Trial Outcomes & Findings for All About Me: An Intervention to Ease the Transition to Long Term Care (NCT NCT05516134)

NCT ID: NCT05516134

Last Updated: 2025-04-29

Results Overview

Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple activities were observed and a mean was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
• Results posted on: 2025-04-29

Participant Flow

Participant milestones

Measure	Treatment Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members These are family members who participated with their loved one in the study's intervention	Staff Members These are staff members who took the training and provided feedback about the training / intervention.
Overall Study STARTED	26	9	16
Overall Study COMPLETED	25	9	16
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Measure	Treatment Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members These are family members who participated with their loved one in the study's intervention	Staff Members These are staff members who took the training and provided feedback about the training / intervention.
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

All About Me: An Intervention to Ease the Transition to Long Term Care

Baseline characteristics by cohort

Measure	Persons With Dementia Who Recieved the Intervention n=26 Participants Participants who receive the intervention (all) SAFE at Home: The All About Me (AAM) app will consist of Serious Digital Health Games for PWD. The market-ready version of the app will consist of five components. (1) The Fun Facts About Me Game will be used when a PWD is moving into LTC. The goal of the game is to provide an enjoyable way for family members and PWD to provide important information about the PWD's background. (2) The Resident Game Bundle will consist of SDHGs that will allow PWD to learn about one another in an enjoyable way. (3) The My Residents Module will provide staff with a convenient way to view information about a PWD with whom they will be working. Staff will launch this module from any device. (4) The Meet the Staff Module, which will be developed and tested in a future Phase II study, will allow residents to learn about staff members at their community. (5) The AAM Training Modules will provide staff and family members with access to video-based training modules that describe how to use relevant portions of the app	Family Members Who Participated in the Intervention With Their Loved One n=9 Participants This is a co-participant, family members who participated with their loved one in the study. Only some family members of participants were available to participate with their loved one. This is why there are more persons with dementia than family membeers	Staff Members n=16 Participants These are staff members who took the training and gave feedback about the intervention	Total n=51 Participants Total of all reporting groups
Age, Continuous	82.8 years STANDARD_DEVIATION 10.2 • n=5 Participants	68.9 years STANDARD_DEVIATION 13.4 • n=7 Participants	41.6 years STANDARD_DEVIATION 14.1 • n=5 Participants	68.5 years STANDARD_DEVIATION 21.4 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants	50 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	26 participants n=5 Participants	9 participants n=7 Participants	16 participants n=5 Participants	51 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)

Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple activities were observed and a mean was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome.

Outcome measures

Measure	Treatment n=21 Participants Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members These are family members who participated with their loved one in the study's intervention	Staff Members These are staff members who took the training and provided feedback about the training / intervention.
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale	0.83 score on a scale Standard Deviation 0.45	—	—

PRIMARY outcome

Timeframe: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)

Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple activities were observed and a mean was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.

Outcome measures

Measure	Treatment n=21 Participants Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members These are family members who participated with their loved one in the study's intervention	Staff Members These are staff members who took the training and provided feedback about the training / intervention.
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale	1.2 score on a scale Standard Deviation 0.86	—	—

PRIMARY outcome

Timeframe: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)

Other Engagement on the Menorah Park Engagement Scale is defined as doing, commenting, listening, or watching something NOT related to the target activity. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple activities were observed and a mean was calculated. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.

Outcome measures

Measure	Treatment n=21 Participants Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members These are family members who participated with their loved one in the study's intervention	Staff Members These are staff members who took the training and provided feedback about the training / intervention.
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale	-1.24 score on a scale Standard Deviation 0.78	—	—

PRIMARY outcome

Timeframe: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)

Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple activities were observed and a mean was calculated. The minimum value for Non-Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.

Outcome measures

Measure	Treatment n=21 Participants Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members These are family members who participated with their loved one in the study's intervention	Staff Members These are staff members who took the training and provided feedback about the training / intervention.
Change From Baseline to Treatment for Non-Engagement on the Menorah Park Engagement Scale	-.17 score on a scale Standard Deviation 0.34	—	—

PRIMARY outcome

Timeframe: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)

Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple activities were observed and a mean was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.

Outcome measures

Measure	Treatment n=21 Participants Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members These are family members who participated with their loved one in the study's intervention	Staff Members These are staff members who took the training and provided feedback about the training / intervention.
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale	.31 score on a scale Standard Deviation .35	—	—

SECONDARY outcome

Timeframe: Baseline (Weeks 1-4) and Post-Treatment (Week 11)

The Dementia Related Quality of Life Scale is a 28 item scale that examines quality of life in persons with dementia. The score ranges for 28 to 112. Higher scores represent a better outcome.

Outcome measures

Measure	Treatment n=25 Participants Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members These are family members who participated with their loved one in the study's intervention	Staff Members These are staff members who took the training and provided feedback about the training / intervention.
Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)	2.40 score on a scale Standard Deviation 7.16	—	—

SECONDARY outcome

Timeframe: Baseline (Weeks 1-4) and Post-Treatment (Week 11)

The NPI-NH examines 10 types of neuropsychiatric symptoms in persons with dementia, with the FxS score looking creating a composite score that takes into account frequency and severity of the symtoms. The score ranges from 0 to 120. Lower scores represent a better outcome.

Outcome measures

Measure	Treatment n=25 Participants Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members These are family members who participated with their loved one in the study's intervention	Staff Members These are staff members who took the training and provided feedback about the training / intervention.
Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)	-9.1 score on a scale Standard Deviation 12.2	—	—

SECONDARY outcome

Timeframe: Baseline (Weeks 1-4) and Post-Treatment (Week 11)

The 15-item Geriatric Depression Scale (GDS-SF) is a screening tool used to assess depressive symptoms in older adults. Each item is answered with a "Yes" or "No"** response, with a total score ranging from 0 to 15, where higher scores indicate greater depressive symptoms. A score of 5 or more** suggests possible depression, warranting further clinical evaluation.

Outcome measures

Measure	Treatment n=25 Participants Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members These are family members who participated with their loved one in the study's intervention	Staff Members These are staff members who took the training and provided feedback about the training / intervention.
Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)	-0.97 score on a scale Standard Deviation 2.8	—	—

SECONDARY outcome

Timeframe: Treatment (Weeks 5-11)

Satisfaction with the app

Outcome measures

Measure	Treatment n=26 Participants Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says).	Family Members n=9 Participants These are family members who participated with their loved one in the study's intervention	Staff Members n=16 Participants These are staff members who took the training and provided feedback about the training / intervention.
Satisfaction With the App	96 % who said they were satisfied (yes/no)	100 % who said they were satisfied (yes/no)	100 % who said they were satisfied (yes/no)

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Family Members

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Staff Members

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

Michael Skrajner

Hopeful Aging

Phone: 4404777881

Email: mike@hopefulaging.com

Results disclosure agreements

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