Implementing a CO-OP Group in the Day Rehab Setting: A Pilot Study.

March 16, 2021 updated by: Sarah Zera, Shirley Ryan AbilityLab

Implementing a Cognitive Orientation to Daily Occupational Performance (CO-OP) Group in the Day Rehab Setting: A Pilot Study

This is pilot study will examine the effectiveness of a group curriculum developed from the CO-OP approach. This study has two aims, the first is to standardize the group curriculum and the second is to compare the data from the group receiving CO-OP group curriculum to the control group. Primary methods will include a standardized observation of occupational performance, an semi-structured interview measuring performance and satisfaction of occupational performance, a survey of community participation, and a focus group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many people affected by acquired brain injury do not return to participating in their environment. Cognition is a primary predictor of participation after stroke (Wong, Baum, Chen, Young, Heinemann, 2016). Metacognitive strategy training (MST) techniques are effective tools for increasing the independence of occupational therapy patients. The Cognitive Orientation to daily Occupational Performance (CO-OP) (Polatajko & Mandich, 2004) approach is an effective form of MST. The goal of CO-OP is to generalize and transfer skills and problem solving strategies learned in therapy to increase participants' participation in their environment. While CO-OP has proven effective in adults with executive function deficits in a one on one structure and in pediatrics in a group structure, adult day rehabilitation occupational therapists have found this intervention difficult to implement secondary to the current one on one structure favored for adults. As there is a dearth of literature on group CO-OP approaches for adults this is a novel study that provides a significant opportunity to improve outcomes for OT patients.

The primary purpose of this study has two aims. The first is to standardize the CO-OP group curriculum first created for Zera's (2018) feasibility study. The second aim is to examine initial data comparing an adult CO-OP group with a control group.

This randomized control pilot study will estimate for 22 participants, 11 for the CO-OP group and 11 for the control group, expecting 8 for each to complete the study.

Quantitative data will be collected through the Canadian Occupational Performance Measure (COPM) (Law et al., 2014) an objective measure of performance and satisfaction of participants' goals, The Assessment of Motor and Process Skills (AMPS) (Fischer, & Bray Jones 2012) an observational assessment of motor and process skills, and the Community Participation Index (CPI) (Heinemann et al., 2011) a survey that measures community participation. To collect qualitative data a focus group will be completed and field notes collected. Groups will also be video recorded to collect additional qualitative data on participant group process and group facilitator use of the CO-OP cueing hierarchy. Videos will be analyzed for themes.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Shirley Ryan AbilityLab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current patient in day rehabilitation admitted for rehabilitation from stroke, able to communicate sufficiently to complete the COPM, able to identify two goals on the COPM, English speaking, receiving occupational therapy services, over 18 years of age.

Exclusion Criteria:

  • Not a patient in day rehabilitation, primary diagnosis other than stroke, inability to communicate sufficiently to complete the COPM, unable to identify two goals on the COPM, not English speaking, not already receiving occupational therapy services, under 18 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allocated to intervention
Participants will participate in a one on one session to complete their COPM and set their goal for the group. Participants will participate in 6 group sessions focusing on the CO-OP approach.
Behavioral: CO-OP Group

Participants in the intervention group will attend one 1:1 session where one goal will be selected from their COPM results to focus on during the group, group expectations will be reviewed, caregivers will be invited, and questions answered. The group will run six sessions as supported by the literature (Chan, 2007; Lee, Fischer, Zera, Robertson, & Hammel 2017).

Day Rehab CO-OP Group Curriculum Session Content

Introduction One on one session. COPM, introduction to group, education for caregiver. Session 1 Introduction to group and CO-OP approach, homework. Session 2 Review CO-OP approach, practice, homework. Session 3 Review CO-OP approach, plan outing, homework. Session 4 Review CO-OP approach, experiential learning according to participants' alternate COPM goals, homework. Session 5 Review CO-OP approach, outing, homework. Session 6 Review CO-OP approach, focus group, lessons learned, final COPM, homework

Other Names:
  • Occupational Therapy
No Intervention: Allocated to control
The control group will receive "usual care" occupational therapy including a mix of individual sessions and occupational therapy groups that do not include the CO-OP group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure
Time Frame: Change from baseline at 8 weeks.
The COPM is a semi-structured interview and objective measure of change in performance and change in satisfaction of participants' goals.
Change from baseline at 8 weeks.
Assessment of Motor and Process Skills
Time Frame: Change from baseline at 8 weeks.
The Assessment of Motor and Process Skills (AMPS) (Fischer, & Bray Jones 2012) an observational assessment of change in motor and change in process (behavioral) skills in which the participant completes two activities of daily living.
Change from baseline at 8 weeks.
The Community Participation Index
Time Frame: Change from baseline at 8 weeks.
The Community Participation Index (CPI) (Heinemann et al., 2011) a survey that measures change in community participation.
Change from baseline at 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Collaborators

Midwestern University

Investigators

  • Principal Investigator: Sarah Zera, OTD, Shirley Ryan AbilityLab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2020

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

January 4, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00211151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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