R/S: Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community

Sponsor

Indiana University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04626804

Collaborator

(none)

Enrollment

Location

Arm

26.1

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression Caregiver Burnout Anxiety Generalized	Other: Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

single dyadic group focused on determining acceptance and feasibility of the in home computer monitor individually programmed for each dyadic needssingle dyadic group focused on determining acceptance and feasibility of the in home computer monitor individually programmed for each dyadic needs

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community

Actual Study Start Date :

Oct 27, 2020

Actual Primary Completion Date :

Dec 16, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Test the usability, perceptions, and acceptability of R/S 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.	Other: Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community testing the usability, perceptions, and acceptability of R/S among dyads of older adults with early Alzheimer's disease and other related dementias Other Names: System Usability Scale Participant Willingness to Use The Behavioral Intention Scale Performance Expectancy Computer Literacy

Arm

Intervention/Treatment

Experimental: 1 Test the usability, perceptions, and acceptability of R/S

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.

Other: Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community

testing the usability, perceptions, and acceptability of R/S among dyads of older adults with early Alzheimer's disease and other related dementias

Other Names:

System Usability Scale

Participant Willingness to Use

The Behavioral Intention Scale

Performance Expectancy

Computer Literacy

Outcome Measures

Primary Outcome Measures

Usability [through study completion, an average of 4 months]
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 [through study completion, an average of 4 months]
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 [through study completion, an average of 4 months]
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 [through study completion, an average of 4 months]
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 [through study completion, an average of 4 months]
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

Other Outcome Measures

Dementia Severity Scale [through study completion, an average of 4 month]
validated tool measuring dementia severity at specific intervals of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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