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Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Telehealth monitoring system (Honni Med)
Sponsored by
South Eastern Health and Social Care Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Telehealth, health related quality of life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Eastern Health and Social Care Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard care

Telehealth monitoring

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change from baseline in St Georges's Respiratory Questionnaire at six months
Self completed questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
January 24, 2012
Last Updated
January 27, 2012
Sponsor
South Eastern Health and Social Care Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01522859
Brief Title
Telehealth Monitoring in Chronic Obstructive Pulmonary Disease
Official Title
The Efficacy of Telehealth Monitoring in the Management of Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Eastern Health and Social Care Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Telehealth, health related quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Telehealth monitoring
Arm Type
Experimental
Arm Description
Daily monitoring of patient's health status using a small telecommunications device.
Intervention Type
Device
Intervention Name(s)
Telehealth monitoring system (Honni Med)
Other Intervention Name(s)
Honni Med
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in St Georges's Respiratory Questionnaire at six months
Description
Self completed questionnaire
Time Frame
Baseline and six months
Secondary Outcome Measure Information:
Title
Change from baseline in EuroQol at six months
Description
self completed questionnaire
Time Frame
Baseline and six months
Title
Change from baseline in Hospital Anxiety and Depression Scale at six months
Description
self administered questionnaire
Time Frame
Baseline and six months
Title
healthcare utilisation
Description
data collected retrospectively from healthcare notes and hospital coding
Time Frame
six months
Title
number of exacerbations
Description
data collected retrospectively from healthcare notes
Time Frame
six months
Title
satisfaction
Description
interview administered questionnaire
Time Frame
six months
Title
cost effectiveness
Description
QALY analysis
Time Frame
six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet E McDowell, BScHons, PhD
Organizational Affiliation
South Eastern Health and Social Care Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Tate, BSc,MD,FRCP
Organizational Affiliation
South Eastern Health and Social Care Trust
Official's Role
Study Director
Facility Information:
Facility Name
South Eastern Health and Social Care Trust
City
Lisburn
State/Province
Co Antrim
ZIP/Postal Code
BT28 1JP
Country
United Kingdom

12. IPD Sharing Statement

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Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

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