Trial document




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  DRKS00000239

Trial Description

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Title

Acceptance of a Telemedical Intervention in Patients with COPD

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Trial Acronym

ATICO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This clinical trial investigates the use of a telehealth programme which is designed to support patients with COPD in self-managing their condition. Patient´s vital signs and symptoms are remotely monitored by healthcare professionals in order to detect acute exacerbations at an early stage. Additionally, patients receive information about their condition and tips in managing their condition. An easy-to-use device, the Health Buddy®, is used to communicate with patients and transmit the recorded data. The study objective is to determine if patients will accept using such a telehealth programme in daily life.

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Brief Summary in Scientific Language

The project objective is the clinical testing of an innovative telehealth programme for the first time in Germany. This telehealth programme is designed to effectively support the therapy of patients with COPD. It consists of the regular monitoring of vitals signs and symptoms as well as the training of healthy behaviour and disease-specific knowledge. The Health Buddy® system is used as a communication tool between patients and healthcare professionals. It is already approved for the European market (CE marked) and is substantially used in the United States. By assessing a patients´s compliance with the system, it will be investigated if such a telehealth approach can be transferred to Germany.

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Organizational Data

  •   DRKS00000239
  •   2009/11/03
  •   [---]*
  •   no
  •   Approved
  •   09034, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  •   U1111-1112-2345 
  •   ATICO  (Robert Bosch Healthcare GmbH)
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Health Condition or Problem studied

  •   chronic obstructive pulmonary disease (COPD)
  •   J44 -  Other chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   In addition to a guideline-based therapy of COPD by his/her pneumologist, the patient experiences an intensive telehealth care with regular monitoring of vital signs (oxygen saturation, heart rate, temperature, and weight) as well as questions about symptoms (shortness of breath, sputum, cough, etc.), behaviour (medication compliance, activity, etc.), and disease-specific knowledge (acute exacerbations, smoking effects, etc.), through the use of the Health Buddy® system.
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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)
  •   IV
  •   [---]*
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Primary Outcome

The patient´s compliance with the system as the primary outcome is measured by:
1. share of patients, who used the system more than two thirds of the available working days;
2. ratio of completely answered daily dialogues;
3. drop-out rate (percentage of patients who not continue to participate in the study until the final visit)

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Secondary Outcome

1. perceived security (SeCu-16)
2. patient´s acceptance of the programme
3. programme induced effort for healthcare professionals
4. healthcare professional´s acceptance of the therapy programme
5. number of acute exacerbations
6. health-related quality of life (SGRQ)
7. smoking status
8. number and type of hospitalisations
9. urgent visits

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/01/26
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. written consent
2. male or female ambulatory treated patients
3. patients with COPD - GOLD classification III and IV
4. patients with COPD - GOLD classification I and II -, with an inpatient treatment of COPD lasting not longer than 3 months
5. patient has blood pressure when resting not higher than 180/100 mmHg
6. patient has the cognitive ability and intention to use the Health Buddy® with its peripherals
7. patient has adequate knowledge of the German language
8. patient has an active telephone connection, preferably analogue
9. patient is motivated to take part in the trial

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Exclusion Criteria

1. patient is currently participating in another trial or finished participation within the previous 4 weeks
2. patient is pregnant or breastfeeding
3. patient currently has known malignant or virulent illnesses
4. patient has a severe restriction of movements (e.g. paresis after stroke)
5. patient is invasively ventilated

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Addresses

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    • Robert Bosch Healthcare GmbH
    • Stuttgarter Str. 130
    • 71301  Waiblingen
    • Germany
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    • Asklepios Klinik Gauting
    • Ms.  Dr. med.  Ortrud  Karg 
    • Robert-Koch-Allee 2
    • 82131  Gauting
    • Germany
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    • Asklepios Klinik Gauting
    • Ms.  Dr. med.  Ortud  Karg 
    • Robert-Koch-Allee 2
    • 82131  Gauting
    • Germany
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Sources of Monetary or Material Support

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    • Robert Bosch Healthcare GmbH
    • Stuttgarter Str. 130
    • 71332  Waiblingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/03/20
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Trial Publications, Results and other Documents

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