Trial Outcomes & Findings for Virtual Patient Behavioral Response Training for Family Caregivers (NCT NCT04489303)

NCT ID: NCT04489303

Last Updated: 2023-05-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 156 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-05-18

Participant Flow

Participant milestones

Measure	Virtual Patient Behavioral Response Training Caring Response mobile app with a behavioral training. Caring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response 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	78	78
Overall Study COMPLETED	60	55
Overall Study NOT COMPLETED	18	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Patient Behavioral Response Training for Family Caregivers

Baseline characteristics by cohort

Measure	Virtual Patient Behavioral Response Training n=78 Participants Caring Response mobile app with a behavioral training. Caring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.	Educational Training n=78 Participants Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.	Total n=156 Participants Total of all reporting groups
Age, Continuous	46.0 years STANDARD_DEVIATION 13.5 • n=5 Participants	51.2 years STANDARD_DEVIATION 14.1 • n=7 Participants	48.6 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	64 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	64 Participants n=7 Participants	138 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

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	Virtual Patient Behavioral Response Training n=60 Participants Caring Response mobile app with a behavioral training. Caring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.	Educational Training n=55 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	0.66 units on a scale Standard Deviation 0.69	0.89 units on a scale Standard Deviation 0.78

PRIMARY outcome

Timeframe: 3 months

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	Virtual Patient Behavioral Response Training n=60 Participants Caring Response mobile app with a behavioral training. Caring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.	Educational Training n=55 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	15.84 units on a scale Standard Deviation 9.97	21.00 units on a scale Standard Deviation 11.76

PRIMARY outcome

Timeframe: 3 months

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	Virtual Patient Behavioral Response Training n=60 Participants Caring Response mobile app with a behavioral training. Caring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.	Educational Training n=55 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	15.78 units on a scale Standard Deviation 6.23	19.01 units on a scale Standard Deviation 7.09

Adverse Events

Virtual Patient Behavioral Response 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