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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
A psycho-social intervention
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson's Disease focused on measuring Patients, Nursing, Parkinsons disease, Deep Brain Stimulation, Spouses

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • living alone

Sites / Locations

  • Department of Neurology, Aarhus University Hospital
  • Department of Neurology , Aarhus University Hospital
  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle counseling

Control group

Arm Description

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.

Patients and spouses enrolled in a control group

Outcomes

Primary Outcome Measures

Change in sense of Coherence in intervention group compared to control group
Questionnaire

Secondary Outcome Measures

Quality of life
PDQ 39 or PDQ Carer

Full Information

First Posted
August 13, 2012
Last Updated
May 28, 2017
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01681641
Brief Title
Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Patients, Nursing, Parkinsons disease, Deep Brain Stimulation, Spouses

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients and spouses enrolled in a control group
Intervention Type
Other
Intervention Name(s)
A psycho-social intervention
Primary Outcome Measure Information:
Title
Change in sense of Coherence in intervention group compared to control group
Description
Questionnaire
Time Frame
Baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
PDQ 39 or PDQ Carer
Time Frame
Baseline, 6 months, 12 months
Other Pre-specified Outcome Measures:
Title
Qualitative interviews
Description
Patients and spouses experience of participating in the intervention. Perceived use of knowledge gained
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: eligible and offered treatment with DBS for PD married or cohabitant Exclusion Criteria: living alone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Haahr, PHD
Organizational Affiliation
Department of Neurology, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Aarhus University Hospital
City
Aarhus
State/Province
Jutland
ZIP/Postal Code
8000 C
Country
Denmark
Facility Name
Department of Neurology , Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000 C
Country
Denmark
Facility Name
Bispebjerg Hospital
City
København
ZIP/Postal Code
2300
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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