NCT05600465 Behavioral Activation + Occupational Therapy: An Innovative Intervention for Empowered Self-Management of Multiple Chronic Conditions
| NCT ID | NCT05600465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oklahoma |
| Condition | Multiple Chronic Conditions |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-11-01 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * at least 2 chronic conditions * at least 1 functional limitation * intention to set at least 1 physical activity goal * live within 15 miles of University of Oklahoma (OU) Schusterman Center Exclusion Criteria: * life expectancy less than 6 months * progressive neurological condition * in active treatment for cancer * not English speaking * cognitive impairment * current or history of severe mental illness * in concurrent treatment with occupational and physical therapy
Contact & Investigator
Tara Klinedinst
PRINCIPAL INVESTIGATOR
University of Oklahoma
Frequently Asked Questions
Who can join the NCT05600465 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Multiple Chronic Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05600465 currently recruiting?
Yes, NCT05600465 is actively recruiting participants. Contact the research team at tara-klinedinst@ouhsc.edu for enrollment information.
Where is the NCT05600465 trial being conducted?
This trial is being conducted at Tulsa, United States.
Who is sponsoring the NCT05600465 clinical trial?
NCT05600465 is sponsored by University of Oklahoma. The principal investigator is Tara Klinedinst at University of Oklahoma. The trial plans to enroll 40 participants.