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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681641
First Posted: September 10, 2012
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
  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: None (Open Label)
Primary Purpose: Other
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 ]
    Questionnaire


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: 12 months ]
    Patients and spouses experience of participating in the intervention. Perceived use of knowledge gained


Enrollment: 32
Study Start Date: February 2011
Study Completion Date: December 2014
Primary Completion Date: December 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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
Denmark
Department of Neurology, Aarhus University Hospital
Aarhus, Jutland, Denmark, 8000 C
Department of Neurology , Aarhus University Hospital
Aarhus, Denmark, 8000 C
Bispebjerg Hospital
København, Denmark, 2300
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Anita Haahr, PHD Department of Neurology, Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01681641     History of Changes
Other Study ID Numbers: AUHN-0211-AH
First Submitted: August 13, 2012
First Posted: September 10, 2012
Last Update Posted: May 31, 2017
Last Verified: September 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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