Clinical trial NCT04626804: Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community
Official title: Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Caregiver Burnout
Anxiety Generalized
Keywords: Alzheimer's disease
Dementia
Caregiving
Caregiver
Anxiety
Telehealth
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single dyadic group focused on determining acceptance and feasibility of the in home computer monitor individually programmed for each dyadic needs
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Usability
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
measure: Acceptability
timeFrame: through study completion, an average of 4 months
measure: Intention of Use
timeFrame: through study completion, an average of 4 months
measure: Performance expectancy
timeFrame: through study completion, an average of 4 months
measure: Computer literacy
timeFrame: through study completion, an average of 4 months
Other outcomes:
measure: Dementia Severity Scale
timeFrame: through study completion, an average of 4 month
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Nicole R Fowler, PhD
role: PRINCIPAL_INVESTIGATOR
References: