NCT04246385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 4, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

January 4, 2020

Last Update Submit

March 16, 2021

Conditions

Cerebral Vascular Accident

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Study Arms (2)

Allocated to intervention

EXPERIMENTAL

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

Allocated to control

NO INTERVENTION

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.

Interventions

CO-OP GroupBEHAVIORAL

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

Also known as: Occupational Therapy
Allocated to intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan Abilitylab

Chicago, Illinois, 60611, United States

Location

Related Publications (10)

  • 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.

    PMID: 23796683BACKGROUND

  • 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.

    PMID: 18400322BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 23769764BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 28956721BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 22389945BACKGROUND

  • 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

    RESULT

MeSH Terms

Conditions

Stroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Sarah Zera, OTD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

January 4, 2020

First Posted

January 29, 2020

Study Start

January 3, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)