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NCT Number: NCT02709629

CCT for Older Diabetic Adults

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Older Diabetic Persons Without Dementia

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joseph Sagol Neuroscience Center, Sheba Medical Center

Ramat Gan, Australian National University, 0200, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized and adaptive computerized cognitive training

Behavioral

Active Control

Behavioral

Primary outcomes

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

    Time frame: 9 weeks

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

    Time frame: 9 weeks

Secondary outcomes

  1. 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)

  2. 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)

  3. Change in meta-memory (subjective ratings of memory performance) as reflect on the Meta-Memory Questionnaire at 9 weeks

    Time frame: 9 weeks

  4. 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)

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

    Time frame: 9 weeks

  6. Change in self-reported mood-related symptoms on the geriatric depression scale at 35 weeks

    Time frame: 35 weeks (6 months follow up)

  7. Change in informant-reported care-giving burden on the Zarit Burden Interview at 9 weeks

    Time frame: 9 weeks

  8. Change in informant-reported care-giving burden on the Zarit Burden Interview at 35 weeks

    Time frame: 35 weeks (6 months follow up)

  9. Change in blood sugar levels on a blood glucose test at 35 weeks

    Time frame: 35 weeks

  10. Change from baseline in global cognition as reflected in a composite cognitive score at 35 weeks

    Time frame: 35 weeks

  11. Change from baseline in diabetes self-management as reflected in scores on the diabetes self-management questionnaire at 35 weeks

    Time frame: 35 weeks

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Maccabi Healthcare Services, Israel

Registry information

Official study title

The Effects of Computerized Cognitive Training on Diabetic Elderly, Who Are at High Risk for Dementia

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2016
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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