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临床试验/NCT06058351
NCT06058351招募中不适用

ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury; an Implementation Study

Majanka H. Heijenbrok-Kal, PhD2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Difference in proportion of patients participating in buddy support programs after rehabilitation discharge

研究概览

简要总结

The goal of this implementation study is to improve aftercare for patients with ABI receiving outpatient rehabilitation. The ABI-motion program was developed to improve and active lifestyle and to prevent persistent complaints after ABI and poor HR-QoL.The main questions it aims to answer are:

  • Is the ABI-motion program feasible?
  • What are the health benefits of the ABI-motion program?

Participants will receive brain education, a joint therapy session with a physical or occupational or movement therapist and a buddy from a patient support organization during outpatient rehabilitation, followed by community buddy support after discharge from outpatient rehabilitation, and follow-up by a rehabilitation physician.

详细描述

Rationale: Many people with acquired brain injury (ABI) experience difficulties in reintegration into their social life after discharge from the rehabilitation center. It is also known that people with ABI do not meet the physical activity guidelines; they have lower physical activity levels than healthy people and they have difficulty maintaining their physical fitness level reached during rehabilitation. An inactive lifestyle may lead to persistent complaints, such as fatigue, anxiety or depression, and may result in a poor health-related quality of life (HR-QoL).

Objective: To improve aftercare for patients with ABI receiving outpatient rehabilitation, aimed at promoting an active lifestyle to prevent persistent complaints after ABI and poor HR-QoL.

Study design: Care improvement study using a prospective mono-center cohort with a pre-post implementation study design.

Study population: Patients with ABI receiving outpatient rehabilitation therapy.

Intervention (if applicable): Implementation of an aftercare program that strengthens the cooperation between rehabilitation center and local patient support organisations in the community. The aftercare program integrates standard outpatient rehabilitation and community services, including: 1) brain education regarding long-term consequences of ABI, physical activity guidelines, and patient support organizations in the area; 2) a joint physical/ occupational/ movement therapy session with a buddy from a patient support organisation during outpatient rehabilitation; 3) buddy support (max 8 hrs) in the community towards an active lifestyle after rehabilitation discharge; 4) follow-up by the rehabilitation physician.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
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

入选标准

  • Diagnosed with ABI
  • Follows an outpatient rehabilitation program for ABI in Rijndam Rehabilitation

排除标准

  • Having a contra-indication for participation in moderate to vigorous exercise
  • Life expectancy < 1 year
  • Incapacitated persons

结局指标

主要结局

Difference in proportion of patients participating in buddy support programs after rehabilitation discharge

时间窗: 3, 6, 12 months

Proportion of patients in the ABI-motion group that continues community buddy support after rehabilitation discharge compared with standard care

Mean rating of satisfaction with the ABI-motion program

时间窗: 12 months

Satisfaction with the ABI-motion program is rated on a rating scale, ranging from 0 (worst) to 10 (best).

次要结局

  • Change in Montreal Cognitive Assessment (MoCA) score at 6 and 12 months compared with controls.(0, 6,12 months)
  • Change in handgrip strength at 6 and 12 months compared with controls(0, 6, 12 months)
  • Change in physical and mental components of health-related quality of life at 3, 6, and 12 months compared with controls(0, 3, 6, 12 months)
  • Change in health care use at 3, 6, 12 months compared with controls(0, 3, 6, 12 months)
  • Change in medical consumption at 3, 6, 12 months compared with controls(0, 3, 6, 12 months)
  • Change in Walking Speed at 6 and 12 months compared with controls(0, 6, 12 months)
  • Change in fatigue at 3, 6, and 12 months compared with controls(0, 3, 6, and 12 months)
  • Change in coping style at 3, 6, and 12 months compared with controls(0, 3, 6, and 12 months)
  • Change in fitness at 3, 6,12 months compared with controls(0, 3, 6, 12 months)
  • Change in social participation and health care use at 3, 6, 12 months compared with controls(0, 3, 6, 12 months)
  • Change in total minutes of physical activity/week at 6 and 12 months compared with controls(0, 6, 12 months)
  • Change in functional exercise capacity at 6 and 12 months compared with controls(0, 6, 12 months)
  • Change in health-related quality of life at 3, 6, and 12 months compared with controls(0, 3, 6, 12 months)
  • Change in physical activity at 3, 6,12 months compared with controls(0, 3, 6, 12 months)
  • Change in anxiety and depression at 3, 6, and 12 months compared with controls(0, 3, 6, and 12 months)
  • Change in cognitive failures at 3, 6, and 12 months compared with controls(0, 3, 6, and 12 months)

研究者

发起方
Majanka H. Heijenbrok-Kal, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Majanka H. Heijenbrok-Kal, PhD

Clinical epidemiologist

Erasmus Medical Center

研究点 (2)

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