Diabetes MellitusTCDMNCT01972412
Telephone Use for Care of Persons With Diabetes Mellitus.
A study testing telephone support in people with Diabetes Mellitus, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
The purpose of this study is to determine whether phone use contributes to diabetes control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- telephone support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 2 sitesBrazil
- Study dates
- Apr 2013to Mar 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetes mellitus type 2
- age
- ability to listen and answer questions
Who cannot join
- often present less than 75% participation in the proposed activities
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
University of São Paulo at Ribeirão Preto College of Nursing
Ribeirão Preto, São Paulo, 14040-902
Carla Regina S Teixeira, Doctor, 551636023434, carlarst@eerp.usp.br
Tânia A Canata Becker, Master
- Recruiting
Universidade de São Paulo
Ribeirão Preto, São Paulo
Carla Regina S Teixeira, Doctor, 551636023434, carlarst@eerp.usp.br
Tânia A Canata Becker, Master
About this study
Official title: Telephone Support for Self-monitoring of Persons With Diabetes Mellitus Using the Chronic Care Model
The purpose of this study is to determine whether phone use contributes to diabetes control.
Read the detailed description
Studies reinforce the need to test innovative care that can serve more patients, since education is a key element for the accession to the treatment of diabetes. Recently, an innovative, feasible and low cost presented in the literature is the use of telephone support as an intervention strategy This study aims to evaluate the implementation of a telephone support for self-monitoring of people with diabetes mellitus treated in ribeirão Preto.
- Conditions
- Diabetes Mellitus
- Being tested
- telephone support
- Keywords
- nursing care, diabetes mellitus, phone support, chronic care model
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone supportBehavioural
Telephone support for four months about healthy diet, physical activity and medication use.
| Study group | Role | What they receive |
|---|---|---|
| Telephone support | Other | Intervention type: Telephone support for four months. Receives: Behavioral: telephone support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telephone Support for self-monitoring of persons with diabetes mellitus using the Chronic Care Model
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014 (estimated)
- Study completionMar 2014 (estimated)
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tânia Alves Canata Becker, University of Sao Paulo
- Investigators
- Tânia A Canata Becker, Master, Principal investigator, University of São Paulo at Ribeirão Preto College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972412
- Sponsor's protocol ID
- EERP - 146.171
- Acronym
- TCDM
- Status last verified
- Oct 2013
- First submitted
- 26 Mar 2013
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Becker TAC, Teixeira CRS, Zanetti ML, Pace AE, Almeida FA, Torquato MTDCG. Effects of supportive telephone counseling in the metabolic control of elderly people with diabetes mellitus. Rev Bras Enferm. 2017 Jul-Aug;70(4):704-710. doi: 10.1590/0034-7167-2017-0089. English, Portuguese.
PubMed 28793098
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Support for Self-monitoring of Persons With Diabetes Mellitus Using the Chronic Care Model
- ClinicalTrials.gov ID
- NCT01972412
- Acronym / sponsor ID
- TCDM / EERP - 146.171
- Conditions
- Diabetes Mellitus
- Keywords
- nursing care, diabetes mellitus, phone support, chronic care model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 30 Oct 2013 (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 whether phone use contributes to diabetes control.
Detailed description
Studies reinforce the need to test innovative care that can serve more patients, since education is a key element for the accession to the treatment of diabetes. Recently, an innovative, feasible and low cost presented in the literature is the use of telephone support as an intervention strategy This study aims to evaluate the implementation of a telephone support for self-monitoring of people with diabetes mellitus treated in ribeirão Preto.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telephone support | Other | Behavioral: telephone supportIntervention type: Telephone support for four months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetes mellitus type 2
- age
- ability to listen and answer questions
Key exclusion criteria (1 listed)
- often present less than 75% participation in the proposed activities
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 |
|---|---|---|
| telephone supportTelephone support for four months about healthy diet, physical activity and medication use. | Behavioural | Telephone support |
Primary outcome
Telephone Support for self-monitoring of persons with diabetes mellitus using the Chronic Care Model
Time frame: Four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
- Derived from this study: PubMed 28793098Becker TAC, Teixeira CRS, Zanetti ML, Pace AE, Almeida FA, Torquato MTDCG. Effects of supportive telephone counseling in the metabolic control of elderly people with diabetes mellitus. Rev Bras Enferm. 2017 Jul-Aug;70(4):704-710. doi: 10.1590/0034-7167-2017-0089. English, Portuguese.
- Affiliated to the International Diabetes Federation.Link provided by the sponsor.
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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.
Tânia A Canata Becker, Master principal investigator
University of São Paulo at Ribeirão Preto College of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone support in people with Diabetes Mellitus, run by University of Sao Paulo at 2 sites 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: status not confirmed, as of the sponsor's last update on 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Tânia A Canata Becker, Master (551636023434, tania.becker@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telephone Support for self-monitoring of persons with diabetes mellitus using the Chronic Care Model (time frame: Four 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 NCT01972412, 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 4 Nov 2013.