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Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by University of Aarhus.
Recruitment status was:  Recruiting
Institute of public health, department of nursing sciences, Århus University, Denmark
Bispebjerg Hospital
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: August 13, 2012
Last updated: September 7, 2012
Last verified: September 2012

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 Intervention
Parkinson's Disease
Other: A psycho-social intervention

Study Type: Interventional
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.

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Change in sense of Coherence in intervention group compared to control group [ Time Frame: Baseline, 6 months, 12 months ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Baseline, 6 months, 12 months ]
    PDQ 39 or PDQ Carer

Other Outcome Measures:
  • Qualitative interviews [ Time Frame: 6 months and 12 months ]

Estimated Enrollment: 60
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)
Arms Assigned Interventions
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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • living alone
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01681641

Contact: Anita Haahr, PHD +45 78463337
Contact: Østergaard Karen, Professor +4578463282

Department of Neurology, Aarhus University Hospital Recruiting
Aarhus, Jutland, Denmark, 8000 C
Contact: Anita Haahr, PHD    +4578463337      
Department of Neurology , Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000 C
Contact: Anita Haahr, PHD    +45 78463337   
Bispebjerg Hospital Recruiting
København, Denmark, 2300
Contact: Steen Rusborg, RN         
Principal Investigator: Anita 1 Haahr, RN, PHD         
Sponsors and Collaborators
University of Aarhus
Institute of public health, department of nursing sciences, Århus University, Denmark
Bispebjerg Hospital
  More Information

Responsible Party: University of Aarhus Identifier: NCT01681641     History of Changes
Other Study ID Numbers: AUHN-0211-AH
Study First Received: August 13, 2012
Last Updated: September 7, 2012

Keywords provided by University of Aarhus:
Parkinsons disease
Deep Brain Stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases processed this record on April 28, 2017