Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2012

Open Access 01-12-2012 | Study protocol

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

Authors: Jochen René Thyrian, Thomas Fiß, Adina Dreier, Georgia Böwing, Aniela Angelow, Sven Lueke, Stefan Teipel, Steffen Fleßa, Hans Jörgen Grabe, Harald Jürgen Freyberger, Wolfgang Hoffmann

Published in: Trials | Issue 1/2012

Login to get access

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
Appendix
Available only for authorised users
Literature
1.
Fendrich K, Hoffmann W: More than just aging societies: the demographic change has an impact on actual numbers of patients. J Public Health. 2007, 15: 345-351. 10.1007/s10389-007-0142-0.CrossRef
2.
Hampel H, Prvulovic D, Teipel S, Jessen F, Luckhaus C, Frölich L, Riepe MW, Dodel R, Leyhe T, Bertram L, Hoffmann W: Faltraco F; German Task Force on Alzheimer’s Disease (GTF-AD): The future of Alzheimer’s disease: the next 10 years. Prog Neurobiol. 2011, 95: 718-728. 10.1016/j.pneurobio.2011.11.008.CrossRefPubMed
3.
4.
5.
Thyrian JR, Dreier A, Fendrich K, Lueke S, Hoffmann W: Demenzerkrankungen: Wirksame Konzepte gesucht. Dtsch Arztebl. 2011, 108: A1954-A1956.
6.
Thyrian JR, John U: Population impact: definition, calculation and its use in prevention science in the example of tobacco smoking reduction. Health Policy. 2007, 82: 348-356. 10.1016/j.healthpol.2006.10.001.CrossRefPubMed
7.
Pentzek M, Fuchs A, Wiese B, Cvetanovska-Pllashniku G, Haller F, Maier W, Riedel-Heller SG, Angermeyer MC, Bickel H, Mösch E, Weyerer S, Werle J, van den Bussche H, Eisele M, Kaduszkiewicz H, AgeCoDe Study Group, AgeCoDe Study Group: General practitioners’ judgment of their elderly patients’ cognitive status. J Gen Intern Med. 2009, 24: 1314-1317. 10.1007/s11606-009-1118-2.CrossRefPubMedPubMedCentral
8.
Ashford JW, Borson S, O’Hara R, Dash P, Frank L, Robert P, Shankle WR, Tierney MC, Brodaty H, Schmitt FA, Kraemer HC, Buschke H, Fillit H: Should older adults be screened for dementia? It is important to screen for evidence of dementia!. Alzheimers Dement. 2007, 3: 75-80. 10.1016/j.jalz.2007.03.005.CrossRefPubMedPubMedCentral
9.
Ashford JW, Borson S: Primary care screening for dementia and mild cognitive impairment. JAMA. 2008, 299: 1132-1133.CrossRefPubMed
10.
Brayne C, Fox C, Boustani M: Dementia screening in primary care: is it time?. JAMA. 2007, 298: 2409-2411. 10.1001/jama.298.20.2409. A published erratum appears in JAMA 2008, 299:634CrossRefPubMed
11.
Rafii MS, Galasko D: Primary care screening for dementia and mild cognitive impairment. JAMA. 2008, 299: 1132-CrossRefPubMed
12.
Marengoni A, Rizzuto D, Wang HX, Winblad B, Fratiglioni L: Patterns of chronic multimorbidity in the elderly population. J Am Geriatr Soc. 2009, 57: 225-230. 10.1111/j.1532-5415.2008.02109.x.CrossRefPubMed
13.
Malone DC, McLaughlin TP, Wahl PM, Leibman C, Arrighi HM, Cziraky MJ, Mucha LM: Burden of Alzheimer’s disease and association with negative health outcomes. Am J Manag Care. 2009, 15: 481-488.PubMed
14.
Dinkel RH, Lebok UH: The effects of dementia in German acute care hospitals. Dement Geriatr Cogn Disord. 1997, 8: 314-319. 10.1159/000106649.CrossRefPubMed
15.
Luck T, Riedel-Heller SG, Kaduszkiewicz H, Bickel H, Jessen F, Pentzek M, Wiese B, Koelsch H, van den Bussche H, Abholz HH, Moesch E, Gorfer S, Angermeyer MC, Maier W, Weyerer S, AgeCoDe Group, AgeCoDe Group: Mild cognitive impairment in general practice: age-specific prevalence and correlate results from the German study on ageing, cognition and dementia in primary care patients (AgeCoDe). Dement Geriatr Cogn Disord. 2007, 24: 307-316. 10.1159/000108099.CrossRefPubMed
16.
Ihl R: Integrative Demenzbehandlung [abstract 94]. Neurogeriatrie. 2011, 8: S15-S16.
17.
18.
Selbständigkeit und Hilfebedarf bei älteren Menschen in Privathaushalten: Pflegearrangements, Demenz, Versorgungsangebote. Edited by: Schneekloth U, Wahl HW. 2008, W Kohlhammer GmbH, Stuttgart, 2
19.
Etters L, Goodall D, Harrison BE: Caregiver burden among dementia patient caregivers: a review of the literature. J Am Acad Nurse Pract. 2008, 20: 423-428. 10.1111/j.1745-7599.2008.00342.x.CrossRefPubMed
20.
Thompson CA, Spilsbury K, Hall J, Birks Y, Barnes C, Adamson J: Systematic review of information and support interventions for caregivers of people with dementia. BMC Geriatr. 2007, 7: 18-10.1186/1471-2318-7-18.CrossRefPubMedPubMedCentral
21.
Dietl M, Kornhuber J, Schöffski O, Gräßel E: Cost-effectiveness model of a community-based service for dementia caregivers] [in German. Gesundheitswesen. 2010, 72: 99-105. 10.1055/s-0029-1220758.CrossRefPubMed
22.
Donath C, Luttenberger K, Gräßel E: Dementia caregiver skill training: predictors for utilisation and expected quality from the family caregiver’s point of view [in German]. Gesundheitswesen. 2009, 71: 291-292. 10.1055/s-0029-1192005.CrossRefPubMed
23.
Boustani M, Callahan CM, Unverzagt FW, Austrom MG, Perkins AJ, Fultz BA, Hui SL, Hendrie HC: Implementing a screening and diagnosis program for dementia in primary care. J Gen Intern Med. 2005, 20: 572-577. 10.1007/s11606-005-0103-7.CrossRefPubMedPubMedCentral
24.
Boustani M, Peterson B, Hanson L, Harris R, Lohr KN, U.S. Preventive Services Task Force, U.S. Preventive Services Task Force: Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003, 138: 927-937.CrossRefPubMed
25.
Callahan CM, Boustani MA, Unverzagt FW, Austrom MG, Damush TM, Perkins AJ, Fultz BA, Hui SL, Counsell SR, Hendrie HC: Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006, 295: 2148-2157. 10.1001/jama.295.18.2148.CrossRefPubMed
26.
Gräßel E, Trilling A, Donath C, Luttenberger K: Support groups for dementia caregivers: predictors for utilisation and expected quality from a family caregiver’s point of view. A questionnaire survey part I*. BMC Health Serv Res. 2010, 10: 219-10.1186/1472-6963-10-219.CrossRefPubMedPubMedCentral
27.
Donath C, Graßel E, Grossfeld-Schmitz M, Menn P, Lauterberg J, Wunder S, Marx P, Ruckdäschel S, Mehlig H, Holle R: Effects of general practitioner training and family support services on the care of home-dwelling dementia patients: results of a controlled cluster-randomized study. BMC Health Serv Res. 2010, 10: 314-10.1186/1472-6963-10-314.CrossRefPubMedPubMedCentral
28.
Dreier A, Thyrian JR, Hoffmann W: Dementia care manager in der ambulanten Demenzversorgung: Entwicklung einer innovativen Qualifizierung für Pflegefachkräfte. Pflege und Gesellschaft. 2011, 16: 53-64.
29.
Kalbe E, Kessler J, Calabrese P, Smith R, Passmore AP, Brand M, Bullock R: DemTect: a new, sensitive cognitive screening test to support the diagnosis of mild cognitive impairment and early dementia. Int J Geriatr Psychiatry. 2004, 19: 136-143. 10.1002/gps.1042.CrossRefPubMed
30.
Kalbe E, Brand M, Kessler J, Calabrese P: Der DemTect in der klinischen Anwendung. Z Gerontol Psychiatrie. 2005, 18: 121-130. 10.1024/1011-6877.18.3.121.CrossRef
31.
Cohen J: Statistical Power Analysis for the Behavioral Sciences. 1988, Lawrence Erlbaum Associates, Hillsdale, NJ, 2
32.
Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J: The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994, 44: 2308-2314. 10.1212/WNL.44.12.2308.CrossRefPubMed
33.
Zaudig M, Mittelhammer J, Hiller W, Pauls A, Thora C, Morinigo A, Mombour W: SIDAM: a structured interview for the diagnosis of dementia of the Alzheimer type, multi-infarct dementia and dementias of other aetiology according to ICD-10 and DSM-III-R. Psychol Med. 1991, 21: 225-236. 10.1017/S0033291700014811.CrossRefPubMed
34.
Kang M, Ragan BG, Park JH: Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008, 43: 215-221. 10.4085/1062-6050-43.2.215.CrossRefPubMedPubMedCentral
35.
Schulz KF, Grimes DA: Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002, 359: 614-618. 10.1016/S0140-6736(02)07750-4.CrossRefPubMed
36.
Logsdon RG, Gibbons LE, McCurry SM, Teri L: Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002, 64: 510-519.CrossRefPubMed
37.
Schaie KW: The database. Developmental Influences on Adult Intelligence: The Seattle Longitudinal Study. 2005, Oxford University Press, Oxford, 38-61.CrossRef
38.
39.
Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin e.V. (DEGAM): DEGAM-Leitlinie Nr 12: Demenz. 2008, Omikron, Düsseldorf
40.
Holt S, Schmiedl S, Thürmann PA: Potentially inappropriate medications in the elderly: the PRISCUS list] [in German. Dtsch Arztebl Int. 2010, 107: 543-551.PubMedPubMedCentral
41.
Campbell N, Boustani M, Limbil T, Ott C, Fox C, Maidment I, Schubert CC, Munger S, Fick D, Miller D, Gulati R: The cognitive impact of anticholinergics: a clinical review. Clin Interv Aging. 2009, 4: 225-233.PubMedPubMedCentral
42.
Erzigkeit H, Lehfeld H, Peña-Casanova J, Bieber F, Yekrangi-Hartmann C, Rupp M, Rappard F, Arnold K, Hindmarch I: The Bayer-Activities of Daily Living Scale (B-ADL): results from a validation study in three European countries. Dement Geriatr Cogn Disord. 2001, 12: 348-358. 10.1159/000051280.CrossRefPubMed
43.
Hindmarch I, Lehfeld H, de Jongh P, Erzigkeit H: The Bayer Activities of Daily Living Scale (B-ADL). Dement Geriatr Cogn Disord. 1998, 9 (Suppl 2): 20-26.CrossRefPubMed
44.
45.
Bullinger M, Kirchberger I: SF-36 Fragebogen zum Gesundheitszustand. 1998, Hogrefe, Handanweisung. Göttingen
46.
Sandholzer H, Hellenbrand W, Renteln-Kruse W, van Weel C, Walker P: STEP: standardized assessment of elderly people in primary care [in German]. Dtsch Med Wochenschr. 2004, 129 (Suppl 4): S183-S226.CrossRefPubMed
47.
Derogatis LR, Melisaratos N: The brief symptom inventory: an introductory report. Psychol Med. 1983, 13: 595-605. 10.1017/S0033291700048017.CrossRefPubMed
48.
Spitzer RL, Kroenke K, Williams JB: Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study: Primary Care Evaluation Of Mental Disorders. Patient Health Questionnaire. JAMA. 1999, 282: 1737-1744. 10.1001/jama.282.18.1737.CrossRefPubMed
49.
Löwe B, Zipfel S, Herzog W: PHQ-D Gesundheitsfragebogen für Patienten. 2002, Pfizer, New York
50.
Wimo A, Ijjungren G, Winblad B: Costs of dementia and dementia care: a review. Int J Geriatr Psychiatry. 1997, 12: 841-856. 10.1002/(SICI)1099-1166(199708)12:8<841::AID-GPS652>3.0.CO;2-R.CrossRefPubMed
51.
Fiß T, Ritter CA, Alte D, van den Berg N, Hoffmann W: Detection of drug related problems in an interdisciplinary health care model for rural areas in Germany. Pharm World Sci. 2010, 32: 566-574. 10.1007/s11096-010-9409-6.CrossRefPubMed
52.
Hoffmann W, van den Berg N, Thyrian JR, Fiß T: Frequency and determinants of potential drug-drug interactions in an elderly population receiving regular home visits by GPs – results of the home medication review in the AGnES-studies. Pharmacoepidemiol Drug Saf. 2011, 20 (12): 1311-8. 10.1002/pds.2224.CrossRefPubMed
Metadata
Title
Life- and person-centred help in Mecklenburg-Western Pomerania, Germany (DelpHi): study protocol for a randomised controlled trial
Authors
Jochen René Thyrian
Thomas Fiß
Adina Dreier
Georgia Böwing
Aniela Angelow
Sven Lueke
Stefan Teipel
Steffen Fleßa
Hans Jörgen Grabe
Harald Jürgen Freyberger
Wolfgang Hoffmann
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Trials / Issue 1/2012
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-13-56

Other articles of this Issue 1/2012

Trials 1/2012 Go to the issue

Study protocol

Clinical efficacy of antazoline in rapid cardioversion of paroxysmal atrial fibrillation -- a protocol of a single center, randomized, double-blind, placebo-controlled study (the AnPAF Study)

Study protocol

Evaluating the effectiveness of using personal tailored risk information and taster sessions to increase the uptake of smoking cessation services: study protocol for a randomised controlled trial

Study protocol

Effectiveness of Physio Acoustic Sound (PAS) therapy in demented nursing home residents with nocturnal restlessness: study protocol for a randomized controlled trial

Methodology

Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people

Methodology

Continuous controllable balloon dilation: a novel approach for cervix dilation

Study protocol

Efficacy of vision restoration therapy after optic neuritis (VISION study): study protocol for a randomized controlled trial