跳至主要内容
临床试验/NCT06919315
NCT06919315招募中不适用

Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP) in a Danish Rehabilitation Context

Louise Møldrup Nielsen2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Experimental

Experimental

干预措施: CO-OP intervention (Behavioral)

Control

Active Comparator

干预措施: Usual practice (Behavioral)

结局指标

主要结局

Canadian Occupational Performance Measure (COPM)

时间窗: Baseline, up to 14 weeks, 26 weeks follow-up

次要结局

  • 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)

研究者

发起方
Louise Møldrup Nielsen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Louise Møldrup Nielsen

Senior associate professor

VIA University College

研究点 (2)

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