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
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Behavioral: Strategy Training Other: Enhanced Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
- 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).
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
|Contact: Juleen Rodakowski, OTD, MS, OTR/Lfirstname.lastname@example.org|
|Contact: Josh Woolford, MPHemail@example.com|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15260|
|Contact: Juleen Rodakowski 412-383-6615 firstname.lastname@example.org|
|Contact: Josh Woolford 412-383-6752 email@example.com|
|Principal Investigator:||Juleen Rodakowski, OTD,MS,OTR/L||University of Pittsburgh|