Caregiver Support in the Context of Multiple Chronic Conditions

Johns Hopkins University

Status: Completed

Conditions: Caregiver Burnout

Treatments: Behavioral: Caregiver-Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04090749

5P30NR018093 (U.S. NIH Grant/Contract)

IRB00203584

Details and patient eligibility

About

This research is being done to learn whether services to the caregiver to provide emotional, instrumental and social support can improve quality of life and other outcomes. The Caregiver-Support program provides services that are not usually available to caregivers of persons with heart failure and other chronic conditions.

Full description

Family caregivers who care for older adults living with multiple chronic conditions, including heart failure (HF), provide substantial cost savings to the US healthcare system. While caregiving can be meaningful and rewarding, extensive research also demonstrates high rates of chronic disease, fatigue and physiologic measures such as stress hormones among caregivers. Family caregivers are often left juggling caregivers' loved one's healthcare as well as caregivers' own. Unmet needs have been identified including increased stress, financial strain and social isolation, but interventions to address these needs in HF caregivers have had mixed results. Due to the limited impact of many caregiver interventions, experts have called for a greater understanding of the dynamic and contextual factors of family caregiving including resources, needs and social support with an increased focus on individualization of interventions for high-risk caregivers to improve outcomes.Following a mixed methods study to better understand these contextual factors and to address this gap between the evidence and uptake of proven strategies by caregivers, the study team has developed a resilience-promoting intervention to improve quality of life for family caregivers of individuals with multiple chronic conditions, including HF, Caregiver-Support. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.

The first phase of the study will be an open label pilot (N=5) followed by a single-masked, two-group, randomized trial (N=40) to test the feasibility and gauge an initial effect size of the intervention. Participants will be visited by study staff in participants' homes for all data collection and intervention visits. Participants will be randomized to receive either the immediate intervention group or the waitlist control group. In the waitlist control group, participants will receive usual care for the first 16 weeks (which is limited to printed materials provided in the clinic) and then begin the intervention.

The intervention will consist of 5 in-home sessions with a nurse interventionist. Each participant will receive each intervention component but interventionists will systematically tailor content to the participants' goals based on protocols. All participants will be reassessed at 16 weeks (in person) and 32 weeks (by phone) by a research assistant (RA) masked to treatment condition. The primary outcome will be improvement in quality of life between baseline and 16 weeks. Other endpoints include group differences in fatigue, caregiver burden, self-reported and physiological measures of resilience up through 32 weeks after the intervention. The investigators will also examine the acceptability of the intervention using intervention compliance and participant satisfaction data.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primary family caregivers, will be identified by patients and providers in the Bridge Clinic
• must live with the patient or visit at least 3 times per week for the purposes of care provision
• provide support for at least one Instrumental Activity of Daily Living,
• Be able to speak English.

Exclusion criteria

• Caregivers with terminal diagnosis will be excluded as goal-setting at end of life may be different than without a terminal diagnosis.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 3 patient groups

Open Label Group

Experimental group

Description:

In this arm, 5 participants will be enrolled in the intervention without blinding or randomization. The intervention and study delivery will be improved based on findings from this arm.

Treatment:

Behavioral: Caregiver-Support

Waitlist Control

Other group

Description:

The waitlist control group (n=20) will be provided written materials with community resources for caregivers during the first 16 weeks, then the intervention will begin.

Treatment:

Behavioral: Caregiver-Support

Immediate Intervention

Experimental group

Description:

The immediate intervention group (n=20) will receive the intervention during weeks 0-16. There will be assessment at week 32 to examine maintenance on primary and secondary outcomes.

Treatment:

Behavioral: Caregiver-Support