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

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Completed
CT.gov ID
NCT04246385
Collaborator
Midwestern University (Other)
11
1
2
10.9
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CO-OP Group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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.
Primary Purpose:
Treatment
Official Title:
Implementing a Cognitive Orientation to Daily Occupational Performance (CO-OP) Group in the Day Rehab Setting: A Pilot Study
Actual Study Start Date :
Jan 3, 2020
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Canadian Occupational Performance Measure [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.

    2. Assessment of Motor and Process Skills [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.

    3. The Community Participation Index [Change from baseline at 8 weeks.]

      The Community Participation Index (CPI) (Heinemann et al., 2011) a survey that measures change in community participation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shirley Ryan Abilitylab Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Shirley Ryan AbilityLab
    • Midwestern University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sarah Zera, Occupational Therapist, Shirley Ryan AbilityLab
    ClinicalTrials.gov Identifier:
    NCT04246385
    Other Study ID Numbers:
    • STU00211151
    First Posted:
    Jan 29, 2020
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 17, 2021