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Adaptation of a Cognitive Training Intervention for Diabetes Self-Management

Primary Purpose

Cognitive Function Abnormal, Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Memory, Attention, and Problem Solving Skills for Diabetes
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cognitive Function Abnormal

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Intervention

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change in Diabetes Self-Care Activities
    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.

    Secondary Outcome Measures

    General Self-Efficacy Scale
    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."
    Multifactorial Memory Questionnaire
    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).
    Change in executive function
    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).
    Center for Epidemiologic Studies Depression Scale
    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.

    Full Information

    First Posted
    July 12, 2017
    Last Updated
    July 14, 2017
    Sponsor
    University of Texas at Austin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03221452
    Brief Title
    Adaptation of a Cognitive Training Intervention for Diabetes Self-Management
    Official Title
    Adaptation of a Cognitive Training Intervention for Diabetes Self-Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2, 2016 (Actual)
    Primary Completion Date
    June 10, 2017 (Actual)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Texas at Austin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Function Abnormal, Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single group study for intervention feasibility
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Memory, Attention, and Problem Solving Skills for Diabetes
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Diabetes Self-Care Activities
    Description
    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.
    Time Frame
    Baseline and immediately post-intervention
    Secondary Outcome Measure Information:
    Title
    General Self-Efficacy Scale
    Description
    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."
    Time Frame
    Baseline and immediately post-intervention
    Title
    Multifactorial Memory Questionnaire
    Description
    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).
    Time Frame
    Baseline and immediately post-intervention
    Title
    Change in executive function
    Description
    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).
    Time Frame
    Baseline and immediately post-intervention
    Title
    Center for Epidemiologic Studies Depression Scale
    Description
    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.
    Time Frame
    Baseline and immediately post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heather E Cuevas, PhD
    Organizational Affiliation
    The University of Texas at Austin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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