Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01566214
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Heart Disease Behavioral: Motivational Interview Phase 2

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Representational Telehealth Nursing Intervention for Veterans With CHD
Actual Study Start Date : April 30, 2012
Actual Primary Completion Date : June 30, 2012
Actual Study Completion Date : October 31, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566214


Locations
Layout table for location information
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2208
Sponsors and Collaborators
VA Office of Research and Development
University of Iowa
Investigators
Layout table for investigator information
Principal Investigator: Mark W Vander Weg, PhD MS BA Iowa City VA Health Care System, Iowa City, IA
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01566214    
Other Study ID Numbers: PPO 09-283
200910778 ( Other Identifier: University of Iowa )
First Posted: March 29, 2012    Key Record Dates
Results First Posted: December 24, 2018
Last Update Posted: December 24, 2018
Last Verified: June 2018
Keywords provided by VA Office of Research and Development:
coronary heart disease (CHD)
myocardial infarction (MI)
acute coronary syndromes (ACS)
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases