Facilitating Optimal Routines in Aging

NCT03913637 | Completed DMC

• 2 other identifiers: STUDY19120012R01AG056351
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Loss of cognitive abilities leading to Alzheimer's disease is progressive and destructive, leaving older adults disabled and unable to recall their past. The number of older adults with Alzheimer's disease is expected to triple by the year 2050, yet little research examines amyloid beta deposition, executive function, and progression of disability. This study will test the influence of a novel and promising non-pharmacological intervention, Strategy Training, on the progression of disability in a sample of 150 older adults with Mild Cognitive Impairment who have the option to complete a Positron Emission Tomography (PET) Imaging with Pittsburgh Compound B (PiB).

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Cognition; Disability; Non-pharmacological Intervention; Behavioral Intervention; Amyloid deposition

Outcome Measures

Primary Outcomes (1)

• Change in disability

  Disability will be measured with the Performance Assessment of Self-Care Skills (PASS) through standardized, criterion-referenced performance assessment of cognitively challenging daily activities (i.e., shopping, bill paying, checkbook balancing, bill mailing, telephone use, medication management, critical information retrieval, and small device repair). A trained and blinded assessor will provide instruction and then observe participants performing each task. If the participant demonstrates difficulty, the assessor provides cues to assist. Assessors will rate disability based on the number of cues needed by the participants to complete the tasks. A higher score indicates more cues provided to complete the tasks or disability. The number of cues required for each task will be combined for a total number of cues provided on all 8 tasks. The outcome will be reported with a mean number of cues provided (range 0-300).

  Baseline to Month 12

Study Arms (2)

Strategy Training

EXPERIMENTAL

In addition to receiving everything in Enhanced Usual Care, participants will engage in 10 sessions over 5 weeks with a trained research interventionist. Participants will describe activities they do, no longer do, or have never done using the cards from the Activity Card Sort as a guide. The therapist will ask the participants to use this information to identify and prioritize activity-based goals to address in the remaining sessions. These sessions will take place in a location of the participant's choice and will last approximately 1 hour.

Behavioral: Strategy Training

Enhanced Usual Care

ACTIVE COMPARATOR

Enhanced usual care will allow older adults to interact with services and support. All mental health treatment (e.g., medications that you may be taking) and psychotherapy (e.g. counseling or social services) will be documented and monitored. Furthermore, all participants assigned to Enhanced Usual Care will receive the same assessments as other participants. The close monitoring will track potential changes in symptoms (e.g., depressive symptoms), and participants will be referred to services as appropriate.

Other: Enhanced Usual Care

Interventions

Strategy Training BEHAVIORAL

Occupational therapists deliver Strategy Training to older adults virtually. Strategy training optimizes engagement in meaningful daily activities through generating self-selected goals, monitoring daily activities, scheduling activities, and problem-solving solutions to barriers experienced when engaging in activities.

Strategy Training

Enhanced Usual Care OTHER

In this comparison condition, usual care will be enhanced by connecting older adults with MCI to resources available to meet their needs, and notify appropriate physicians when required. Enhanced Usual Care provides a usual care comparison while providing the participants with close monitoring of changes in symptoms.

Enhanced Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Mild Cognitive Impairment
• Acknowledge difficulty with a daily activity
• Community dwelling

You may not qualify if:

• Pregnant
• Central Nervous System disorder (other than MCI)
• Substance disorder in past 5 years
• Lifetime history of bipolar disorder, schizophrenia, or deemed unsafe to proceed in the study (e.g., untreated Major Depressive Disorder)
• Severe medical condition that limits engagement in daily activities

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Amyloidosis

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Juleen Rodakowski, OTD,MS,OTR/L

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chair, Department of Occupational Therapy

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: July 31, 2019
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal.

Locations

US (1)