Interprofessional Dementia Care (InDePendent)

March 16, 2023 updated by: Wolfgang Hoffmann, German Center for Neurodegenerative Diseases (DZNE)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

465

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Brandenburg
      • Elsterwerda, Brandenburg, Germany, 04910
        • MEDIS Ärztenetz medizinischer Versorgung Südbrandenburg
    • Hessen
      • Frankfurt, Hessen, Germany, 60528
        • GNEF Gesundheitsnetz Frankfurt am Main
    • Mecklenburg- Western Pommerania
      • Prenzlau, Mecklenburg- Western Pommerania, Germany, 17291
        • Demenz-Netzwerk Uckermark e.V.
      • Ueckermünde, Mecklenburg- Western Pommerania, Germany, 17373
        • HaffNet Management GmbH
    • Mecklenburg-Western-Pomerania
      • Greifswald, Mecklenburg-Western-Pomerania, Germany, 17487
        • DZNE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- not able to provide written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Other: Dementia Care Management (DCM)
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).
No Intervention: Care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of unmet needs (CANE)
Time Frame: 6 months after baseline assessment

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (Qol-AD)
Time Frame: 6 months after baseline assessment
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.
6 months after baseline assessment
Health status (EQ-5D-5L)
Time Frame: 6 months after baseline assessment
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.
6 months after baseline assessment
Costs of informal care (Resource Utilization in Dementia)
Time Frame: 6 months after baseline assessment
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.
6 months after baseline assessment
Costs of formal care (Utilization of Medical and Nursing services)
Time Frame: 6 months after baseline assessment
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.
6 months after baseline assessment
Caregiver Burden (Zarit)
Time Frame: 6 months after baseline assessment
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.
6 months after baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Center for Neurodegenerative Diseases (DZNE)

Collaborators

University Medicine Greifswald
Techniker Krankenkasse
Federal Joint Committee
AOK Nordost
University Medicine Rostock
GNEF Gesundheitsnetz Frankfurt am Main eG
Haffnet Management GmbH
Demenznetzwerk Uckermark e.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01NVF18034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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