Compensatory Training to Support Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The Researchers are trying to better understand if behavioral interventions can help improve memory compensation and engagement in healthy lifestyle behaviors in those with memory concerns but normal mental status exam.

Official Title
-----------------
Compensatory Training to Support Everyday Function and Adherence to Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease

Conditions
-----------------
Cognitive Symptom, Pre Senile Dementia, Alzheimer Disease

Intervention / Treatment
-----------------
* Behavioral: Cognitive rehabilitation and health behavior change intervention
* Behavioral: Self-implementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 50 or older A positive complaint or concern in response to two questions ('Do you feel like your memory or other aspects of thinking are becoming worse?' and 'Does this worry you?') Normal cognitive performance on the Montreal Cognitive Assessment (adjusted for age and education) Self-reported independent function in daily life as measure by the Lawson IADL scale (IADL=8) English speaking Approval letter from a physician (due to the exercise component) Exclusion Criteria: Known neurological disorder with potential cognitive symptoms (a diagnosis of Parkinson's disease, epilepsy, a history of significant TBI, etc.) Uncontrolled moderate or severe depression (e.g., CES-D > 21).

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized to one of 1 arms: 1) provided recommendations and materials without coaching for implementation 2) provided recommendations and materials with 10 coaching classes
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-implementation<br>Individuals randomized to this group will be given all the materials about cognitive compensations techniques and brain health behavior guidelines and encouraged to implement those on their own. | Behavioral: Self-implementation<br>* Self-implementation of cognitive rehabilitation and health behavior change recommendations<br>|
| Experimental: Health-behavior intervention<br>Individuals randomized to this group will attend 10 weekly classes designed to provide information about cognitive compensation techniques and brain health behaviors as well as interventional support to implement those recommendations with homework and follow-up classes. | Behavioral: Cognitive rehabilitation and health behavior change intervention<br>* Cognitive rehabilitation and health behavior change intervention in a group-based program intervention compared to self-implementation of techniques without these interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Everyday Compensation Questionnaire | self-report and informant report if an informant is available of compensatory strategy use; range 0-148 with higher scores indicating more compensatory use | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| Lifestyle Activities Questionnaire | self-report of cognitive activities, range 13-65 with higher scores indicating more activity | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| BrainHQ | Number of minutes on BrainHQ computer exercise program | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| Physical Activities Questionnaire | self-report of physical activity; scores include number of days per week across 7 activity types and number of minutes in each activity when completed. | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| Mindful Attention Awareness Scale | self-report of mindfulness, range of 11-66 with higher scores indicating more mindful daily experience | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Everyday Cognition | self-report of everyday functioning, range 39-156 with higher scores indicating more problems in daily functioning | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| Quality of Life (in aging and cognitive health) | self-report of quality of life, range of 13-52 with higher scores indicating better quality of life | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| Psychological well-being | self-report of psychological well-being/happiness; there is a total score plus subscales of autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, self-acceptance. Each subscale has 9 items for a total of 54 items. Total scores range from 54-324 with higher scores indicating higher psychological well being. Each subscale ranges from 9-54 with higher scores indicating greater well-being on that construct. | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| Centers for Epidemiological Studies - Depression | self-report of symptoms of depression.Range 0-60 with higher scores indicating more depression | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| Cognitive measure of memory | Hopkins Verbal Memory test. Staff administered standardized verbal memory task. Scores include total words recalled and total recalled after a delay with higher scores indicating greater recall | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| cognitive measure of executive functioning | Trailmaking test; Staff administered standardized measure of attention and executive functioning. Scores include time to complete the task (with higher scores being slower) and number of errors | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| cognitive measure of verbal fluency | Controlled Oral Word Association Test; Staff administered standardized measure of speed and verbal fluency. Score is number of items in one minute with higher scores indicating better functioning | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| cognitive measure of visual scanning speed | Symbol Digit Modalities Test; Staff administered standardize measure of speed and visual scanning. Scores indicate number of items completed in the time frame with higher scores indicating better functioning. | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 
| cognitive measure of response inhibition | Stroop Color Word Test; Staff administered standardized measure of speed and response inhibition. Scores indicate number of items completed in the time limit with higher scores indicating better functioning | baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subjective cognitive complaint