Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP)

NCT ID: NCT06919315

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-02

Study Completion Date

2027-07-31

Brief Summary

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The goal of this clinical study is to examine the effectiveness of the Cognitive Orientation to daily Occupational Performance (CO-OP) in adults (18+) with accuired brain injury when applied in Danish rehabilitation context. The primary research question is: What is the effectiveness of the CO-OP approach on improvement of performance of daily activities (ADL) and quality of life compared to usual rehabilitation practice.

Participants in the intervention group will recieve the CO-OP intervention as part of their rehabilitation in the following phases:

Initial phase: Goalsetting is mandatory and based on the participant's prioritized ADL performance issues identified in their baseline COPM. Education phase: Individual education in the metacognitive Goal-Plan-Do-Check strategy. Training phase: CO-OP training that involves repetitive use of the Goal-Plan-Do-Check for problem solving and skill acquisition. The therapist employs dynamic performance analysis and guided discovery to help participants understand performance issues and formulate plans for achieving their goals. Participants then execute and evaluate these plans, with a focus on developing domain-specific cognitive strategies. The therapist actively encourages generalization and transfer of skills. Homework is mandatory.

Participants in the control group will recieve usual rehabilitation practice in the following phases:

Initial phase: Goalsetting is optional and may be based on previous assessment or on a conversation with the participant. Training phase: Different approaches may be taken such as observation and practice of activities or consultation about performance issues and how participants may deal with them. The therapist may guide the participant's performance verbally, physically or trough picture materials. Homework may be included.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A quasi-experimental superiority trial will compare a usual practice (control) group and a CO-OP intervention group. The study will be conducted in two phases. In phase I, usual practice is delivered and in phase II, CO-OP is delivered.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Experimental

Group Type EXPERIMENTAL

CO-OP intervention

Intervention Type BEHAVIORAL

CO-OP intervention: Initial phase: Goalsetting is mandatory and based on the participant's prioritized ADL performance issues identified in their baseline COPM. Education phase: Individual education in the metacognitive Goal-Plan-Do-Check strategy. Training phase: CO-OP training that involves repetitive use of the Goal-Plan-Do-Check for problem solving and skill acquisition. The therapist employs dynamic performance analysis and guided discovery to help participants understand performance issues and formulate plans for achieving their goals. Participants then execute and evaluate these plans, with a focus on developing domain-specific cognitive strategies. The therapist actively encourages generalization and transfer of skills. Homework is mandatory.

Control

Group Type ACTIVE_COMPARATOR

Usual practice

Intervention Type BEHAVIORAL

Usual practice: Initial phase: Goalsetting is optional and may be based on previous assessment or on a conversation with the participant. Training phase: Different approaches may be taken such as observation and practice of activities or consultation about performance issues and how participants may deal with them. The therapist may guide the participant's performance verbally, physically or trough picture materials. Homework may be included.

Interventions

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Usual practice

Usual practice: Initial phase: Goalsetting is optional and may be based on previous assessment or on a conversation with the participant. Training phase: Different approaches may be taken such as observation and practice of activities or consultation about performance issues and how participants may deal with them. The therapist may guide the participant's performance verbally, physically or trough picture materials. Homework may be included.

Intervention Type BEHAVIORAL

CO-OP intervention

CO-OP intervention: Initial phase: Goalsetting is mandatory and based on the participant's prioritized ADL performance issues identified in their baseline COPM. Education phase: Individual education in the metacognitive Goal-Plan-Do-Check strategy. Training phase: CO-OP training that involves repetitive use of the Goal-Plan-Do-Check for problem solving and skill acquisition. The therapist employs dynamic performance analysis and guided discovery to help participants understand performance issues and formulate plans for achieving their goals. Participants then execute and evaluate these plans, with a focus on developing domain-specific cognitive strategies. The therapist actively encourages generalization and transfer of skills. Homework is mandatory.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Stroke or traumatic brain injury
* Reffered from acute hospital or specialized rehabilitation units to municipal rehabilitation
* Having at least on ADL performance issue

Exclusion Criteria

* Dementia, Psychotic diagnoses, commotio, Brain tumor or degenerative neurological conditions.
* Alkohol or drug abuse
* Not speeking or understanding Danish
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Louise Møldrup Nielsen

OTHER

Sponsor Role lead

Responsible Party

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Louise Møldrup Nielsen

Senior associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rehabilitation center

Skive, , Denmark

Site Status RECRUITING

Rehabilitation center

Viborg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Louise M Nielsen

Role: CONTACT

+4587552413

Facility Contacts

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Heidi Kjær

Role: primary

Role: backup

+4524627394

Mie Tholstrup

Role: primary

+4520695540

Other Identifiers

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CO-OP project

Identifier Type: -

Identifier Source: org_study_id

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