DanA
Organizational Data
- DRKS-ID:
- DRKS00015755
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2019-03-06
- Last update in DRKS:
- 2019-03-06
- Registration type:
- Prospective
Acronym/abbreviation of the study
Delirium-intervention in the acute-geriatric Setting. A non-pharmacological team-based Approach. Measurement for the early prevention, recognition and treatment of sudden confusion of older inpatients.
URL of the study
No Entry
Brief summary in lay language
A sudden state of confusion ("delirium") is common to patients undergoing hospital treatment. This state of confusion often remains undetected and can also be associated with severe consequences for older people. Various measures are available to prevent or treat sudden confusion. However, most of these have not been specifically tailored to the specific needs of older people. In addition, the way in which these interventions are provided by a health care team (consisting of physicians, nurses, and therapists) has not yet been sufficiently investigated. Although the current study data demonstrates that the quality of interprofessional collaboration has a significant impact on treatment quality, this so-called "team-based approach" has not been widely used to prevent or to treat sudden confusion. Therefore, in the DanA study, the team-based approach will be transfered into clinical practice with the aim to prevent sudden confusional states of older people or in case of existing confusional states to influence a favorable course of treatment.
Brief summary in scientific language
Delirium is a common, severe and often undiscovered syndrome that may be associated with serious consequences for those patients that affected, especially the group of acute-geriatric patients. The currently available intervention programs have not yet been sufficiently evaluated for this clientele. In addition, the way in which delirium interventions are provided by health care professionals has not been sufficiently investigated. As a result, team-based approaches in the context of delirium prevention and management are still not well established in clinical practice and therefore insufficiently investigated. However, the current study data indicates in general that an intensivied interprofessional collaboration and communication between different health care professionals can enhance the effectiveness of health services and the quality of care. According to this, it is hypothesized that intensified interprofessional collaboration, based on the team-based approach of a regular and systematic exchange will also contribute to optimized delirium care. Therefore, in the DanA study, the team-based approach will be transfered into clinical practice with the aim to prevent delirium and to decline prävalence and incidence, and in case of unavoidable deliria to influence a favorable course of treatment.
Health condition or problem studied
- ICD10:
- F05.0 - Delirium not superimposed on dementia, so described
- ICD10:
- F05.1 - Delirium superimposed on dementia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Pre-intervention group (control group) = measurement of prevalence and incidence of delirium (without Intervention)
- Arm 2:
- Intervention group = Measurement of the effect of a systematic, daily, interprofessional exchange on the prevalence and incidence of delirium. Within the framework of this exchange, any changes and signs that may indicate a delirium are discussed and the consequences of action derived from them for the individual case are coordinated on an interprofessional basis.
Endpoints
- Primary outcome:
- Aim: Further development of interprofessional teamwork. T0= before the intervention phase (03(2019); T1= after the intervention phase 11/2019 using the Assessment of Interprofessional Team Collaboration Scale (AITCS-II).
- Secondary outcome:
- Collection of primary endpoints of delirium-incidence and prevalence by secondary analysis of routine clinical data of each included patient treated in acute-geriatric ward in the pre-intervention phase (01.10.2018-28.02.2019) and in the intervention phase (01.06.2019-31.10.2019).
Study Design
- Purpose:
- Prevention
- Allocation:
- Non-randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Other
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsmedizin Mannheim; II Med. Klinik, Sektion Altersmedizin Mannheim
Recruitment period and number of participants
- Planned study start date:
- 2019-04-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 407
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 65 Years
- Maximum Age:
- 105 Years
- Additional Inclusion Criteria:
- Patients aged 65 and over (with and without cognitive impairments/dementia); patients with and without delirium at admission, non-ethyltoxic genesis; acute geriatric treatment.
Exclusion Criteria
Patients with severely impaired communication skills; estimated hospital stay less than 48 hours.
Addresses
Primary Sponsor
- Address:
- UMM MannheimMedizinische Klinik IISektion Altersmedizin/Geriatrisches ZentrumPD Dr. med. Heinrich BurkhardtTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49 (0)621 383 5981
- Fax:
- +49 (0)621 383 2182
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://w2.umm.de/ii-medizinische-klinik/mitarbeiter/sektionsleiter/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin Mannheim, II. Medizinische Universitätsklinik, Sektion AltersmedizinPD Dr. med. Heinrich Burkhardt-StudienleitungTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49 (0)621 383 5981
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://w2.umm.de/ii-medizinische-klinik/kompetenzzentren/altersmedizin/
Contact for Public Queries
- Address:
- Universitätsmedizin Mannheim, II Medizinische Universitätsklinik, Sektion Altersmedizin,Claudia EcksteinTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49 (0)621 383 2553
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://w2.umm.de/ii-medizinische-klinik/kompetenzzentren/altersmedizin/
Principal Investigator
- Address:
- Universitätsmedizin Mannheim, II. Medizinische Universitätsklinik, Sektion AltersmedizinPD Dr. med. Heinrich Burkhardt-StudienleitungTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49 (0)621 383 5981
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://w2.umm.de/ii-medizinische-klinik/kompetenzzentren/altersmedizin/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Netzwerk Alternsforschung (NAR) der Universität HeidelbergBergheimerstr. 2069115 HeidelbergGermany
- Telephone:
- +49(0)6221 548128
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.nar.uni-heidelberg.de/juniorforscher/demenz/eckstein.html
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- UMM MannheimMedizinische Klinik IISektion Altersmedizin/Geriatrisches ZentrumTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49 (0)621 383 5981
- Fax:
- +49 (0)621 383 2182
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://w2.umm.de/ii-medizinische-klinik/mitarbeiter/sektionsleiter/
Ethics Committee
Address Ethics Committee
- Address:
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-11-20
- Ethics committee number:
- 2018-636N-MA
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-12-12
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry