Clinical trial NCT03717597: Nonrandomized Evaluation of a Multidimensional Behavioral Intervention
Official title: A Nonrandomized Evaluation of a Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Cognitive Concerns (SCC)
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: While subjects will be enrolled in multiple groups, all subjects will receive the same intervention and will complete the same study activities.
Primary purpose: PREVENTION

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).

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)

Primary outcomes:
measure: Change in compensation use
timeFrame: baseline and 6 months follow up
measure: Change in cognition
timeFrame: baseline and 6 months follow up
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
measure: Beck Anxiety Inventory
timeFrame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
measure: List learning task
timeFrame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
measure: Executive function task
timeFrame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
measure: Psychomotor Speed Task
timeFrame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
measure: GRIT
timeFrame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Michelle Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.