Clinical trial NCT05516134: All About Me: An Intervention to Ease the Transition to Long Term Care
Official title: All About Me: An Intervention to Ease the Transition to Long-term Care, Build Community, and Improve Quality of Care for Persons With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Dementia, Vascular
Dementia, Mixed
Dementia of Alzheimer Type
Lead sponsor: Hopeful Aging
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 51
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the intervention
Primary purpose: TREATMENT

Brief summary: This Phase I study will involve initial development and evaluation of an innovative cross-platform software app called All About Me (AAM), which will consist of Serious Digital Health Games (SDHGs) for PWD. The AAM app will assist staff in providing person-centered care and enable residents to improve relationships with one another and with staff, thereby promoting a sense of community. This Phase I study has three Specific Aims: (1) Develop an Alpha version of the AAM App, (2) Examine acceptability of and satisfaction with the AAM App, and (3) Examine the impact of the Resident Game Bundle / Survey Says Game on engagement/affect.

Detailed description: Study Design: The study will utilize a quasi-experimental pre-post design.

Sample:

PWD: Twenty-four PWD will take part in the study, including 12 ALF residents and 12 living in a NH.

Family Members: Twenty-four family members will also take part in the study-i.e., one for each PWD. In some cases, the "family member" may be a friend or legally authorized representative.

Staff Members: Twelve LTC staff members will take part in the quasi-experiment-five at the ALF and five at the NH.

Inclusion/Exclusion Criteria:

PWD must reside in an ALF or NH, be 60+ years old, speak and read English, be diagnosed with dementia (of any type), and score at least eight on the MMSE.

Family Members, LTC Staff Members, and Focus Group Staff Members must be 18+ years old and speak and read English.

Baseline Period/Measures:

PWD: During Month 8, the following data will be collected via chart review: demographics, medications, diagnoses (including type of dementia), and primary language. In addition, the MMSE48 and the Dementia Quality of Life Scale (DEMQOL)50 will be administered via direct interview. The Neuropsychiatric Inventory-Nursing Home (NPI-NH),51,52 done via staff interview, will be used to collect data on challenging behaviors. PWD will also be observed taking part in standard activities using the Menorah Park Engagement Scale (MPES).53 The MPES is an observational scale that measures four types of engagement: Constructive Engagement (motor/verbal behavior exhibited clearly in response to the target activity); Passive Engagement (listening/watching a target activity); Distracted Engagement (motor/verbal behavior exhibited in response to something other than the target activity); and Non-Engagement/Apathy (outward signs/indicators of apathy, such as sleeping, closing one's eyes, and staring into space). The MPES also measures Pleasure, defined as clearly observable smiling/laughing. MPES data for standard activities will allow us to conduct a robust comparison to the RGB/Survey Says Game.

Family Members: researchers will interview family members to obtain demographics.

LTC Staff Members: Researchers will only interview staff members to obtain demographics during Phase I. Since this study is about development and feasibility testing, we do not want to unnecessarily burden staff with measures in Phase I. In the future Phase II, we will use the Caregiving Difficulty Scale-Intellectual Disability (CDS-ID)54 and the Maslach Burnout Inventory (MBI).

Intervention Period/Measures: During Month 9, family members will play the FFAM Game with their loved one on an Android tablet. A relatively lengthy four-week time period was chosen to ensure that even very busy family members will find time to play the game. We expect the game to take 60 minutes to complete, but we will encourage family members to split up the game into two 30-minute sessions. The app will automatically capture data about how many questions/items were completed and the length of time to complete the game. In addition, after playing the FFAM Game, family members and PWD will be asked questions related to ease of use and satisfaction. During Month 10, PWD will play the RGB/Survey Says Game twice per week for four weeks. The game will be played on an Android tablet, which will be connected to a large screen TV. The activity will be facilitated by a researcher; however, each staff member will observe an RGB/Survey Says Game session at least once, so that they can provide feedback about the game. An RA (not the researcher facilitating game) will observe PWD with the MPES while they are taking part in the Survey Says Game. After each Survey Says Game session, PWD and Staff Members will be asked questions related to ease of use and satisfaction (e.g., did you find the game easy to use? Did you enjoy the game? Would you recommend it to others?) During this same time period, LTC staff members will use the MRM daily when working with PWD. Each staff member will be given an Android smartphone and they will be encouraged to briefly review information about PWD before interacting with and/or providing care to them. At the end of this time period, staff will be asked questions related to ease of use and satisfaction for the MRM (e.g., Did you find it easy to use? Would you recommend it to others? Did it help you provide better care?)

Treatment Fidelity/Process Measures: In the backend of the app, a variety of treatment fidelity/process measures will automatically be collected by the app, including dates/times each participant used the app, length of time for each session; number of buttons pressed in each activity, and dates/times of any crashes.

Post-Treatment/Distal Measures:

PWD: The DEMQOL and NPI-NH will be re-administered. Family Members: No post-treatment measures will be taken. LTC Staff Members: No post-treatment measures will be taken.

Please note that, since the purpose of Phase I is to demonstrate proof of concept and feasibility, and since the intervention period will be relatively brief, changes are not expected from baseline to post-treatment on longer-term measures (i.e., the DEMQOL and NPI-NH). These measures are being used in Phase I exclusively to obtain means and standard deviations to conduct a power analysis to ensure that a sufficiently sized sample is used in Phase II.

Analyses: The AAM App will be considered successful if the following results are found: (1) at least 85% of participants complete 85% of the FFAM Game; (2) mean completion time for the FFAM Game is 45-75 minutes; (3) at least 85% of family members and PWD are satisfied with the FFAM Game and find it easy to use; (4) for PWD, levels of positive engagement/affect are higher, and levels of negative engagement are lower, during the Survey Says Game, as compared to standard programming (based upon a paired sample t-test); with the proposed sample size, and using means and standard deviations from the previous studies by the PI, we will have a power of 93% to detect effects (alpha = .05; one-tailed test). (5) at least 85% of PWD and LTC staff members are satisfied with the Survey Says Game and find it easy to use; and (6) at least 85% of LTC staff members are satisfied with the My Resident Module and find it easy to use.

Eligibility criteria: Inclusion Criteria:

* must be 60+ years old
* must speak and read English
* must have a clinical diagnosis of dementia (of any type)
* must score at least eight on the Mini-Mental Status Examination (MMSE)

Exclusion Criteria:

-shows signs of rapid physical / cognitive decline over the past six months, as indicated by medical records

Primary outcomes:
measure: Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
measure: Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
measure: Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
measure: Change From Baseline to Treatment for Non-Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
measure: Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
Secondary outcomes:
measure: Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
timeFrame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
measure: Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
timeFrame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
measure: Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)
timeFrame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
measure: Satisfaction With the App
timeFrame: Treatment (Weeks 5-11)
Other outcomes:
Locations:
city: Winchester
country: United States
facility: Hopeful Aging
state: Massachusetts
Study officials:
affiliation: Hopeful Aging
name: Michael Skrajner, MA
role: PRINCIPAL_INVESTIGATOR
References: