Diabetes MellitusNCT02710799
Evaluation of the Effects of Teleconsultations on a Endocrinology Referral List
A study testing Teleconsultation and Protocol in people with Diabetes Mellitus and Hypothyroidism, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study is evaluate the effects of telephone teleconsultations to primary care physicians (compared to the state's referral protocol) in the referrals waiting list for endocrinological appointments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypothyroidism, Hyperthyroidism
- What is being tested?
- Teleconsultation and Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,470 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from counties with at least 5 endocrinology referrals waiting appointment.
- Patients referred from primary care physicians
- Patients referred because one of the protocol conditions (Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid nodule, Obesity).
Who cannot join
- Patients from counties with more than one hundred endocrinology referrals waiting appointment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Secretaria Estadual da Saúde
Porto Alegre, Rio Grande do Sul, 90110-150
About this study
Official title: Evaluation of the Effectivity of Teleconsultations for Improving the Referrals From Primary Care to Specialized Care of Patients With Chronic Endocrinological Conditions
The aim of this study is evaluate the effects of telephone teleconsultations to primary care physicians (compared to the state's referral protocol) in the referrals waiting list for endocrinological appointments.
Read the detailed description
Rio Grande do Sul state's referral list for endocrinology evaluation in specialized care is highly overloaded. There is currently a referral protocol to select patients how should be referred. It will be evaluated if a intervention of telephone-based teleconsultations provided by the TelessaúdeRS to the primary care physicians can provide additional benefits. TelessaúdeRS is a telehealth program from the University of Rio Grande do Sul. This will be evaluated in a cluster randomized clinical trial.
- Conditions
- Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid Nodule, Obesity
- Being tested
- Teleconsultation, Protocol
- Keywords
- Endocrinology, Referral list, Teleconsultation, Telemedicine, Cluster randomized clinical trial
- Medical subject headings
- Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid Nodule, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleconsultationOther
The teleconsultations will be performed by medical doctors, mostly family physicians, but also internists and endocrinologists. The teleconsultations will follow a structured format to discuss some topics on the disease and access the relevant information (based on the state's protocols). The doubts from the primary care physician will be addressed.
ProtocolOther
The informations provided in the referral list will be evaluated through the state's referrals protocols.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Referrals will be evaluated through the state's protocols Receives: Other: Protocol |
| Intervention | Experimental | Referrals will be evaluated through the state's protocols associated with telephone-based teleconsultations. Receives: Other: Teleconsultation; Other: Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of consultations authorized
Number of consultations authorized after the evaluation by the control and intervention strategies.
Measured: 1 year
Secondary outcomes (3)
Number of new referrals for endocrinology
Total number of new referrals performed by the county.
Measured: 1 year
Adherence to the state's protocols
Number of new referrals for endocrinology with adequate informations according to the state's protocols.
Measured: 1 year
Usage of TelessaúdeRS teleconsultations
Total number of calls to TelessaúdeRS hotline (available to every primary care physician working in brazilian public health system)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3,470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Secretaria Estadual da Saúde do Estado do Rio Grande do Sul, Programa de Pesquisa e Pós-Graduação em Epidemiologia da UFRGS, TelessaúdeRS / UFRGS
- Responsible party
- Sponsor
- Investigators
- Erno Harzheim, MD, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710799
- Sponsor's protocol ID
- 32981014.0.0000.5327
- Other IDs
- U1111-1179-2949
- Status last verified
- Aug 2016
- First submitted
- 7 Mar 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: We plan to publish trial results in an indexed medical journal. The results will be reported by the authors and the authorship criteria from ICMJE will be followed. After publishing the main results of the trial the unidentified dataset will be available by contacting the authors and providing an analyses plan which will be evaluated by the study's main investigator.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectivity of Teleconsultations for Improving the Referrals From Primary Care to Specialized Care of Patients With Chronic Endocrinological Conditions
- ClinicalTrials.gov ID
- NCT02710799
- Acronym / sponsor ID
- 32981014.0.0000.5327
- Conditions
- Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid Nodule, Obesity
- Keywords
- Endocrinology, Referral list, Teleconsultation, Telemedicine, Cluster randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,470 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Secretaria Estadual da Saúde do Estado do Rio Grande do Sul, Programa de Pesquisa e Pós-Graduação em Epidemiologia da UFRGS, TelessaúdeRS / UFRGS
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Mar 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 aim of this study is evaluate the effects of telephone teleconsultations to primary care physicians (compared to the state's referral protocol) in the referrals waiting list for endocrinological appointments.
Detailed description
Rio Grande do Sul state's referral list for endocrinology evaluation in specialized care is highly overloaded. There is currently a referral protocol to select patients how should be referred. It will be evaluated if a intervention of telephone-based teleconsultations provided by the TelessaúdeRS to the primary care physicians can provide additional benefits. TelessaúdeRS is a telehealth program from the University of Rio Grande do Sul. This will be evaluated in a cluster randomized clinical trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ProtocolReferrals will be evaluated through the state's protocols |
| Intervention | Experimental | Other: Teleconsultation, Other: ProtocolReferrals will be evaluated through the state's protocols associated with telephone-based teleconsultations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients from counties with at least 5 endocrinology referrals waiting appointment.
- Patients referred from primary care physicians
- Patients referred because one of the protocol conditions (Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid nodule, Obesity).
Key exclusion criteria (1 listed)
- Patients from counties with more than one hundred endocrinology referrals waiting appointment.
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 |
|---|---|---|
| TeleconsultationThe teleconsultations will be performed by medical doctors, mostly family physicians, but also internists and endocrinologists. The teleconsultations will follow a structured format to discuss some topics on the disease and access the relevant information (based on the state's protocols). The doubts from the primary care physician will be addressed. | Other | Intervention |
| ProtocolThe informations provided in the referral list will be evaluated through the state's referrals protocols. | Other | Control, Intervention |
Primary outcome
Number of consultations authorized
Time frame: 1 year
Number of consultations authorized after the evaluation by the control and intervention strategies.
3 secondary outcomes
Number of new referrals for endocrinology
Time frame: 1 year
Adherence to the state's protocols
Time frame: 1 year
Usage of TelessaúdeRS teleconsultations
Time frame: 1 year
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 10 Aug 2016.
- Individual participant dataSharing planned: Undecided. We plan to publish trial results in an indexed medical journal. The results will be reported by the authors and the authorship criteria from ICMJE will be followed. After publishing the main results of the trial the unidentified dataset will be available by contacting the authors and providing an analyses plan which will be evaluated by the study's main investigator.
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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, MD study chair
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsultation and Protocol in people with Diabetes Mellitus and Hypothyroidism, 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 3 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 10 Aug 2016. 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?
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?
Number of consultations authorized (time frame: 1 year). 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 10 Aug 2016.