18 and older, any sex, with Caregiver Burnout. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Quality of Life as Assessed by the Short Form Health SurveyPrimary· 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.
16 weeks
Group
Value
95% CI
Open Label Pilot
72.3
± 25.9
Immediate Intervention
74.1
± 20.6
Waitlist Control
70.4
± 20.6
32 weeks
Group
Value
95% CI
Immediate Intervention
76.1
± 21.2
Waitlist Control
74.0
± 21.2
Fatigue as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)Secondary· 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. 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
Group
Value
95% CI
Open Label Pilot
50.3
± 8.1
Immediate Intervention
54.3
± 7.7
Waitlist Control
49.1
± 10.7
32 weeks
Group
Value
95% CI
Immediate Intervention
48.2
± 9
Waitlist Control
53.6
± 14.9
Caregiver Burden as Assessed by the Oberst Caregiving Burden ScaleSecondary· 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.
16 weeks
Group
Value
95% CI
Open Label Pilot
44
± 4.8
Immediate Intervention
46
± 3.4
Waitlist Control
39.3
± 4.5
32 weeks
Group
Value
95% CI
Immediate Intervention
38.5
± 3.2
Waitlist Control
37.5
± 4.6
Caregiver Burden as Assessed by the Zarit Caregiver Burden Interview (ZBI)Secondary· 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.
16 weeks
Group
Value
95% CI
Open Label Pilot
13.9
± 10.2
Immediate Intervention
11.3
± 10.6
Waitlist Control
14.8
± 10.6
32 weeks
Group
Value
95% CI
Immediate Intervention
10.2
± 9
Waitlist Control
9.9
± 9
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06418971 — Testing & Refinement of CarePair: An Assessment and Referral Platform to Support Family Caregivers of Alzheimer's Diseas
· NA
· recruiting
NCT07167641 — Caring for the Carer
· NA
· recruiting
NCT07528261 — ACT Group for Stroke Caregivers
· NA
· recruiting
NCT06722352 — Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)
· NA
· recruiting
NCT06687486 — Effect of Autogenic Relaxation Therapy on Caregivers on Perceived Stress Quality of Life and Caregiver Burden
· NA
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 22 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04090749.