Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

NCT ID: NCT01522859

Last Updated: 2012-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Telehealth monitoring

Daily monitoring of patient's health status using a small telecommunications device.

Group Type EXPERIMENTAL

Telehealth monitoring system (Honni Med)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Honni Med

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Eastern Health and Social Care Trust

OTHER

Sponsor Role lead

Responsible Party

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JE McDowell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janet E McDowell, BScHons, PhD

Role: PRINCIPAL_INVESTIGATOR

South Eastern Health and Social Care Trust

Stephen Tate, BSc,MD,FRCP

Role: STUDY_DIRECTOR

South Eastern Health and Social Care Trust

Locations

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South Eastern Health and Social Care Trust

Lisburn, Co Antrim, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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09/NIR01/26

Identifier Type: -

Identifier Source: org_study_id

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