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

NCT06919315 | Recruiting

• 1 other identifier: CO-OP project
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Rehabilitation; CO-OP; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• Canadian Occupational Performance Measure (COPM)

  Baseline, up to 14 weeks, 26 weeks follow-up

Secondary Outcomes (4)

• Assessment of Motor and Process Skills (AMPS) - ADL performance quality

  Baseline, up to 14 weeks, 26 weeks follow-up

• EuroQol-5 Domain (EQ-5D-5L)

  Baseline, up to 14 weeks, 26 weeks follow-up

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  Baseline, up to 14 weeks, 26 weeks follow-up

• World Health Organization Quality Of Life (WHOQOL-bref)

  Baseline, up to 14 weeks, 26 weeks follow-up

Study Arms (2)

Experimental

EXPERIMENTAL

Behavioral: CO-OP intervention

Control

ACTIVE COMPARATOR

Behavioral: Usual practice

Interventions

CO-OP intervention 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.

Experimental

Usual practice 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Dementia, Psychotic diagnoses, commotio, Brain tumor or degenerative neurological conditions.
• Alkohol or drug abuse
• Not speeking or understanding Danish

Sponsors & Collaborators

• Louise Møldrup Nielsen: lead

Study Sites (2)

Rehabilitation center

Skive, 7300, Denmark

RECRUITING

Rehabilitation center

Viborg, 8800, Denmark

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Louise M Nielsen

CONTACT

+4587552413; lmn@via.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior associate professor

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 9, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)