Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community (R/S)
Primary Purpose
Anxiety, Depression, Caregiver Burnout
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Telehealth
Eligibility Criteria
Patient Inclusion Criteria:
- achieve a Montreal Cognitive Assessment (MoCA) score of 6-17 (mild to moderate dementia)
- diagnosis of early Alzheimer's disease or related dementia or caregiver reports ADRD diagnosis (if community based recruitment)
- provide identification of a caregiver (living with or otherwise involved in the ongoing care of the person with ADRD)
- able to communicate in English
- able to provide informed consent
Patient Exclusion Criteria:
- lives in a nursing home or long term care facility or assisted living facility
- do not pass the MoCA with a score between 6-17
- unable to identify a caregiver
- is limited by severe arthritis or other condition in the use of his/her hands
Caregiver Inclusion Criteria:
- 21 years or older
- able to provide informed consent
- able to communicate in English
Caregiver Exclusion Criteria:
- under 21 years of age
- does not have access to a computer/device
- diagnosis of ADRD
- diagnosis of serious mental illness (i.e. schizophrenia)
Sites / Locations
- Indiana University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 Test the usability, perceptions, and acceptability of R/S
Arm Description
Dyads will use the R/S unit for 90 days, unless they request it to be removed prior to the end of the study. . The primary outcome is a caregiver-assessed measure usability.
Outcomes
Primary Outcome Measures
Usability
Satisfaction and use of the monitor and apps using the Usability Scale, a validated 10-item scale sithe items suchs as "learning to use the calendar function was quick for me", using a 5 point response scale (0= strongly disagree to 5= strongly agree)
Usability Scale, a validated 10-item scale (e.g. "Learning to use Calendar function was quick for me" using a 5-point response scale (0=strongly disagree to 5= strongly agree)
Secondary Outcome Measures
Acceptability
Acceptability satisfaction assessed by the VAS using a 3-item score: participants willingness to use "Assuming I have access to this technology today, I would use it". Participants' willingness to use in the future "I could imagine using this technology in the future". Perceived usefulness scale -Using this technology would be a relief for my daily care routine. "Altogether I think this technology would be useful in my daily care routine. Perecived ease of use scale- Interacting with the technology would not require a lot of mental effort "I think I would have the technology under control- Altogether I think the technology would be easy to use".
Intention of Use
The Behavioral Intention scale (e.g., "If it were up to you, to what extent would you want to use RememberStuff®?"). The 4-item scale uses a 7-point response scale from 0 (not at all) to 6 (a great deal). Behavioral intention is the canonical assessment for user acceptance of technology
Performance expectancy
7 items (e.g. "Thinking about using RememberStuff® in the past 90 days, to what extent do you find it useful in your daily life?") that use a 7-point response scale from 0 (not at all) to 6 (a great deal). 3-5 Semi-structured and open-ended questions about experience using the technology.
Computer literacy
The Computer Literacy Scale for Older Adults-12 (CLS-12)24 is a validated measure that assess frequency of 11 different computer related tasks including knowledge of symbols, terms related to computers and electronic devices, and internet use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04626804
Brief Title
Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community
Acronym
R/S
Official Title
Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Test the usability, perceptions and acceptability of a computer monitor for participant diagnosed with ADRD and their caregiver who will program the applications specifically for each individual to help them remember activities of daily living. Goal is to keep participants in their homes longer and delay the need for institutional care
Detailed Description
Dyads will use the R/S unit for 90 days, unless they request it to be removed prior to the end of the study. The research team (N. Fowler, PhD) will assess measures at baseline, 30 days, 60 days and 90 days. The primary outcome is a caregiver-assessed measure usability. Secondary measures include patient- assessed usability, and objective measures of frequency and type of use and computer literacy for both caregiver and the individual with ADRD22. Methods to collect user data (frequency, clicks, etc.) will be collected using tools developed in Aim 2. Desired outcome measures include (1) a mean score of >80 ("Good") on the ten-item System Usability Scale (SUS) modified by IU investigators to accommodate older adults23; (2) a 80 percent acceptability rate on the Behavioral Intention 3-item scale; and, (3) at least 70 percent of participants using R/S a minimum of weekly. SUS is a validated ten-item scale (e.g., "Learning to use RememberStuff® was quick for me") using a five-point response scale (strongly disagree to strongly agree). Acceptance will be assessed as the mean score on a 3-item Satisfaction scale (e.g., "Rate your satisfied with RememberStuff®?"). This scale was adapted by IU Investigators for health IT and uses a seven-point response scale from 0 (not at all) to 6 (a great deal). Satisfaction is one of the canonical assessments for user acceptance of technology. SUS and Satisfaction questionnaires will be researcher-administered by study staff either face-to-face in the participant's homes, or via telephone. The mean and standard deviation for the composite SUS, acceptability rate and weekly usage will be calculated to a 90% confidence interval. Other secondary measures are adapted from Holden et al and are guided by the UTAUT221. Mean caregiver scores on the measures will also be compared to mean scores of the patient measures to examine congruence in usability and acceptability within the dyad.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Caregiver Burnout, Anxiety Generalized
Keywords
Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Telehealth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single dyadic group focused on determining acceptance and feasibility of the in home computer monitor individually programmed for each dyadic needs
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Test the usability, perceptions, and acceptability of R/S
Arm Type
Experimental
Arm Description
Dyads will use the R/S unit for 90 days, unless they request it to be removed prior to the end of the study. . The primary outcome is a caregiver-assessed measure usability.
Intervention Type
Other
Intervention Name(s)
Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community
Other Intervention Name(s)
System Usability Scale, Participant Willingness to Use, The Behavioral Intention Scale, Performance Expectancy, Computer Literacy
Intervention Description
testing the usability, perceptions, and acceptability of R/S among dyads of older adults with early Alzheimer's disease and other related dementias
Primary Outcome Measure Information:
Title
Usability
Description
Satisfaction and use of the monitor and apps using the Usability Scale, a validated 10-item scale sithe items suchs as "learning to use the calendar function was quick for me", using a 5 point response scale (0= strongly disagree to 5= strongly agree)
Usability Scale, a validated 10-item scale (e.g. "Learning to use Calendar function was quick for me" using a 5-point response scale (0=strongly disagree to 5= strongly agree)
Time Frame
through study completion, an average of 4 months
Secondary Outcome Measure Information:
Title
Acceptability
Description
Acceptability satisfaction assessed by the VAS using a 3-item score: participants willingness to use "Assuming I have access to this technology today, I would use it". Participants' willingness to use in the future "I could imagine using this technology in the future". Perceived usefulness scale -Using this technology would be a relief for my daily care routine. "Altogether I think this technology would be useful in my daily care routine. Perecived ease of use scale- Interacting with the technology would not require a lot of mental effort "I think I would have the technology under control- Altogether I think the technology would be easy to use".
Time Frame
through study completion, an average of 4 months
Title
Intention of Use
Description
The Behavioral Intention scale (e.g., "If it were up to you, to what extent would you want to use RememberStuff®?"). The 4-item scale uses a 7-point response scale from 0 (not at all) to 6 (a great deal). Behavioral intention is the canonical assessment for user acceptance of technology
Time Frame
through study completion, an average of 4 months
Title
Performance expectancy
Description
7 items (e.g. "Thinking about using RememberStuff® in the past 90 days, to what extent do you find it useful in your daily life?") that use a 7-point response scale from 0 (not at all) to 6 (a great deal). 3-5 Semi-structured and open-ended questions about experience using the technology.
Time Frame
through study completion, an average of 4 months
Title
Computer literacy
Description
The Computer Literacy Scale for Older Adults-12 (CLS-12)24 is a validated measure that assess frequency of 11 different computer related tasks including knowledge of symbols, terms related to computers and electronic devices, and internet use
Time Frame
through study completion, an average of 4 months
Other Pre-specified Outcome Measures:
Title
Dementia Severity Scale
Description
validated tool measuring dementia severity at specific intervals of the study
Time Frame
through study completion, an average of 4 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Inclusion Criteria:
achieve a Montreal Cognitive Assessment (MoCA) score of 6-17 (mild to moderate dementia)
diagnosis of early Alzheimer's disease or related dementia or caregiver reports ADRD diagnosis (if community based recruitment)
provide identification of a caregiver (living with or otherwise involved in the ongoing care of the person with ADRD)
able to communicate in English
able to provide informed consent
Patient Exclusion Criteria:
lives in a nursing home or long term care facility or assisted living facility
do not pass the MoCA with a score between 6-17
unable to identify a caregiver
is limited by severe arthritis or other condition in the use of his/her hands
Caregiver Inclusion Criteria:
21 years or older
able to provide informed consent
able to communicate in English
Caregiver Exclusion Criteria:
under 21 years of age
does not have access to a computer/device
diagnosis of ADRD
diagnosis of serious mental illness (i.e. schizophrenia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole R Fowler, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46022
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
In future manuscripts, the authors will list contact information and state that the IPD is available upon request
IPD Sharing Time Frame
at the completion of the study, within 12 months
IPD Sharing Access Criteria
at the completion of the study, within 12 months
Learn more about this trial
Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community
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