Trial Outcomes & Findings for Self-Care for Dementia Caregivers (NCT NCT05309577)

Last Updated: 2026-01-23

Results Overview

The 9-item Patient Health Questionnaire (PHQ-9) scale is a self-reported questionnaire to be completed by the participant that assesses severity of depression. The PHQ-9 will be administered throughout the study to assess changes in depressive symptoms pre- and post-intervention. A minimum score on this metric is a 0, indicating no impact to patient health, and ranges up to a maximum score of 27, indicating more severe impacts to patient health.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

Up to 6 weeks

Results posted on

2026-01-23

Participant Flow

This study recruited dementia caregivers (CG) from university-affiliated research registries. Eligible/interested dementia caregivers were screened for whether their care recipients, a person with dementia (PWD), would be eligible/interested in using the myRW app to track and monitor daily rhythms. Of the 25 dementia CGs we screened, 15 CGs were enrolled and allocated to the intervention; and 6 PWD were included in the intervention rendering a total sample of 21.

This single-arm pilot trial enrolled participants between March 2023 and April 2024 in Pittsburgh, PA.

Participant milestones

Participant milestones
Measure	Behavioral Intervention (Caregivers) Rest-activity rhythm monitoring via the myRW app plus motivational interviewing techniques to optimize rhythms in older dementia caregivers.	Behavioral Intervention (PWD) Rest-activity rhythm monitoring via the myRW app to optimize rhythms in older persons with dementia (PWD).
Overall Study STARTED	15	6
Overall Study COMPLETED	15	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-Care for Dementia Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Intervention (Caregivers) n=15 Participants Rest-activity rhythm monitoring via the myRW app plus motivational interviewing techniques to optimize rhythms in older dementia caregivers.	Behavioral Intervention (PWD) n=6 Participants Rest-activity rhythm monitoring via the myRW app plus motivational interviewing techniques to optimize rhythms in persons with dementia (PWD).	Total n=21 Participants Total of all reporting groups
Age, Continuous	61.78 years STANDARD_DEVIATION 8.40 • n=270 Participants	81.45 years STANDARD_DEVIATION 8.46 • n=4 Participants	66.62 years STANDARD_DEVIATION 12.05 • n=9 Participants
Sex: Female, Male Female	13 Participants n=270 Participants	4 Participants n=4 Participants	17 Participants n=9 Participants
Sex: Female, Male Male	2 Participants n=270 Participants	2 Participants n=4 Participants	4 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	4 Participants n=270 Participants	1 Participants n=4 Participants	5 Participants n=9 Participants
Race (NIH/OMB) White	9 Participants n=270 Participants	5 Participants n=4 Participants	14 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=270 Participants	0 Participants n=4 Participants	2 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=270 Participants	6 Participants n=4 Participants	21 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Depression symptoms	6.64 score on a scale STANDARD_DEVIATION 5.00 • n=270 Participants	6.80 score on a scale STANDARD_DEVIATION 7.40 • n=4 Participants	6.68 score on a scale STANDARD_DEVIATION 5.50 • n=9 Participants
Insomnia symptoms	11.43 score on a scale STANDARD_DEVIATION 5.10 • n=270 Participants	8.60 score on a scale STANDARD_DEVIATION 5.41 • n=4 Participants	10.68 score on a scale STANDARD_DEVIATION 5.19 • n=9 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks

Population: Eleven of the 15 caregivers completed pre-and post-treatment assessments and were included in the health outcome analysis.

Outcome measures

Outcome measures
Measure	Behavioral Intervention n=11 Participants Rest-activity rhythm monitoring via the myRW app plus motivational interviewing techniques to optimize rhythms.
Pre/Post Change in Depressive Symptoms	2.27 score on a scale Standard Deviation 2.61

PRIMARY outcome

Timeframe: Up to 6 weeks

Population: Eleven of the 15 caregivers completed pre-and post-treatment assessments and were included in the health outcome analysis.

The 7-item Insomnia Severity Index (ISI) is a self-reported questionnaire to be completed by the participant that assesses severity of insomnia. The ISI will be administered throughout the study to assess changes in insomnia symptoms pre- and post-intervention. A minimum score on this metric is a 0, indicating no impact to patient health, and ranges up to a maximum score of 28, indicating more severe impacts to patient health.

Outcome measures

Outcome measures
Measure	Behavioral Intervention n=11 Participants Rest-activity rhythm monitoring via the myRW app plus motivational interviewing techniques to optimize rhythms.
Pre/Post Change in Insomnia Symptoms	5.64 score on a scale Standard Deviation 5.73

Adverse Events

Behavioral Intervention (Caregivers)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Behavioral Intervention (PWD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah T. Stahl, PhD

University of Pittsburgh

Phone: 4122466003

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place