Chronic Obstructive Pulmonary DiseaseSweetAgeNCT01481506
Multiparametric Telemonitoring In Elderly People With Chronic Obstructive Pulmonary Disease
A study testing Telemonitoring in people with Chronic Obstructive Pulmonary Disease, run by Campus Bio-Medico University.
Trial summary
Chronic obstructive pulmonary disease (COPD) determines an important risk of disability and disease-related need of care. Selected interventions were able to reduce the number and the severity of exacerbations. Telemedicine has also been proposed for this purpose. Current evidences, however, are scant. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Telemonitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2011
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with chronic obstructive pulmonary disease stage II-III (GOLD classification)
Who cannot join
- Cognitive impairment precluding the use of the experimental device.
About this study
Official title: Efficacy Of Multiparametric Telemonitoring On Respiratory Outcomes In Elderly People With Chronic Obstructive Pulmonary Disease.
Chronic obstructive pulmonary disease (COPD) determines an important risk of disability and disease-related need of care. Selected interventions were able to reduce the number and the severity of exacerbations. Telemedicine has also been proposed for this purpose. Current evidences, however, are scant. The investigators present a randomized, parallel-group trial of a multiparametric remote monitoring system to test its ability to improve early exacerbation detection rates and impact on clinical outcomes.
Read the detailed description
All patients performed a simple spirometry that was carried out using a Stead-Wells bell spirometer (Biomedin, Padua, Italy). Upon provision of informed consent, patients in the telemonitoring group were invited to a session during which they were instructed on how to wear the wristband and to operate the cellular telephone. A study physician was available on call during office hours to assist patients needing further instructions. A technician was also available in order to solve ingoing hardware problems.
All participants were also clinically evaluated at baseline and received a multi-dimensional assessment including: Activities of daily living scale (ADL), Instrumental activities of daily living scale (IADL), Mini-mental state examination (MMSE) test. These are well validated and routinely used tools to screen geriatric patients in order to detect global, physical and instrumental autonomy and consequent degree of dependence, as well as cognitive status.
Patients in both groups were followed up for 9 months, during this period they attended the standard schedule of clinical controls. For patients in the SweetAge group, the parameters received were evaluated daily by a study physician. In case of abnormal readings, the physician systematically contacted the patient to verify whether their symptoms had worsened or new symptoms had arose. In this event, the patient's adherence to her/his therapy was checked and, if unsatisfactory, individually tailored interventions promoting adherence were carried up. Otherwise, a diagnosis of exacerbation was made and, on the basis of its severity, an outpatient clinical assessment (for mild exacerbations) or a hospital admission was scheduled.
The outcome measures of these study were: number of exacerbations (defined as a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medications, and number of hospital admissions.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Telemonitoring
- 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.
TelemonitoringProcedure or surgery
Use of wearable sensors for heart rate, haemoglobin oxygen saturation, physical activity, respiratory rate with automatic transmission to the monitoring central.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | Not described Receives: Procedure: Telemonitoring |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Events
Rate of COPD exacerbations, defined as a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medications. Rate of hospital admission for respiratory problems (COPD exacerbations, lower respiratory tract infections, respiratory failure).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raffaele Antonelli Incalzi, Campus Bio-Medico University
- Investigators
- Raffaele Antonelli Incalzi, MD, Principal investigator, Campus BioMedico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481506
- Sponsor's protocol ID
- 29/2009 ComEt CBM - SweetAge
- Acronym
- SweetAge
- Status last verified
- Nov 2011
- First submitted
- 8 Nov 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pedone C, Chiurco D, Scarlata S, Incalzi RA. Efficacy of multiparametric telemonitoring on respiratory outcomes in elderly people with COPD: a randomized controlled trial. BMC Health Serv Res. 2013 Mar 6;13:82. doi: 10.1186/1472-6963-13-82.
PubMed 23497109
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Multiparametric Telemonitoring On Respiratory Outcomes In Elderly People With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT01481506
- Acronym / sponsor ID
- SweetAge / 29/2009 ComEt CBM - SweetAge
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 29 Nov 2011 (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.
Chronic obstructive pulmonary disease (COPD) determines an important risk of disability and disease-related need of care. Selected interventions were able to reduce the number and the severity of exacerbations. Telemedicine has also been proposed for this purpose. Current evidences, however, are scant. The investigators present a randomized, parallel-group trial of a multiparametric remote monitoring system to test its ability to improve early exacerbation detection rates and impact on clinical outcomes.
Detailed description
All patients performed a simple spirometry that was carried out using a Stead-Wells bell spirometer (Biomedin, Padua, Italy). Upon provision of informed consent, patients in the telemonitoring group were invited to a session during which they were instructed on how to wear the wristband and to operate the cellular telephone. A study physician was available on call during office hours to assist patients needing further instructions. A technician was also available in order to solve ingoing hardware problems.
All participants were also clinically evaluated at baseline and received a multi-dimensional assessment including: Activities of daily living scale (ADL), Instrumental activities of daily living scale (IADL), Mini-mental state examination (MMSE) test. These are well validated and routinely used tools to screen geriatric patients in order to detect global, physical and instrumental autonomy and consequent degree of dependence, as well as cognitive status.
Patients in both groups were followed up for 9 months, during this period they attended the standard schedule of clinical controls. For patients in the SweetAge group, the parameters received were evaluated daily by a study physician. In case of abnormal readings, the physician systematically contacted the patient to verify whether their symptoms had worsened or new symptoms had arose. In this event, the patient's adherence to her/his therapy was checked and, if unsatisfactory, individually tailored interventions promoting adherence were carried up. Otherwise, a diagnosis of exacerbation was made and, on the basis of its severity, an outpatient clinical assessment (for mild exacerbations) or a hospital admission was scheduled.
The outcome measures of these study were: number of exacerbations (defined as a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medications, and number of hospital admissions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Procedure: Telemonitoring |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients with chronic obstructive pulmonary disease stage II-III (GOLD classification)
Key exclusion criteria (1 listed)
- Cognitive impairment precluding the use of the experimental device.
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 |
|---|---|---|
| TelemonitoringUse of wearable sensors for heart rate, haemoglobin oxygen saturation, physical activity, respiratory rate with automatic transmission to the monitoring central. | Procedure or surgery | Telemonitoring |
Primary outcome
Respiratory Events
Time frame: 9 months
Rate of COPD exacerbations, defined as a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medications. Rate of hospital admission for respiratory problems (COPD exacerbations, lower respiratory tract infections, respiratory failure).
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 29 Nov 2011.
- Derived from this study: PubMed 23497109Pedone C, Chiurco D, Scarlata S, Incalzi RA. Efficacy of multiparametric telemonitoring on respiratory outcomes in elderly people with COPD: a randomized controlled trial. BMC Health Serv Res. 2013 Mar 6;13:82. doi: 10.1186/1472-6963-13-82.
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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.
Raffaele Antonelli Incalzi, MD principal investigator
Campus BioMedico University
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Chronic Obstructive Pulmonary Disease, run by Campus Bio-Medico University.
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: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Respiratory Events (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481506, which also lists 1 linked publication.
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 29 Nov 2011.