- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05016856
Smart Reminders to Promote Home-based Cognitive Training
February 20, 2025 updated by: Walter Boot, Florida State University
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.
Study Overview
Status
Completed
Conditions
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).
Study Type
Interventional
Enrollment (Actual)
190
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306-4301
- Department of Psychology, Florida State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 65 years of age or older
- normal or corrected to normal visual acuity
- must pass a dementia screening
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Reminder Only Condition
To 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.
|
A typical text message reminder system.
|
|
Experimental: Smart Adherence Support Condition
To 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.
|
A personalized and adaptive text message reminder system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence (session number)
Time Frame: 6 months
|
Number of sessions over 6 months
|
6 months
|
|
Adherence (session length)
Time Frame: 6 months
|
Number of sessions reaching at least 80% of the assigned session duration over 6 months
|
6 months
|
|
Adherence (holidays)
Time Frame: 6 months
|
Number of extended gaps in between sessions over 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Cognition (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
|
A composite measure of objective cognitive ability
|
Assessed at baseline, predicting adherence variables over 6 months
|
|
Subjective Cognition (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
|
A composite measure of subjective cognitive deficit
|
Assessed at baseline, predicting adherence variables over 6 months
|
|
Self-Efficacy (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
|
A composite measure of self-efficacy (beliefs held about ability to complete tasks)
|
Assessed at baseline, predicting adherence variables over 6 months
|
|
Technology Proficiency (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
|
A composite measure of proficiency with technology
|
Assessed at baseline, predicting adherence variables over 6 months
|
|
Perceived Training Efficacy (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
|
A composite measure of belief in the the efficacy of cognitive training
|
Assessed at baseline, predicting adherence variables over 6 months
|
|
Personality (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
|
Measure of stable traits
|
Assessed at baseline, predicting adherence variables over 6 months
|
|
Dementia Worry (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
|
A composite measure of anxiety over cognitive decline
|
Assessed at baseline, predicting adherence variables over 6 months
|
|
Busyness Scale (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
|
Self-reported environmental demands of day-to-day life
|
Assessed at baseline, predicting adherence variables over 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interview
Time Frame: 6 months
|
Interview assessing experience in study
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2022
Primary Completion (Actual)
October 31, 2024
Study Completion (Actual)
January 1, 2025
Study Registration Dates
First Submitted
July 28, 2021
First Submitted That Met QC Criteria
August 17, 2021
First Posted (Actual)
August 23, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 20, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00000064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified adherence data (time and date of intervention engagement) and scored individual difference measures (at the level of the individual) will be shared online.
IPD Sharing Time Frame
Data will be made available one year after the publication of the first primary outcome paper or two years after the collection of the final participants' data, whichever come first.
IPD Sharing Access Criteria
Data will be freely available online.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adherence, Treatment
-
Universiti Putra MalaysiaCompletedMedication Adherence | Adherence, TreatmentPakistan
-
University of MichiganCompletedPhysical Inactivity | Adherence, TreatmentUnited States
-
University of California, DavisBill and Melinda Gates FoundationCompletedAdherence, TreatmentUnited States
-
Masarykova Nemocnice v Usti nad Labem, Krajska...Completed
-
Utah State UniversityCompletedTreatment AdherenceUnited States
-
Cerina TherapeuticsUniversity of Ulster; European CommissionRecruitingTreatment Adherence | Treatment Adherence and Compliance | Generalized AnxietyUnited Kingdom
-
University of GiessenKruse Johannes; Florian Blachutzik; Andreas RiethNot yet recruitingHeart Failure | Adherence, Medication | Adherence, Treatment
-
Arizona State UniversityCalm.com, Inc.Completed
-
National Tainan Junior College of NursingCompletedExploring the Effectiveness to Web-based Exercise Among Community-dwelling Adults With High Body FatExercise | Adherence, Treatment
-
Universidad Rey Juan CarlosUnknownCardiovascular Diseases | Physical Disability | Treatment Adherence | Satisfaction | Adherence, PatientSpain
Clinical Trials on Standard Reminder System (Active Control)
-
British Columbia Cancer AgencyCanadian Breast Cancer FoundationCompleted
-
Mahsa UniversityCompleted
-
Ohio State UniversityAetna FoundationCompleted
-
Asociación para Evitar la Ceguera en MéxicoNot yet recruitingDry Eye Syndromes | Meibomian Gland Dysfunction (Disorder)
-
Institut de Recherche pour le DeveloppementChiang Mai University; Expertise FranceCompletedHIV, Hepatitis B, Hepatitis C and Syphilis InfectionsThailand
-
Mayo ClinicNational Cancer Institute (NCI)CompletedPapillomavirus VaccinesUnited States
-
Hunter College of City University of New YorkNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Gilead SciencesCompletedHuman Immunodeficiency Virus (HIV)United States
-
University of AlbertaAlberta Health servicesCompletedKnowledge Translation | Sustainability of InnovationsCanada
-
Boehringer IngelheimCompleted
-
University of CalgaryAlberta Children's HospitalTerminatedCancer | Autologous Hematopoietic Stem Cell TransplantationCanada