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

Cerebral Vascular Accident Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246385
• Other study ID #: STU00211151
• Status: Completed
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: March 2021
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Vascular Accident
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Shirley Ryan Abilitylab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Midwestern University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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:

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. — View 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

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

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. — View 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. — View Citation

Law, M., Baptiste, S., Carswell, Al, McColl, Ml, Polatajk, H., & Pollack, N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications

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. — View 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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at 8 weeks.
Primary	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.	Change from baseline at 8 weeks.
Primary	The Community Participation Index	The Community Participation Index (CPI) (Heinemann et al., 2011) a survey that measures change in community participation.	Change from baseline at 8 weeks.