A Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia
Primary Purpose
Functional Aging, Subjective Cognitive Concerns, Compensation Strategies
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Functional Aging
Eligibility Criteria
Inclusion Criteria:
- A positive complaint in response to two questions ('Do you feel like your memory or other aspects of thinking are becoming worse?'; 'Does this worry you?')
- normal cognitive performance corrected for age and education on a global measure of cognitive functioning
- independent in all activities of daily living.
- English speaking;
- Available informant to complete surveys;
- Ambulatory
Exclusion Criteria:
- Known neurological condition;
- Severe psychiatric illness (e.g., current depression).
Sites / Locations
- University of California Davis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Participants will complete an initial assessment within 2 weeks prior to starting the course or during the first class. The course will include 10 sessions conducted on a weekly basis. Following completion of the course, participants will again complete another assessment during the last class or within 2 weeks of course completion. Participants may be invited to complete assessments at 3- and 6-months following course completion.
Outcomes
Primary Outcome Measures
Everyday Compensation Questionnaire
a 54-item self-report questionnaire that asks participants how often they engage in a variety of activities that help them stay cognitively and physically active.
Everyday Cognition
self-rated questionnaire of cognitively-based everyday abilities. The ECog comprises of 39 items on which the participant's current level of everyday functioning is compared to 10 years earlier. Items are rated on a four-point scale: 1= better or no change compared to 10 years earlier; 4= consistently much worse. Higher scores indicate greater functional limitations
Secondary Outcome Measures
Beck Depression Inventory
Measures depressive symptomatology
Beck Anxiety Inventory
Measures anxiety symptomatology
List learning task
measures learning and memory
Executive function task
measures executive function
psychomotor speed task
measures psychomotor speed function
GRIT
an 8-item questionnaire assessing consistency of interest and perseverance of effort on a five-point scale: 1 = not at all like me, 5 = very much like me.
Full Information
NCT ID
NCT03549078
First Posted
May 15, 2018
Last Updated
June 10, 2020
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03549078
Brief Title
A Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia
Official Title
A Randomized Evaluation of a Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
August 14, 2019 (Actual)
Study Completion Date
August 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
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
This intervention is designed to promote enhanced use of compensation strategies including calendar and task list use, and organization systems, as well as increased engagement with brain health activities including physical exercise, cognitive activities, and stress reduction.
Detailed Description
The purpose of this study is to test the feasibility and efficacy of a 10-week multi-dimensional intervention for older adults with subjective cognitive concerns (SCC). The goal of this intervention is to enhance compensation skills related to everyday executive and everyday memory functions through training in the systematic use of a calendar system, goal setting and task list system, and organizational strategies within the context of the individual's daily life. This multidimensional intervention program also targets engagement in healthy lifestyle activities (physical exercise, intellectual stimulation, positive emotional functioning) to further promote brain health and functional resilience. Importantly, both treatment components work synergistically as the use of compensation strategies assists in building healthy activities into daily routines (e.g., scheduling exercise into one's calendar and putting it on a task list).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Aging, Subjective Cognitive Concerns, Compensation Strategies, Brain Health Activities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will complete an initial assessment within 2 weeks prior to starting the course or during the first class. The course will include 10 sessions conducted on a weekly basis. Following completion of the course, participants will again complete another assessment during the last class or within 2 weeks of course completion. Participants may be invited to complete assessments at 3- and 6-months following course completion.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
Subjects will attend a series of 2 hour classes, once a week for 10 weeks. Topics discussed in group sessions will cover compensation strategies (e.g., calendar, goal setting and task lists, functional zones) and brain health behaviors (e.g., exercise, cognitive activity, stress reduction and mindfulness).
Subjects may be asked to wear an actigraphy monitor (that looks like a wrist watch) and/or heart rate sensor that is designed to collect information regarding physical activity.
Primary Outcome Measure Information:
Title
Everyday Compensation Questionnaire
Description
a 54-item self-report questionnaire that asks participants how often they engage in a variety of activities that help them stay cognitively and physically active.
Time Frame
Change from baseline to immediately post-intervention and through 6 month follow up
Title
Everyday Cognition
Description
self-rated questionnaire of cognitively-based everyday abilities. The ECog comprises of 39 items on which the participant's current level of everyday functioning is compared to 10 years earlier. Items are rated on a four-point scale: 1= better or no change compared to 10 years earlier; 4= consistently much worse. Higher scores indicate greater functional limitations
Time Frame
Change from baseline to immediately post-intervention and through 6 month follow up
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
Measures depressive symptomatology
Time Frame
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
Title
Beck Anxiety Inventory
Description
Measures anxiety symptomatology
Time Frame
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
Title
List learning task
Description
measures learning and memory
Time Frame
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
Title
Executive function task
Description
measures executive function
Time Frame
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
Title
psychomotor speed task
Description
measures psychomotor speed function
Time Frame
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
Title
GRIT
Description
an 8-item questionnaire assessing consistency of interest and perseverance of effort on a five-point scale: 1 = not at all like me, 5 = very much like me.
Time Frame
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A positive complaint in response to two questions ('Do you feel like your memory or other aspects of thinking are becoming worse?'; 'Does this worry you?')
normal cognitive performance corrected for age and education on a global measure of cognitive functioning
independent in all activities of daily living.
English speaking;
Available informant to complete surveys;
Ambulatory
Exclusion Criteria:
Known neurological condition;
Severe psychiatric illness (e.g., current depression).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine G Denny, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29357670
Citation
Tomaszewski Farias S, Schmitter-Edgecombe M, Weakley A, Harvey D, Denny KG, Barba C, Gravano JT, Giovannetti T, Willis S. Compensation Strategies in Older Adults: Association With Cognition and Everyday Function. Am J Alzheimers Dis Other Demen. 2018 May;33(3):184-191. doi: 10.1177/1533317517753361. Epub 2018 Jan 23.
Results Reference
background
PubMed Identifier
28306147
Citation
Farias ST, Lau K, Harvey D, Denny KG, Barba C, Mefford AN. Early Functional Limitations in Cognitively Normal Older Adults Predict Diagnostic Conversion to Mild Cognitive Impairment. J Am Geriatr Soc. 2017 Jun;65(6):1152-1158. doi: 10.1111/jgs.14835. Epub 2017 Mar 17.
Results Reference
background
PubMed Identifier
22678947
Citation
Greenaway MC, Duncan NL, Smith GE. The memory support system for mild cognitive impairment: randomized trial of a cognitive rehabilitation intervention. Int J Geriatr Psychiatry. 2013 Apr;28(4):402-9. doi: 10.1002/gps.3838. Epub 2012 Jun 7.
Results Reference
background
PubMed Identifier
18955724
Citation
Greenaway MC, Hanna SM, Lepore SW, Smith GE. A behavioral rehabilitation intervention for amnestic mild cognitive impairment. Am J Alzheimers Dis Other Demen. 2008 Oct-Nov;23(5):451-61. doi: 10.1177/1533317508320352.
Results Reference
background
PubMed Identifier
26391766
Citation
Lau KM, Parikh M, Harvey DJ, Huang CJ, Farias ST. Early Cognitively Based Functional Limitations Predict Loss of Independence in Instrumental Activities of Daily Living in Older Adults. J Int Neuropsychol Soc. 2015 Oct;21(9):688-98. doi: 10.1017/S1355617715000818. Epub 2015 Sep 22.
Results Reference
background
PubMed Identifier
34412558
Citation
Denny KG, Chan ML, Gravano J, Harvey D, Meyer OL, Huss O, Farias ST. A randomized control trial of a behavioral intervention for older adults with subjective cognitive complaints that combines cognitive rehabilitation strategies and lifestyle modifications. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2023 Jan;30(1):78-93. doi: 10.1080/13825585.2021.1965530. Epub 2021 Aug 19.
Results Reference
derived
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A Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia
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