AnxietyR/SNCT04626804
Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community
A study testing Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community in people with Anxiety and Depression, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Anxiety, Depression, Caregiver Burnout
- What is being tested?
- Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Anxiety, Depression, Caregiver Burnout, Anxiety Generalized
- Being tested
- Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community
- Keywords
- Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Telehealth
- Medical subject headings
- Anxiety Disorders, Depression, Caregiver Burden, Generalized Anxiety Disorder, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the CommunityOther
Also called System Usability Scale, Participant Willingness to Use, The Behavioral Intention Scale, Performance Expectancy
testing the usability, perceptions, and acceptability of R/S among dyads of older adults with early Alzheimer's disease and other related dementias
| Study group | Role | What they receive |
|---|---|---|
| 1 Test the usability, perceptions, and acceptability of R/S | Experimental | 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. Receives: Other: Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 4 months
Secondary outcomes (4)
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".
Measured: through study completion, an average of 4 months
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
Measured: through study completion, an average of 4 months
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.
Measured: through study completion, an average of 4 months
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
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start27 Oct 2020
- Primary completion16 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole R. Fowler, PhD, Indiana University
- Investigators
- Nicole R Fowler, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626804
- Sponsor's protocol ID
- 2006294326
- Acronym
- R/S
- Status last verified
- Feb 2023
- First submitted
- 3 Nov 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In future manuscripts, the authors will list contact information and state that the IPD is available upon request
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community
- ClinicalTrials.gov ID
- NCT04626804
- Acronym / sponsor ID
- R/S / 2006294326
- Conditions
- Anxiety, Depression, Caregiver Burnout, Anxiety Generalized
- Keywords
- Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single dyadic group focused on determining acceptance and feasibility of the in home computer monitor individually programmed for each dyadic needs
| Arm | Type | Receives |
|---|---|---|
| 1 Test the usability, perceptions, and acceptability of R/S | Experimental | Other: Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the CommunityDyads 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. |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the CommunityAlso: System Usability Scale, Participant Willingness to Use, The Behavioral Intention Scale, Performance Expectancytesting the usability, perceptions, and acceptability of R/S among dyads of older adults with early Alzheimer's disease and other related dementias | Other | 1 Test the usability, perceptions, and acceptability of R/S |
Primary outcome
Usability
Time frame: 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)
4 secondary outcomes
Acceptability
Time frame: through study completion, an average of 4 months
Intention of Use
Time frame: through study completion, an average of 4 months
Performance expectancy
Time frame: through study completion, an average of 4 months
Computer literacy
Time frame: through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: Yes. In future manuscripts, the authors will list contact information and state that the IPD is available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole R Fowler, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community in people with Anxiety and Depression, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.