Implementing a CO-OP Group in the Day Rehab Setting: A Pilot Study.
Primary Purpose
Cerebral Vascular Accident
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CO-OP Group
Sponsored by

About this trial
This is an interventional treatment trial for Cerebral Vascular Accident
Eligibility Criteria
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.
Sites / Locations
- Shirley Ryan Abilitylab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Allocated to intervention
Allocated to control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Canadian Occupational Performance Measure
The COPM is a semi-structured interview and objective measure of change in performance and change in satisfaction of participants' goals.
Assessment of Motor and Process Skills
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.
The Community Participation Index
The Community Participation Index (CPI) (Heinemann et al., 2011) a survey that measures change in community participation.
Secondary Outcome Measures
Full Information
NCT ID
NCT04246385
First Posted
January 4, 2020
Last Updated
March 16, 2021
Sponsor
Shirley Ryan AbilityLab
Collaborators
Midwestern University
1. Study Identification
Unique Protocol Identification Number
NCT04246385
Brief Title
Implementing a CO-OP Group in the Day Rehab Setting: A Pilot Study.
Official Title
Implementing a Cognitive Orientation to Daily Occupational Performance (CO-OP) Group in the Day Rehab Setting: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
Midwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Vascular Accident
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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. Each individual CO-OP group will be expected to include three to six participants to remain consistent with the literature (Chan, 2007; Green, Chambers, & Sugden, 2008).
Masking
None (Open Label)
Masking Description
The principle investigator (PI) will be providing the intervention and therefore will not be blinded to the COPM of the intervention group as the COPM not only provides the objective data of the participant's' performance and satisfaction of goals but the goals themselves to be addressed within the intervention. However, the PI will not be providing the intervention of the control group, the AMPS assessments, and CPI evaluations.
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allocated to intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Allocated to control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CO-OP Group
Other Intervention Name(s)
Occupational Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
The COPM is a semi-structured interview and objective measure of change in performance and change in satisfaction of participants' goals.
Time Frame
Change from baseline at 8 weeks.
Title
Assessment of Motor and Process Skills
Description
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.
Time Frame
Change from baseline at 8 weeks.
Title
The Community Participation Index
Description
The Community Participation Index (CPI) (Heinemann et al., 2011) a survey that measures change in community participation.
Time Frame
Change from baseline at 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Zera, OTD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan Abilitylab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23796683
Citation
Dawson DR, Binns MA, Hunt A, Lemsky C, Polatajko HJ. Occupation-based strategy training for adults with traumatic brain injury: a pilot study. Arch Phys Med Rehabil. 2013 Oct;94(10):1959-63. doi: 10.1016/j.apmr.2013.05.021. Epub 2013 Jun 22.
Results Reference
background
PubMed Identifier
18400322
Citation
Green D, Chambers ME, Sugden DA. Does subtype of developmental coordination disorder count: is there a differential effect on outcome following intervention? Hum Mov Sci. 2008 Apr;27(2):363-82. doi: 10.1016/j.humov.2008.02.009. Epub 2008 Apr 8.
Results Reference
background
Citation
Fischer, H., Zera, S., Robertson, R., Lee, D., Hammel, J. (2018). Implementing research into everyday occupational therapy practice: the IPASS-R program. SIS Quarterly Practice Connections. 3 (3), 26 - 28
Results Reference
background
Citation
Fischer, A.G. & Bray Jones, K. (2012) Assessment of Motor and Process Skills: Volume I - Development, Standardization, and Administration Manual. Seventh Edition, Revised. Fort Collin, Colorado: Three Star Press
Results Reference
background
PubMed Identifier
23769764
Citation
Heinemann AW, Magasi S, Bode RK, Hammel J, Whiteneck GG, Bogner J, Corrigan JD. Measuring enfranchisement: importance of and control over participation by people with disabilities. Arch Phys Med Rehabil. 2013 Nov;94(11):2157-65. doi: 10.1016/j.apmr.2013.05.017. Epub 2013 Jun 13.
Results Reference
background
Citation
Law, M., Baptiste, S., Carswell, Al, McColl, Ml, Polatajk, H., & Pollack, N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications
Results Reference
background
PubMed Identifier
28956721
Citation
Lee D, Fischer H, Zera S, Robertson R, Hammel J. Examining a participation-focused stroke self-management intervention in a day rehabilitation setting: a quasi-experimental pilot study. Top Stroke Rehabil. 2017 Dec;24(8):601-607. doi: 10.1080/10749357.2017.1375222. Epub 2017 Sep 28.
Results Reference
background
Citation
Polatajko, H. J., & Mandich, A. (2004). Enabling occupation in children: The cognitive orientation to daily occupational performance (CO-OP) approach. Ottawa, Ont: CAOT Publications ACE
Results Reference
background
PubMed Identifier
22389945
Citation
Polatajko HJ, McEwen SE, Ryan JD, Baum CM. Pilot randomized controlled trial investigating cognitive strategy use to improve goal performance after stroke. Am J Occup Ther. 2012 Jan-Feb;66(1):104-9. doi: 10.5014/ajot.2012.001784.
Results Reference
background
Citation
Chan, D. Y. K. (2007). The application of cognitive orientation to daily occupational performance (CO-OP) in children with developmental coordination disorder (DCD) in hong kong: A pilot study. Hong Kong Journal of Occupational Therapy, 17(2), 39-44. doi:10.1016/S1569-1861(08)70002-0
Results Reference
result
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Implementing a CO-OP Group in the Day Rehab Setting: A Pilot Study.
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