Dementia Clinical Trial
— InDePendentOfficial title:
Interprofessional Dementia Care: Redistribution of Tasks Between Physicians and Qualified Nurses in Primary Care
Verified date | March 2023 |
Source | German Center for Neurodegenerative Diseases (DZNE) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
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 |
Germany,
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
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 |
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