Caregiver Support in the Context of Multiple Chronic Conditions

NCT04090749 | Completed Results DMC

• 2 other identifiers: IRB002035845P30NR018093
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burnout

Keywords

coping; resilience; quality of life

Outcome Measures

Primary Outcomes (1)

• Quality of Life as Assessed by the Short Form Health Survey

  The Short Form Health Survey (36 items) measures self-rated quality of life using 8 sub-scales. Items are scored on a 0-100 range, with total scores averaged for each subscale. The eight domains are also averaged to create an overall score from 0-100. Higher scores indicate a more favorable health state.

  16 weeks and 32 weeks

Secondary Outcomes (3)

• Fatigue as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)

  16 weeks and 32 weeks

• Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale

  16 weeks and 32 weeks

• Caregiver Burden as Assessed by the Zarit Caregiver Burden Interview (ZBI)

  16 weeks and 32 weeks

Other Outcomes (3)

• Change in Interleukin 6 (ng/mL)

  Baseline, 16 weeks and 32 weeks

• Change in Interleukin 10 (pg/ml)

  Baseline, 16 weeks and 32 weeks

• Change in Resilience to Stress as Assessed by Heart Rate Variability

  Baseline, 16 weeks and 32 weeks

Study Arms (3)

Open Label Group

EXPERIMENTAL

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.

Behavioral: Caregiver-Support

Waitlist Control

OTHER

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.

Behavioral: Caregiver-Support

Immediate Intervention

EXPERIMENTAL

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.

Behavioral: Caregiver-Support

Interventions

Caregiver-Support 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; Open Label Group; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• 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.

  PMID: 35602009 BACKGROUND

• 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.

  PMID: 37707361 RESULT

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Martha Abshire Saylor
• Organization: Johns Hopkins University School of Nursing

mabshir1@jhu.edu

4433406201

Study Officials

• Martha Abshire, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistant collecting data will be blinded to group assignment for each participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: August 28, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: December 22, 2023
• Results First Posted: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)