Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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.

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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: Telehealth monitoring system (Honni Med)


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care<br>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<br>Daily monitoring of patient's health status using a small telecommunications device. | Device: Telehealth monitoring system (Honni Med)<br>* 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.<br>* 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 | Self completed questionnaire | Baseline and six months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Telehealth, health related quality of life