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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT04118985
Collaborator
(none)
21
1
2
12.7
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive rehabilitation and health behavior change intervention
  • Behavioral: Self-implementation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 classesRandomized 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 (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Compensatory Training to Support Everyday Function and Adherence to Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease
Actual Study Start Date :
Oct 10, 2019
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Self-implementation

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
Self-implementation of cognitive rehabilitation and health behavior change recommendations

Experimental: Health-behavior intervention

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
Cognitive rehabilitation and health behavior change intervention in a group-based program intervention compared to self-implementation of techniques without these interventions

Outcome Measures

Primary Outcome Measures

  1. Everyday Compensation Questionnaire [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    self-report and informant report if an informant is available of compensatory strategy use; range 0-148 with higher scores indicating more compensatory use

  2. Lifestyle Activities Questionnaire [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    self-report of cognitive activities, range 13-65 with higher scores indicating more activity

  3. BrainHQ [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    Number of minutes on BrainHQ computer exercise program

  4. Physical Activities Questionnaire [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    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.

  5. Mindful Attention Awareness Scale [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    self-report of mindfulness, range of 11-66 with higher scores indicating more mindful daily experience

Secondary Outcome Measures

  1. Everyday Cognition [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    self-report of everyday functioning, range 39-156 with higher scores indicating more problems in daily functioning

  2. Quality of Life (in aging and cognitive health) [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    self-report of quality of life, range of 13-52 with higher scores indicating better quality of life

  3. Psychological well-being [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    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.

  4. Centers for Epidemiological Studies - Depression [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    self-report of symptoms of depression.Range 0-60 with higher scores indicating more depression

  5. Cognitive measure of memory [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    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

  6. cognitive measure of executive functioning [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    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

  7. cognitive measure of verbal fluency [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    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

  8. cognitive measure of visual scanning speed [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    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.

  9. cognitive measure of response inhibition [baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Scottsdale Arizona United States 85259

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Dona Locke, PhD, Mayo Clinic

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Dona E. Locke, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04118985
Other Study ID Numbers:
  • 19-006676
First Posted:
Oct 8, 2019
Last Update Posted:
Nov 17, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dona E. Locke, Principal Investigator, Mayo Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2020