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Behavioral Activation and Occupational Therapy for Multiple Chronic Conditions (BA+OT Trial)

N/A
Recruiting
Led By Tara Klinedinst
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 10 and 22 weeks
Awards & highlights

BA+OT Trial Summary

This trial will test a combined Occupational Therapy & Behavioral Activation approach to help older adults with multiple chronic conditions & functional limitations manage their health better.

Who is the study for?
This trial is for older adults living near the University of Oklahoma who have at least two chronic conditions like arthritis or diabetes, and also have a functional limitation. They must be willing to set a physical activity goal but cannot be in other therapy treatments, have severe mental illness, cognitive impairments, progressive neurological conditions, or a short life expectancy.Check my eligibility
What is being tested?
The study is testing an innovative approach combining Behavioral Activation with Occupational Therapy against enhanced usual care. It aims to help older adults manage multiple chronic conditions by planning health-promoting activities and adapting their environment.See study design
What are the potential side effects?
Since this intervention involves behavioral activation and occupational therapy rather than medication, side effects are not typical as with drugs; however, participants may experience discomfort adjusting to new routines or frustration if goals aren't met.

BA+OT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 10 and 22 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10 and 22 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Canadian Occupational Performance Measure (COPM) from baseline to 22 weeks
Change in Self-management Assessment Scale from baseline to 22 weeks
Secondary outcome measures
Mental Depression
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy managing chronic conditions from baseline to 22 weeks

BA+OT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BA+OT interventionExperimental Treatment1 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.
Group II: Enhanced Usual CarePlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
98,261 Total Patients Enrolled
Presbyterian Health FoundationUNKNOWN
Tara KlinedinstPrincipal InvestigatorUniversity of Oklahoma

Media Library

Behavioral Activation + Occupational Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05600465 — N/A
Multiple Chronic Conditions Research Study Groups: BA+OT intervention, Enhanced Usual Care
Multiple Chronic Conditions Clinical Trial 2023: Behavioral Activation + Occupational Therapy Highlights & Side Effects. Trial Name: NCT05600465 — N/A
Behavioral Activation + Occupational Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05600465 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment capacity of this clinical trial?

"Affirmative. The research posted on clinicaltrials.gov reveals that recruitment for this experiment is currently underway, having been published on November 1st 2022 and modified most recently on October 26th 2022. 40 participants must be recruited from a single site."

Answered by AI

Is enrollment available for this trial at the present moment?

"The information hosted on clinicaltrials.gov reveals that this medical trial is actively sourcing participants. It was first announced on the 1st of November 2022, and its details were last modified at the end of October in 2021."

Answered by AI
~6 spots leftby Jul 2024