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

Part of paid clinical trials in Tulsa, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT05600465
Status
Recruiting
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Conditions

  • Disability Physical
  • Multiple Chronic Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Activation + Occupational Therapy — BEHAVIORAL
    In the BA-OT Approach, the PI will use an evidence-based 4-step process (Goal-Plan-Do-Check) to assist the older adults to develop strategies to plan and execute daily health self-management activities. BA-OT teaches older adults with MCC and functional limitations to 1) set achievable and meaningful activity goals, 2) engage in action planning that includes brainstorming strategies to overcome barriers, 3) evaluate the results after performing the activity, and 4) to modify the plan or choose a new goal, then generalize strategies to new problems. By assisting participants to develop daily routines and integrate safe health self-management activities into these routines, occupational therapists are providing strategies that support adaptation in the face of stressful situations.. Goal examples may include adapting and scheduling exercise plans, or exploring assistive devices and strategies for safe and healthy meal preparation.
  • Enhanced Usual Care — BEHAVIORAL
    Fitbit, 1 hour training, handout on managing chronic conditions

Study Details

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.

Key Dates

Start date
Nov 1, 2022
Status verified
Sep 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BA+OT intervention
    Following baseline assessment, the PI, a BA-trained, licensed occupational therapist will deliver a 10-session manualized program in the participants' homes to ensure optimal uptake of the active ingredients and integration into daily life routines. This intervention occurs over 10 weeks. The intervention manual will include educational materials for the 4-step approach, and worksheets for goal setting and developing daily routines. In the 1st BA-OT session, the PI will collect baseline assessments and use Canadian Occupational Performance Measure (COPM) data to facilitate goal setting. The top 5 participant-selected goals chosen will be the subject of the 4-step process in sessions 2 - 10. At least one goal must be related to improving physical activity routines; each participant will receive a Fitbit Charge 5 to self-monitor fitness progress. The unbiased evaluator will carry out follow-up assessments at 10 weeks and 22 weeks with participants in both conditions.
  • Placebo Comparator: Enhanced Usual Care
    The enhanced usual care control group will receive the same assessment battery, a Fitbit Charge 5 with 1 hour training, and a handout about living with chronic conditions.

Primary Outcome Measure

Change in Canadian Occupational Performance Measure (COPM) from baseline to 22 weeks [ Time Frame: baseline, 10 and 22 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OU Health Internal Medicine- Schusterman ClinicTulsaOklahoma74135
Martina Jelley, MD
[email protected]

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OU Health Internal Medicine- Schusterman Clinic· Tulsa, OK

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