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

NCT05600465 | Recruiting

• 1 other identifier: 14683
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Chronic Conditions; Disability Physical

Keywords

functional limitation

Outcome Measures

Primary Outcomes (2)

• Change in Canadian Occupational Performance Measure (COPM) from baseline to 22 weeks

  self-report, self-rated activity performance

  baseline, 10 and 22 weeks.

• Change in Self-management Assessment Scale from baseline to 22 weeks

  self-report measuring effective self-management of chronic conditions. Scores range from 10 - 60, where higher is better.

  baseline, 10 and 22 weeks

Secondary Outcomes (2)

• Change in Behavioral Activation for Depression Scale from baseline to 22 weeks

  baseline, 10 and 22 weeks

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy managing chronic conditions from baseline to 22 weeks

  baseline, 10 and 22 weeks

Study Arms (2)

BA+OT intervention

EXPERIMENTAL

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.

Behavioral: Behavioral Activation + Occupational Therapy

Enhanced Usual Care

PLACEBO COMPARATOR

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.

Behavioral: Enhanced Usual Care

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.

BA+OT intervention

Enhanced Usual Care BEHAVIORAL

Fitbit, 1 hour training, handout on managing chronic conditions

Enhanced Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• Presbyterian Health Foundation: collaborator

Study Sites (1)

OU Health Internal Medicine- Schusterman Clinic

Tulsa, Oklahoma, 74135, United States

RECRUITING

MeSH Terms

Conditions

Multiple Chronic Conditions

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Tara Klinedinst

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Klinedinst, PhD

CONTACT

918 - 660 - 3283; tara-klinedinst@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: October 31, 2022
• Study Start: November 1, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)