Trial Outcomes & Findings for Caring Light Project for Family Caregivers (NCT NCT04517877)

NCT ID: NCT04517877

Last Updated: 2023-05-18

Results Overview

The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 164 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-05-18

Participant Flow

Participant milestones

Measure	Caring Light Training Caring Light mobile app with coping skills training. Caring Response App: Participants will receive the Caring Light mobile app containing the coping skills training.	Educational Training Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.
Overall Study STARTED	82	82
Overall Study COMPLETED	63	58
Overall Study NOT COMPLETED	19	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Caring Light Project for Family Caregivers

Baseline characteristics by cohort

Measure	Caring Light Training n=82 Participants Caring Light mobile app with coping skills training. Caring Response App: Participants will receive the Caring Light mobile app containing the coping skills training.	Educational Training n=82 Participants Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.	Total n=164 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 11.1 • n=5 Participants	56.3 years STANDARD_DEVIATION 12.0 • n=7 Participants	55.9 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	70 Participants n=7 Participants	138 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants	71 Participants n=7 Participants	139 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Caregivers with full data for the CES-D instrument were included in the outcomes analysis.

The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.

Outcome measures

Measure	Caring Light Training n=63 Participants Caring Light mobile app with coping skills training. Caring Response App: Participants will receive the Caring Light mobile app containing the coping skills training.	Educational Training n=58 Participants Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.
Center for Epidemiological Studies Depression Scale	17.72 units on a scale Standard Deviation 10.90	21.70 units on a scale Standard Deviation 9.93

PRIMARY outcome

Timeframe: 3 months

Population: Caregivers with full data for the "Revised Memory and Behavior Problems Checklist" were included in the outcomes analysis.

This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.

Outcome measures

Measure	Caring Light Training n=62 Participants Caring Light mobile app with coping skills training. Caring Response App: Participants will receive the Caring Light mobile app containing the coping skills training.	Educational Training n=53 Participants Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.
Revised Memory and Behavior Problems Checklist	0.52 units on a scale Standard Deviation 0.54	0.64 units on a scale Standard Deviation 0.55

PRIMARY outcome

Timeframe: 3 months

Population: Caregivers with full data for the "Perceived Stress Scale" were included in the outcomes analysis.

The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.

Outcome measures

Measure	Caring Light Training n=62 Participants Caring Light mobile app with coping skills training. Caring Response App: Participants will receive the Caring Light mobile app containing the coping skills training.	Educational Training n=57 Participants Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.
Perceived Stress Scale	17.16 units on a scale Standard Deviation 7.41	19.36 units on a scale Standard Deviation 5.82

Adverse Events

Caring Light Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Educational Training

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

Bruno Kajiyama

Photozig, Inc.

Phone: 6506947496

Email: info@photozig.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place