Congestive Heart FailureNCT00789100
Evaluation of Remote Patient Monitoring.
An observational study of Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, run by Brunel University at 1 site in United Kingdom.
Trial summary
Nottingham Primary Care Trust has launched telemonitoring to support: independent living and self-management ability of people with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and co-morbidities; and reduce the health care utilisation associated with these patients, including the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Feb 2011
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and co-morbidities referred to the community specialist nurse or care matron
Who may be able to join
- Participants selected will be those: diagnosed with CHF, COPD or co-morbidities and referred to the community management service by its selection procedure for severity of the condition; are considered eligible for home-based telemonitoring; consent to receiving telemonitoring; have an active phone connection; are able to read and speak English (language of the equipment); are capable and willing to use the home monitoring device.
Who cannot join
- Patients are considered ineligible: if they have psychological or psychiatric disorders; if they have a cognitive deficiency that makes them unable to participate in their self-treatment; if they have a visual or motor deficiency that renders them incapable of using the telemonitoring device (unless a spouse or an informal caregiver is able to help); if they are currently scheduled for a hospital admission; if their life expectancy is shorter than 2 years; or if they already participate in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Home-based Telemonitor Service
Nottingham Primary Care Trust has launched telemonitoring to support: independent living and self-management ability of people with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and co-morbidities; and reduce the health care utilisation associated with these patients, including the number of hospitalisations, GP visits and community matron and specialist community nurse home visits.
The Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) will evaluate the technology and its impact of this telemonitoring system on quality of care (i.e. process measures), patient outcomes and direct healthcare costs from an NHS perspective.
Read the detailed description
The study is designed to evaluate the impact of home-based monitoring to support community based nursing services and care matrons in the management of patients with CHF and COPD and co-morbidities. The main issue is to design a study that will determine the impact of the use of the technology independent of other factors. A randomised controlled trial has been chosen in which equal numbers of participants with and without home-based monitoring will be followed over the study to determine differences in utilisation of healthcare services including number of hospitalisations, length of stay in hospital, GP visits and community matron and specialist community nurse home visits.
The ethical issue is how to determine those that will receive home-based monitoring and those that will be denied. The study requires that participants are matched for severity of their condition in each arm and this could deny some from the potential benefits of monitoring. However, as only a limited number of home-based monitors are available and all participants will continue to receive normal health care services, we believe that those denied monitoring will not receive care that is different to patients not in the study and the ethical issues are acceptable.
- Keywords
- telehealth, telemonitor, telemedicine, Co-morbidities
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group provided with home-based monitor | |
| 2 | Group receives no home-based monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalizations, hospital days, encounters with health professionals
Measured: Collected until end date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startFeb 2009
- Primary completionAug 2010
- Study completionFeb 2011
Why it stopped: Nottingham PCT withdrew for financial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brunel University
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham City Primary Care Trust
- Responsible party
- Principal investigator, Malcolm Clarke, Brunel University
- Investigators
- Malcolm Clarke, PhD, Principal investigator, Brunel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789100
- Sponsor's protocol ID
- Nottingham-001
- Status last verified
- Jul 2014
- First submitted
- 10 Nov 2008
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Home-based Telemonitor Service
- ClinicalTrials.gov ID
- NCT00789100
- Acronym / sponsor ID
- Nottingham-001
- Keywords
- telehealth, telemonitor, telemedicine, Co-morbidities
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Nottingham PCT withdrew for financial reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brunel UniversityUniversity, hospital or other
- Collaborators
- Nottingham City Primary Care Trust
- Study start
- Feb 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Nov 2008 (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.
Nottingham Primary Care Trust has launched telemonitoring to support: independent living and self-management ability of people with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and co-morbidities; and reduce the health care utilisation associated with these patients, including the number of hospitalisations, GP visits and community matron and specialist community nurse home visits.
The Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) will evaluate the technology and its impact of this telemonitoring system on quality of care (i.e. process measures), patient outcomes and direct healthcare costs from an NHS perspective.
Detailed description
The study is designed to evaluate the impact of home-based monitoring to support community based nursing services and care matrons in the management of patients with CHF and COPD and co-morbidities. The main issue is to design a study that will determine the impact of the use of the technology independent of other factors. A randomised controlled trial has been chosen in which equal numbers of participants with and without home-based monitoring will be followed over the study to determine differences in utilisation of healthcare services including number of hospitalisations, length of stay in hospital, GP visits and community matron and specialist community nurse home visits.
The ethical issue is how to determine those that will receive home-based monitoring and those that will be denied. The study requires that participants are matched for severity of their condition in each arm and this could deny some from the potential benefits of monitoring. However, as only a limited number of home-based monitors are available and all participants will continue to receive normal health care services, we believe that those denied monitoring will not receive care that is different to patients not in the study and the ethical issues are acceptable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Group provided with home-based monitor |
| 2 | – | –Group receives no home-based monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and co-morbidities referred to the community specialist nurse or care matron
Key inclusion criteria (1 listed)
- Participants selected will be those: diagnosed with CHF, COPD or co-morbidities and referred to the community management service by its selection procedure for severity of the condition; are considered eligible for home-based telemonitoring; consent to receiving telemonitoring; have an active phone connection; are able to read and speak English (language of the equipment); are capable and willing to use the home monitoring device.
Key exclusion criteria (1 listed)
- Patients are considered ineligible: if they have psychological or psychiatric disorders; if they have a cognitive deficiency that makes them unable to participate in their self-treatment; if they have a visual or motor deficiency that renders them incapable of using the telemonitoring device (unless a spouse or an informal caregiver is able to help); if they are currently scheduled for a hospital admission; if their life expectancy is shorter than 2 years; or if they already participate in another study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospitalizations, hospital days, encounters with health professionals
Time frame: Collected until end date
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
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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.
Malcolm Clarke, PhD principal investigator
Brunel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, run by Brunel University 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 17 Jul 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
Hospitalizations, hospital days, encounters with health professionals (time frame: Collected until end date). 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 17 Jul 2014.