Interprofessional Dementia Care

Dementia Clinical Trial

— InDePendent  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04741932
• Other study ID #: 01NVF18034
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2023
• Source: German Center for Neurodegenerative Diseases (DZNE)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 465
• Est. completion date: March 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Nurse Physician Relations
• Nurse's Role

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).

Locations

Country	Name	City	State
Germany	MEDIS Ärztenetz medizinischer Versorgung Südbrandenburg	Elsterwerda	Brandenburg
Germany	GNEF Gesundheitsnetz Frankfurt am Main	Frankfurt	Hessen
Germany	DZNE	Greifswald	Mecklenburg-Western-Pomerania
Germany	Demenz-Netzwerk Uckermark e.V.	Prenzlau	Mecklenburg- Western Pommerania
Germany	HaffNet Management GmbH	Ueckermünde	Mecklenburg- Western Pommerania

Sponsors (9)

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

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months after baseline assessment
Secondary	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.	6 months after baseline assessment
Secondary	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.	6 months after baseline assessment
Secondary	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.	6 months after baseline assessment
Secondary	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.	6 months after baseline assessment