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NCT05600465 · ClinicalTrials.gov registry record · NA

Behavioral Activation + Occupational Therapy: An Innovative Intervention for Empowered Self-Management of Multiple Chronic Conditions

A NA study of Disability Physical and Multiple Chronic Conditions, sponsored by University of Oklahoma.

Recruiting
Registry status
NA
Development phase
40
Enrollment target
1
Study location

NCT05600465 is a NA study of Disability Physical and Multiple Chronic Conditions that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 40 participants, below the 156-participant average among 16 other Disability Physical trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05600465, a NA study of Disability Physical and Multiple Chronic Conditions, is actively recruiting participants, sponsored by University of Oklahoma.

RECRUITING
Registry status
NA
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

Approximately 45% of older adults in the U.S. have 2 or more chronic health conditions (e.g., arthritis, hypertension, diabetes) in addition to functional limitations that prevent performance of health self-management activities. Self-management continues to be the gold standard for managing MCC, but functional limitations create difficulty with these activities (e.g., physical activity, symptom monitoring). Restricted self-management accelerates the downward spiral of disability and accumulating chronic conditions which, in turn, increases rates of institutionalization and death by 5-fold. Currently, there are no tested interventions designed to improve independence in health self-management activities in older adults with MCC and functional limitations. Research suggests that older adults are more likely to change behavior with interventions that assist with planning health-promoting daily activities, especially when contending with complex medical regimens and functional limitations. Combined with occupational therapy (OT), behavioral activation (BA) shows promise to improve health self-management in populations with chronic conditions and/or functional limitations. This innovative combination uses the goal setting, scheduling/monitoring activities, and problem-solving components of the BA approach as well as the environmental modification, activity adaptation, and focus on daily routines from OT practice. The investigators will test the effect of this combined approach in a Stage I, randomized controlled pilot feasibility study compared to enhanced usual care. The investigators will recruit 40 older adults with MCC and functional limitation and randomize 20 to the PI- delivered BA-OT protocol. This research will inform modification and larger-scale testing of this novel intervention and provide data for a federally funded career development award.

Interventions

  • BEHAVIORAL Enhanced Usual Care
  • BEHAVIORAL Behavioral Activation + Occupational Therapy

Study Locations (1)

Oklahoma

  • OU Health Internal Medicine- Schusterman Clinic - Tulsa

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2022-11-01
Est. Completion 2025-07
Phase NA

Sponsor

University of Oklahoma

358 total trials

What the Registry Record Tells You About NCT05600465

The ClinicalTrials.gov registry entry for NCT05600465 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 156-participant average among 16 other Disability Physical trials with a reported enrollment target (74% lower). The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Disability Physical appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Usual Care is the first listed.

NCT05600465 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.

Frequently Asked Questions

What is clinical trial NCT05600465 about?

NCT05600465 is a clinical study titled "Behavioral Activation + Occupational Therapy: An Innovative Intervention for Empowered Self-Management of Multiple Chronic Conditions". Approximately 45% of older adults in the U.S. have 2 or more chronic health conditions (e.g., arthritis, hypertension, diabetes) in addition to functional limitations that prevent performance of health self-management activities. Self-management continues to be the gold standard for managing MCC, bu...

What is the current status of trial NCT05600465?

This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2022-11-01. Estimated completion is 2025-07.

What conditions does trial NCT05600465 study?

This clinical trial studies the following conditions: Disability Physical, Multiple Chronic Conditions.

What interventions are being tested in trial NCT05600465?

The interventions under investigation include: Enhanced Usual Care (BEHAVIORAL), Behavioral Activation + Occupational Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT05600465?

This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05600465 being conducted?

This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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