AgingNCT03262506
Evaluation of Adherence and Engagement in a Cognitive Training Program for Older Adults
A study testing Computerized cognitive training in people with Aging, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
There is evidence that computerized cognitive training can improve cognition in healthy older adults and in people at risk of developing dementia, although an effective model to implement the training in the daily life of people and to ensure engagement is missing. Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Computerized cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jun 2017to 30 Sep 2017
- 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 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be an associate of ASASTEL, or the spouse of an associate,
- To have access to the internet at home and proficiency on accessing and navigating the internet,
- Availability to be evaluated and followed by the professional team.
Who cannot join
- Any medical condition that precludes performing the computerized training exercises,
- Score below 27 points in the Mini Mental State Examination (MEEM),
- Moderated or advanced dementia.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
Rogério Panizzutti, MD, Phd, 5521999090498, rogerio@icb.ufrj.br
Aline D'Avila, MSc, 5531987778981, lininha_davila@yahoo.com.br
About this study
There is evidence that computerized cognitive training can improve cognition in healthy older adults and in people at risk of developing dementia, although an effective model to implement the training in the daily life of people and to ensure engagement is missing. This project studies the adherence, engagement and progress on computerized cognitive training exercises that were offered by the Association of Retirees from the Telecommunications (ASASTEL) to its associates. One hundred subjects in three different cities (Rio de Janeiro, Belo Horizonte and Brasilia) received licenses to perform the exercises on line and were followed by a team of psychologists. We will evaluate adherence, engagement and progress on the computerized cognitive training exercises of those subjects.
- Conditions
- Aging
- Being tested
- Computerized cognitive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive trainingOther
The cognitive training program consists of a set of computerized exercises designed to improve the speed and accuracy of auditory information processing while engaging neuromodulatory systems involved in attention and reward. These exercises continuously adjust the difficulty level to user performance to maintain an approximately 85% rate of correct responses. Trials with correct responses are rewarded with points and animations.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Not described Receives: Other: Computerized cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training adherence
Training adherence will be defined as a continuous variable (number of hours of training completed by the participant).
Measured: 1 year
Secondary outcomes (3)
Individual gains on the computerized exercises
The computerized cognitive training platform, called BrainHQ, provided by Posit Science Inc, provides the individual gains on the computerized exercises with training.
Measured: 1 year
Motivation with the computerized training exercise
Motivation will be assessed by quantitative (measured as a percentage of all stimulus sets available in the exercises of the BrainHq computerized cognitive training platform) and qualitative questionnaires (Adapted Ultrech Engagement Scale - UWES).
Measured: 1 year
Training adherence (dichotomic variable)
Additionally training adherence will be defined as a dichotomic variable (below or above 10 hours of training).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start7 Jun 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion30 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rogerio Panizzutti, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262506
- Sponsor's protocol ID
- ASASTEL study
- Status last verified
- Aug 2017
- First submitted
- 7 Jun 2017
- Last updated
- 25 Aug 2017
- 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 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adherence and Engagement in a Cognitive Training Program for Older Adults
- ClinicalTrials.gov ID
- NCT03262506
- Acronym / sponsor ID
- ASASTEL study
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 30 Sep 2017 (estimated)
- First posted
- 25 Aug 2017 (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.
There is evidence that computerized cognitive training can improve cognition in healthy older adults and in people at risk of developing dementia, although an effective model to implement the training in the daily life of people and to ensure engagement is missing. This project studies the adherence, engagement and progress on computerized cognitive training exercises that were offered by the Association of Retirees from the Telecommunications (ASASTEL) to its associates. One hundred subjects in three different cities (Rio de Janeiro, Belo Horizonte and Brasilia) received licenses to perform the exercises on line and were followed by a team of psychologists. We will evaluate adherence, engagement and progress on the computerized cognitive training exercises of those subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Other: Computerized cognitive training |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be an associate of ASASTEL, or the spouse of an associate,
- To have access to the internet at home and proficiency on accessing and navigating the internet,
- Availability to be evaluated and followed by the professional team.
Key exclusion criteria (3 listed)
- Any medical condition that precludes performing the computerized training exercises,
- Score below 27 points in the Mini Mental State Examination (MEEM),
- Moderated or advanced dementia.
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 |
|---|---|---|
| Computerized cognitive trainingThe cognitive training program consists of a set of computerized exercises designed to improve the speed and accuracy of auditory information processing while engaging neuromodulatory systems involved in attention and reward. These exercises continuously adjust the difficulty level to user performance to maintain an approximately 85% rate of correct responses. Trials with correct responses are rewarded with points and animations. | Other | Cognitive Training |
Primary outcome
Training adherence
Time frame: 1 year
Training adherence will be defined as a continuous variable (number of hours of training completed by the participant).
3 secondary outcomes
Individual gains on the computerized exercises
Time frame: 1 year
Motivation with the computerized training exercise
Time frame: 1 year
Training adherence (dichotomic variable)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive training in people with Aging, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Aug 2017. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training adherence (time frame: 1 year). 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 25 Aug 2017.