Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease

NCT01566214 | Completed Phase 2 Results

• 2 other identifiers: PPO 09-283200910778
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease

Keywords

coronary heart disease (CHD); myocardial infarction (MI); acute coronary syndromes (ACS)

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (2)

Motivational Interview

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

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.

Motivational Interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Iowa: collaborator

Study Sites (1)

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

MeSH Terms

Conditions

Heart Diseases; Coronary Disease; Myocardial Infarction; Acute Coronary Syndrome

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Mark Vander Weg
• Organization: Iowa City VA Health Care System

mark.vanderweg@va.gov

319-338-0581

Study Officials

• Mark W Vander Weg, PhD MS BA

  Iowa City VA Health Care System, Iowa City, IA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 29, 2012
• Study Start: April 30, 2012
• Primary Completion: June 30, 2012
• Study Completion: October 31, 2012
• Last Updated: December 24, 2018
• Results First Posted: December 24, 2018

Record last verified: 2018-06

Locations

US (1)