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

Depression Clinical Trial

— R/S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626804
• Other study ID #: 2006294326
• Status: Completed
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Anxiety
• Anxiety Disorders
• Anxiety Generalized
• Caregiver Burden
• Caregiver Burnout
• Depression

Intervention

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

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dementia Severity Scale	validated tool measuring dementia severity at specific intervals of the study	through study completion, an average of 4 month
Primary	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)	through study completion, an average of 4 months
Secondary	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".	through study completion, an average of 4 months
Secondary	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	through study completion, an average of 4 months
Secondary	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.	through study completion, an average of 4 months
Secondary	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	through study completion, an average of 4 months