- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03221452
Adaptation of a Cognitive Training Intervention for Diabetes Self-Management
July 14, 2017 updated by: University of Texas at Austin
The aims of this project are: (1) to refine an existing cognitive rehabilitation intervention and tailor it for persons with T2DM by using current literature and interview data from 10 participants with T2DM and (2) to conduct a feasibility study of the adapted intervention with 20 participants with T2DM.
The intervention consists of 8 weekly group educational sessions to teach compensatory cognitive strategies.
Participants will also use a web-based, game-like program to build on the didactic information and practice activities to improve cognitive health.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Type 2 diabetes mellitus (T2DM) increases the risk for cognitive impairment and doubles the rate of cognitive decline after diabetes is diagnosed.
In turn, the presence of cognitive dysfunction can make diabetes self-management more difficult.
Few interventions have attempted to focus on cognitive function in the context of diabetes and none, to date have tested an intervention to improve cognition in order to improve diabetes self-management.
Therefore the aims of this project are: (1) to refine an existing cognitive rehabilitation intervention and tailor it for persons with T2DM by using current literature and interview data from 10 participants with T2DM and (2) to conduct a feasibility study of the adapted intervention with 20 participants with T2DM.
The intervention consists of 8 weekly group educational sessions to teach compensatory cognitive strategies.
Additionally, participants will use a web-based, game-like program to build on the didactic information and practice activities to improve cognitive health.
The project will provide baseline data for further research on diabetes self-management in the context of cognitive dysfunction.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 40 to 70
- Have been diagnosed with type 2 diabetes for at least 2 years
- Score of at least 10 on the Perceived Deficits Questionnaire
- Read and write in English
- Have access to transportation and telephone and Internet services
Exclusion Criteria:
- limitations that preclude study activities
- have been diagnosed with dementia or disorders that can affect cognition such as depression
- type 1 diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
The intervention includes 4 every other week, 2-hour educational sessions to teach compensatory strategies along with skill development and training.
Educational sessions will include content on common cognitive problems experienced by people with T2DM and discussion of compensatory strategies to improve cognitive skills as well as content on behaviors and lifestyle strategies to maintain cognitive functioning.
Each participant will use the online training program (BrainHQ/Posit Science) for a minimum of 45 minutes 3 times a week and to record practice times and dates.
Tasks in the computer training are arranged so that as the user moves forward, the tasks become more challenging.
Each task is in a game-like format.
|
Classes will include: (1) information on diabetes self-management including glucose self-monitoring and medication management; (2) assessment of cognitive problems; (3) resources and barriers to self-management; and (4) lifestyle changes to maximize cognitive health.
Participants will also practice those skills with online computer games.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Diabetes Self-Care Activities
Time Frame: Baseline and immediately post-intervention
|
Summary of Diabetes Self-Care Activities Questionnaire; 18 items; Participants answer questions regarding how many days in the last week have they performed a certain aspect of diabetes self-management behaviors such as diet, smoking, and physical activity.
|
Baseline and immediately post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Self-Efficacy Scale
Time Frame: Baseline and immediately post-intervention
|
10 items; confidence in ability to influence outcomes.
Responses are made on a 4-point scale (1 = not true at all, 2= hardly true, 3 = moderately true, 4= exactly true) to items such as "I can always manage to solve difficult problems If I try hard enough."
|
Baseline and immediately post-intervention
|
Multifactorial Memory Questionnaire
Time Frame: Baseline and immediately post-intervention
|
57 items; assesses contentment with one's memory, subjective memory capability, and use of memory aids.
Participants rate their level of agreement with each item on a 5-point scale (strongly agree = 1, agree = 2, undecided = 3, disagree = 4, strongly disagree = 5) for the Contentment subscale; The Ability subscale asks participants to indicate the frequency with which each memory failure has occurred in the past 2 weeks on a 5-point scale (all the time = 1, often =2, sometimes = 3, rarely =4, never =5); The third subscale, Strategy, asks participants to rate the frequency of use of certain memory strategies on a 5-point scale (never =1, rarely =2, sometimes =3, often =4, all the time =5).
|
Baseline and immediately post-intervention
|
Change in executive function
Time Frame: Baseline and immediately post-intervention
|
Barkley Deficits in Executive Functioning Scale - Short Form Scale; 20 items assessing the frequency at which participants have exhibited certain behaviors in specific executive functioning areas over the past 6 months.
The areas include: self-management to time, self-organization/problem-solving, self-restraint, self-motivation, and self-regulation of emotion.
Items are measured using a 4-point Likert scale, ranging from never or rarely (1) to very often (4).
|
Baseline and immediately post-intervention
|
Center for Epidemiologic Studies Depression Scale
Time Frame: Baseline and immediately post-intervention
|
20 items; measurement of depressive symptoms.
Participants indicate responses on a 4-point item scale from rarely/none of the time to most/all of the time in 8 health dimensions: role limitations due to physical problems, social functioning, physical functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions.
|
Baseline and immediately post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heather E Cuevas, PhD, The University of Texas at Austin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2016
Primary Completion (Actual)
June 10, 2017
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
July 12, 2017
First Submitted That Met QC Criteria
July 14, 2017
First Posted (Actual)
July 18, 2017
Study Record Updates
Last Update Posted (Actual)
July 18, 2017
Last Update Submitted That Met QC Criteria
July 14, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-08-0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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