Diabetes MellitusNCT02768480
Effectiveness of Phone Calls Intervention on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center
A study testing Primary Care and Phone Calls Support and Primary Care in people with Diabetes Mellitus, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The study is a randomized clinical trial, controlled, open label that aimed to compare two groups after discharge of a tertiary care: type 2 diabetes patients followed exclusively by primary care (control group) and patients followed by primary care and supported by phone calls (intervention group). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Primary Care and Phone Calls Support and Primary Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes;
- Patients who met discharges criteria according to endocrinology team;
- Patients with HbA1C < 8%.
Who cannot join
- Patients with stage IV or V nephropathy;
- Patients with not controlled Ischemic heart disease;
- Patients with severe autonomous or peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Evaluation of the Effectiveness of Phone Calls Intervention (TelessaúdeRS) on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center: A Randomized Clinical Trial
The study is a randomized clinical trial, controlled, open label that aimed to compare two groups after discharge of a tertiary care: type 2 diabetes patients followed exclusively by primary care (control group) and patients followed by primary care and supported by phone calls (intervention group).
Read the detailed description
The investigators designed a randomized controlled trial. Patients with stable and controlled type 2 diabetes, and considered to be eligible to discharge from specialized care to primary care will be included. Patients with severe neuropathy, not controlled ischemic heart disease and nephropathy stage IV/V will be excluded. Enrolled patients will be randomized in two groups: follow-up supported by periodic nurse phone calls plus primary care (intervention group) or followed by primary care team (control group). The intervention group will receive regular telephone calls (every 3 months for 1 year) and will have a toll-free number to resolve questions about the disease management. Main outcome is the glycemic control between groups after 1 year of follow-up. Secondary outcomes include: rate of hypoglycaemia, blood pressure control,emergency visits, nephropathy progression and death.
- Conditions
- Diabetes Mellitus
- Being tested
- Primary Care, Phone Calls Support and Primary Care
- Keywords
- Diabetes, phone calls, glycemic control
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary CareOther
Patients will be followed by primary care team according to the usual health system routine.
Phone Calls Support and Primary CareOther
Patients in intervention group will receive periodic phone calls (every three months) and will have a toll-free number to resolve questions about the disease management. The phone-calls will be performed by trained nurses and will follow a structured format. Nurses will address some topics: patient's treatment adherence, technique of insulin administration, disease understanding, hypoglycaemia management, healthy diet, smoke cessation and foot care.
| Study group | Role | What they receive |
|---|---|---|
| Primary Care | Active comparator | Patients will be followed by primary care team exclusively. Receives: Other: Primary Care |
| Phone Calls Support and Primary Care | Experimental | Patients will be followed by primary care team and supported by periodic nurse phone calls. Receives: Other: Phone Calls Support and Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
Evaluation after 1 year of discharge with HbA1c
Measured: 1 year
Secondary outcomes (12)
Visits to the doctor, nurse, nutritionist, psychologist
Evaluation after 1 year of discharge with a structured questionnaire
Measured: 1 year
Rate of referring to tertiary care
Evaluation after 1 year of discharge with a structured questionnaire
Measured: 1 year
Care satisfaction with diabetes treatment
Evaluation after 1 year of discharge with a structured questionnaire
Measured: 1 year
Emergency visits because of diabetes acute complications
Evaluation after 1 year of discharge with a structured questionnaire
Measured: 1 year
Hypoglycaemic rate
Evaluation after 1 year of discharge with a structured questionnaire
Measured: 1 year
Treatment adherence
Evaluation after 1 year of discharge with the Brief Medication Questionnaire
Measured: 1 year
Lipid control
Evaluation after 1 year of discharge with blood lipid levels
Measured: 1 year
Antiplatelet therapy/ statin use
Evaluation after 1 year of discharge with a structured questionnaire
Measured: 1 year
Nephropathy emergence or worsening
Evaluation after 1 year of discharge with microalbuminuria and blood creatinine measurement
Measured: 1 year
Retinopathy emergence or worsening
Evaluation after 1 year of discharge with retinography and ophthalmologist advice if is necessary.
Measured: 1 year
Major cardiovascular events
Evaluation after 1 year of discharge with a structured questionnaire
Measured: 1 year
Death
Evaluation after 1 year of discharge with telephone contact and active search
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 posted11 May 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 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
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra P Silveiro, MD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768480
- Sponsor's protocol ID
- 150503
- Status last verified
- Feb 2019
- First submitted
- 29 Apr 2016
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Moreira AM, Rados DV, de Farias CB, Coelli S, de Almeida Faller L, Dos Santos LF, Matzenbacher AM, Katz N, Harzeim E, Silveiro SP. Effects of nurse tele support via telephone calls on transition between specialized and primary care in type 2 diabetes mellitus patients: a CONSORT-compliant randomized clinical trial. Endocrine. 2025 Mar;87(3):978-986. doi: 10.1007/s12020-024-04095-6. Epub 2024 Nov 29.
PubMed 39614069Moreira AM, Marobin R, Rados DV, de Farias CB, Coelli S, Bernardi BL, Faller LA, Dos Santos LF, Matzenbacher AM, Katz N, Harzheim E, Silveiro SP; TelessaudeRS. Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial. Trials. 2017 May 18;18(1):222. doi: 10.1186/s13063-017-1954-z.
PubMed 28521796
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Phone Calls Intervention (TelessaúdeRS) on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02768480
- Acronym / sponsor ID
- 150503
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, phone calls, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 May 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 study is a randomized clinical trial, controlled, open label that aimed to compare two groups after discharge of a tertiary care: type 2 diabetes patients followed exclusively by primary care (control group) and patients followed by primary care and supported by phone calls (intervention group).
Detailed description
The investigators designed a randomized controlled trial. Patients with stable and controlled type 2 diabetes, and considered to be eligible to discharge from specialized care to primary care will be included. Patients with severe neuropathy, not controlled ischemic heart disease and nephropathy stage IV/V will be excluded. Enrolled patients will be randomized in two groups: follow-up supported by periodic nurse phone calls plus primary care (intervention group) or followed by primary care team (control group). The intervention group will receive regular telephone calls (every 3 months for 1 year) and will have a toll-free number to resolve questions about the disease management. Main outcome is the glycemic control between groups after 1 year of follow-up. Secondary outcomes include: rate of hypoglycaemia, blood pressure control,emergency visits, nephropathy progression and death.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Care | Active comparator | Other: Primary CarePatients will be followed by primary care team exclusively. |
| Phone Calls Support and Primary Care | Experimental | Other: Phone Calls Support and Primary CarePatients will be followed by primary care team and supported by periodic nurse phone calls. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes;
- Patients who met discharges criteria according to endocrinology team;
- Patients with HbA1C < 8%.
Key exclusion criteria (3 listed)
- Patients with stage IV or V nephropathy;
- Patients with not controlled Ischemic heart disease;
- Patients with severe autonomous or peripheral neuropathy.
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 |
|---|---|---|
| Primary CarePatients will be followed by primary care team according to the usual health system routine. | Other | Primary Care |
| Phone Calls Support and Primary CarePatients in intervention group will receive periodic phone calls (every three months) and will have a toll-free number to resolve questions about the disease management. The phone-calls will be performed by trained nurses and will follow a structured format. Nurses will address some topics: patient's treatment adherence, technique of insulin administration, disease understanding, hypoglycaemia management, healthy diet, smoke cessation and foot care. | Other | Phone Calls Support and Primary Care |
Primary outcome
Glycemic Control
Time frame: 1 year
Evaluation after 1 year of discharge with HbA1c
12 secondary outcomes
Visits to the doctor, nurse, nutritionist, psychologist
Time frame: 1 year
Rate of referring to tertiary care
Time frame: 1 year
Care satisfaction with diabetes treatment
Time frame: 1 year
Emergency visits because of diabetes acute complications
Time frame: 1 year
Hypoglycaemic rate
Time frame: 1 year
Treatment adherence
Time frame: 1 year
Lipid control
Time frame: 1 year
Antiplatelet therapy/ statin use
Time frame: 1 year
Nephropathy emergence or worsening
Time frame: 1 year
Retinopathy emergence or worsening
Time frame: 1 year
Major cardiovascular events
Time frame: 1 year
Death
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 26 Feb 2019.
- Derived from this study: PubMed 39614069Moreira AM, Rados DV, de Farias CB, Coelli S, de Almeida Faller L, Dos Santos LF, Matzenbacher AM, Katz N, Harzeim E, Silveiro SP. Effects of nurse tele support via telephone calls on transition between specialized and primary care in type 2 diabetes mellitus patients: a CONSORT-compliant randomized clinical trial. Endocrine. 2025 Mar;87(3):978-986. doi: 10.1007/s12020-024-04095-6. Epub 2024 Nov 29.
- Derived from this study: PubMed 28521796Moreira AM, Marobin R, Rados DV, de Farias CB, Coelli S, Bernardi BL, Faller LA, Dos Santos LF, Matzenbacher AM, Katz N, Harzheim E, Silveiro SP; TelessaudeRS. Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial. Trials. 2017 May 18;18(1):222. doi: 10.1186/s13063-017-1954-z.
- Individual participant dataSharing planned: No
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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.
Sandra P Silveiro, MD study director
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 Primary Care and Phone Calls Support and Primary Care in people with Diabetes Mellitus, 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 3 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 26 Feb 2019. 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?
Glycemic Control (time frame: 1 year). 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 NCT02768480, which also lists 2 linked publications.
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 26 Feb 2019.