Facilitating Optimal Routines in Aging

Mild Cognitive Impairment Clinical Trial

— ForAging  

Official title:

Influence of Strategy Training on Disability for Older Adults With Mild Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03913637
• Other study ID #: STUDY19120012
• Secondary ID: R01AG056351
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: Juleen Rodakowski, OTD, MS, OTR/L
• Phone: 412-383-6615
• Email: jur17[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This trial will test the effect of Strategy Training compared to Enhanced Usual Care on change in disability among older adults with Mild Cognitive Impairment (MCI) and assess the extent to which Central Nervous System amyloid-beta deposition and neurocognitive function modify the relationship between Strategy Training and Enhanced Usual Care on change in disability. Assessments will be obtained at Baseline, 8 week short assessment, 6 and 12 months post intervention. Interventions, such as Strategy Training, focused on slowing emergence of disability despite underlying pathology may keep older adults as engaged in meaningful daily activities for as long as possible. This project tests a novel and promising non-pharmacological intervention and will inform our understanding of important effect modifiers- amyloid beta deposition and executive function- on change in performance of cognitively challenging daily activities. Enhancing our understanding of amyloid beta deposition, executive function, disability, and a promising non-pharmacological intervention could support aging for millions of older adults who, in the near future, will experience disability related to MCI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Strategy Training
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.

Other:
• Enhanced Usual Care
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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