Enhancing Caregiver Support for Heart Failure Patients: the CarePartner Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00555360
First received: November 6, 2007
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

Informal caregivers, assisted by health information technology may help to fill the gaps in VA care management of heart failure patients by enhancing support for patients' treatment adherence, behavior changes, and symptom monitoring.


Condition Intervention
Heart Failure, Congestive
Behavioral: HITCM+CP
Behavioral: HITCM only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancing Caregiver Support for Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Health-related quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mental health, health service use, and mortality risk [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 372
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Veterans with heart failure that can identify an out-of-home informal caregiver
Behavioral: HITCM+CP
Weekly automated assessment calls with follow-up by a care manager and a CarePartner for 12 months. Baseline, 6-month and 12-month follow-up.
Active Comparator: Arm 2
Veterans with heart failure that can identify an out-of-home informal caregiver
Behavioral: HITCM only
Weekly automated assessment calls with follow-up by a care manager for 12 months. Baseline, 6-month and 12-month follow-up.

Detailed Description:

Background: Heart failure (HF) is a leading cause of preventable hospitalization and death in the VA and many patients fall short of self-care goals. Numerous efficacy trials have shown that HF care management supported by health information technology (i.e., HITCM) can improve patients' outcomes, although VA care managers in 'real-world' health systems are often overwhelmed by the need to provide monitoring and behavior change services. Informal caregivers may help to fill the gaps in VA care management and enhance support for patients' treatment adherence, behavior changes, and symptom monitoring. The challenge will be to identify ways to leverage assistance from informal caregivers (ICGs) who lack the resources to fill this role effectively.

Objectives: We will evaluate the impact of extending the reach of HITCM by incorporating a protocol-driven model for improved monitoring and self-management support by a CarePartner (CP). CPs will be adult children or friends living outside the patient's home who are willing to play a structured role to support self-care. The specific aims of the trial are: (1) to determine whether an intervention that uses automated patient monitoring and behavior change calls with follow-up to HF patients' care manager and CP (HITCM+CP) improves key patient-centered outcomes relative to a system that only uses the same technology to support patients' care management (HITCM-only). Outcomes of interest include patients' health-related quality of life, mental health, health service use, and mortality risk; (2) to evaluate the impact of HITCM+CP on patients' self-care behaviors compared to HITCM-only; and (3) to determine whether the intervention increases the quality and quantity of support for HF patients' self-care compared to HITCM-only.

Methods: 372 HF patient-CP pairs will be recruited from the VA Louis Stokes (Cleveland) Healthcare System. Patients will receive automated telephone assessment and behavior change calls weekly for 12 months. For patients in both study arms, a care manager will monitor patients' assessment results via a secure website and will receive reports concerning urgent health problems by fax and pager. In the HITCM+CP group, patients' CPs also will receive tailored e-mail reports based on patients' weekly assessments and access to summary data about the patient via the internet. HITCM+CP patients and their CPs will use a structured protocol to review the patient's assessment results, identify self-care goals and barriers, and ensure that the patient's in-home caregivers and healthcare team remain involved. All patients and CPs will complete quantitative surveys at baseline, 6, and 12 months. The study will include a mixed-methods approach including qualitative interviews with patients, CPs and clinicians to evaluate intervention use and the service's potential for translation. The primary outcome will be HF-related quality of life at 12 months. Secondary outcomes will include self-care behavior, patient-CP relationship indicators, hospitalization, and death.

Impact: This study will evaluate a model for leveraging ICGs and structuring their role in HF patients' overall disease management. If effective, the service may provide the frequent monitoring and behavior change assistance that patients need, allowing VA to extend its impact beyond what current care management programs can realistically deliver.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Veterans with heart failure (HF) treated at the VA Louis Stokes (Cleveland) facility will be eligible if they have New York Heart Association (NYHA) Class II-III diastolic or systolic HF noted by inpatient or outpatient ICD-9 codes.

Exclusion Criteria:

Veterans treated at the VA Louis Stokes (Cleveland) facility will be ineligible if they:

  • have a serious mental illness or cognitive dysfunction, e.g., psychosis, dementia, or active substance abuse (alcohol and/or other drugs);
  • do not speak English fluently;
  • are receiving palliative care due to advanced HF or other health problems;
  • receive the majority of their HF care from providers outside of the VA;
  • are unable to use a telephone to respond to weekly automated self-management support calls; or
  • are unable to nominate an eligible informal caregiver.
  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: NCT00555360

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Investigators
Principal Investigator: John D. Piette, PhD VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00555360     History of Changes
Other Study ID Numbers: IIR 07-185
Study First Received: November 6, 2007
Last Updated: January 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Health Information Technology
Patient Care Management
Self Care
Quality of Life
Family or non-Family Informal Caregivers

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014