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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
  Purpose

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


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Device: Telehealth monitoring system (Honni Med)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Efficacy of Telehealth Monitoring in the Management of Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by South Eastern Health and Social Care Trust:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 110
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522859

Locations
United Kingdom
South Eastern Health and Social Care Trust
Lisburn, Co Antrim, United Kingdom, BT28 1JP
Sponsors and Collaborators
South Eastern Health and Social Care Trust
Investigators
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
  More Information

No publications provided

Responsible Party: JE McDowell, Principal Investigator, South Eastern Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT01522859     History of Changes
Other Study ID Numbers: 09/NIR01/26
Study First Received: January 24, 2012
Last Updated: January 27, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by South Eastern Health and Social Care Trust:
COPD
Telehealth
health related quality of life

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013