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

Primary Purpose

Dementia, Alzheimer Disease, Dementia, Vascular

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SAFE at Home
Sponsored by
The Hearthstone Institute, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Participants who receive the intervention (all)

    Outcomes

    Primary Outcome Measures

    Menorah Park Engagement Scale
    The MPES is an observational scale that measures four types of engagement: Constructive Engagement, Passive Engagement, Distracted Engagement, and Non-Engagement / Apathy The MPES also measures Pleasure, defined as clearly observable smiling or laughing.
    Menorah Park Engagement Scale
    The MPES is an observational scale that measures four types of engagement: Constructive Engagement, Passive Engagement, Distracted Engagement, and Non-Engagement / Apathy The MPES also measures Pleasure, defined as clearly observable smiling or laughing.

    Secondary Outcome Measures

    Neuropsychiatric Inventory-Nursing Home (NPI-NH)
    The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency.
    Neuropsychiatric Inventory-Nursing Home (NPI-NH)
    The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency.
    Dementia-Related Quality of Life (DEMQOL)
    The DEMQOL measures quality of life, composed of 28 items. It also has a proxy versio
    Dementia-Related Quality of Life (DEMQOL)
    The DEMQOL measures quality of life, composed of 28 items. It also has a proxy versio

    Full Information

    First Posted
    August 10, 2022
    Last Updated
    August 23, 2022
    Sponsor
    The Hearthstone Institute, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05516134
    Brief Title
    All About Me: An Intervention to Ease the Transition to Long Term Care
    Acronym
    AAM
    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

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2023 (Anticipated)
    Study Completion Date
    May 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hearthstone Institute, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia, Alzheimer Disease, Dementia, Vascular, Dementia, Mixed, Dementia of Alzheimer Type

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    All participants will receive the intervention
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Participants who receive the intervention (all)
    Intervention Type
    Behavioral
    Intervention Name(s)
    SAFE at Home
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Menorah Park Engagement Scale
    Description
    The MPES is an observational scale that measures four types of engagement: Constructive Engagement, Passive Engagement, Distracted Engagement, and Non-Engagement / Apathy The MPES also measures Pleasure, defined as clearly observable smiling or laughing.
    Time Frame
    Baseline-that is week 1 thru week 4
    Title
    Menorah Park Engagement Scale
    Description
    The MPES is an observational scale that measures four types of engagement: Constructive Engagement, Passive Engagement, Distracted Engagement, and Non-Engagement / Apathy The MPES also measures Pleasure, defined as clearly observable smiling or laughing.
    Time Frame
    Treatment-that is week 5 thru 12
    Secondary Outcome Measure Information:
    Title
    Neuropsychiatric Inventory-Nursing Home (NPI-NH)
    Description
    The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency.
    Time Frame
    Baseline-that is week 1 thru week 4
    Title
    Neuropsychiatric Inventory-Nursing Home (NPI-NH)
    Description
    The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency.
    Time Frame
    Post-Treatment--that is week 12 thru week 13
    Title
    Dementia-Related Quality of Life (DEMQOL)
    Description
    The DEMQOL measures quality of life, composed of 28 items. It also has a proxy versio
    Time Frame
    Baseline-that is week 1 thru week 4
    Title
    Dementia-Related Quality of Life (DEMQOL)
    Description
    The DEMQOL measures quality of life, composed of 28 items. It also has a proxy versio
    Time Frame
    Post-Treatment--that is week 12 thru week 13

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Skrajner, MA
    Phone
    4404777881
    Email
    skrajner@thehearth.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Skrajner, MA
    Organizational Affiliation
    The Hearthstone Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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