Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

January 27, 2012 updated by: JE McDowell, South Eastern Health and Social Care Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Co Antrim
      • Lisburn, Co Antrim, United Kingdom, BT28 1JP
        • South Eastern Health and Social Care Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Honni Med

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in St Georges's Respiratory Questionnaire at six months
Time Frame: Baseline and six months
Self completed questionnaire
Baseline and six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in EuroQol at six months
Time Frame: Baseline and six months
self completed questionnaire
Baseline and six months
Change from baseline in Hospital Anxiety and Depression Scale at six months
Time Frame: Baseline and six months
self administered questionnaire
Baseline and six months
healthcare utilisation
Time Frame: six months
data collected retrospectively from healthcare notes and hospital coding
six months
number of exacerbations
Time Frame: six months
data collected retrospectively from healthcare notes
six months
satisfaction
Time Frame: six months
interview administered questionnaire
six months
cost effectiveness
Time Frame: six months
QALY analysis
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (ESTIMATE)

February 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/NIR01/26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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