Clinical trial NCT06919315: Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP)
Official title: Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP) in a Danish Rehabilitation Context
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
CO-OP
Occupational Therapy
Lead sponsor: VIA University College
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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 (45+) 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.


Eligibility criteria: 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

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline, up to 14 weeks, 26 weeks follow-up
Secondary outcomes:
measure: Assessment of Motor and Process Skills (AMPS) - ADL performance quality
timeFrame: Baseline, up to 14 weeks, 26 weeks follow-up
measure: EuroQol-5 Domain (EQ-5D-5L)
timeFrame: Baseline, up to 14 weeks, 26 weeks follow-up
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline, up to 14 weeks, 26 weeks follow-up
measure: World Health Organization Quality Of Life (WHOQOL-bref)
timeFrame: Baseline, up to 14 weeks, 26 weeks follow-up
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: Rehabilitation center
city: Viborg
country: Denmark
facility: Rehabilitation center
Study officials:
References: