CCT for Older Diabetic Adults

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709629
• Other study ID #: 0573-13-SMC
• Status: Completed
• Phase: N/A
• First received: February 25, 2016
• Last updated: April 18, 2018
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Diabetes
• Older Diabetic Persons Without Dementia

Intervention

Behavioral:
• Individualized and adaptive computerized cognitive training

• Active control

Locations

Country	Name	City	State
Israel	Joseph Sagol Neuroscience Center, Sheba Medical Center	Ramat-Gan	Australian National University

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Maccabi Healthcare Services, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks		9 weeks
Primary	Change from baseline in diabetes self management as reflected in the diabetes self-management questionnaire		9 weeks
Secondary	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)
Secondary	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)
Secondary	Change in meta-memory (subjective ratings of memory performance) as reflect on the Meta-Memory Questionnaire at 9 weeks		9 weeks
Secondary	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)
Secondary	Change in self-reported mood-related symptoms on the geriatric depression scale at 9 weeks		9 weeks
Secondary	Change in self-reported mood-related symptoms on the geriatric depression scale at 35 weeks		35 weeks (6 months follow up)
Secondary	Change in informant-reported care-giving burden on the Zarit Burden Interview at 9 weeks		9 weeks
Secondary	Change in informant-reported care-giving burden on the Zarit Burden Interview at 35 weeks		35 weeks (6 months follow up)
Secondary	Change in blood sugar levels on a blood glucose test at 35 weeks		35 weeks
Secondary	Change from baseline in global cognition as reflected in a composite cognitive score at 35 weeks		35 weeks
Secondary	Change from baseline in diabetes self-management as reflected in scores on the diabetes self-management questionnaire at 35 weeks		35 weeks