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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLouise Møldrup Nielsen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stroke or traumatic brain injury

Reffered from acute hospital or specialized rehabilitation units to municipal rehabilitation

Having at least on ADL performance issue

Disqualifiers

Dementia, Psychotic diagnoses, commotio, Brain tumor or degenerative neurological conditions.

Alkohol or drug abuse

Not speeking or understanding Danish

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Canadian Occupational Performance Measure (COPM)

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

Secondary outcomes

1

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

Participants ADL performance quality will be measured with the Occupational Therapy assesment instrument, AMPS. Both process and motor skills in ADL performance will be measured and reported separately

Time frame
Baseline, up to 14 weeks, 26 weeks follow-up
2

EuroQol-5 Domain (EQ-5D-5L)

Time frame
Baseline, up to 14 weeks, 26 weeks follow-up
3

World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

Time frame
Baseline, up to 14 weeks, 26 weeks follow-up
4

World Health Organization Quality Of Life (WHOQOL-bref)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Louise Møldrup Nielsen

Lead sponsor

VIA University College

Sponsor institution