Caregiver Support in the Context of Multiple Chronic Conditions

Caregiver Support in the Context of Multiple Chronic Conditions: Randomized Waitlist Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Caregiver Burnout
• Intervention / Treatment: Behavioral: Caregiver-Support

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Other: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)	The PROMIS 7-item fatigue measure has a score range from 0-35 with higher scores indicating higher levels of fatigue. We use T-scores for analysis (where standard scores with a mean of 50 and standard deviation of 10 in the U.S. general population).	16 weeks and 32 weeks
Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale	The investigators will use the task difficulty and time caring subscales of the Oberst Caregiving Burden Scale, which include 15 likert scale items. Scores range from 15-75. Higher scores indicate greater task difficulty and more time spent on each task, higher burden.	16 weeks and 32 weeks
Caregiver Burden as Assessed by the Zarit Caregiver Burden Interview (ZBI)	The ZBI is a 12 item measure with higher scores representing higher feelings of burden; the range of summed scores is 0-48.	16 weeks and 32 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Interleukin 6 (ng/mL)	Participants will wear a non-occlusive sweatpatch to collect interleukin 6. Higher levels of interleukin 6 suggest increased activation of inflammatory response and decreased resilience to stress.	Baseline, 16 weeks and 32 weeks
Change in Interleukin 10 (pg/ml)	Participants will wear a non-occlusive sweatpatch to collect interleukin 10. Higher levels of interleukin 10 suggest increased activation of the anti-inflammatory response and increased resilience to stress.	Baseline, 16 weeks and 32 weeks
Change in Resilience to Stress as Assessed by Heart Rate Variability	Participants will touch a finger pad for 2-5 minutes to obtain heart rate variability. Heart rate variability is assessed through multiple calculations including: percentage of pairs of adjacent N-N intervals differing by more than 50 milliseconds (pNN50), high-frequency power (HF power), and low frequency to high frequency (LF/HF) ratio. Higher pNN50, HF power and LF/HF ratio levels suggest increased resilience to stress.	Baseline, 16 weeks and 32 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Martha Abshire, PhD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• 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 Sep 14:7334648231191595. doi: 10.1177/07334648231191595. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; coping; resilience
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Stress, Psychological; Chronic Disease; Caregiver Burden; Multiple Chronic Conditions
• Other Study ID Numbers: IRB00203584; 5P30NR018093 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No