Telehealth Monitoring in Chronic Obstructive Pulmonary Disease
|ClinicalTrials.gov Identifier: NCT01522859|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Device: Telehealth monitoring system (Honni Med)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Efficacy of Telehealth Monitoring in the Management of Patients With Chronic Obstructive Pulmonary Disease|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
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
- Change from baseline in St Georges's Respiratory Questionnaire at six months [ Time Frame: Baseline and six months ]Self completed questionnaire
- Change from baseline in EuroQol at six months [ Time Frame: Baseline and six months ]self completed questionnaire
- Change from baseline in Hospital Anxiety and Depression Scale at six months [ Time Frame: Baseline and six months ]self administered questionnaire
- healthcare utilisation [ Time Frame: six months ]data collected retrospectively from healthcare notes and hospital coding
- number of exacerbations [ Time Frame: six months ]data collected retrospectively from healthcare notes
- satisfaction [ Time Frame: six months ]interview administered questionnaire
- cost effectiveness [ Time Frame: six months ]QALY analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522859
|South Eastern Health and Social Care Trust|
|Lisburn, Co Antrim, United Kingdom, BT28 1JP|
|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|