Chronic Obstructive Pulmonary DiseaseRESPIRANET-CNCT02901535
Tele-spirometry in Primary Care-Randomized Clinical Trial Cluster:Telemedicine in Chronic Obstructive Pulmonary Disease
A study testing Spirometry, telemonitoring and teleconsultation in people with Chronic Obstructive Pulmonary Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Spirometry, telemonitoring and teleconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Dec 2017
- 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 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- spirometry from TelessaudeRS-Universidade Federal do Rio Grande do Sul (from randomization cluster), Modified Medical Research Council Dyspnea > 0
Who cannot join
- normal or restrictive spirometry, low quality spirometries (inadequate)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
TelessaudeRS-Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90670000
Cynthia G Molina-Bastos, MD, 5191322585 ext. +55, cyncarol@gmail.com
Marcelo R. Gonçalves, PhD, 5191175156 ext. +55, marcelorog@gmail.com
About this study
Official title: Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Multifaceted Intervention in Symptoms Patients With Respiratory Illness
The purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with chronic obstructive pulmonary disease.
Read the detailed description
This study is a randomized clinical trial for patients with chronic obstructive pulmonary disease from a primary care. The purpose is to determine the effectiveness of telemedicine (teleconsultation and telemonitoring) in control of chronic obstructive pulmonary disease symptoms.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Spirometry, telemonitoring, teleconsultation, Spirometry - 20 weeks
- Keywords
- telemedicine, chronic obstructive pulmonary disease, Primary Health care, spirometry
- 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.
SpirometryOther
Spirometry in baseline
telemonitoringOther
telemonitoring (phone call nurse - 45 and 90 days)
teleconsultationOther
teleconsultation (general practioner received phone call to respiratory care)
Spirometry - 20 weeksOther
Spirometry (20 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Spirometry in baseline Spirometry - 20 weeks Receives: Other: Spirometry; Other: Spirometry - 20 weeks |
| Intervention | Experimental | Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks Receives: Other: Spirometry; Other: telemonitoring; Other: teleconsultation; Other: Spirometry - 20 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms
Modified Medical Research Council Dyspnea Scale (difference in mMRC)
Measured: 20 a 22 weeks
Secondary outcomes (2)
Spirometry - FEV1
spirometry parameters - FEV 1 (forced expiratory volume in one second)
Measured: 20 a 22 weeks
Spirometry - FVC
spirometry parameters - FVC (forced vital capacity)
Measured: 20 a 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startApr 2015
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
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.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Erno Harzheim, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901535
- Sponsor's protocol ID
- 227190 COPD
- Acronym
- RESPIRANET-C
- Status last verified
- Jan 2017
- First submitted
- 12 Sep 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Multifaceted Intervention in Symptoms Patients With Respiratory Illness
- ClinicalTrials.gov ID
- NCT02901535
- Acronym / sponsor ID
- RESPIRANET-C / 227190 COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- telemedicine, chronic obstructive pulmonary disease, Primary Health care, spirometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil
- Study start
- Apr 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Sep 2016 (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 purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with chronic obstructive pulmonary disease.
Detailed description
This study is a randomized clinical trial for patients with chronic obstructive pulmonary disease from a primary care. The purpose is to determine the effectiveness of telemedicine (teleconsultation and telemonitoring) in control of chronic obstructive pulmonary disease symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Spirometry, Other: Spirometry - 20 weeksSpirometry in baseline Spirometry - 20 weeks |
| Intervention | Experimental | Other: Spirometry, Other: telemonitoring, Other: teleconsultation, Other: Spirometry - 20 weeksSpirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- spirometry from TelessaudeRS-Universidade Federal do Rio Grande do Sul (from randomization cluster), Modified Medical Research Council Dyspnea > 0
Key exclusion criteria (1 listed)
- normal or restrictive spirometry, low quality spirometries (inadequate)
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 |
|---|---|---|
| SpirometrySpirometry in baseline | Other | Control, Intervention |
| telemonitoringtelemonitoring (phone call nurse - 45 and 90 days) | Other | Intervention |
| teleconsultationteleconsultation (general practioner received phone call to respiratory care) | Other | Intervention |
| Spirometry - 20 weeksSpirometry (20 weeks) | Other | Control, Intervention |
Primary outcome
Symptoms
Time frame: 20 a 22 weeks
Modified Medical Research Council Dyspnea Scale (difference in mMRC)
2 secondary outcomes
Spirometry - FEV1
Time frame: 20 a 22 weeks
Spirometry - FVC
Time frame: 20 a 22 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Erno Harzheim, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry, telemonitoring and teleconsultation in people with Chronic Obstructive Pulmonary Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 18 Jan 2017. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo R. Gonçalves, PhD (5191175156 ext. +55, marcelorog@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms (time frame: 20 a 22 weeks). 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 18 Jan 2017.