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

Primary Purpose

Multiple Chronic Conditions, Disability Physical

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation + Occupational Therapy
Enhanced Usual Care
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Chronic Conditions focused on measuring functional limitation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OU Health Internal Medicine- Schusterman ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BA+OT intervention

Enhanced Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Canadian Occupational Performance Measure (COPM) from baseline to 22 weeks
self-report, self-rated activity performance
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.

Secondary Outcome Measures

Change in Behavioral Activation for Depression Scale from baseline to 22 weeks
self-report mood, depression. Scores range from 0 - 150, with higher scores indicating greater activation.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy managing chronic conditions from baseline to 22 weeks
self-report self-efficacy for managing chronic conditions. Range from 20 - 100, higher scores indicate greater self-efficacy. covers topics such as managing daily activity, managing medications, managing symptoms, managing social interactions, and managing emotions.

Full Information

First Posted
July 29, 2022
Last Updated
January 9, 2023
Sponsor
University of Oklahoma
Collaborators
Presbyterian Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05600465
Brief Title
Behavioral Activation + Occupational Therapy: An Innovative Intervention for Empowered Self-Management of Multiple Chronic Conditions
Acronym
BA+OT
Official Title
Behavioral Activation + Occupational Therapy: An Innovative Intervention for Empowered Self-Management of Multiple Chronic Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Presbyterian Health Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Americans with multiple chronic health conditions (MCC) are living longer lives, but there is a costly tradeoff. Approximately 81% of older adults in the U.S. have 2 or more health conditions (e.g., arthritis, hypertension, diabetes) that are long-term and cumulative. For these older adults, there are direct and positive relationships among age, higher number of chronic conditions, and higher incidence of disability and functional limitations. Because functional limitations interfere with daily health self-management activities (e.g., physical activity, managing medications, preparing healthy meals, and accessing health care), MCC ranks high among the disabling and costly conditions of aging. For example, older adults with MCC perform fewer health self-management activities and attend nearly double the number of outpatient healthcare visits as their peers with fewer or no MCC. Besides the high cost, difficulties with health self-management accelerate the downward spiral of restricted daily activity and accumulating chronic conditions which, in turn, increases rates of institutionalization and death by 5-fold. Among the emergent health problems of the 21st century, MCC stand out as one of the most challenging to treat, not only for the individual, but the larger health system as well. Pharmacological interventions for MCC (i.e., gero-protectors: targeting multiple diseases of aging with one drug) have focused on deterring the cascading disease development in this population but do not address limitations in daily health self-management deficits, a primary instigator of the downward spiral. Thus far, non-pharmacological interventions have primarily focused on health care organization, exercise, and self-management education, with null or mixed results. Studies have shown that simply providing self-management education is insufficient to facilitate health behavior changes in older age, and especially in the presence of functional limitations. Often overlooked is the importance of integrating the complicated health self-management activities into daily life routines. Indeed, research suggests that older adults are more likely to change behavior with interventions that assist with planning health-promoting daily activities. This is particularly true when older adults are also contending with functional limitations. Currently, there are no tested interventions designed to improve independence in health self-management activities in older adults with MCC and functional limitations. Behavioral activation (BA), an evidence-based behavior change intervention, can improve performance in daily activity, including health self-management behaviors. Combined with occupational therapy (OT), BA shows promise to improve participation in daily activities in cancer survivors, older adults with mild cognitive impairment, and individuals with post-stroke functional limitations. This innovative combination focuses on 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 (BA-OT). Due to the complexity of managing MCC in conjunction with functional limitations, BA-OT is the ideal approach. Paramount to our approach is the execution of daily health self-management activities in participant homes to ensure optimal real-world application. The Principal Investigator (PI), a BA-trained and licensed occupational therapist will deliver BA-OT over 10 weeks (1 session/wk). This is a pilot randomized controlled trial and feasibility study (Stage I) in which 40 older adults with MCC and functional imitations will be assigned to BA-OT or enhanced usual care comparison group. Specific Aim 1: Collect preliminary data to test the effect of BA-OT for improving independence in health self-management activities for older adults with MCC and functional limitation compared to enhanced usual care. Hypothesis: Older adults who receive BA-OT will demonstrate improved independence in health self-management activity as measured by the self-report Canadian Occupational Performance Measure and the Self-Management Assessment Scale. Rationale: Though similar interventions have shown promise in populations with different disease courses, BA-OT has not been tested in older adults with MCC and functional limitations. Specific Aim 2: Examine the feasibility of recruitment and conduct of the BA-OT intervention with older adults with MCC and functional limitation. Quantitative measures include recruitment rates, proportions of participants who initiate and complete the intervention, and adherence to study procedures as well as in-depth qualitative information to understand acceptability and suitability of the intervention. Rationale: Similar interventions have been successful, but not with older adults with MCC and functional limitations, a group that is difficult to treat. The investigators will answer the critical question "can it work?" and seek evidence to inform adaptation to a larger study. Combining these two approaches to address the persistent problem of health self-management in this population is novel and promising. This specific combination of active ingredients has potential to prevent functional limitations, prevent costly hospitalizations, and reduce disability in older adults with MCC. This project will inform the modification and testing of BA-OT with a larger sample, as well as generating preliminary data for a federally funded career development award.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chronic Conditions, Disability Physical
Keywords
functional limitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BA+OT intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation + Occupational Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Fitbit, 1 hour training, handout on managing chronic conditions
Primary Outcome Measure Information:
Title
Change in Canadian Occupational Performance Measure (COPM) from baseline to 22 weeks
Description
self-report, self-rated activity performance
Time Frame
baseline, 10 and 22 weeks.
Title
Change in Self-management Assessment Scale from baseline to 22 weeks
Description
self-report measuring effective self-management of chronic conditions. Scores range from 10 - 60, where higher is better.
Time Frame
baseline, 10 and 22 weeks
Secondary Outcome Measure Information:
Title
Change in Behavioral Activation for Depression Scale from baseline to 22 weeks
Description
self-report mood, depression. Scores range from 0 - 150, with higher scores indicating greater activation.
Time Frame
baseline, 10 and 22 weeks
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy managing chronic conditions from baseline to 22 weeks
Description
self-report self-efficacy for managing chronic conditions. Range from 20 - 100, higher scores indicate greater self-efficacy. covers topics such as managing daily activity, managing medications, managing symptoms, managing social interactions, and managing emotions.
Time Frame
baseline, 10 and 22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tara Klinedinst, PhD
Phone
918 - 660 - 3283
Email
tara-klinedinst@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Klinedinst
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
OU Health Internal Medicine- Schusterman Clinic
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Jelley, MD
Email
martina-jelley@ouhsc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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