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OpenTrials
Completed

NCT Number: NCT01522859

Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

The the aim of this study is to determine the benefits of Telehealth monitoring in the management of patients with chronic obstructive pulmonary disease.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease 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

South Eastern Health and Social Care Trust

Lisburn, Co Antrim, BT28 1JP, United Kingdom

About this study

Chronic obstructive pulmonary disease (COPD) is a major burden on healthcare systems worldwide. The current management of patients with COPD includes well established interventions such as pulmonary rehabilitation and inhaled therapies which have demonstrated variable impact on reducing rates of exacerbation and improving health related quality of life.

Telehealth is a home monitoring system used to record clinical observations and carry out question and answer sessions. It has been proposed that Telehealth medicine may offer an alternative strategy to the overall management of these patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD)
  • a minimum of two: Emergency Department admissions; hospital admissions or emergency GP contacts in the 12 months previous to the study

Exclusion criteria

  • any respiratory disorder other than COPD
  • patients cognitively unable to learn the process of monitoring

Treatment and study plan

Telehealth monitoring system (Honni Med)

Device

The system is uploaded with personal information including: monitoring start time; clinical observations (blood pressure, heart rate, oxygen saturations); and questions relating to symptoms. The patient is instructed on use and observed monitoring. The patient is monitored daily for a period of six months. The monitoring session lasts approximately 10 minutes during which the patient attaches a finger probe and blood pressure cuff and responds 'yes' or 'no' to the set questions. Daily data is transmitted via a phone line to a secure server to be downloaded and reviewed by a Telehealth nurse.If one or more of the clinical observations is outside normal limits the appropriate healthcare intervention is utilised.

Other names: Honni Med

Primary outcomes

  1. Change from baseline in St Georges's Respiratory Questionnaire at six months

    Time frame: Baseline and six months

    Self completed questionnaire

Secondary outcomes

  1. Change from baseline in EuroQol at six months

    Time frame: Baseline and six months

    self completed questionnaire

  2. Change from baseline in Hospital Anxiety and Depression Scale at six months

    Time frame: Baseline and six months

    self administered questionnaire

  3. healthcare utilisation

    Time frame: six months

    data collected retrospectively from healthcare notes and hospital coding

  4. number of exacerbations

    Time frame: six months

    data collected retrospectively from healthcare notes

  5. satisfaction

    Time frame: six months

    interview administered questionnaire

  6. cost effectiveness

    Time frame: six months

    QALY analysis

Sponsors and collaborators

Lead sponsor

South Eastern Health and Social Care Trust

Other

Registry information

Official study title

The Efficacy of Telehealth Monitoring in the Management of Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2012
Registry last updated
Feb 1, 2012

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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