CCT for Older Diabetic Adults

NCT ID: NCT02709629

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-12-31

Brief 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. 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.

Conditions

Diabetes; Older Diabetic Persons Without Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Individualized and adaptive computerised cognitive training

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.

Group Type: EXPERIMENTAL

Individualized and adaptive computerized cognitive training

Intervention Type: BEHAVIORAL

Active control

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.

Group Type: ACTIVE_COMPARATOR

Active control

Intervention Type: BEHAVIORAL

Interventions

Individualized and adaptive computerized cognitive training

Intervention Type: BEHAVIORAL

Active control

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maccabi Healthcare Services, Israel

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Alex Bahar-Fuchs

Dr Alex Bahar-Fuchs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Joseph Sagol Neuroscience Center, Sheba Medical Center

Ramat Gan, Australian National University, Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 30868154 (View on PubMed)

Other Identifiers

0573-13-SMC

Identifier Type: -

Identifier Source: org_study_id