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Facilitating Optimal Routines in Aging (ForAging)

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ClinicalTrials.gov Identifier: NCT03913637
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : October 25, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Juleen Rodakowski, University of Pittsburgh

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 completed a Positron Emission Tomography (PET) Imaging with Pittsburgh Compound B (PiB).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Strategy Training Other: Enhanced Usual Care Not Applicable

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, 6 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Strategy Training on Disability for Older Adults With Mild Cognitive Impairment
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Arm Intervention/treatment
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 in older adults' homes to enhance real-world application. 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.




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Mild Cognitive Impairment
  • Acknowledge difficulty with a daily activity
  • Community dwelling
  • Eligible to complete the MRI/PET

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913637


Contacts
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Contact: Juleen Rodakowski, OTD, MS, OTR/L 412-383-6615 jur17@pitt.edu
Contact: Josh Woolford, MPH 412-383-6752 jww49@pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Juleen Rodakowski    412-383-6615    jur17@pitt.edu   
Contact: Josh Woolford    412-383-6752    jww49@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Juleen Rodakowski, OTD,MS,OTR/L University of Pittsburgh

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Responsible Party: Juleen Rodakowski, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03913637     History of Changes
Other Study ID Numbers: PRO18110414
R01AG056351 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://www.gaain.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juleen Rodakowski, University of Pittsburgh:
Mild Cognitive Impairment
Cognition
Disability
Non-pharmacological Intervention
Behavioral Intervention
Amyloid deposition
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders