Trial document




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  DRKS00000705

Trial Description

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Title

Monocentric, randomized study to investigate the impact of telemonitoring on the frequency of hospital admissions due to exacerbations in patients with chronic obstructive lung disease under the observance of atmospheric conditions

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Background: The incidence of chronic diseases increases with higher age what affects also patients with chronic obstructive pulmonary disease (COPD). Nowadays this becomes more and more important because of the demographic change. In addition these patients are exposed to stress because of the climate change which affects the atmospheric conditions.
The positive effect of telemonitoring in cardiovascular diseases is already shown but there are no data for COPD patients. There are only one study which shows a general cost reduction in comparison with standard care. Studies without continuous telemonitoring have shown that COPD patients with intensive, repeated schooling about their disease have a significant lower rate of exacerbations and hospitalisations.

During the first year of the study patients will be split into two groups- intervention and control- group- and observed in hospital admissions due to exacerbations. The patients in intervention group will be daily monitored via a telemonitoring systems which transfer the data of the home-spirometry, self-evaluation and COPD assessment- test (CAT)to the computer of the study personal. The patients will be informed if there were any abnormal measures. Both groups have to come to a control visit every three month.
In the one year follow- up phase there will be only a control- visit every three month in both groups.

Hypothesis
1) The daily telemonitoring of lung function and a symptom- orientated score will allow an early therapeutic intervention which can prevent hospital admissions because of an exacerbation-
2) There is a correlation between heat waves in summer and cold waves in winter and the incidence of exacerbations.

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Brief Summary in Scientific Language

Patients with COPD will be daily telemonitored via lung function and symtoms. Like the control group these patients will get an general check up every three month. Additional we want to analyse the data if there is any correlation between the change of atmospheric conditions and the course of disease.

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Organizational Data

  •   DRKS00000705
  •   2011/02/16
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  •   yes
  •   Approved
  •   EA1/033/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1119-2353 
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Health Condition or Problem studied

  •   Chronic obstructive pulmonary disease (COPD), GOLD II- IV°
  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
  •   J44.8 -  Other specified chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   Intervention Group- Telemonitoring, daily measurement of PEF, FEV1, FEV6, COPD Assessment Test (CAT) and self evaluation, weekly: 6-MWT during the first year. Addionally there are planned control- visits every three month during the intervention phase and also during the one year follow up. Extreme weather conditions in the intervention phase will lead to max. 2 extra- visits in the clinic.
  •   Control Group- standard Care with control visits every three month for one year and one year follow- up.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Health care system
  •   Parallel
  •   N/A
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Primary Outcome

Frequency of hospitalisations with a primary diagnosis of COPD exacerbation per year

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Secondary Outcome

Exacerbations:
- Time to first hospitalisation with the primary diagnosis of a COPD exacerbation (time to first event)
- Difference in the mean hospitalisation duration by admissions due to exacerbation
- overall exacerbations per year
- overall hospitalisations per year
- Number of exacerbations per patient per year (worsening of symptoms and/or medical treatment)
- Observance of changes in FEV1-/ FEV6/ PEF and progression during exacerbations during one year
- Influence of heat/cold waves on the number and severety of exacerbations during one year

Quality of life:
- Number of patients with an improvement in quality of life during one year (improvement in St. George Respiratory Questionaire=SGRQ ≥ 4 points, COPD Assessment Test=CAT improvement ≥4 points)
- Influence of heat/cold waves on patients quality of life during one year (SGRQ/ CAT improvement in 3month/daily measurement

Cost effectiveness:
- cost for quality adjusted life years (QUALYs) during one year (EuroQol (EQ-5D), duration of hospital admission)

Activity:
- changes of BODE-Index (body-mass index (B), the degree of airflow obstruction (O) and dyspnea
(D), and exercise capacity (E))per year
- changes in 6-Minute Walk per year

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2011/03/01
  •   220
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

COPD (GOLD: II-IV°) (FEV1 < 70% pred, FEV1/FVC < 70%), agreement of the patient, min. one exacerbation during the last year (antibiotics and/ or steroids and/or hospitalisation), min. 4 weeks of stable COPD befor inclusion into the study (no change of symptoms or medication)

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Exclusion Criteria

o2- longterm-therapy (24h), cancer (expectation of life < 6 month), Asthma bronchiale, is not able to understand the studyprotocol and to use the devices because of a cognitive deficiency, diagnosis of left heart decompensation during the last year (chest X-ray or therapy with diuretics), lives not in or close to Berlin, high grade depression

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Addresses

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    • Charité Campus Charité Mitte CC12, Med. Klinik m. S. Infektiologie und Pneumologie Arbeitsbereich Pneumologie
    • Mr.  Prof. Dr. med  Christian  Witt 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Campus Charité Mitte CC12 Med. Klinik m.S. Infektiologie und Pneumologie Arbeitsbereich Pneumologie
    • Mr.  Prof. Dr. med.  Christian  Witt 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Campus Charité Mitte CC12, Med. Klinik für Infektiologie und Pneumologie Arbeitsbereich Pneumologie
    • Ms.  Nora  Döhnert 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung - BMBF
    • 53170  Bonn
    • Germany
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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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