Enhancing Caregiver Support for Heart Failure Patients: the CarePartner Study

Heart Failure, Congestive Clinical Trial

Official title:

Enhancing Caregiver Support for Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555360
• Other study ID #: IIR 07-185
• Status: Completed
• Phase: N/A
• First received: November 6, 2007
• Last updated: August 12, 2015
• Start date: June 2009
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: December 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Veterans with heart failure (HF) treated at the VA Louis Stokes (Cleveland) facilities 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) facilities 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

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.
• HITCM only
Weekly automated assessment calls with follow-up by a care manager for 12 months. Baseline, 6-month and 12-month follow-up.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	VA Medical Center, Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Piette JD, Rosland AM, Marinec NS, Striplin D, Bernstein SJ, Silveira MJ. Engagement with automated patient monitoring and self-management support calls: experience with a thousand chronically ill patients. Med Care. 2013 Mar;51(3):216-23. doi: 10.1097/ML — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Failure-specific Quality of Life	Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.	twelve-month followup	No
Secondary	Revised Heart Failure Self-Care Behavior Scale (HFSCB)	Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to145.	twelve-month follow-up	No
Secondary	Adherent to Heart Failure Medication	Percent of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence.	twelve-month follow-up	No