Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01681641|
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : May 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Other: A psycho-social intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease - Designing and Developing a Targeted Nursing Program to Patients and Spouses.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
Experimental: Lifestyle counseling
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.
Other: A psycho-social intervention
No Intervention: Control group
Patients and spouses enrolled in a control group
- Change in sense of Coherence in intervention group compared to control group [ Time Frame: Baseline, 6 months, 12 months ]Questionnaire
- Quality of life [ Time Frame: Baseline, 6 months, 12 months ]PDQ 39 or PDQ Carer
- Qualitative interviews [ Time Frame: 12 months ]Patients and spouses experience of participating in the intervention. Perceived use of knowledge gained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681641
|Department of Neurology, Aarhus University Hospital|
|Aarhus, Jutland, Denmark, 8000 C|
|Department of Neurology , Aarhus University Hospital|
|Aarhus, Denmark, 8000 C|
|København, Denmark, 2300|
|Principal Investigator:||Anita Haahr, PHD||Department of Neurology, Aarhus University Hospital|