Open Access Study protocol

Life- and person-centred help in Mecklenburg-Western Pomerania, Germany (DelpHi): study protocol for a randomised controlled trial

Jochen René Thyrian18*, Thomas Fiß1, Adina Dreier2, Georgia Böwing1, Aniela Angelow13, Sven Lueke14, Stefan Teipel56, Steffen Fleßa4, Hans Jörgen Grabe7, Harald Jürgen Freyberger7 and Wolfgang Hoffmann12

Author Affiliations

1 German Center for Neurodegenerative Diseases (DZNE) Greifswald, Ellernholzstrasse 1-2, Greifswald, D-17487, Germany

2 Department Epidemiology of Health Care and Community Health, Institute for Community Medicine, Ernst-Moritz-Arndt-University, Ellernholzstrasse 1-2, Greifswald, D-17487, Germany

3 Department of Family Medicine, Institute for Community Medicine, Ellernholzstrasse 1-2, Greifswald, D-17487, Germany

4 Institute for Business Administration and Health Care Management, Ernst-Moritz-Arndt-University, Friedrich-Loeffler-Strasse 70, Greifswald, D-17489, Germany

5 Department of Psychiatry and Psychotherapy, University of Rostock, Gehlsheimer Strasse 20, Rostock, D-18471, Germany

6 German Center for Neurodegenerative Diseases (DZNE) Rostock, Gehlsheimer Strasse 20, Rostock, D-18471, Germany

7 Department of Psychiatry and Psychotherapy, University of Greifswald, Ellernholzstrasse 1-2, D-17489, Greifswald, Germany

8 German Center for Neurodegenerative Diseases (DZNE) Rostock/Greifswald, Ellernholzstrasse 1-2, D-Greifswald, 17487, Germany

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Trials 2012, 13:56  doi:10.1186/1745-6215-13-56

Published: 10 May 2012

Abstract

Background

The provision of appropriate medical and nursing care for people with dementia is a major challenge for the healthcare system in Germany. New models of healthcare provision need to be developed, tested and implemented on the population level. Trials in which collaborative care for dementia in the primary care setting were studied have demonstrated its effectiveness. These studies have been conducted in different healthcare systems, however, so it is unclear whether these results extend to the specific context of the German healthcare system.

The objective of this population-based intervention trial in the primary care setting is to test the efficacy and efficiency of implementing a subsidiary support system on a population level for persons with dementia who live at home.

Methods and study design

The study was designed to assemble a general physician-based epidemiological cohort of people above the age of 70 who live at home (DelpHi cohort). These people are screened for eligibility to participate in a trial of dementia care management (DelpHi trial). The trial is a cluster-randomised, controlled intervention trial with two arms (intervention and control) designed to test the efficacy and efficiency of implementing a subsidiary support system for persons with dementia who live at home. This subsidiary support system is initiated and coordinated by a dementia care manager: a nurse with dementia-specific qualifications who delivers the intervention according to a systematic, detailed protocol. The primary outcome is quality of life and healthcare for patients with dementia and their caregivers. This is a multidimensional outcome with a focus on four dimensions: (1) quality of life, (2) caregiver burden, (3) behavioural and psychological symptoms of dementia and (4) pharmacotherapy with an antidementia drug and prevention or suspension of potentially inappropriate medication. Secondary outcomes include the assessment of dementia syndromes, activities of daily living, social support health status, utilisation of health care resources and medication.

Discussion

The results will provide evidence for specific needs in ambulatory care for persons with dementia and will show effective ways to meet those needs. Qualification requirements will be evaluated, and the results will help to modify existing guidelines and treatment paths.

Trial registration

NCT01401582

Keywords:
Dementia care; Population-based; Care management; Intervention