An interventional study of Dementia Care Management (DCM) in Dementia, Nurse's Role and Nurse Physician Relations, sponsored by German Center for Neurodegenerative Diseases (DZNE). Completed at 5 sites in Germany. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by German Center for Neurodegenerative Diseases (DZNE) · Not applicable, Interventional, and Health services research
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Among 96 studies in Dementia with a site in Germany — 13 open to participants now, 18 under way, 8 of them phase 3. Dementia · Germany.
Among the 96 studies in Dementia with a site in Germany, this one is the 28th largest by enrollment of the 77 interventional ones that give a count, is one of 2 that started in 2021, is one of 28 with no phase, and was the 76th registered.
2,373 studies on the registry are indexed under Dementia; 574 are open to participants now.
Browse Dementia studies →13 of the 96 studies in Dementia with a site in Germany are open now. Recruiting first, the newest first:
Exciva GmbH · Sites in Germany, United States, Canada and 6 more countries
Ages 55–90
German Center for Neurodegenerative Diseases (DZNE) · Sites in Germany
University Hospital, Bonn · Sites in Germany
Ages 50–80 · Healthy volunteers
Aarhus University Hospital · Sites in Germany, Denmark, Norway and 2 more countries
Ages 50+
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
Ages 70+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 383 Dementia studies recruiting now, 244 (64%) set no upper age limit and 25 (7%) stop at 75 or younger; 16 take children under 18; 164 take healthy volunteers.
This study: 70 Years and older · all sexes · no healthy volunteers.
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96 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 23 · Phase 3 32 · Phase 4 1
First in 2001; this study’s year is marked. 2 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 471 is above the median of 90 across 1,759 interventional studies indexed under Dementia.
Median enrollment 327 across the 77 interventional studies, 441 across the 18 observational. Of the 65 that completed or were terminated, 20 (31%) have results posted.
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40 of 96 have an industry lead sponsor. The 10 most frequent:
German Center for Neurodegenerative Diseases (DZNE) is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
German Center for Neurodegenerative Diseases (DZNE) has 7 studies filed under Dementia — fewer than ten, so there is no comparison to draw.
1 of the studies in Dementia with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07114458Universitätsklinikum Hamburg-EppendorfDelirium and Cognitive Impairment Development in Hospitalized Older Adults Under Isolation Conditions | 2027-04 |
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Among the 96 studies in Dementia with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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).
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.
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Exclusion Criteria:
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).
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.
Time frame: 6 months after baseline assessment
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.
Time frame: 6 months after baseline assessment
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.
Time frame: 6 months after baseline assessment
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.
Time frame: 6 months after baseline assessment
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.
Time frame: 6 months after baseline assessment
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.
Time frame: 6 months after baseline assessment
Plan to share: No
Ran from Jan 2021 to primary completion in Aug 2023, 31 months.
Of 858 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 31 months is above that.
Counting every sponsor, half of 904 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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German Center for Neurodegenerative Diseases (DZNE)