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

Primary Purpose

Heart Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motivational Interview
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Disease focused on measuring coronary heart disease (CHD), myocardial infarction (MI), acute coronary syndromes (ACS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iowa City VA Health Care System, Iowa City, IA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Motivational Interview

Usual Care

Arm Description

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.

For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2012
Last Updated
June 12, 2018
Sponsor
VA Office of Research and Development
Collaborators
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT01566214
Brief Title
Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease
Acronym
VHPI
Official Title
Representational Telehealth Nursing Intervention for Veterans With CHD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 30, 2012 (Actual)
Primary Completion Date
June 30, 2012 (Actual)
Study Completion Date
October 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Iowa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
coronary heart disease (CHD), myocardial infarction (MI), acute coronary syndromes (ACS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interview
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interview
Intervention Description
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 Measure Information:
Title
SF-36v Physical Function Scale
Description
Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
SF-36v Role Limitations Due to Physical Health Scale
Description
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.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
SF-36v Role Limitations Due to Emotional Problems Scale
Description
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.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
SF-36v Energy-Fatigue Scale
Description
Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
SF-36v Emotional Well-Being Scale
Description
Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
SF-36v Social Functioning Scale
Description
Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
SF-36v Pain Scale
Description
Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
SF-36v General Health Scale
Description
General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
Seattle Angina Questionnaire Physical Limitations Scale
Description
Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
Seattle Angina Questionnaire Angina Stability Scale
Description
Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
Seattle Angina Questionnaire Angina Frequency Scale
Description
Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
Seattle Angina Questionnaire Treatment Satisfaction Scale
Description
Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge
Title
Seattle Angina Questionnaire Disease Perception Scale
Description
Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame
Change from baseline to 3-months post hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark W Vander Weg, PhD MS BA
Organizational Affiliation
Iowa City VA Health Care System, Iowa City, IA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa City VA Health Care System, Iowa City, IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2208
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease

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