Cognitive Training for Diabetes Self-Management

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to determine the effects of a comprehensive cognitive rehabilitation intervention on biological, cognitive, and diabetes self-management outcomes.

Detailed Description
-----------------
Aim 1: Test the efficacy of the MAPSS-DM intervention for improving cognitive function, A1C, and DM-SM. Based on preliminary data, the working hypothesis is that compared with the control group, persons who receive the intervention will have improved memory, executive function, and perceived cognitive function, greater use of cognitive strategies, and improved DM-SM immediately post-intervention and at three and six-months post-intervention. Aim 2: To explore changes in glycemic variability and their association with changes in cognitive function. The working hypothesis here is that MAPSS-DM participants will exhibit less glycemic variability post-intervention as compared with baseline and glycemic variability will mediate improvements in cognitive test performance.

Official Title
-----------------
Cognitive Training for Diabetes Self-Management

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Memory, Attention, and Problem Solving Skills for Diabetes
* Behavioral: Brain Games


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 50 years old or greater T2DM diagnosis for 2 years access to phone and Internet Score of ≥10 on the Perceived Deficits Questionnaire (PDQ) A1C of >7%. Exclusion Criteria: a diagnosis of dementia/head injury score of >5 on the Mini-Cog inability to speak English, and T1DM diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memory, Attention, and Problem Solving Skills for Diabetes<br>The intervention is composed of 4 small-group webinar classes and home-based individual online cognitive skills practice over 8 weeks. Classes 1 & 2 will focus on common cognitive problems in T2DM and strategies to improve cognitive skills. Classes 3 & 4 focus on lifestyle changes to support cognitive functioning and DM-SM skills. The computer-training component uses a model for cognitive training that adapts to the user through an integrated hierarchical structure. The BrainHQ website houses the interactive program that runs on standard web browsers. Each participant will be registered by the project staff using anonymous ID numbers that will allow unlimited access during the study. The website stores each session completed, and participants can start subsequent sessions wherever they stopped the last time logged on. The intervention group will be asked to practice 20 minutes, 7 days a week. | Behavioral: Memory, Attention, and Problem Solving Skills for Diabetes<br>* The intervention is composed of 4 small-group webinar classes and home-based individual online cognitive skills practice and will be held over 8 weeks. The classes will be taught by a GRA. Classes 1 & 2 will focus on common cognitive problems in T2DM and strategies to improve cognitive skills. Classes 3 & 4 focus on lifestyle changes to support cognitive functioning and DM-SM skills. Each online class will follow the same format: (1) introduction/revisiting content from the previous class; (2) review of progress on computer exercises; (3) practicing cognitive strategies in class; and (4) a weekly topic. The GRA will also prescribe exercises for the following weeks.<br>|
| Active Comparator: Brain Games Only<br>An active control group will be used. The differing variable between the two groups is the class sessions. Those randomized to the control group will only receive a link to the BrainHQ games site. A specific amount of practice will not be prescribed, but the frequency and duration of participant's practice will be obtained from BrainHQ. Participants will receive a weekly phone call to maintain connection to the study. Data collection will be on the same schedule as the intervention group. | Behavioral: Brain Games<br>* The computer-training component uses a model for cognitive training that adapts to the user through an integrated hierarchical structure. The BrainHQ website houses the interactive program that runs on standard web browsers. Participants will only need a computer, smart phone, or tablet with Internet access to securely log onto the website. Each participant will be registered by the project staff using anonymous ID numbers that will allow unlimited access during the study. The website stores each session completed, and participants can start subsequent sessions wherever they stopped the last time logged on.<br>* Other names: BrainHQ;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1C at week 22 | Measure of average glucose over 3 months | Baseline, and week 22 | 
| Change in diabetes self-management adherence at week 22 | Summary of Diabetes Self-Care Activities: 8 items; Brief assessment of diabetes related psychosocial self-efficacy. Responses are made on a 5-point scale (1 = strongly disagree to 4 = strongly agree) to items such as I believe that I am able to turn my diabetes goals into a workable plan. Cronbach's alphas range from 0.81 to 0.96. Higher scores indicate higher levels of self-management adherence. | Baseline, week 8, and week 22 | 
| Change in glucose variability at week 22 | Continuous Glucose Monitor (CGM): To be worn for 2 weeks at baseline and week 22; The following glucose composites will be calculated: (1) the overall mean, (2) the proportion of readings indicating hypoglycemia (%<70mg/dL), (3) the proportion of readings indicating hyperglycemia (% >160mg/dL), (4) the proportion of out of range readings (% either <70mg/dL or >160mg/dL) and (5) the SD of CGM glucose readings. | Baseline, week 8, and week 22 | 
| Change in attention, visual scanning and motor speed at week 22 | Symbol Digit Modalities Test: Participants are given a series of symbols and digits and instructed to verbalize the digit associated with each symbol. The number of correct responses in 90 sec constitutes the score, and higher scores reflect better cognitive function. | Baseline, week 8, and week 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived cognitive function at week 22 | PROMIS v2.0 - Cognitive Function: 32 items; assess patient-perceived cognitive deficits including the areas of mental acuity, concentration, verbal and nonverbal memory, and verbal fluency. Reliability has been measured at 0.94 and test-retest correlation at 0.83. Higher scores indicate more perceived difficulty with cognitive function. | Baseline, week 8, and week 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive function, glucose variability