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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: A psycho-social intervention

• Registration Number: NCT01681641
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-08-13
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-10
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Last Update Submitted: 2017-05-28
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

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Exclusion Criteria

• living alone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	A psycho-social intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in sense of Coherence in intervention group compared to control group	Baseline, 6 months, 12 months	Questionnaire

Secondary Outcome Measures

Name	Time	Method
Quality of life	Baseline, 6 months, 12 months	PDQ 39 or PDQ Carer

Trial Locations

Locations (3)

Department of Neurology, Aarhus University Hospital; 🇩🇰 Aarhus, Jutland, Denmark

Department of Neurology , Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Bispebjerg Hospital; 🇩🇰 København, Denmark