Interprofessional Dementia Care

NCT04741932 | Completed

• 1 other identifier: 01NVF18034
• Study Type: interventional
• Target: 471
• Locations: 1 country
• Sites: 5

Brief Summary

Currently, around 1.7 million people with dementia live in Germany. The number of new cases per year is estimated to be around 244,000. At this time, no curative treatment for dementia exists. The progression of the disease results in high needs for care. Only a minority among People with Dementia (PwD) receive needs-based treatment and directive-compliant care. Previous studies found that more than 95% of PwD have an open need for care. The increase in chronically and multimorbid impaired patients leads to an increased number of patients in primary care. Particularly in rural regions, innovative care concepts based on a redistribution of tasks between specialized nurses and doctors could help to guarantee high-value care at all times. Nursing care can be expanded with regards to tasks and competencies, which is thought to increase the attractiveness of the nursing profession. Unfortunately, there are currently no scientific studies on the effectiveness and impact of such care concepts in Germany. The Aim of this study is to implement a structured care concept for the reallocation of tasks between general practitioners (GPs) and nurses and to evaluate its effectiveness on the living and care situation of people with dementia living at home. "InDePendent" is a multicenter, cluster-randomized, controlled intervention study with a waiting-control group. Randomization is carried out at the level of the participating GPs in a ratio of 1:2 (intervention group : waiting-control group).

Conditions

Dementia; Nurse's Role; Nurse Physician Relations

Keywords

Dementia; Dementia Care; Caregiver of people with dementia; Unmet needs; Medical management

Outcome Measures

Primary Outcomes (1)

• Number of unmet needs (CANE)

  The CANE questionnaire (Camberwell Assessment of Need for the Elderly, Stein et al., 2019) will be used to assess participants' and their relatives' unmet needs in group comparison between IG compared to the CG. The CANE comprises 27 areas of daily life for assessing the physical, psychological, social and environmental needs of older people. There are two versions of the CANE for both participant and caregiver.

  6 months after baseline assessment

Secondary Outcomes (5)

• Quality of life (Qol-AD)

  6 months after baseline assessment

• Health status (EQ-5D-5L)

  6 months after baseline assessment

• Costs of informal care (Resource Utilization in Dementia)

  6 months after baseline assessment

• Costs of formal care (Utilization of Medical and Nursing services)

  6 months after baseline assessment

• Caregiver Burden (Zarit)

  6 months after baseline assessment

Study Arms (2)

Care as usual

NO INTERVENTION

Intervention

EXPERIMENTAL

Other: Dementia Care Management (DCM)

Interventions

Dementia Care Management (DCM) OTHER

A computerized "Information and Care Management System" (IMS) will identify unmet nursing, medical, psychosocial and social needs of the PwD and its informal caregiver. Based on this data, the IMS generates suggestions for interventions: The DCM in cooperation with the general practitioner (GP) develops an individual treatment and care plan that is tailored to the needs of the PwD and its caregiver. The DCM will initiate the implementation of respective actions and monitor the status of implementation. Therefore, the DCMs are supposed to take on activities that were previously usually performed by doctors (redistribution of tasks between physicians and qualified nurses in primary care).

Intervention

Eligibility Criteria

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

You may qualify if:

• + years
• PwD lives at home
• existing dementia diagnosis or screening result of DemTect \<9
• caregiver: main caregiver of a PwD (Hauptversorgungsperson)

You may not qualify if:

• \- not able to provide written consent

Sponsors & Collaborators

• German Center for Neurodegenerative Diseases (DZNE): lead
• University Medicine Greifswald: collaborator
• University Medicine Rostock: collaborator
• GNEF Gesundheitsnetz Frankfurt am Main eG: collaborator
• Haffnet Management GmbH: collaborator
• Demenznetzwerk Uckermark e.V.: collaborator
• Techniker Krankenkasse: collaborator
• AOK Nordost: collaborator
• Federal Joint Committee: collaborator

Study Sites (5)

MEDIS Ärztenetz medizinischer Versorgung Südbrandenburg

Elsterwerda, Brandenburg, 04910, Germany

Location

GNEF Gesundheitsnetz Frankfurt am Main

Frankfurt am Main, Hesse, 60528, Germany

Location

Demenz-Netzwerk Uckermark e.V.

Prenzlau, Mecklenburg- Western Pommerania, 17291, Germany

Location

HaffNet Management GmbH

Ueckermünde, Mecklenburg- Western Pommerania, 17373, Germany

Location

DZNE

Greifswald, Mecklenburg-Vorpommern, 17487, Germany

Location

Related Publications (13)

• 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 BACKGROUND

• van der Roest HG, Meiland FJ, Comijs HC, Derksen E, Jansen AP, van Hout HP, Jonker C, Droes RM. What do community-dwelling people with dementia need? A survey of those who are known to care and welfare services. Int Psychogeriatr. 2009 Oct;21(5):949-65. doi: 10.1017/S1041610209990147. Epub 2009 Jul 15.

  PMID: 19602305 BACKGROUND

• 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 BACKGROUND

• Reynolds T, Thornicroft G, Abas M, Woods B, Hoe J, Leese M, Orrell M. Camberwell Assessment of Need for the Elderly (CANE). Development, validity and reliability. Br J Psychiatry. 2000 May;176:444-52. doi: 10.1192/bjp.176.5.444.

  PMID: 10912220 BACKGROUND

• Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.

  PMID: 12021425 BACKGROUND

• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

  PMID: 7203086 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Wimo A, Jonsson L, Zbrozek A. The Resource Utilization in Dementia (RUD) instrument is valid for assessing informal care time in community-living patients with dementia. J Nutr Health Aging. 2010 Oct;14(8):685-90. doi: 10.1007/s12603-010-0316-2.

  PMID: 20922346 BACKGROUND

• Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.

  PMID: 23184421 BACKGROUND

• Radke A, Michalowsky B, Kleinke F, Platen M, Scharf A, Pfaff M, Buchholz M, Muhlichen F, Penndorf P, Schade S, Dombrowski J, Lerch PEM, Reber KC, Austenat-Wied M, Martens C, van den Berg N, Hoffmann W. Efficacy and cost-effectiveness of extended nursing roles in dementia care: Results of the cluster-randomized trial InDePendent. Alzheimers Dement. 2025 Oct;21(10):e70727. doi: 10.1002/alz.70727.

  PMID: 41143334 DERIVED

• Scharf A, Michalowsky B, Radke A, Kleinke F, Schade S, Platen M, Buchholz M, Pfaff M, Iskandar A, van den Berg N, Hoffmann W. Identifying and Addressing Unmet Needs in Dementia: The Role of Care Access and Psychosocial Support. Int J Geriatr Psychiatry. 2025 Apr;40(4):e70066. doi: 10.1002/gps.70066.

  PMID: 40148225 DERIVED

• Scharf A, Kleinke F, Michalowsky B, Radke A, Pfitzner S, Muhlichen F, Buchholz M, van den Berg N, Hoffmann W. Sociodemographic and Clinical Characteristics of People Living with Dementia and Their Associations with Unmet Healthcare Needs: Insights from the Baseline Assessment of the InDePendent Study. J Alzheimers Dis. 2024;99(2):559-575. doi: 10.3233/JAD-231173.

  PMID: 38669533 DERIVED

• Kleinke F, Michalowsky B, Radke A, Platen M, Muhlichen F, Scharf A, Mohr W, Penndorf P, Bahls T, van den Berg N, Hoffmann W. Advanced nursing practice and interprofessional dementia care (InDePendent): study protocol for a multi-center, cluster-randomized, controlled, interventional trial. Trials. 2022 Apr 11;23(1):290. doi: 10.1186/s13063-022-06249-1.

  PMID: 35410437 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Wolfgang Hoffmann, MD, MPH, Prof.

  German Center for Neurodegenerative Diseases (DZNE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group Leader and Site Speaker

Model Details: Special qualified nurses with an extended nursing role (Dementia Care Manager) record all nursing, medical, drug, psychosocial and social care needs using an IT-based care management system and then implement them over a period of six months.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: January 13, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)