A Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia

June 10, 2020 updated by: University of California, Davis

A Randomized Evaluation of a Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • University of California Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Behavioral: Intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Everyday Compensation Questionnaire
Time Frame: Change from baseline to immediately post-intervention and through 6 month follow up
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.
Change from baseline to immediately post-intervention and through 6 month follow up
Everyday Cognition
Time Frame: Change from baseline to immediately post-intervention and through 6 month follow up
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
Change from baseline to immediately post-intervention and through 6 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory
Time Frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
Measures depressive symptomatology
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
Beck Anxiety Inventory
Time Frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
Measures anxiety symptomatology
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
List learning task
Time Frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
measures learning and memory
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
Executive function task
Time Frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
measures executive function
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
psychomotor speed task
Time Frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
measures psychomotor speed function
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
GRIT
Time Frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits
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.
Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Katherine G Denny, PhD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

August 14, 2019

Study Completion (Actual)

August 14, 2019

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 7, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 967764

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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