Nonrandomized Evaluation of a Multidimensional Behavioral Intervention

NCT03717597 | Completed

• 1 other identifier: 1210286
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Cognitive Concerns (SCC)

Outcome Measures

Primary Outcomes (2)

• Change in compensation use

  Measured using the 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.

  baseline and 6 months follow up

• Change in cognition

  Measured using the Everyday Cognition (ECog) scale, a 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.

  baseline and 6 months follow up

Secondary Outcomes (6)

• Beck Depression Inventory

  baseline, immediately after intervention, and 3 and 6 month follow-up visits

• Beck Anxiety Inventory

  baseline, immediately after intervention, and 3 and 6 month follow-up visits

• List learning task

  baseline, immediately after intervention, and 3 and 6 month follow-up visits

• Executive function task

  baseline, immediately after intervention, and 3 and 6 month follow-up visits

• Psychomotor Speed Task

  baseline, immediately after intervention, and 3 and 6 month follow-up visits

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Intervention 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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95816, United States

Location

Related Publications (5)

• 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.

  PMID: 29357670 BACKGROUND

• 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.

  PMID: 28306147 BACKGROUND

• 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.

  PMID: 22678947 BACKGROUND

• 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.

  PMID: 18955724 BACKGROUND

• 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.

  PMID: 26391766 BACKGROUND

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Michelle Chan, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: While subjects will be enrolled in multiple groups, all subjects will receive the same intervention and will complete the same study activities.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: October 24, 2018
• Study Start: April 26, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 10, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)