Nonrandomized Evaluation of a Multidimensional Behavioral Intervention

NCT ID: NCT03717597

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2021-12-10

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).

Conditions

Subjective Cognitive Concerns (SCC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• a diagnosis of subjective cognitive complaints (SCC)
• Age 65+
• English speaking
• Available informant to complete surveys
• Ambulatory

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Chan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis

Sacramento, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29357670 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28306147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22678947 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18955724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26391766 (View on PubMed)

Other Identifiers

1210286

Identifier Type: -

Identifier Source: org_study_id