AzTrials
AzTrials

Adherence, TreatmentNCT05016856

Smart Reminders to Promote Home-based Cognitive Training

A study testing Adherence Promotion With Person-centered Technology (APPT) System in people with Adherence, Treatment, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will examine whether among older adults an adaptive and personalized reminder system can better support adherence to home-based cognitive training over typical reminder systems. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Adherence, Treatment
What is being tested?
Adherence Promotion With Person-centered Technology (APPT) System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
1 siteUnited States
Study dates
7 Nov 2022to 1 Jan 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 65 years of age or older
  • normal or corrected to normal visual acuity
  • must pass a dementia screening

Who cannot join

  • Parkinson's, Alzheimer's disease, or any other neurodegenerative disease
  • terminal illness
  • blindness or deafness
  • severe motor impairment
  • not living in the Tallahassee area for the entire 6 month study period
  • unable to read at or above 6th grade level

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Department of Psychology, Florida State University

    Tallahassee, Florida, 32306-4301

Other trials in United States

About this study

Official title: Adherence Promotion With Person-centered Technology (APPT): Promoting Adherence to Cognitive Intervention

This study will examine whether among older adults an adaptive and personalized reminder system can better support adherence to home-based cognitive training over typical reminder systems.

Read the detailed description

Many cognitive training interventions are associated with poor adherence, and poor adherence is associated with fewer benefits. Further, poor adherence in cognitive intervention studies can interfere with answering fundamental questions regarding intervention efficacy. This study will compare the effects of non-adaptive and smart adherence support systems. Participants will be asked to engage in frequent home-based cognitive training on a computer tablet. In the smart adherence support condition, participants will receive adaptive and tailored reminders based on dynamic algorithms that deploy reminders in a way that considers participant preferences, days and times of previous successful engagement, the success of previous reminder attempts, and answers to brief questions contained within reminder prompts. Parameter weights for these variables will be adjusted dynamically over a 6-month assessment period to ensure that reminders are deployed when they are most likely to be acted upon. This study will investigate adherence to training sessions, multiple times each week for 6 months, representing a large challenge to adherence. Participants will be randomly assigned to one condition or another, and adherence at home will be monitored. This will be an Individually Randomized Group-Treatment Trial (IRGT).

Being tested
Adherence Promotion With Person-centered Technology (APPT) System, Standard Reminder System (Active Control)
Keywords
adherence, cognitive intervention, memory support, artificial intelligence, aging, technology
Medical subject headings
Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adherence Promotion With Person-centered Technology (APPT) SystemBehavioural

    A personalized and adaptive text message reminder system.

  • Standard Reminder System (Active Control)Behavioural

    A typical text message reminder system.

Study groups in NCT05016856
Study groupRoleWhat they receive
Reminder Only ConditionActive comparatorTo promote adherence, participants will receive generic reminders when home-based cognitive training has not been completed. This will be in the form of a text message to participants' smart phone.
Receives: Behavioral: Standard Reminder System (Active Control)
Smart Adherence Support ConditionExperimentalTo promote adherence, participants will receive reminders when home-based cognitive training has not been completed. This will be in the form of a text message to participants' smart phone. In this condition, participants will receive adaptive and tailored reminders based on dynamic algorithms that deploy reminders in a way that considers participant preferences, days and times of previous successful assessments, the success of previous reminder attempts, and answers to brief questions contained within reminder prompts. Parameter weights for these variables will be adjusted dynamically over a 6-month assessment period to ensure that reminders are deployed when they are most likely to be acted upon.
Receives: Behavioral: Adherence Promotion With Person-centered Technology (APPT) System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence (Session Number)

    Adherence was measured over the course of four months, in terms of the number of days participants engaged with the intervention.

    Measured: 4 months

  2. Adherence (Holidays)

    The number of adherence holidays (count) a participant experienced during the four-month period (Note: adherence holiday was defined as a period of one to five consecutive weeks of non-engagement that occurred after a participant had engaged with the intervention during a week and was followed by subsequent disengagement and re-engagement).

    Measured: 4 months

Secondary outcomes (7)
  1. Subjective Cognition (Predictor of Adherence)

    A 5-item scale measuring subjective cognitive declines. Scores range from 0-20. A higher score indicates a higher level of perceived cognitive dysfunction (Cronbach's α = .704).

    Measured: Assessed at baseline, predicting adherence variables over 4 months

  2. Self-Efficacy (Predictor of Adherence)

    A 10-item scale measuring perceived self-efficacy. Scores range from 10-40. A higher score indicates higher self-efficacy (Cronbach's α = .892).

    Measured: Assessed at baseline, predicting adherence variables over 4 months

  3. Technology Proficiency (Predictor of Adherence)

    A 16-item scale assessing proficiency in using mobile devices in 8 domains (Mobile Device Basics, Communication, Data and File Storage, Internet, Calendar, Entertainment, Privacy, Troubleshooting and Software Management). Total score ranges from 5-40. A higher score indicates a higher level of proficiency. Cronbach's α for the scale is .912 and Cronbach's αs for the subscales range from .616 to .976.

    Measured: Assessed at baseline, predicting adherence variables over 4 months

  4. Perceived Training Efficacy (Predictor of Adherence)

    This scale was adapted from the Perception of Video Game Training Effectiveness measure (Boot, W. R., Champion, M., Blakely, D. P., Wright, T., Souders, D. J., \& Charness, N. (2013). Video games as a means to reduce age-related cognitive decline: Attitudes, compliance, and effectiveness. Frontiers in Psychology, 4, Article 31. https://doi.org/10.3389/fpsyg.2013.00031). Participants rated their agreement, on a scale from 1 (strong disagreement) to 7 (strong agreement), that game training could improve seven abilities: vision, reaction time, memory, hand-eye coordination, reasoning ability, multitasking ability, and the performance of everyday tasks. Responses were averaged to produce a composite score ranging from 1 to 7, with higher scores indicating stronger belief in the efficacy of game training.

    Measured: Assessed at baseline, predicting adherence variables over 4 months

  5. Conscientiousness (Predictor of Adherence)

    Conscientiousness was assessed using the 12-item Conscientiousness domain of the Big Five Inventory-2 (BFI-2; Soto, C. J., \& John, O. P. (2017). The next Big Five Inventory (BFI-2): Developing and assessing a hierarchical model with 15 facets to enhance bandwidth, fidelity, and predictive power. Journal of Personality and Social Psychology, 113(1), 117-143. https://doi.org/10.1037/pspp0000096). The domain comprises three facets: Organization, Productiveness, and Responsibility. Participants rated how well each statement described them on a scale from 1 (disagree strongly) to 5 (agree strongly). After reverse-scoring the appropriate items, scores were computed as the mean of the 12 items, ranging from 1 to 5, with higher scores indicating greater conscientiousness. Internal consistency in the current sample was good (α = .862).

    Measured: Assessed at baseline, predicting adherence variables over 4 months

  6. Dementia Worry (Predictor of Adherence)

    A 12-item scale measuring dementia worry. Scores range from 12-60. A higher score indicates greater worry about dementia (Cronbach's α = .922).

    Measured: Assessed at baseline, predicting adherence variables over 4 months

  7. Busyness Subscale of the Martin and Park Environmental Demands (MPED) Questionnaire (Predictor of Adherence)

    Busyness was assessed using the seven-item Busyness subscale of the Martin and Park Environmental Demands (MPED) Questionnaire (Martin \& Park, 2003), which measures the density or pace of daily events (e.g., "How often are you so busy that you miss your regular meal times?"). Items were rated on a 5-point scale (1 = not busy at all or never; 5 = extremely busy or very often) and averaged, with higher scores indicating greater busyness.

    Measured: Assessed at baseline, predicting adherence variables over 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2021
  2. Study start7 Nov 2022
  3. Primary completion31 Oct 2024
  4. Study completion1 Jan 2025

Resources

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
Basic science
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05016856
Sponsor's protocol ID
STUDY00000064
Other IDs
R01AG064529
Status last verified
Oct 2026
First submitted
28 Jul 2021
Last updated
29 Oct 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified adherence data (time and date of intervention engagement) and scored individual difference measures (at the level of the individual) will be shared online.

Questions about this trial

What is this clinical trial studying?

A study testing Adherence Promotion With Person-centered Technology (APPT) System in people with Adherence, Treatment, run by Florida State 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?

The sponsor lists 3 inclusion and 6 exclusion criteria. 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 29 Oct 2026. 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?

Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adherence (Session Number) (time frame: 4 months). The study lists 2 primary outcomes in all. 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 29 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in