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Completed

NCT Number: NCT01580072

Telemonitoring of Patients With COPD in Carinthia

Evaluation whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of reduced hospital readmissions, improved health related quality of life and health status. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LKH Laas, Kötschach, Carintha, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COPD 3 or 4
  • Be able to use the system provided
  • Life expectancy > 12 months

Exclusion criteria

Treatment and study plan

self-monitoring for patients with severe COPD

Other

Intervention Group entering vital parameters via Web Portal or automatic call center.

nurse-monitoring for patients with severe COPD

Other

Nurses are entering vital parameters of the patient with mobile devices.

Primary outcomes

  1. Health Related Quality of Life as Measured by the Short-Form 36 Version 2 Questionnaire; The Short Form (36) Health Survey is a 36-item, Patient-reported Survey of Patient Health. The SF-36 is a Measure of Health Status.

    Time frame: 12 months

    Baseline analyses and analyses after 12 months were conducted. Normal distribution is not given for SF-36 scales, means and Standard Deviation are reported. A high score defines a more favorable health state, items are scored on a 0 to 100 range. Scale scores represent the average for all items in the scale that the respondent answered.

  2. Number of Inpatient Stays

    Time frame: 12 months

Secondary outcomes

  1. Number of Bed Days for Hospitalised Patients

    Time frame: 12 months

  2. Number of Primary Care Visits

    Time frame: 12 months

    Not all data were available, so only participants with consistent data were taken into comparison, this lead to a lower number of patients in this outcome measurement.

  3. Number of Specialist Visits

    Time frame: 12 months

  4. Number of Consultations of Emergency Doctor

    Time frame: 12 months

  5. All Cause Mortality

    Time frame: 12 months

    deceased patients in respect to participating patients, by obituary column

  6. COPD Assessment Test CAT (Carinthia)

    Time frame: 12 months

    No data available

  7. St. George's Respiratory Questionnaire SGRQ (Carinthia)

    Time frame: 12 months

    The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction.

    Scores are calculated for three domains:

    Symptoms, Activity and Impacts as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials.

    A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.Due to missing data not all questoinnaires could be taken into consideration. Normal distribution is not given for SGRQ scales; Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best pos

  8. BODE Index (Carinthia)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Landeskrankenanstalten-Betriebsgesellschaft

Industry

Collaborators

  • European Commission

Registry information

Official study title

REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)

Acronym: RenewingHealth

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Apr 18, 2012
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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