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Caregiver Support in the Context of Multiple Chronic Conditions

NCT ID: NCT04090749

Last Updated: 2023-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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Caregiver Burnout

Keywords

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coping resilience quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The research assistant collecting data will be blinded to group assignment for each participant.

Study Groups

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Open Label Group

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.

Group Type EXPERIMENTAL

Caregiver-Support

Intervention Type BEHAVIORAL

intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. 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.

Waitlist Control

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.

Group Type OTHER

Caregiver-Support

Intervention Type BEHAVIORAL

intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. 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.

Immediate Intervention

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.

Group Type EXPERIMENTAL

Caregiver-Support

Intervention Type BEHAVIORAL

intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. 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.

Interventions

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Caregiver-Support

intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martha Abshire, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins School of Nursing

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 35602009 (View on PubMed)

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.

Reference Type RESULT
PMID: 37707361 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5P30NR018093

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00203584

Identifier Type: -

Identifier Source: org_study_id