Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Caregiver Support in the Context of Multiple Chronic Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04090749
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE September 12, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date May 15, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
Change in Quality of Life as assessed by the Short Form Health Survey [ Time Frame: Baseline, 16 weeks and 32 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • Change in Fatigue as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline, 16 weeks and 32 weeks ]
    The PROMIS 7-item fatigue measure has a score range from 0-35 with higher scores indicating higher levels of fatigue.
  • Change in Caregiver Burden as assessed by the Oberst Caregiving Burden Scale [ Time Frame: Baseline, 16 weeks and 32 weeks ]
    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.
  • Change in Caregiver Burden as assessed by the Zarit Caregiver Burden Interview (ZBI) [ Time Frame: Baseline, 16 weeks and 32 weeks ]
    The ZBI is a 12 item measure with higher scores representing higher feelings of burden; the range of summed scores is 0-48.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • Change in Fatigue as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline, 16 weeks and 32 weeks ]
    The PROMIS 7-item fatigue measure has a score range from 0-35 with higher scores indicating higher levels of fatigue.
  • Change in Caregiver Burden as assessed by the Oberst Caregiving Burden Scale [ Time Frame: Baseline, 16 weeks and 32 weeks ]
    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.
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2019)
  • Change in Interleukin 6 (ng/mL) [ Time Frame: Baseline, 16 weeks and 32 weeks ]
    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.
  • Change in Interleukin 10 (pg/ml) [ Time Frame: Baseline, 16 weeks and 32 weeks ]
    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.
  • Change in resilience to stress as assessed by Heart Rate Variability [ Time Frame: Baseline, 16 weeks and 32 weeks ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Caregiver Support in the Context of Multiple Chronic Conditions
Official Title  ICMJE Caregiver Support in the Context of Multiple Chronic Conditions: Randomized Waitlist Control Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The research assistant collecting data will be blinded to group assignment for each participant.
Primary Purpose: Supportive Care
Condition  ICMJE Caregiver Burnout
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Caregiver-Support
  • 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.
    Intervention: Behavioral: Caregiver-Support
  • 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.
    Intervention: Behavioral: Caregiver-Support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
53
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Martha Abshire, PhD 4433406201 mabshir1@jh.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090749
Other Study ID Numbers  ICMJE IRB00203584
5P30NR018093 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Martha Abshire, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP