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

NCT ID: NCT01681641

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

A psycho-social intervention

Intervention Type OTHER

Control group

Patients and spouses enrolled in a control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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A psycho-social intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* living alone
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anita Haahr, PHD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Aarhus University Hospital

Locations

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Department of Neurology, Aarhus University Hospital

Aarhus, Jutland, Denmark

Site Status

Department of Neurology , Aarhus University Hospital

Aarhus, , Denmark

Site Status

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AUHN-0211-AH

Identifier Type: -

Identifier Source: org_study_id

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