DiabetesNCT02709629
CCT for Older Diabetic Adults
A study testing Individualized and adaptive computerized cognitive training in people with Diabetes and Older Diabetic Persons Without Dementia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The current study examines the efficiency of a home-based computerized cognitive training (CT) intervention targeting older adults with diabetes.The primary aim of the study is to evaluate the effects of CCT on cognitive and disease management in non-demented older diabetes adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes, Older Diabetic Persons Without Dementia
- What is being tested?
- Individualized and adaptive computerized cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 and over
- diagnosis of type 2 diabetes
- Health cover provided by Maccabi Health Services (MHS)
- Access to a home computer and internet connection
- Availability of a close relative/informant with regular and frequent contact with the participant (at least 10 hours per week), willing to respond to questionnaires at all time points.
- Fluency in Hebrew or English
- Living in the Tel-Aviv metropolitan area and surrounds
Who cannot join
- An existing diagnosis of dementia
- Prescription of dementia-related medication.
- Participation in a previous cognitive intervention study in the preceding year.
- Significant hearing/vision impairment likely to interfere with assessment and/or training
- Significant psychiatric/neurological or medical issues that may affect cognitive function.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Joseph Sagol Neuroscience Center, Sheba Medical Center
Ramat Gan, Australian National University, 0200
About this study
Official title: The Effects of Computerized Cognitive Training on Diabetic Elderly, Who Are at High Risk for Dementia
The current study examines the efficiency of a home-based computerized cognitive training (CT) intervention targeting older adults with diabetes.The primary aim of the study is to evaluate the effects of CCT on cognitive and disease management in non-demented older diabetes adults. Investigators will also evaluate the effect of the intervention on a range of secondary outcomes, including mood, caregiver burden, self-efficacy, and for a small sub-sample, on brain activity as reflected in changes in task-related blood-flow on fMRI.
Read the detailed description
Evidence suggests a link between diabetes-related processes and increased risk of cognitive decline and dementia in older adults. Optimal disease self-management may be key in the prevention of cognitive decline among older diabetic patients, but this may be compromised due to sub-clinical cognitive impairment.
In the current study, 120 community-dwelling, non-demented participants aged 65 and over, with a diagnosis of Type 2 diabetes will be randomly assigned either to an 8-week, home-based individually-tailored CCT program with adaptive difficulty level, and regular performance feedback, or to an 8-week, home-based active control (AC) condition, involving training on a generic CCT program with fixed difficulty level and without performance feedback. Both intervention groups also include a range of theory-informed behavior change techniques (BCTs), including self-efficacy management, self-monitoring and goal-setting in order to enhance treatment fidelity, and to maximize treatment compliance and adherence. In both groups, participants train approx. 30 min. per day, 3 times per-week for 8-weeks. Participants undergo a comprehensive evaluation of all outcomes at baseline, immediately after the intervention, and at a 6-month follow-up, with 1-week booster training completed 3 months from completion of the intervention.
- Conditions
- Diabetes, Older Diabetic Persons Without Dementia
- Being tested
- Individualized and adaptive computerized cognitive training, Active control
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized and adaptive computerized cognitive trainingBehavioural
Active controlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Individualized and adaptive computerised cognitive training | Experimental | Training in this group is individualized using a computer algorithm which assigns tasks (from a pool of 33 training tasks) on the basis of cognitive strengths and weaknesses as determined by the training program. In addition, task difficulty is adaptive and responsive to performance level. Participants are able to see feedback on their progress each training session in the form of a session-score. A range of behavior change techniques are used throughout the training period (delivered via scheduled monitoring phone calls, and email contact with participants) to support the compliance and adherence of participants. These include a range of motivation and confidence building strategies, based on a theoretical framework. Participants are required to train for approx. 30 min., 3 times per week, for 8 weeks. Receives: Behavioral: Individualized and adaptive computerized cognitive training |
| Active control | Active comparator | Training in this group is generic, and tasks (from the same pool of 33 training tasks) are randomly selected by the training program. In addition, task difficulty is fixed, such that irrespective of performance, each time a participant is presented with a given task, the level of difficulty returns to the basic level. Participants in this arm do not receive feedback on their progress at the end of each training session. The same protocol of behavior change techniques is used in this intervention arm.
Participants are also required to train for approx. 30 min., 3 times per week, for 8 weeks. Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks
Measured: 9 weeks
Change from baseline in diabetes self management as reflected in the diabetes self-management questionnaire
Measured: 9 weeks
Secondary outcomes (11)
Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 9 weeks
Measured: 9 weeks(immediately post-intervention)
Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 35 weeks
Measured: 35 weeks (6 months follow up)
Change in meta-memory (subjective ratings of memory performance) as reflect on the Meta-Memory Questionnaire at 9 weeks
Measured: 9 weeks
Change in meta-memory (subjective ratings of memory performance), as reflect on the Meta-Memory Questionnaire, at 35 weeks
Measured: 35 weeks (6 months follow up)
Change in self-reported mood-related symptoms on the geriatric depression scale at 9 weeks
Measured: 9 weeks
Change in self-reported mood-related symptoms on the geriatric depression scale at 35 weeks
Measured: 35 weeks (6 months follow up)
Change in informant-reported care-giving burden on the Zarit Burden Interview at 9 weeks
Measured: 9 weeks
Change in informant-reported care-giving burden on the Zarit Burden Interview at 35 weeks
Measured: 35 weeks (6 months follow up)
Change in blood sugar levels on a blood glucose test at 35 weeks
Measured: 35 weeks
Change from baseline in global cognition as reflected in a composite cognitive score at 35 weeks
Measured: 35 weeks
Change from baseline in diabetes self-management as reflected in scores on the diabetes self-management questionnaire at 35 weeks
Measured: 35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Principal investigator, Dr. Alex Bahar-Fuchs, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709629
- Sponsor's protocol ID
- 0573-13-SMC
- Status last verified
- Apr 2018
- First submitted
- 25 Feb 2016
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bahar-Fuchs A, Barendse MEA, Bloom R, Ravona-Springer R, Heymann A, Dabush H, Bar L, Slater-Barkan S, Rassovsky Y, Schnaider Beeri M. Computerized Cognitive Training for Older Adults at Higher Dementia Risk due to Diabetes: Findings From a Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Mar 9;75(4):747-754. doi: 10.1093/gerona/glz073.
PubMed 30868154
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Computerized Cognitive Training on Diabetic Elderly, Who Are at High Risk for Dementia
- ClinicalTrials.gov ID
- NCT02709629
- Acronym / sponsor ID
- 0573-13-SMC
- Conditions
- Diabetes, Older Diabetic Persons Without Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- Aug 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Mar 2016 (estimated)
- 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.
The current study examines the efficiency of a home-based computerized cognitive training (CT) intervention targeting older adults with diabetes.The primary aim of the study is to evaluate the effects of CCT on cognitive and disease management in non-demented older diabetes adults. Investigators will also evaluate the effect of the intervention on a range of secondary outcomes, including mood, caregiver burden, self-efficacy, and for a small sub-sample, on brain activity as reflected in changes in task-related blood-flow on fMRI.
Detailed description
Evidence suggests a link between diabetes-related processes and increased risk of cognitive decline and dementia in older adults. Optimal disease self-management may be key in the prevention of cognitive decline among older diabetic patients, but this may be compromised due to sub-clinical cognitive impairment.
In the current study, 120 community-dwelling, non-demented participants aged 65 and over, with a diagnosis of Type 2 diabetes will be randomly assigned either to an 8-week, home-based individually-tailored CCT program with adaptive difficulty level, and regular performance feedback, or to an 8-week, home-based active control (AC) condition, involving training on a generic CCT program with fixed difficulty level and without performance feedback. Both intervention groups also include a range of theory-informed behavior change techniques (BCTs), including self-efficacy management, self-monitoring and goal-setting in order to enhance treatment fidelity, and to maximize treatment compliance and adherence. In both groups, participants train approx. 30 min. per day, 3 times per-week for 8-weeks. Participants undergo a comprehensive evaluation of all outcomes at baseline, immediately after the intervention, and at a 6-month follow-up, with 1-week booster training completed 3 months from completion of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized and adaptive computerised cognitive training | Experimental | Behavioral: Individualized and adaptive computerized cognitive trainingTraining in this group is individualized using a computer algorithm which assigns tasks (from a pool of 33 training tasks) on the basis of cognitive strengths and weaknesses as determined by the training program. In addition, task difficulty is adaptive and responsive to performance level. Participants are able to see feedback on their progress each training session in the form of a session-score. A range of behavior change techniques are used throughout the training period (delivered via scheduled monitoring phone calls, and email contact with participants) to support the compliance and adherence of participants. These include a range of motivation and confidence building strategies, based on a theoretical framework. Participants are required to train for approx. 30 min., 3 times per week, for 8 weeks. |
| Active control | Active comparator | Behavioral: Active controlTraining in this group is generic, and tasks (from the same pool of 33 training tasks) are randomly selected by the training program. In addition, task difficulty is fixed, such that irrespective of performance, each time a participant is presented with a given task, the level of difficulty returns to the basic level. Participants in this arm do not receive feedback on their progress at the end of each training session. The same protocol of behavior change techniques is used in this intervention arm. Participants are also required to train for approx. 30 min., 3 times per week, for 8 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65 and over
- diagnosis of type 2 diabetes
- Health cover provided by Maccabi Health Services (MHS)
- Access to a home computer and internet connection
- Availability of a close relative/informant with regular and frequent contact with the participant (at least 10 hours per week), willing to respond to questionnaires at all time points.
Key exclusion criteria (5 listed)
- An existing diagnosis of dementia
- Prescription of dementia-related medication.
- Participation in a previous cognitive intervention study in the preceding year.
- Significant hearing/vision impairment likely to interfere with assessment and/or training
- Significant psychiatric/neurological or medical issues that may affect cognitive function.
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 |
|---|---|---|
| Individualized and adaptive computerized cognitive training | Behavioural | Individualized and adaptive computerised cognitive training |
| Active control | Behavioural | Active control |
Primary outcome
Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks
Time frame: 9 weeks
Change from baseline in diabetes self management as reflected in the diabetes self-management questionnaire
Time frame: 9 weeks
11 secondary outcomes
Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 9 weeks
Time frame: 9 weeks(immediately post-intervention)
Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 35 weeks
Time frame: 35 weeks (6 months follow up)
Change in meta-memory (subjective ratings of memory performance) as reflect on the Meta-Memory Questionnaire at 9 weeks
Time frame: 9 weeks
Change in meta-memory (subjective ratings of memory performance), as reflect on the Meta-Memory Questionnaire, at 35 weeks
Time frame: 35 weeks (6 months follow up)
Change in self-reported mood-related symptoms on the geriatric depression scale at 9 weeks
Time frame: 9 weeks
Change in self-reported mood-related symptoms on the geriatric depression scale at 35 weeks
Time frame: 35 weeks (6 months follow up)
Change in informant-reported care-giving burden on the Zarit Burden Interview at 9 weeks
Time frame: 9 weeks
Change in informant-reported care-giving burden on the Zarit Burden Interview at 35 weeks
Time frame: 35 weeks (6 months follow up)
Change in blood sugar levels on a blood glucose test at 35 weeks
Time frame: 35 weeks
Change from baseline in global cognition as reflected in a composite cognitive score at 35 weeks
Time frame: 35 weeks
Change from baseline in diabetes self-management as reflected in scores on the diabetes self-management questionnaire at 35 weeks
Time frame: 35 weeks
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 19 Apr 2018.
- Derived from this study: PubMed 30868154Bahar-Fuchs A, Barendse MEA, Bloom R, Ravona-Springer R, Heymann A, Dabush H, Bar L, Slater-Barkan S, Rassovsky Y, Schnaider Beeri M. Computerized Cognitive Training for Older Adults at Higher Dementia Risk due to Diabetes: Findings From a Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Mar 9;75(4):747-754. doi: 10.1093/gerona/glz073.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized and adaptive computerized cognitive training in people with Diabetes and Older Diabetic Persons Without Dementia, run by Sheba Medical Center at 1 site in Israel.
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 7 inclusion and 5 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 19 Apr 2018. 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 Israel. 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?
Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks (time frame: 9 weeks). 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?
On the ClinicalTrials.gov record for NCT02709629, which also lists 1 linked publication.
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 19 Apr 2018.