Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease
1 other identifier
interventional
32
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 13, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 31, 2017
September 1, 2012
2.8 years
August 13, 2012
May 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in sense of Coherence in intervention group compared to control group
Questionnaire
Baseline, 6 months, 12 months
Secondary Outcomes (1)
Quality of life
Baseline, 6 months, 12 months
Other Outcomes (1)
Qualitative interviews
12 months
Study Arms (2)
Lifestyle counseling
EXPERIMENTALPatients 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.
Control group
NO INTERVENTIONPatients and spouses enrolled in a control group
Interventions
Eligibility Criteria
You may qualify if:
- eligible and offered treatment with DBS for PD
- married or cohabitant
You may not qualify if:
- living alone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
Study Sites (3)
Department of Neurology, Aarhus University Hospital
Aarhus, Jutland, 8000 C, Denmark
Department of Neurology , Aarhus University Hospital
Aarhus, 8000 C, Denmark
Bispebjerg Hospital
Copenhagen, 2300, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anita Haahr, PHD
Department of Neurology, Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2012
First Posted
September 10, 2012
Study Start
February 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
May 31, 2017
Record last verified: 2012-09
Data Sharing
- IPD Sharing
- Will not share