Intervention Study to Improve Life and Care for People With Dementia and Their Caregivers in Primary Care

NCT01401582 | Completed Results DMC

• 1 other identifier: DZNE_DelpHi-MV_001
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 1

Brief Summary

Caring for people with dementia and treating them is a major challenge for the health care system in Germany. Among the challenges for population-based health care research are (a) identification and early recognition, (b) multimorbidity and (c) the integration of persons with dementia into the health care system. One setting which is identified to meet the challenges is the primary care setting and there especially the general physician. There have been a few interventional studies, which have been restricted to selective samples and have been conducted in inpatient settings. The purpose of this study is to test the efficacy of implementing a subsidiary support system for persons with dementia living at home. This subsidiary support system is initiated by a Dementia Care Manager (DCM), a nurse with dementia-specific advanced training. The main goals are to improve quality of life and health care of the person with dementia and reduce caregiver´s burden. The study is a general physician based cluster-randomised controlled intervention trial. A population based sample of general physicians will be asked to participate in a systematic screening trial to identify people with dementia in primary care in Mecklenburg Western Pommerania (MV), a federal state in Germany. Upon identification the people will be asked to participate in the DelpHi-MV study and after having given written informed consent will then be assigned to an intervention and a control group. Identification of people with dementia will be achieved by a short screening questionnaire in the physician's office. An extended in-depth data assessment will be conducted after inclusion into the study and then annually to measure the course of the people's health. Data assessment will be done at the people's homes. People assigned to the intervention group will receive an intervention provided by "Dementia Care Manager". The Dementia Care Manager is a specialised nurse that is going into the person's home to manage the care of dementia as well as caring for the person's relative/ or carer.

Conditions

Dementia

Keywords

health care; dementia care; caregiver support; epidemiological study

Outcome Measures

Primary Outcomes (5)

• Change in Quality of Life

  The Quality of Life in Alzheimer's Disease (Qol-AD; Logsdon et al. 2002) was used. This measure designed specifically to obtain a rating of the patient's quality of life from both the patient and the caregiver. Each item is rated on a four point scale, with 1 being poor and 4 being excellent. Total scores, obtained by the sum of all 13 items, range from 13 to 52.

  one year after baseline assessment

• Change in Caregiver Burden

  Caregiver burden was assessed using the "Berliner Inventar zur Angehörigenbelastung - Demenz" (BIZA-D) (Zank et al., 2006). The BIZAD was developed to assess objective as well as subjective burden due to caring for a person wit dementia (PWD). It consists of 88 items covering 20 dimensions of caregiver burden. Objective burden is divided into six dimensions: 1) basic care tasks like support eating, hygiene etc (7 items), 2) extended care tasks like supporting grocery shopping, legal affairs etc. (3 items), 3) Motivation and Guidance (4 items), 4) emotional support (4 items), 5) supporting maintenance of social contacts (3 items) and 6) supervision (4 items). Each item has to be rated regarding the frequency of the support needed on a 5-Point scale (example: supervision; Does the patient need this kind of support: 1=always, 2= mostly, 3=partly, 4=hardly, 5= not at all). Then each item asks: Who is providing this support: all by someone else, mostly by someone else, evenly distributed

  one year after baseline assessment

• Change in Behavioral and Psychological Symptoms of Dementia

  Neuropsychiatric Inventory (NPI; Cummings 1997); The NPI represents an interview by proxy on twelve dimensions of neuropsychiatric behaviors, i.e. delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The presence (0= no, 1= yes) is asked. If present, the severity (rated 1 through 3; mild to severe) and frequency (1 to 4, rarely to very often) of each neuropsychiatric symptom are rated on. Thus the score for each dimension ranges from 0 = not present, 1= mildly and rarely to 12 = severe and often. A total NPI score is calculated as the sum of the frequency by severity scores ofeach domain range: 0 to 144, the higher the more neuropsychiatric symptomatic).

  one year after baseline assessment

• Change in Medical Treatment With Antidementia Drugs

  medication was systematically reviewed; A computer-based home medication review (HMR) encompasses all medications used by the study participants and includes questions about compliance, adverse effects and drug administration. The collection of primary data on medication in the context of the HMR includes both prescription drugs and over-the-counter drugs. The assignment was then integrated using a master file of the Pharmaceutical Index. The following antidementia drugs were considered: donepezil (N06AD02), rivastigmine (N06AD03), galantamine (N06AD04) and memantine (N06AX01).

  one year after baseline assessment

• Reduction of Potential Inapropriate Medication (PIM)

  Having to deal with multimorbidity and polypharmacy in a sample of chronically ill elderly, we also analyze potentially inappropriate medication (PIM), defined as "a drug for which the risk of an adverse event outweighs the clinical benefit, particularly when there is evidence in favor of a safer or more effective alternative therapy for the same condition". The PIM were identified using the Priscus list, which contains 83 drugs from 18 different drug classes.

  one year after baseline assessment

Secondary Outcomes (5)

• Person With Dementia: Change in Activities of Daily Living

  one year after baseline assessment

• Person With Dementia: Change in Social Support

  participants will be followed yearly until institutionalisation or death after an expected average of 5 years

• Person With Dementia and Caregiver: Change in Health Status

  participants will be followed yearly until institutionalisation or death after an expected average of 5 years

• Person With Dementia: Change in Utilization of Health Care Resources

  participants will be followed yearly until institutionalisation or death after an expected average of 5 years

• Person With Dementia: Change in Medication

  participants will be followed yearly until institutionalisation or death after an expected average of 5 years

Study Arms (2)

care as usual

NO INTERVENTION

care as usual, no intervention, just observation of natural change/ trajectories over time

Implementation of Dementia Care Manager

EXPERIMENTAL

Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system

Other: Implementation of Dementia Care Manager

Interventions

Implementation of Dementia Care Manager OTHER

Home-visits of trained "Dementia Care Manager (DCM)" at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.

Also known as: Dementia Care Manager, Care Management, counselling, supporting caregivers

Implementation of Dementia Care Manager

Eligibility Criteria

• Age: 70 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• + years
• must be living at home
• screening positive (DEMTECT \< 9), indicating dementia

You may not qualify if:

• medical conditions not allowing testing

Sponsors & Collaborators

• German Center for Neurodegenerative Diseases (DZNE): lead
• University Medicine Greifswald: collaborator

Study Sites (1)

Institute for Community Medicine

Greifswald, Mecklenburg- Western Pommerania, 17489, Germany

Location

Related Publications (48)

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  BACKGROUND

• Fydrich T, Sommer G, Brähler E. F-SozU. Fragebogen zur sozialen Unterstützung. Göttingen: Hogrefe; 2007.

  BACKGROUND

• Zank S, Schacke C, Leipold B. Berliner Inventar zur Angehörigenbelastung - Demenz (BIZA-D). Zeitschrift für Klinische Psychologie und Psychotherapie 2006; 35(4):296-305.

  BACKGROUND

• Monsch AU. [Neuropsychological examination in evaluating dementia]. Praxis (Bern 1994). 1997 Aug 27;86(35):1340-2. German.

  PMID: 9381025 BACKGROUND

• Reiner K, Eichler T, Hertel J, Hoffmann W, Thyrian JR. The Clock Drawing Test: A Reasonable Instrument to Assess Probable Dementia in Primary Care? Curr Alzheimer Res. 2018;15(1):38-43. doi: 10.2174/1567205014666170908101822.

  PMID: 28891446 RESULT

• Eichler T, Thyrian JR, Hertel J, Richter S, Michalowsky B, Wucherer D, Dreier A, Kilimann I, Teipel S, Hoffmann W. Patient Variables Associated with the Assignment of a Formal Dementia Diagnosis to Positively Screened Primary Care Patients. Curr Alzheimer Res. 2018;15(1):44-50. doi: 10.2174/1567205014666170908095707.

  PMID: 28891445 RESULT

• Wucherer D, Thyrian JR, Eichler T, Hertel J, Kilimann I, Richter S, Michalowsky B, Zwingmann I, Dreier-Wolfgramm A, Ritter CA, Teipel S, Hoffmann W. Drug-related problems in community-dwelling primary care patients screened positive for dementia. Int Psychogeriatr. 2017 Nov;29(11):1857-1868. doi: 10.1017/S1041610217001442. Epub 2017 Aug 7.

  PMID: 28780910 RESULT

• Thyrian JR, Hertel J, Wucherer D, Eichler T, Michalowsky B, Dreier-Wolfgramm A, Zwingmann I, Kilimann I, Teipel S, Hoffmann W. Effectiveness and Safety of Dementia Care Management in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Oct 1;74(10):996-1004. doi: 10.1001/jamapsychiatry.2017.2124.

  PMID: 28746708 RESULT

• Dreier-Wolfgramm A, Michalowsky B, Austrom MG, van der Marck MA, Iliffe S, Alder C, Vollmar HC, Thyrian JR, Wucherer D, Zwingmann I, Hoffmann W. Dementia care management in primary care : Current collaborative care models and the case for interprofessional education. Z Gerontol Geriatr. 2017 May;50(Suppl 2):68-77. doi: 10.1007/s00391-017-1220-8. Epub 2017 Mar 31.

  PMID: 28364258 RESULT

• Michalowsky B, Flessa S, Eichler T, Hertel J, Dreier A, Zwingmann I, Wucherer D, Rau H, Thyrian JR, Hoffmann W. Healthcare utilization and costs in primary care patients with dementia: baseline results of the DelpHi-trial. Eur J Health Econ. 2018 Jan;19(1):87-102. doi: 10.1007/s10198-017-0869-7. Epub 2017 Feb 3.

  PMID: 28160100 RESULT

• Wucherer D, Eichler T, Hertel J, Kilimann I, Richter S, Michalowsky B, Thyrian JR, Teipel S, Hoffmann W. Potentially Inappropriate Medication in Community-Dwelling Primary Care Patients who were Screened Positive for Dementia. J Alzheimers Dis. 2017;55(2):691-701. doi: 10.3233/JAD-160581.

  PMID: 27716668 RESULT

• Thyrian JR, Winter P, Eichler T, Reimann M, Wucherer D, Dreier A, Michalowsky B, Zarm K, Hoffmann W. Relatives' burden of caring for people screened positive for dementia in primary care : Results of the DelpHi study. Z Gerontol Geriatr. 2017 Jan;50(1):4-13. doi: 10.1007/s00391-016-1119-9. Epub 2016 Aug 17.

  PMID: 27534949 RESULT

• Eichler T, Thyrian JR, Hertel J, Wucherer D, Michalowsky B, Reiner K, Dreier A, Kilimann I, Teipel S, Hoffmann W. Subjective memory impairment: No suitable criteria for case-finding of dementia in primary care. Alzheimers Dement (Amst). 2015 Apr 30;1(2):179-86. doi: 10.1016/j.dadm.2015.02.004. eCollection 2015 Jun.

  PMID: 27239503 RESULT

• Thyrian JR, Eichler T, Pooch A, Albuerne K, Dreier A, Michalowsky B, Wucherer D, Hoffmann W. Systematic, early identification of dementia and dementia care management are highly appreciated by general physicians in primary care - results within a cluster-randomized-controlled trial (DelpHi). J Multidiscip Healthc. 2016 Apr 19;9:183-90. doi: 10.2147/JMDH.S96055. eCollection 2016.

  PMID: 27143912 RESULT

• Thyrian JR, Eichler T, Michalowsky B, Wucherer D, Reimann M, Hertel J, Richter S, Dreier A, Hoffmann W. Community-Dwelling People Screened Positive for Dementia in Primary Care: A Comprehensive, Multivariate Descriptive Analysis Using Data from the DelpHi-Study. J Alzheimers Dis. 2016 Mar 30;52(2):609-17. doi: 10.3233/JAD-151076.

  PMID: 27031481 RESULT

• Eichler T, Hoffmann W, Hertel J, Richter S, Wucherer D, Michalowsky B, Dreier A, Thyrian JR. Living Alone with Dementia: Prevalence, Correlates and the Utilization of Health and Nursing Care Services. J Alzheimers Dis. 2016;52(2):619-29. doi: 10.3233/JAD-151058.

  PMID: 27031480 RESULT

• Eichler T, Thyrian JR, Hertel J, Richter S, Wucherer D, Michalowsky B, Teipel S, Kilimann I, Dreier A, Hoffmann W. Unmet Needs of Community-Dwelling Primary Care Patients with Dementia in Germany: Prevalence and Correlates. J Alzheimers Dis. 2016;51(3):847-55. doi: 10.3233/JAD-150935.

  PMID: 26890767 RESULT

• Thyrian JR, Eichler T, Reimann M, Wucherer D, Dreier A, Michalowsky B, Hoffmann W. Depressive symptoms and depression in people screened positive for dementia in primary care - results of the DelpHi-study. Int Psychogeriatr. 2016 Jun;28(6):929-37. doi: 10.1017/S1041610215002458. Epub 2016 Jan 20.

  PMID: 26785854 RESULT

• Michalowsky B, Thyrian JR, Eichler T, Hertel J, Wucherer D, Flessa S, Hoffmann W. Economic Analysis of Formal Care, Informal Care, and Productivity Losses in Primary Care Patients who Screened Positive for Dementia in Germany. J Alzheimers Dis. 2016;50(1):47-59. doi: 10.3233/JAD-150600.

  PMID: 26639964 RESULT

• Michalowsky B, Eichler T, Thyrian JR, Hertel J, Wucherer D, Hoffmann W, Flessa S. Healthcare resource utilization and cost in dementia: are there differences between patients screened positive for dementia with and those without a formal diagnosis of dementia in primary care in Germany? - ERRATUM. Int Psychogeriatr. 2016 Mar;28(3):371. doi: 10.1017/S1041610215001908. Epub 2015 Oct 29.

  PMID: 26510524 RESULT

• Dreier A, Thyrian JR, Eichler T, Hoffmann W. Qualifications for nurses for the care of patients with dementia and support to their caregivers: A pilot evaluation of the dementia care management curriculum. Nurse Educ Today. 2016 Jan;36:310-7. doi: 10.1016/j.nedt.2015.07.024. Epub 2015 Jul 31.

  PMID: 26277428 RESULT

• Thyrian JR, Eichler T, Hertel J, Wucherer D, Dreier A, Michalowsky B, Killimann I, Teipel S, Hoffmann W. Burden of Behavioral and Psychiatric Symptoms in People Screened Positive for Dementia in Primary Care: Results of the DelpHi-Study. J Alzheimers Dis. 2015;46(2):451-9. doi: 10.3233/JAD-143114.

  PMID: 25765916 RESULT

• Eichler T, Thyrian JR, Hertel J, Michalowsky B, Wucherer D, Dreier A, Kilimann I, Teipel S, Hoffmann W. Rates of formal diagnosis of dementia in primary care: The effect of screening. Alzheimers Dement (Amst). 2015 Mar 29;1(1):87-93. doi: 10.1016/j.dadm.2014.11.007. eCollection 2015 Mar.

  PMID: 27239495 RESULT

• Wucherer D, Eichler T, Kilimann I, Hertel J, Michalowsky B, Thyrian JR, Teipel S, Hoffmann W. Antidementia drug treatment in people screened positive for dementia in primary care. J Alzheimers Dis. 2015;44(3):1015-21. doi: 10.3233/JAD-142064.

  PMID: 25391382 RESULT

• Teipel SJ, Thyrian JR, Hertel J, Eichler T, Wucherer D, Michalowsky B, Kilimann I, Hoffmann W. Neuropsychiatric symptoms in people screened positive for dementia in primary care. Int Psychogeriatr. 2015 Jan;27(1):39-48. doi: 10.1017/S1041610214001987. Epub 2014 Sep 23.

  PMID: 25247664 RESULT

• Eichler T, Wucherer D, Thyrian JR, Kilimann I, Hertel J, Michalowsky B, Teipel S, Hoffmann W. Antipsychotic drug treatment in ambulatory dementia care: prevalence and correlates. J Alzheimers Dis. 2015;43(4):1303-11. doi: 10.3233/JAD-141554.

  PMID: 25147117 RESULT

• Michalowsky B, Eichler T, Thyrian JR, Hertel J, Wucherer D, Laufs S, Flessa S, Hoffmann W. Medication cost of persons with dementia in primary care in Germany. J Alzheimers Dis. 2014;42(3):949-58. doi: 10.3233/JAD-140804.

  PMID: 25125471 RESULT

• Eichler T, Thyrian JR, Hertel J, Kohler L, Wucherer D, Dreier A, Michalowsky B, Teipel S, Hoffmann W. Rates of formal diagnosis in people screened positive for dementia in primary care: results of the DelpHi-Trial. J Alzheimers Dis. 2014;42(2):451-8. doi: 10.3233/JAD-140354.

  PMID: 24898640 RESULT

• Eichler T, Thyrian JR, Fredrich D, Kohler L, Wucherer D, Michalowsky B, Dreier A, Hoffmann W. The benefits of implementing a computerized intervention-management-system (IMS) on delivering integrated dementia care in the primary care setting. Int Psychogeriatr. 2014 Aug;26(8):1377-85. doi: 10.1017/S1041610214000830. Epub 2014 May 9.

  PMID: 24811145 RESULT

• Fiss T, Thyrian JR, Wucherer D, Assmann G, Kilimann I, Teipel SJ, Hoffmann W. Medication management for people with dementia in primary care: description of implementation in the DelpHi study. BMC Geriatr. 2013 Nov 13;13:121. doi: 10.1186/1471-2318-13-121.

  PMID: 24225205 RESULT

• Eichler T, Thyrian JR, Dreier A, Wucherer D, Kohler L, Fiss T, Bowing G, Michalowsky B, Hoffmann W. Dementia care management: going new ways in ambulant dementia care within a GP-based randomized controlled intervention trial. Int Psychogeriatr. 2014 Feb;26(2):247-56. doi: 10.1017/S1041610213001786. Epub 2013 Oct 23.

  PMID: 24152974 RESULT

• Thyrian JR, Fiss T, Dreier A, Bowing G, Angelow A, Lueke S, Teipel S, Flessa S, Grabe HJ, Freyberger HJ, Hoffmann W. Life- and person-centred help in Mecklenburg-Western Pomerania, Germany (DelpHi): study protocol for a randomised controlled trial. Trials. 2012 May 10;13:56. doi: 10.1186/1745-6215-13-56.

  PMID: 22575023 RESULT

• Michalowsky B, Blotenberg I, Platen M, Teipel S, Kilimann I, Portacolone E, Bohlken J, Radke A, Buchholz M, Scharf A, Muehlichen F, Xie F, Thyrian JR, Hoffmann W. Clinical Outcomes and Cost-Effectiveness of Collaborative Dementia Care: A Secondary Analysis of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419282. doi: 10.1001/jamanetworkopen.2024.19282.

  PMID: 38967926 DERIVED

• Muhlichen F, Michalowsky B, Radke A, Platen M, Mohr W, Thyrian JR, Hoffmann W. Tasks and Activities of an Effective Collaborative Dementia Care Management Program in German Primary Care. J Alzheimers Dis. 2022;87(4):1615-1625. doi: 10.3233/JAD-215656.

  PMID: 35491783 DERIVED

• Muller B, Kropp P, Cardona MI, Michalowsky B, van den Berg N, Teipel S, Hoffmann W, Thyrian JR. Types of leisure time physical activities (LTPA) of community-dwelling persons who have been screened positive for dementia. BMC Geriatr. 2021 Apr 23;21(1):270. doi: 10.1186/s12877-021-02201-1.

  PMID: 33892624 DERIVED

• Zwingmann I, Dreier-Wolfgramm A, Esser A, Wucherer D, Thyrian JR, Eichler T, Kaczynski A, Monsees J, Keller A, Hertel J, Kilimann I, Teipel S, Michalowsky B, Hoffmann W. Why do family dementia caregivers reject caregiver support services? Analyzing types of rejection and associated health-impairments in a cluster-randomized controlled intervention trial. BMC Health Serv Res. 2020 Feb 14;20(1):121. doi: 10.1186/s12913-020-4970-8.

  PMID: 32059724 DERIVED

• Zwingmann I, Michalowsky B, Esser A, Kaczynski A, Monsees J, Keller A, Hertel J, Wucherer D, Thyrian JR, Eichler T, Kilimann I, Teipel S, Dreier Wolfgramm A, Hoffmann W. Identifying Unmet Needs of Family Dementia Caregivers: Results of the Baseline Assessment of a Cluster-Randomized Controlled Intervention Trial. J Alzheimers Dis. 2019;67(2):527-539. doi: 10.3233/JAD-180244.

  PMID: 30584136 DERIVED

• Brueggen K, Dyrba M, Kilimann I, Henf J, Hoffmann W, Thyrian JR, Teipel S. Hippocampal Mean Diffusivity for the Diagnosis of Dementia and Mild Cognitive Impairment in Primary Care. Curr Alzheimer Res. 2018;15(11):1005-1012. doi: 10.2174/1567205015666180613114829.

  PMID: 29895247 DERIVED

• Zwingmann I, Hoffmann W, Michalowsky B, Wucherer D, Eichler T, Teipel S, Dreier-Wolfgramm A, Kilimann I, Thyrian JR. [Unmet needs of family dementia caregivers of persons with dementia : Primary medical care]. Nervenarzt. 2018 May;89(5):495-499. doi: 10.1007/s00115-018-0509-1. German.

  PMID: 29619534 DERIVED

• Teipel SJ, Keller F, Thyrian JR, Strohmaier U, Altiner A, Hoffmann W, Kilimann I. Hippocampus and Basal Forebrain Volumetry for Dementia and Mild Cognitive Impairment Diagnosis: Could It Be Useful in Primary Care? J Alzheimers Dis. 2017;55(4):1379-1394. doi: 10.3233/JAD-160778.

  PMID: 27834778 DERIVED

MeSH Terms

Conditions

Dementia

Interventions

Counseling

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: PD Dr. JR Thyrian
• Organization: Geman Centr for Neurodegenerative Diseases (DZN)

rene.thyrian@dzne.de

+49383486

Study Officials

• Wolfgang Hoffmann, MD, MPH

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Group Leader

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 25, 2011
• Study Start: January 1, 2012
• Primary Completion: March 31, 2016
• Study Completion: December 31, 2024
• Last Updated: August 20, 2025
• Results First Posted: June 16, 2017

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)