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Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JE McDowell, South Eastern Health and Social Care Trust
ClinicalTrials.gov Identifier:
NCT01522859
First received: January 24, 2012
Last updated: January 27, 2012
Last verified: January 2012
History of Changes

January 24, 2012
January 27, 2012
August 2009
June 2010   (final data collection date for primary outcome measure)
Change from baseline in St Georges's Respiratory Questionnaire at six months [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]
Self completed questionnaire
Same as current
Complete list of historical versions of study NCT01522859 on ClinicalTrials.gov Archive Site
  • Change from baseline in EuroQol at six months [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]
    self completed questionnaire
  • Change from baseline in Hospital Anxiety and Depression Scale at six months [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]
    self administered questionnaire
  • healthcare utilisation [ Time Frame: six months ] [ Designated as safety issue: No ]
    data collected retrospectively from healthcare notes and hospital coding
  • number of exacerbations [ Time Frame: six months ] [ Designated as safety issue: No ]
    data collected retrospectively from healthcare notes
  • satisfaction [ Time Frame: six months ] [ Designated as safety issue: No ]
    interview administered questionnaire
  • cost effectiveness [ Time Frame: six months ] [ Designated as safety issue: No ]
    QALY analysis
Same as current
Not Provided
Not Provided
 
Telehealth Monitoring in Chronic Obstructive Pulmonary Disease
The Efficacy of Telehealth Monitoring in the Management of Patients With 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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Chronic Obstructive Pulmonary Disease
Device: Telehealth monitoring system (Honni Med)
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 Name: Honni Med
  • No Intervention: standard care
    A standardised home based programme of specialist respiratory assessment and monitoring provided by the local Community Respiratory Team (CRT) and General Practitioner (GP) for a period of six months.
  • Experimental: Telehealth monitoring
    Daily monitoring of patient's health status using a small telecommunications device.
    Intervention: Device: Telehealth monitoring system (Honni Med)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01522859
09/NIR01/26
No
JE McDowell, South Eastern Health and Social Care Trust
South Eastern Health and Social Care Trust
Not Provided
Principal Investigator: Janet E McDowell, BScHons, PhD South Eastern Health and Social Care Trust
Study Director: Stephen Tate, BSc,MD,FRCP South Eastern Health and Social Care Trust
South Eastern Health and Social Care Trust
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP