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Facilitating Optimal Routines in Aging (ForAging)

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strategy Training
Enhanced Usual Care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Cognition, Disability, Non-pharmacological Intervention, Behavioral Intervention, Amyloid deposition

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strategy Training

Enhanced Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 10, 2019
Last Updated
June 5, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03913637
Brief Title
Facilitating Optimal Routines in Aging
Acronym
ForAging
Official Title
Influence of Strategy Training on Disability for Older Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Cognition, Disability, Non-pharmacological Intervention, Behavioral Intervention, Amyloid deposition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strategy Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strategy Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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 Measure Information:
Title
Change in disability
Description
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).
Time Frame
Baseline to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juleen Rodakowski, OTD, MS, OTR/L
Phone
412-383-6615
Email
jur17@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Josh Woolford, MPH
Phone
412-383-6752
Email
jww49@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juleen Rodakowski, OTD,MS,OTR/L
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juleen Rodakowski
Phone
412-383-6615
Email
jur17@pitt.edu
First Name & Middle Initial & Last Name & Degree
Josh Woolford
Phone
412-383-6752
Email
jww49@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.gaain.org

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Facilitating Optimal Routines in Aging

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