跳至主要内容
临床试验/NCT01681641
NCT01681641已完成不适用

Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease - Designing and Developing a Targeted Nursing Program to Patients and Spouses.

University of Aarhus3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
3
主要终点
Change in sense of Coherence in intervention group compared to control group

研究概览

简要总结

Parkinson's disease is a chronic progressive neurological disorder. Symptoms are tremor, slowness in movement, rigidity and postural instability. As the disease progresses and treatment with L-dopa is no longer sufficient, some patients may be treated with deep brain stimulation.

When treated with deep brain stimulation, electrodes are inserted in the affected area of the brain and through stimulation, motor symptoms of Parkinson's disease are significantly reduced.

During the first year of DBS treatment patients and spouses may experience changes in everyday life and illness trajectory posing new opportunities as well as new challenges.

The purpose of the study is to develop an individualised and targeted nursing program to support patients and relatives manage changes and challenges in life the first three months after Deep Brain Stimulation. The intervention is expected to generate important knowledge that will serve as a foundation for the further development of a future nursing program.

详细描述

The intervention is designed as a psychosocial intervention, targeted both patients and spouses.

The intervention consists of individually targeted meetings with a specialized DBS nurse several times during the first six months og DBS. Patients and spouses likewise have to fill out a diary for use in the meetings.

All meetings have specific topics, addressing aspects of challenges in adjusting to DBS, and the aim is to off patients and spouses a tailored intervention, supporting each individual based on an individual assessment.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •eligible and offered treatment with DBS for PD
  • •married or cohabitant

排除标准

  • •living alone

研究组 & 干预措施

Control group

No Intervention

Patients and spouses enrolled in a control group

Lifestyle counseling

Experimental

Patients and spouses in the intervention group are offered 3 targeted meetings with the DBS nurse, focusing on goal setting for each individual, following DBS, based on patients and spouses own expectations, challenges and goals for everyday life after DBS.

干预措施: A psycho-social intervention (Other)

结局指标

主要结局

Change in sense of Coherence in intervention group compared to control group

时间窗: Baseline, 6 months, 12 months

Questionnaire

次要结局

  • Quality of life(Baseline, 6 months, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验