Educational ProblemsSMSNCT04191902
Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus
An observational study of Educational Problems, run by Universidade Federal Fluminense.
Trial summary
The investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- orientation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2021to 15 Feb 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all patients from the ward
Who may be able to join
- diabetes
Who cannot join
- non diabetes
About this study
Official title: Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus: A Brazilian Case Study
The investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group.
Read the detailed description
Patients with diabetes mellitus (DM) have greater control over the disease when they acquire some knowledge about it. In this context, the use of technology by health professionals for nutritional guidance and self-care has shown promising results. This study aims to evaluate the impact of these educational approaches via SMS on glycemic control of patients with DM, followed at the Endocrinology Outpatient Clinic of the Antonio Pedro University Hospital (HUAP). Also, the investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group. The patients in the intervention group received weekly SMS for six months, with dietary guidelines and DM care. Both groups answered a questionnaire at the beginning and end of the intervention, which consisted of assessing satisfaction with the health service received and their care for DM. Similarly, the investigators collected their clinical and laboratory data from medical records at the beginning and end of the intervention.
- Conditions
- Educational Problems
- Being tested
- orientation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orientationBehavioural
patients will be oriented
| Study group | Role | What they receive |
|---|---|---|
| 1 | control | |
| 2 | treated Receives: Behavioral: orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in glycemic control
Evaluation of the glycemic indices
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 posted10 Dec 2019
- Study start5 Jan 2021 (estimated)
- Primary completion5 Jan 2022 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle Taboada, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191902
- Sponsor's protocol ID
- Diabetes Mellitus
- Acronym
- SMS
- Status last verified
- Nov 2020
- First submitted
- 28 Nov 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: none information will be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus: A Brazilian Case Study
- ClinicalTrials.gov ID
- NCT04191902
- Acronym / sponsor ID
- SMS / Diabetes Mellitus
- Conditions
- Educational Problems
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 5 Jan 2021 (estimated)
- Primary completion
- 5 Jan 2022 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 10 Dec 2019 (actual)
- 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 investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group.
Detailed description
Patients with diabetes mellitus (DM) have greater control over the disease when they acquire some knowledge about it. In this context, the use of technology by health professionals for nutritional guidance and self-care has shown promising results. This study aims to evaluate the impact of these educational approaches via SMS on glycemic control of patients with DM, followed at the Endocrinology Outpatient Clinic of the Antonio Pedro University Hospital (HUAP). Also, the investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group. The patients in the intervention group received weekly SMS for six months, with dietary guidelines and DM care. Both groups answered a questionnaire at the beginning and end of the intervention, which consisted of assessing satisfaction with the health service received and their care for DM. Similarly, the investigators collected their clinical and laboratory data from medical records at the beginning and end of the intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –control |
| 2 | – | Behavioral: orientationtreated |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients from the ward
Key inclusion criteria (1 listed)
- diabetes
Key exclusion criteria (1 listed)
- non diabetes
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 |
|---|---|---|
| orientationpatients will be oriented | Behavioural | 2 |
Primary outcome
differences in glycemic control
Time frame: 1 year
Evaluation of the glycemic indices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No. none information will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Educational Problems, run by Universidade Federal Fluminense.
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 6 Nov 2020. 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?
Results are not available in the source record.
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?
differences in 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?
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 6 Nov 2020.