Clinical trial NCT04090749: Caregiver Support in the Context of Multiple Chronic Conditions
Official title: Caregiver Support in the Context of Multiple Chronic Conditions: Randomized Waitlist Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burnout
Keywords: coping
resilience
quality of life
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-09-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life as Assessed by the Short Form Health Survey
timeFrame: 16 weeks and 32 weeks
Secondary outcomes:
measure: Fatigue as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 16 weeks and 32 weeks
measure: Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale
timeFrame: 16 weeks and 32 weeks
measure: Caregiver Burden as Assessed by the Zarit Caregiver Burden Interview (ZBI)
timeFrame: 16 weeks and 32 weeks
Other outcomes:
measure: Change in Interleukin 6 (ng/mL)
timeFrame: Baseline, 16 weeks and 32 weeks
measure: Change in Interleukin 10 (pg/ml)
timeFrame: Baseline, 16 weeks and 32 weeks
measure: Change in Resilience to Stress as Assessed by Heart Rate Variability
timeFrame: Baseline, 16 weeks and 32 weeks
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Martha Abshire, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abshire Saylor M, Pavlovic NV, DeGroot L, Jajodia A, Hladek MD, Perrin N, Wolff J, Davidson PM, Szanton S. Strengths-building through life purpose, self-care goal setting and social support: Study protocol for Caregiver Support. Contemp Clin Trials Commun. 2022 May 5;28:100917. doi: 10.1016/j.conctc.2022.100917. eCollection 2022 Aug.
citation: Abshire Saylor M, Pavlovic N, DeGroot L, Peeler A, Nelson KE, Perrin N, Gilotra NA, Wolff JL, Davidson PM, Szanton SL. Feasibility of a Multi-Component Strengths-Building Intervention for Caregivers of Persons With Heart Failure. J Appl Gerontol. 2023 Dec;42(12):2371-2382. doi: 10.1177/07334648231191595. Epub 2023 Sep 14.