Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522859
• Other study ID #: 09/NIR01/26
• Status: Completed
• Phase: N/A
• First received: January 24, 2012
• Last updated: January 27, 2012
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2012
• Source: South Eastern Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	South Eastern Health and Social Care Trust	Lisburn	Co Antrim

Sponsors (1)

Lead Sponsor	Collaborator
South Eastern Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in St Georges's Respiratory Questionnaire at six months	Self completed questionnaire	Baseline and six months	No
Secondary	Change from baseline in EuroQol at six months	self completed questionnaire	Baseline and six months	No
Secondary	Change from baseline in Hospital Anxiety and Depression Scale at six months	self administered questionnaire	Baseline and six months	No
Secondary	healthcare utilisation	data collected retrospectively from healthcare notes and hospital coding	six months	No
Secondary	number of exacerbations	data collected retrospectively from healthcare notes	six months	No
Secondary	satisfaction	interview administered questionnaire	six months	No
Secondary	cost effectiveness	QALY analysis	six months	No