Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

NCT01522859 | Completed

• 1 other identifier: 09/NIR01/26
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Telehealth; health related quality of life

Outcome Measures

Primary Outcomes (1)

• Change from baseline in St Georges's Respiratory Questionnaire at six months

  Self completed questionnaire

  Baseline and six months

Secondary Outcomes (6)

• Change from baseline in EuroQol at six months

  Baseline and six months

• Change from baseline in Hospital Anxiety and Depression Scale at six months

  Baseline and six months

• healthcare utilisation

  six months

• number of exacerbations

  six months

• satisfaction

  six months

Study Arms (2)

standard care

NO INTERVENTION

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.

Telehealth monitoring

EXPERIMENTAL

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

Device: Telehealth monitoring system (Honni Med)

Interventions

Telehealth monitoring system (Honni Med) DEVICE

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.

Also known as: Honni Med

Telehealth monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• any respiratory disorder other than COPD
• patients cognitively unable to learn the process of monitoring

Sponsors & Collaborators

• South Eastern Health and Social Care Trust: lead

Study Sites (1)

South Eastern Health and Social Care Trust

Lisburn, Co Antrim, BT28 1JP, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janet E McDowell, BScHons, PhD

  South Eastern Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

• Stephen Tate, BSc,MD,FRCP

  South Eastern Health and Social Care Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: February 1, 2012
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

GB (1)