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Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01522859
Enrollment
110
Registered
2012-02-01
Start date
2009-08-31
Completion date
2010-06-30
Last updated
2012-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Telehealth, health related quality of life

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.

Interventions

DEVICETelehealth 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.

Sponsors

South Eastern Health and Social Care Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in St Georges's Respiratory Questionnaire at six monthsBaseline and six monthsSelf completed questionnaire

Secondary

MeasureTime frameDescription
Change from baseline in Hospital Anxiety and Depression Scale at six monthsBaseline and six monthsself administered questionnaire
healthcare utilisationsix monthsdata collected retrospectively from healthcare notes and hospital coding
Change from baseline in EuroQol at six monthsBaseline and six monthsself completed questionnaire
satisfactionsix monthsinterview administered questionnaire
cost effectivenesssix monthsQALY analysis
number of exacerbationssix monthsdata collected retrospectively from healthcare notes

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026