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DementiaInDePendentNCT04741932

Interprofessional Dementia Care

A study testing Dementia Care Management (DCM) in people with Dementia and Nurse's Role, run by German Center for Neurodegenerative Diseases (DZNE) at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Dementia, Nurse's Role, Nurse Physician Relations
What is being tested?
Dementia Care Management (DCM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
471 participants
Where
5 sitesGermany
Study dates
13 Jan 2021to 31 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • not able to provide written consent

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • MEDIS Ärztenetz medizinischer Versorgung Südbrandenburg

    Elsterwerda, Brandenburg, 04910

  • GNEF Gesundheitsnetz Frankfurt am Main

    Frankfurt am Main, Hesse, 60528

  • DZNE

    Greifswald, Mecklenburg-Vorpommern, 17487

  • Demenz-Netzwerk Uckermark e.V.

    Prenzlau, Mecklenburg- Western Pommerania, 17291

  • HaffNet Management GmbH

    Ueckermünde, Mecklenburg- Western Pommerania, 17373

Other trials in Germany

About this study

Official title: Interprofessional Dementia Care: Redistribution of Tasks Between Physicians and Qualified Nurses in Primary Care

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).

Read the detailed description

Previous studies found that PwD treated by primary care physicians on average have 8.8 (± 5.04; range = 0-31) unmet care needs, mainly related to nursing care (38%) and drug therapy (15%). PwD had additional needs for daily activities, social participation and showed a high level of psychological stress. The number of unmet care needs is more dependent on the physical limitations than on the cognitive impairments. The progression of dementia is therefore associated with an increase in open and unmet care needs and a reduced opportunity to recognize these needs in the primary care setting and to address them appropriately. At this time, no curative treatment for dementia exists. Thus, innovative models of high-value care have to be found in order to enable PwD to live an independent, self-determined life with a high quality of life for as long as possible. The increasing burden of disease associated with an increase in prevalence of dementia is associated with high health expenditures, which puts additional pressure on health care systems. From a health economical perspective the minimization of supply deficits and open needs of care are crucial aspects to avoid or delay a cost-intensive transfer to an inpatient facility. The overall goal of the InDePendent project is to improve the living and care situation of PwD and their relatives at home. Following this aim, an innovative redistribution of tasks between general practitioners and specialized nurses for dementia patients will be implemented and evaluated. In addition, the specialized nurses will be trained for cross-sector as well as cross-professional dementia care management (DCM), by acquisition of specific competencies to carry out medical tasks in delegation and substitution. Collaborating Dementia Networks and GP clinics will serve as the units of randomization and determine the patients' group status (control or intervention group). The GPs will systematically screen the patients for eligibility to participate in the study during routine care (eligibility criteria for screening: age ≥70 years, living at home). Patients will be screened using the validated DemTect questionnaire (eligibility for study participation: <9 points). In case of a positive screening or an existing dementia diagnosis, potential participants will receive detailed information about the study including a study-information sheet from their GP, be invited to participate and asked to provide written informed consent.

Being tested
Dementia Care Management (DCM)
Keywords
Dementia, Dementia Care, Caregiver of people with dementia, Unmet needs, Medical management
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT04741932
Study groupRoleWhat they receive
Care as usualNo interventionNot described
InterventionExperimentalNot described
Receives: Other: Dementia Care Management (DCM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after baseline assessment

Secondary outcomes (5)

  1. Quality of life (Qol-AD)

    The Quality of life in Alzheimer's Disease (Qol-AD; Logsdon et al. 2002) will be used to assess participants' quality of life. The instrument contains 13 items. Each item is rated on a four point likert scale, in which 1 stands for being poor and 4 being excellent. Result is a sum of all 13 items from 13 to 52. Higher numbers indicate higher quality of life.

    Measured: 6 months after baseline assessment

  2. Health status (EQ-5D-5L)

    The EQ-5D-5L instrument (Janssen et al. 2013) will be used to assess participants' health status, quality of life and for the health economic evaluation. The instrument contains 5 dimensions and one score from 0 to 100 to assess participants' current health status. Each of the 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/ Depression) are rated on a five point likert scale. Result of the EQ-5D-5L is an individual health index.

    Measured: 6 months after baseline assessment

  3. Costs of informal care (Resource Utilization in Dementia)

    Informal care is an essential part of society's resource consumption and the costs of dementia care. For the health economic evaluation the RUD (Resource Utilization in Dementia Questionnaire, Wimo, Jonsson \& Zbrozek, 2010) will be used to determine the supply costs and the informal care provided. The RUD instrument was developed to capture the use of resources by demented patients in a clinical trial setting, which in a further step can be calculated into costs.

    Measured: 6 months after baseline assessment

  4. Costs of formal care (Utilization of Medical and Nursing services)

    For the health economic evaluation the FIMA (Questionnaire for Health-Related Resource Use in an Elderly Population, Seidl et al. 2015) will be used to determine the supply costs and the formal care provided.

    Measured: 6 months after baseline assessment

  5. Caregiver Burden (Zarit)

    Caregiver burden will be assessed by using the Zarit Burden Inventory (Zarit, 1980). The instrument consists of 22 items. The result of the instrument is a sum between 22 and 88 - higher results indicate a higher subjective level of burden.

    Measured: 6 months after baseline assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start13 Jan 2021
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
471 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04741932
Sponsor's protocol ID
01NVF18034
Acronym
InDePendent
Status last verified
Aug 2024
First submitted
2 Feb 2021
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26890767

  • 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.

    PubMed 19602305

  • 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.

    PubMed 25125471

  • 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.

    PubMed 10912220

  • 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.

    PubMed 12021425

  • 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.

    PubMed 7203086

  • 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.

    PubMed 21479777

  • 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.

    PubMed 20922346

  • 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.

    PubMed 23184421

  • 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.

    PubMed 41143334

  • 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.

    PubMed 40148225

  • 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.

    PubMed 38669533

  • 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.

    PubMed 35410437

Questions about this trial

What is this clinical trial studying?

A study testing Dementia Care Management (DCM) in people with Dementia and Nurse's Role, run by German Center for Neurodegenerative Diseases (DZNE) at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of unmet needs (CANE) (time frame: 6 months after baseline assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04741932, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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