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Functional AgingNCT03549078

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

A study testing Intervention in people with Functional Aging and Subjective Cognitive Concerns, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteUnited States
Study dates
1 Jan 2017to 14 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • Known neurological condition;
  • Severe psychiatric illness (e.g., current depression).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Davis

    Sacramento, California, 95816

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    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.

Study groups in NCT03549078
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Behavioral: Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline to immediately post-intervention and through 6 month follow up

  2. 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

    Measured: Change from baseline to immediately post-intervention and through 6 month follow up

Secondary outcomes (6)

  1. Beck Depression Inventory

    Measures depressive symptomatology

    Measured: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

  2. Beck Anxiety Inventory

    Measures anxiety symptomatology

    Measured: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

  3. List learning task

    measures learning and memory

    Measured: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

  4. Executive function task

    measures executive function

    Measured: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

  5. psychomotor speed task

    measures psychomotor speed function

    Measured: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

  6. 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.

    Measured: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2018
  2. Study start1 Jan 2017
  3. Primary completion14 Aug 2019
  4. Study completion14 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03549078
Sponsor's protocol ID
967764
Status last verified
Jun 2020
First submitted
15 May 2018
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29357670

  • 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.

    PubMed 28306147

  • 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.

    PubMed 22678947

  • 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.

    PubMed 18955724

  • 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.

    PubMed 26391766

  • 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.

    PubMed 34412558

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Functional Aging and Subjective Cognitive Concerns, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Everyday Compensation Questionnaire (time frame: Change from baseline to immediately post-intervention and through 6 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03549078, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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