Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00014737

Trial Description

start of 1:1-Block title

Title

Charité-Dome-Study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Charité-Dome

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Admission to a hospital’s emergency department (ED) due to an acute medical incident is a threatening situation for patients with dementia (PWD). The overstimulating surroundings often lead to more agitation and increase the probability of complications such as the development of delirium, the risk of falls and injuries as well as getting lost. PWDs’ lack of understanding and therefore missing cooperation makes their therapy a difficult task to fit in hospital routine, especially in the ED. Often, the only possibility to deal with PWD is to administer sedatives with sometimes hazardous side effects or their fixation with belts. These conditions result in longer stays, higher mortality rates and increased functional decline for PWD in hospital compared to patients without dementia. Therefore, there is a need for special care in terms of ED architecture or devices to protect PWD and detect and monitor upcoming agitation, possibly indicated by a change of vital signs, e.g. heart rate and respiratory rate. As monitoring of vital signs usually requires the use of adhesive electrodes, which PWD tend to tear off their body due to discomfort, the development of new technical tools for non-contact monitoring of vital signs is necessary. Thus, wearable devices have been developed that have to be worn continuously, which is difficult in a hospital situation with frequent change of gown and the need of quick access to the patients’ chest in the case of an emergency. A visible bedside device used e.g. for sleep apnoea studies might be removed or damaged by agitated patients.
Many attempts have been made to prevent worsening of a beginning agitated state in PWD. There is evidence for preventive efficacy of non-pharmacological treatments, though there are no in-hospital studies, especially in the ED, regarding that topic yet which mirrors the difficulty to implement them.
In this study we aim to develop an innovative concept composed of a new non-contact monitoring system (NCMSys) to monitor agitation and vital signs and the “Charité Dome (ChD)”, aimed to shelter PWD from their surroundings.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Objectives: Agitation is common in geriatric patients with dementia (PWD) admitted to an emergency department (ED) and is associated with a higher risk of an unfavourable clinical course. However, monitoring of agitation in the ED is difficult, since PWD rarely tolerate fixed monitoring devices. In this study we aim to develop a new concept combining a non-contact monitoring system (NCMSys) and a sheltering device (“Charité Dome”, ChD), both attached to patient’s bed, to monitor and prevent upcoming agitation in PWD in the ED.
METHODS: The technical reliability and other safety issues of the NCMSys and the ChD will be tested with healthy volunteers. Afterwards, the reliability will be evaluated during a two hours application of the NCMSys with and without the ChD in patients in the ED and on a geriatric-gerontopsychiatric ward. Staff, patients, and relatives will assess effects of the combined system on patients’ wellbeing and agitation in a standardized manner.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00014737
  •   2018/06/06
  •   [---]*
  •   yes
  •   Approved
  •   EA4/070/12, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F05.0 -  Delirium not superimposed on dementia, so described
  •   F05.1 -  Delirium superimposed on dementia
  •   F05.8 -  Other delirium
  •   F05.9 -  Delirium, unspecified
  •   F03 -  Unspecified dementia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The combined system of NCMSys and the ChD will be evaluated during a two hours application with (1h) and without (1h) the ChD in patients in the ED and on a geriatric-gerontopsychiatric ward. The study will not affect the treatment of the patients.
  •   The same procedure will be performed on patients without dementia in the hospital.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Supportive care
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Measurements of heart rate and respiratory rate by a sensor mat with and without sheltering of patients with the Charité-Dome. Measurements of acoustics and body movements by respective sensors.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Staff, patients, and relatives will assess effects of the combined system on patients’ wellbeing and agitation in a standardized manner.
For dementia patients, staff and relatives will use the Cohen-Mansfield Agitation Inventory (CMAI), the Clinical Global Impressions (CGI), and the Observed Emotion Rating Scale (OERS).
Non-dementia patients will fill out a patient evaluation form which will be used to deduce an informed and standardized evaluation sheet during the further project.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/01/11
  •   40
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Dementia patients: - Age ≥ 60
- dementia diagnosed by mini mental status test (MMST) and general deterioration scale (GDS)
- with and without delir
- consent of the patient or the respective keeper and the patient;
Non-dementia patients:
- age ≥18
- consent of the patient

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Dementia patients:
- missing consent
- any comorbidity that not allows a flat lying in the bed (e.g. decompensated heart failure);

Non-dementia patients:
- acute life-threatening somatic disease (manchester triage "red")
acute psychiatric disease (according to Mini
International Neuropsychiatric Interview M.I.N.I. and structured clinical interview SKID for DSM-IV)
- missing consent ability

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Zentrale Notaufnahme und Aufnahmestation
    • Mr.  Prof. Dr. med.  Rajan  Somasundaram 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Oberhavel-Kliniken GmbH
    • Ms.  PD Dr. med.  Maria  Jockers-Scherübl 
    • Marwitzer Str. 91
    • 16761  Hennigsdorf
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Zentrale Notaufnahme und Aufnahmestation
    • Mr.  Prof. Dr. med.  Rajan  Somasundaram 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Zentrale Notaufnahme und Aufnahmestation
    • Mr.  Prof. Dr. med.  Rajan  Somasundaram 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Zentrale Notaufnahme und Aufnahmestation
    • Mr.  Prof. Dr. med.  Rajan  Somasundaram 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting suspended on temporary hold
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.