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

Parkinson's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681641
• Other study ID #: AUHN-0211-AH
• Status: Completed
• Phase: N/A
• First received: August 13, 2012
• Last updated: May 28, 2017
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: September 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• eligible and offered treatment with DBS for PD

• married or cohabitant

Exclusion Criteria:

• living alone

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• A psycho-social intervention

Locations

Country	Name	City	State
Denmark	Department of Neurology , Aarhus University Hospital	Aarhus
Denmark	Department of Neurology, Aarhus University Hospital	Aarhus	Jutland
Denmark	Bispebjerg Hospital	København

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative interviews	Patients and spouses experience of participating in the intervention. Perceived use of knowledge gained	12 months
Primary	Change in sense of Coherence in intervention group compared to control group	Questionnaire	Baseline, 6 months, 12 months
Secondary	Quality of life	PDQ 39 or PDQ Carer	Baseline, 6 months, 12 months