CCT for Older Diabetic Adults

NCT02709629 | Completed

• 1 other identifier: 0573-13-SMC
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Older Diabetic Persons Without Dementia

Outcome Measures

Primary Outcomes (2)

• Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks

  9 weeks

• Change from baseline in diabetes self management as reflected in the diabetes self-management questionnaire

  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

  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

  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

  9 weeks

• Change in meta-memory (subjective ratings of memory performance), as reflect on the Meta-Memory Questionnaire, at 35 weeks

  35 weeks (6 months follow up)

• Change in self-reported mood-related symptoms on the geriatric depression scale at 9 weeks

  9 weeks

Study Arms (2)

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.

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.

Behavioral: Active control

Interventions

Individualized and adaptive computerized cognitive training BEHAVIORAL

Individualized and adaptive computerised cognitive training

Active control BEHAVIORAL

Active control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead
• Maccabi Healthcare Services, Israel: collaborator

Study Sites (1)

Joseph Sagol Neuroscience Center, Sheba Medical Center

Ramat Gan, Australian National University, 0200, Israel

Location

Related Publications (1)

• 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.

  PMID: 30868154 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Alex Bahar-Fuchs

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 16, 2016
• Study Start: August 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

IL (1)