Clinical trial NCT01681641: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Patients
Nursing
Parkinsons disease
Deep Brain Stimulation
Spouses
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2012-09-10
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* living alone

Primary outcomes:
measure: Change in sense of Coherence in intervention group compared to control group
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
measure: Qualitative interviews
timeFrame: 12 months
Locations:
city: Aarhus
country: Denmark
facility: Department of Neurology, Aarhus University Hospital
state: Jutland
city: Aarhus
country: Denmark
facility: Department of Neurology , Aarhus University Hospital
city: København
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Department of Neurology, Aarhus University Hospital
name: Anita Haahr, PHD
role: PRINCIPAL_INVESTIGATOR
References: