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CCT for Older Diabetic Adults

Primary Purpose

Diabetes, Older Diabetic Persons Without Dementia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Individualized and adaptive computerized cognitive training
Active control
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Joseph Sagol Neuroscience Center, Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized and adaptive computerised cognitive training

Active control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks
Change from baseline in diabetes self management as reflected in the diabetes self-management questionnaire

Secondary Outcome Measures

Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 9 weeks
Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 35 weeks
Change in meta-memory (subjective ratings of memory performance) as reflect on the Meta-Memory Questionnaire at 9 weeks
Change in meta-memory (subjective ratings of memory performance), as reflect on the Meta-Memory Questionnaire, at 35 weeks
Change in self-reported mood-related symptoms on the geriatric depression scale at 9 weeks
Change in self-reported mood-related symptoms on the geriatric depression scale at 35 weeks
Change in informant-reported care-giving burden on the Zarit Burden Interview at 9 weeks
Change in informant-reported care-giving burden on the Zarit Burden Interview at 35 weeks
Change in blood sugar levels on a blood glucose test at 35 weeks
Change from baseline in global cognition as reflected in a composite cognitive score at 35 weeks
Change from baseline in diabetes self-management as reflected in scores on the diabetes self-management questionnaire at 35 weeks

Full Information

First Posted
February 25, 2016
Last Updated
April 18, 2018
Sponsor
Sheba Medical Center
Collaborators
Maccabi Healthcare Services, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT02709629
Brief Title
CCT for Older Diabetic Adults
Official Title
The Effects of Computerized Cognitive Training on Diabetic Elderly, Who Are at High Risk for Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Maccabi Healthcare Services, Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Older Diabetic Persons Without Dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized and adaptive computerised cognitive training
Arm Type
Experimental
Arm Description
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.
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individualized and adaptive computerized cognitive training
Intervention Type
Behavioral
Intervention Name(s)
Active control
Primary Outcome Measure Information:
Title
Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks
Time Frame
9 weeks
Title
Change from baseline in diabetes self management as reflected in the diabetes self-management questionnaire
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Change in meta-memory (subjective ratings of memory performance) as reflect on the Meta-Memory Questionnaire at 9 weeks
Time Frame
9 weeks
Title
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)
Title
Change in self-reported mood-related symptoms on the geriatric depression scale at 9 weeks
Time Frame
9 weeks
Title
Change in self-reported mood-related symptoms on the geriatric depression scale at 35 weeks
Time Frame
35 weeks (6 months follow up)
Title
Change in informant-reported care-giving burden on the Zarit Burden Interview at 9 weeks
Time Frame
9 weeks
Title
Change in informant-reported care-giving burden on the Zarit Burden Interview at 35 weeks
Time Frame
35 weeks (6 months follow up)
Title
Change in blood sugar levels on a blood glucose test at 35 weeks
Time Frame
35 weeks
Title
Change from baseline in global cognition as reflected in a composite cognitive score at 35 weeks
Time Frame
35 weeks
Title
Change from baseline in diabetes self-management as reflected in scores on the diabetes self-management questionnaire at 35 weeks
Time Frame
35 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Joseph Sagol Neuroscience Center, Sheba Medical Center
City
Ramat-Gan
State/Province
Australian National University
ZIP/Postal Code
0200
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30868154
Citation
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.
Results Reference
derived

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CCT for Older Diabetic Adults

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