Chronic Obstructive Pulmonary DiseaseNCT01522859
Telehealth Monitoring in Chronic Obstructive Pulmonary Disease
A study testing Telehealth monitoring system (Honni Med) in people with Chronic Obstructive Pulmonary Disease, run by South Eastern Health and Social Care Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Telehealth monitoring system (Honni Med)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any respiratory disorder other than COPD
- patients cognitively unable to learn the process of monitoring
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South Eastern Health and Social Care Trust
Lisburn, Co Antrim, BT28 1JP
About this study
Official title: The Efficacy of Telehealth Monitoring in the Management of Patients With Chronic Obstructive Pulmonary Disease
The the aim of this study is to determine the benefits of Telehealth monitoring in the management of patients with chronic obstructive pulmonary disease.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Telehealth monitoring system (Honni Med)
- Keywords
- COPD, Telehealth, health related quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth monitoring system (Honni Med)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Telehealth monitoring system (Honni Med) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in St Georges's Respiratory Questionnaire at six months
Self completed questionnaire
Measured: Baseline and six months
Secondary outcomes (6)
Change from baseline in EuroQol at six months
self completed questionnaire
Measured: Baseline and six months
Change from baseline in Hospital Anxiety and Depression Scale at six months
self administered questionnaire
Measured: Baseline and six months
healthcare utilisation
data collected retrospectively from healthcare notes and hospital coding
Measured: six months
number of exacerbations
data collected retrospectively from healthcare notes
Measured: six months
satisfaction
interview administered questionnaire
Measured: six months
cost effectiveness
QALY analysis
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startAug 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Eastern Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JE McDowell, South Eastern Health and Social Care Trust
- Investigators
- Janet E McDowell, BScHons, PhD, Principal investigator, South Eastern Health and Social Care TrustStephen Tate, BSc,MD,FRCP, Study director, South Eastern Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522859
- Sponsor's protocol ID
- 09/NIR01/26
- Status last verified
- Jan 2012
- First submitted
- 24 Jan 2012
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Telehealth Monitoring in the Management of Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01522859
- Acronym / sponsor ID
- 09/NIR01/26
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Telehealth, health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- South Eastern Health and Social Care TrustUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Telehealth monitoring system (Honni Med)Daily monitoring of patient's health status using a small telecommunications device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- any respiratory disorder other than COPD
- patients cognitively unable to learn the process of monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth monitoring system (Honni Med)Also: Honni MedThe 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. | Device | Telehealth monitoring |
Primary outcome
Change from baseline in St Georges's Respiratory Questionnaire at six months
Time frame: Baseline and six months
Self completed questionnaire
6 secondary outcomes
Change from baseline in EuroQol at six months
Time frame: Baseline and six months
Change from baseline in Hospital Anxiety and Depression Scale at six months
Time frame: Baseline and six months
healthcare utilisation
Time frame: six months
number of exacerbations
Time frame: six months
satisfaction
Time frame: six months
cost effectiveness
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet E McDowell, BScHons, PhD principal investigator
South Eastern Health and Social Care Trust
Stephen Tate, BSc,MD,FRCP study director
South Eastern Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth monitoring system (Honni Med) in people with Chronic Obstructive Pulmonary Disease, run by South Eastern Health and Social Care Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in St Georges's Respiratory Questionnaire at six months (time frame: Baseline and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012.