Interprofessional Dementia Care

NCT ID: NCT04741932

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 471 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2023-08-31

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).

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.

Conditions

Dementia; Nurse's Role; Nurse Physician Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Care as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Group Type: EXPERIMENTAL

Dementia Care Management (DCM)

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medicine Greifswald

OTHER

Sponsor Role: collaborator

University Medicine Rostock

UNKNOWN

Sponsor Role: collaborator

GNEF Gesundheitsnetz Frankfurt am Main eG

UNKNOWN

Sponsor Role: collaborator

Haffnet Management GmbH

UNKNOWN

Sponsor Role: collaborator

Demenznetzwerk Uckermark e.V.

UNKNOWN

Sponsor Role: collaborator

Techniker Krankenkasse

OTHER

Sponsor Role: collaborator

AOK Nordost

INDUSTRY

Sponsor Role: collaborator

Federal Joint Committee

OTHER_GOV

Sponsor Role: collaborator

German Center for Neurodegenerative Diseases (DZNE)

OTHER

Sponsor Role: lead

Responsible Party

Wolfgang Hoffmann

Group Leader and Site Speaker

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolfgang Hoffmann, MD, MPH, Prof.

Role: PRINCIPAL_INVESTIGATOR

German Center for Neurodegenerative Diseases (DZNE)

Locations

MEDIS Ärztenetz medizinischer Versorgung Südbrandenburg

Elsterwerda, Brandenburg, Germany

GNEF Gesundheitsnetz Frankfurt am Main

Frankfurt am Main, Hesse, Germany

Demenz-Netzwerk Uckermark e.V.

Prenzlau, Mecklenburg- Western Pommerania, Germany

HaffNet Management GmbH

Ueckermünde, Mecklenburg- Western Pommerania, Germany

DZNE

Greifswald, Mecklenburg-Vorpommern, Germany

Countries

Germany

References

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Other Identifiers

01NVF18034

Identifier Type: -

Identifier Source: org_study_id