Facilitating Optimal Routines in Aging (ForAging)

March 2, 2026 updated by: Juleen Rodakowski, University of Pittsburgh

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Juleen Rodakowski, OTD, MS, OTR/L
  • Phone Number: 412-383-6615
  • Email: jur17@pitt.edu

Study Contact Backup

  • Name: Josh Woolford, MPH
  • Phone Number: 412-383-6752
  • Email: jww49@pitt.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Strategy Training
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
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.
Active Comparator: Enhanced Usual Care
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in disability
Time Frame: Baseline to Month 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juleen Rodakowski, OTD,MS,OTR/L, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY19120012
  • R01AG056351 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will be included on The Global Alzheimer's Association Interactive Network (GAAIN). It is an operational online integrated research platform, which links scientists, shared data, and sophisticated analysis tools. Investigators can address scientific questions of unprecedented complexity by accessing massive shared data sets and can share their own data by joining our global network of Alzheimer's disease study centers.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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