Adherence, TreatmentDeepCareNCT06175299
Social Functions to Promote Home-based Cognitive Training
A study testing Adherence Promotion With Person-centered Technology (APPT) System with Social Functions in people with Adherence, Treatment and Social Isolation, run by Florida State University at 1 site in United States.
Trial summary
This study will examine whether among older adults social interaction functions in a home-based cognitive training program can better support adherence to training and reduce social isolation. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Adherence, Treatment, Social Isolation
- What is being tested?
- Adherence Promotion With Person-centered Technology (APPT) System with Social Functions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2023to 30 Jul 2024
- 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 65 to 90 years
- 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
- Severe motor impairment
- Not living in the Tallahassee area for the entire 6 month study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Evaluating the Social Functions to Promote the Adherence and Reduce Social Isolation in Home-based Cognitive Training
This study will examine whether among older adults social interaction functions in a home-based cognitive training program can better support adherence to training and reduce social isolation.
Read the detailed description
The goal of this project is to conduct a pilot study to test the feasibility of two new features, a chat function and a leaderboard function, to encourage social interactions and support adherence to cognitive training protocols (mental exercises delivered via a tablet) over a period of time (2 months), and uncover individual difference factors that can predict poor adherence in the future and social interactions in the game. Even effective cognitive interventions may fail if individuals do not adhere to them for an extended period. This project will compare cognitive training games with chat function and leaderboard in reducing social isolation and improving adherence to the training, compared to an external control group using a generic reminder system delivered via smartphone text messages to promote adherence. The ultimate goal, as effective technology-based interventions to improve cognition become available, is to help support their benefit for older adults by maximizing long-term adherence.
- Conditions
- Adherence, Treatment, Social Isolation
- Being tested
- Adherence Promotion With Person-centered Technology (APPT) System with Social Functions
- Keywords
- Cognition, Adherence, Social isolation
- Medical subject headings
- Treatment Adherence and Compliance, Social Isolation
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) System with Social FunctionsBehavioural
The system has seven games for cognitive training and two social interactions functions: a chat function and a leaderboard function.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training with Social Function | Experimental | To promote adherence and reduce social isolation, participants will be asked to use home-based cognitive training program on a tablet for 30 minutes per day for 5 days a week for 1 month, then use it freely for another month. The cognitive training program has a chat function and a leadership board to allow interaction between participants. Receives: Behavioral: Adherence Promotion With Person-centered Technology (APPT) System with Social Functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-Item Loneliness Scale
The Three-Item Loneliness Scale was developed by Hughes et al. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2394670/). The minimum value is 3. The maximum value is 9. Higher scores mean more loneliness.
Measured: Assessed at baseline and at the end of the 2-months of training
Secondary outcomes (5)
Adherence (session number)
Number of sessions over 2 months
Measured: 2 months
Adherence (session length)
Number of sessions reaching at least 80% of the assigned session duration over 2 months
Measured: 2 months
General Self-Efficacy (predictor of adherence)
The 10-item General Self-Efficacy Scale (GSE) was developed by Ralf Schwarzer \& Matthias Jerusalem (http://userpage.fu-berlin.de/~health/engscal.htm). The minimum value is 10. The minimum value is 40. Higher scores mean higher general self-efficacy.
Measured: Assessed at baseline, predicting adherence variables over 2 months
Perceived Training Efficacy (predictor of adherence)
The 7-item Cognitive Training Belief Scale (NICT scale) measures perceived usefulness of brain training. It was developed by Rabipour \& Davidson in 2015 (https://pubmed.ncbi.nlm.nih.gov/25591472/). The minimum value is 7. The maximum value is 49. High scores mean higher expectations of brain training efficacy.
Measured: Assessed at baseline
Self-Efficacy of Cognitive Training (predictor of adherence and training outcome)
The 12-item Self-Efficacy of Cognitive Training is a composite measure of self-efficacy of cognitive training based on the Health Belief Model. The minimum value is 12. The maximum value is 84. Higher scores mean lower confidence in computerized cognitive training.
Measured: Assessed at baseline and at the end of the 2-months of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start30 Sep 2023
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, TreatmentStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhe He, Florida State University
- Investigators
- Zhe He, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175299
- Sponsor's protocol ID
- FSU00004067
- Acronym
- DeepCare
- Status last verified
- Aug 2024
- First submitted
- 6 Dec 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Social Functions to Promote the Adherence and Reduce Social Isolation in Home-based Cognitive Training
- ClinicalTrials.gov ID
- NCT06175299
- Acronym / sponsor ID
- DeepCare / FSU00004067
- Conditions
- Adherence, Treatment, Social Isolation
- Keywords
- Cognition, Adherence, Social isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 18 Dec 2023 (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.
This study will examine whether among older adults social interaction functions in a home-based cognitive training program can better support adherence to training and reduce social isolation.
Detailed description
The goal of this project is to conduct a pilot study to test the feasibility of two new features, a chat function and a leaderboard function, to encourage social interactions and support adherence to cognitive training protocols (mental exercises delivered via a tablet) over a period of time (2 months), and uncover individual difference factors that can predict poor adherence in the future and social interactions in the game. Even effective cognitive interventions may fail if individuals do not adhere to them for an extended period. This project will compare cognitive training games with chat function and leaderboard in reducing social isolation and improving adherence to the training, compared to an external control group using a generic reminder system delivered via smartphone text messages to promote adherence. The ultimate goal, as effective technology-based interventions to improve cognition become available, is to help support their benefit for older adults by maximizing long-term adherence.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training with Social Function | Experimental | Behavioral: Adherence Promotion With Person-centered Technology (APPT) System with Social FunctionsTo promote adherence and reduce social isolation, participants will be asked to use home-based cognitive training program on a tablet for 30 minutes per day for 5 days a week for 1 month, then use it freely for another month. The cognitive training program has a chat function and a leadership board to allow interaction between participants. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years of age or older
- Normal or corrected to normal visual acuity
- Must pass a dementia screening.
Key exclusion criteria (4 listed)
- Parkinson's, Alzheimer's disease, or any other neurodegenerative disease
- Terminal illness
- Severe motor impairment
- Not living in the Tallahassee area for the entire 6 month study period
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 |
|---|---|---|
| Adherence Promotion With Person-centered Technology (APPT) System with Social FunctionsThe system has seven games for cognitive training and two social interactions functions: a chat function and a leaderboard function. | Behavioural | Cognitive Training with Social Function |
Primary outcome
Three-Item Loneliness Scale
Time frame: Assessed at baseline and at the end of the 2-months of training
The Three-Item Loneliness Scale was developed by Hughes et al. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2394670/). The minimum value is 3. The maximum value is 9. Higher scores mean more loneliness.
5 secondary outcomes
Adherence (session number)
Time frame: 2 months
Adherence (session length)
Time frame: 2 months
General Self-Efficacy (predictor of adherence)
Time frame: Assessed at baseline, predicting adherence variables over 2 months
Perceived Training Efficacy (predictor of adherence)
Time frame: Assessed at baseline
Self-Efficacy of Cognitive Training (predictor of adherence and training outcome)
Time frame: Assessed at baseline and at the end of the 2-months of training
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 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Zhe He, PhD principal investigator
Florida State 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 Adherence Promotion With Person-centered Technology (APPT) System with Social Functions in people with Adherence, Treatment and Social Isolation, 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 4 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 9 Aug 2024. 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?
Three-Item Loneliness Scale (time frame: Assessed at baseline and at the end of the 2-months of training). 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 9 Aug 2024.