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Completed

NCT Number: NCT01681641

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Aarhus University Hospital, Aarhus, Jutland, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • living alone

Treatment and study plan

A psycho-social intervention

Other

Primary outcomes

  1. Change in sense of Coherence in intervention group compared to control group

    Time frame: Baseline, 6 months, 12 months

    Questionnaire

Secondary outcomes

  1. Quality of life

    Time frame: Baseline, 6 months, 12 months

    PDQ 39 or PDQ Carer

Other outcomes

  1. Qualitative interviews

    Time frame: 12 months

    Patients and spouses experience of participating in the intervention. Perceived use of knowledge gained

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease - Designing and Developing a Targeted Nursing Program to Patients and Spouses.

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Sep 10, 2012
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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