scale

    Time frame: 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.

  7. SF-36v Pain Scale

    Time frame: 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.

  8. SF-36v General Health Scale

    Time frame: 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.

  9. Seattle Angina Questionnaire Physical Limitations Scale

    Time frame: 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.

  10. Seattle Angina Questionnaire Angina Stability Scale

    Time frame: 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.

  11. Seattle Angina Questionnaire Angina Frequency Scale

    Time frame: 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.

  12. Seattle Angina Questionnaire Treatment Satisfaction Scale

    Time frame: 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.

  13. Seattle Angina Questionnaire Disease Perception Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Iowa

Registry information

Official study title

Representational Telehealth Nursing Intervention for Veterans With CHD

Acronym: VHPI

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2012
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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