Skip to content

Enhancing Caregiver Support for Heart Failure Patients: the CarePartner Study

Enhancing Caregiver Support for Patients With Heart Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00555360
Enrollment
372
Registered
2007-11-08
Start date
2009-06-30
Completion date
2014-12-31
Last updated
2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

Keywords

Health Information Technology, Patient Care Management, Self Care, Quality of Life, Family or non-Family Informal Caregivers

Brief 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.

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. 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.

Interventions

BEHAVIORALHITCM+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.

BEHAVIORALHITCM only

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

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Heart Failure-specific Quality of Lifetwelve-month followupMeasured 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.

Secondary

MeasureTime frameDescription
Revised Heart Failure Self-Care Behavior Scale (HFSCB)twelve-month follow-upHigher 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.
Adherent to Heart Failure Medicationtwelve-month follow-upPercent 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard mHealth
Weekly IVR calls for 12 months
156
mHealth Plus CarePartner
Wkly IVR calls for 12 months+feedback to CarePartner
153
Total309

Baseline characteristics

CharacteristicmHealth Plus CarePartnerStandard mHealthTotal
Adherent to Heart Failure Medication84 participants81 participants165 participants
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
79 Participants86 Participants165 Participants
Age, Categorical
Between 18 and 65 years
74 Participants70 Participants144 Participants
Age, Continuous67.8 years
STANDARD_DEVIATION 10.6
68.3 years
STANDARD_DEVIATION 10.6
68.1 years
STANDARD_DEVIATION 10.6
Heart Failure-specific Quality of Life41.2 units on a scale
STANDARD_DEVIATION 23.7
40.4 units on a scale
STANDARD_DEVIATION 25.1
40.8 units on a scale
STANDARD_DEVIATION 24.4
Region of Enrollment
United States
153 participants156 participants309 participants
Revised Heart Failure Self-Care Behavior Scale (HFSCB)83.1 units on a scale
STANDARD_DEVIATION 16.3
82.9 units on a scale
STANDARD_DEVIATION 19.3
83.0 units on a scale
STANDARD_DEVIATION 17.8
Sex: Female, Male
Female
0 Participants2 Participants2 Participants
Sex: Female, Male
Male
153 Participants154 Participants307 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1830 / 189
serious
Total, serious adverse events
0 / 1830 / 189

Outcome results

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.

Time frame: twelve-month followup

ArmMeasureValue (MEAN)Dispersion
Standard mHealthHeart Failure-specific Quality of Life37.0 units on a scaleStandard Deviation 25.7
mHealth+CarepartnerHeart Failure-specific Quality of Life38.6 units on a scaleStandard Deviation 24.8
p-value: 0.97595% CI: [-4.62, 4.77]Regression, Logistic
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.

Time frame: twelve-month follow-up

ArmMeasureValue (NUMBER)
Standard mHealthAdherent to Heart Failure Medication52.6 percentage of participants/perfect adher
mHealth+CarepartnerAdherent to Heart Failure Medication66.7 percentage of participants/perfect adher
p-value: 0.00795% CI: [3.9, 24.2]Regression, Logistic
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.

Time frame: twelve-month follow-up

ArmMeasureValue (MEAN)Dispersion
Standard mHealthRevised Heart Failure Self-Care Behavior Scale (HFSCB)92.1 units on a scaleStandard Deviation 18.7
mHealth+CarepartnerRevised Heart Failure Self-Care Behavior Scale (HFSCB)90.5 units on a scaleStandard Deviation 17
p-value: 0.34995% CI: [-5.78, 2.05]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026