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

This study is currently recruiting participants.
Verified September 2012 by University of Aarhus
Sponsor:
Collaborators:
Institute of public health, department of nursing sciences, Århus University, Denmark
Bispebjerg Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01681641
First received: August 13, 2012
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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 ] [ Designated as safety issue: No ]
    Questionnaire


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    PDQ 39 or PDQ Carer


Other Outcome Measures:
  • Qualitative interviews [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • living alone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681641

Contacts
Contact: Anita Haahr, PHD +45 78463337 anitaaru@rm.dk
Contact: Østergaard Karen, Professor +4578463282 kareoest@rm.dk

Locations
Denmark
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    anitaaru@rm.dk   
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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01681641     History of Changes
Other Study ID Numbers: AUHN-0211-AH
Study First Received: August 13, 2012
Last Updated: September 7, 2012
Health Authority: Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014