Trial document




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  DRKS00012132

Trial Description

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Title

Quickstart Evaluation: Pilot Study to investigate specific distress-related physiological reactions by means of a new multi-sensor device

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Trial Acronym

iSenDi - Pilot Study "Quickstart Evaluation"

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URL of the Trial

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Brief Summary in Lay Language

Patients suffering from cognitive impairment may lose their capacity to communicate conditions of discomfort to their caregivers, such as pain, dyspnea and anxiety. These manifestations of suffering are collectively referred to as “distress”. A major challenge for formal and informal caregivers is the prompt identification of distress episodes in those patients. This would require constant, around-the-clock patient surveillance at his or her bedside, which is obviously almost impossible in most settings. The project iSenDi aims to develop a sensory device which will automatically detect distress situations of affected patients and give alarm to the caregivers, enabling their prompt intervention.
A contactless multi-sensory device consisting of commercially available sensors will be employed in this pilot study, named “Quickstart Evaluation”. Thanks to its design, the device is hardly perceptible and should not in any way disturb the patient. The device will continuously record sensory signals associated with the occurrence of patient's distress episodes. In parallel, the patient will be monitored by an instructed study assistant who will document arisen distress situations and any required immediate intervention of the caregivers. The so-obtained data sets will be analyzed retrospectively in order to develop an algorithm which should be able to automatically identify distress episodes at an early stage. This will enable an immediate intervention of the caregiving staff and therefore spare avoidable sufferings to affected patients.

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Brief Summary in Scientific Language

The demographic change in western countries is leading to a marked increase in the incidence of dementia. Dementia mostly affects old patients and severely reduces their quality of life.
Due to progressive cognitive impairment, patients with dementia in advanced stages of the disease are no longer able to communicate their discomfort to their caregivers. In palliative care, cognitive failure frequently occurs also in other patients with terminal illness, especially during their last days of life. Pain, dyspnoea, anxiety and delirium are frequently reported in patients with life-threatening diseases, including dementia patients. As self-reporting of distress is often no longer feasible in these patients, the current gold standard relies on observer-rated distress. For this, formal or informal caregivers are urged to monitor for alterations in motor activity (restlessness, hypo-activity or signs for relieving postures), be aware of screaming, moaning or other “verbal” indicators for discomfort along with identifying alterations in the activity of the autonomic nervous system (e.g. tachycardia, tachypnea) and facial expression. A major challenge for formal and informal caregivers is the prompt identification of sudden distress episodes in those patients. This would require constant, around-the-clock patient surveillance at his or her bedside, which is obviously almost impossible in most settings. Additionally, a uniform measure or operationalization of the so-called “objective parameters” (see above: motor activity etc.) for the identification of distress is not yet available. This highlights the need of: a) An algorithm that is able (with reasonable sensitivity and specificity) to identify distress from a set of objective parameters; b) An automated system with the sensor capacity to detect (ideally with contactless sensors) the objective parameters mentioned in available observer tools for the identification of distress. Both goals will be pursued in the course of the iSenDi joint research project.
Within this pilot study, named “Quickstart Evaluation”, a pilot contactless multi-sensor device will be applied to the bed of recruited patients at two study centers. By means of its sensors, the device will monitor potential indicators of distress, such as restlessness, loud voice, tachycardia, tachypnea, stress-induced hyperhidrosis (excessive sweat production) and enuresis. The associated sensory signals will be recorded and labelled with a time-stamp. To define to which extent the sensory system might be able to autonomously detect distress episodes with high specificity (distinguishing them from other emotional states), a reference is required. Therefore, a trained study assistant will in parallel document arisen distress episodes, based on personal estimation and according to a well-established questionnaire. The so-obtained data sets will be in turn subjected to a high-end analysis which will aim to develop an algorithm able to filter distress episodes out of a continuous stream of sensor information.

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Organizational Data

  •   DRKS00012132
  •   2017/04/25
  •   [---]*
  •   yes
  •   Approved
  •   46/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Organic brain diseases (F00, F01, F02, F03)
  •   Organic diseases requiring palliative care
  •   F00 -  Dementia in Alzheimer disease
  •   F01 -  Vascular dementia
  •   F02 -  Dementia in other diseases classified elsewhere
  •   F03 -  Unspecified dementia
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Interventions/Observational Groups

  •   The sensory device will be fixed at the patient´s bed in his/her absence. During the bed times the device will record continuously data (for approximately 14 hours, from 18:00 until 08:00). In parallel, a trained study assistant will observe the patient and document arisen distress episodes. This represents the only discrepancy from the regular care, as all usual medical treatments and visits will be guaranteed. Moreover, if the patient falls into a significant distress situation, the responsible
    caregivers are bound to provide immediate intervention.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome of this study is the recording of sensory signals produced by distress in patients with limited ability or unable to self-report, by means of a new multi-sensory device. Simultaneous manual expert annotation of distress episodes will allow determining how far the sensory device can detect distress episodes with high specificity, distinguishing them from other emotional states.

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Secondary Outcome

Analysis of the sensory data captured by the new device during the study to develop an algorithm for the autonomous identification of distress episodes from a continuous stream of sensory information. The study will also further aim to characterize distress-associated sensor signals and to define the optimal sensor configuration enabling their detection.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2017/05/02
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Written informed consent obtained from the patient or his/her legally acceptable representative (if available) according to international guidelines and local laws.

2. Either adult persons (age >/= 18 years) who due to an organic disease are inpatients of the Clinic for Palliative Care (Medical Center - University of Freiburg) or persons above 65 years who due to an organic brain disease (ICD F00-F03) are inpatients of the Clinic for Geriatric Psychiatry and Psychotherapy (Center for Psychiatry, Emmendingen), who are likely to get into a distress situation.

3. Persons with limited ability or unable to self-report their discomfort.

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Exclusion Criteria

1. Persons who demonstrate dissent regarding their participation in the clinical study.

2. Persons who are not able to provide written informed consent for which a legally acceptable representative is not available.

3. Persons whose overall condition seems not suitable for inclusion in the study.

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Palliativmedizin
    • Ms.  Prof. Dr. med.  Gerhild  Becker 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Palliativmedizin
    • Ms.  Prof. Dr. med.  Gerhild  Becker 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.