Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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.|
- Change in sense of Coherence in intervention group compared to control group [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]Questionnaire
- Quality of life [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]PDQ 39 or PDQ Carer
- Qualitative interviews [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|