Caregiver Support in the Context of Multiple Chronic Conditions

Caregiver Burnout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090749
• Other study ID #: IRB00203584
• Secondary ID: 5P30NR018093
• Status: Completed
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Chronic Disease
• Multiple Chronic Conditions

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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