- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04191902
Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus (SMS)
November 4, 2020 updated by: Giselle Taboada, Universidade Federal Fluminense
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
all patients from the ward
Description
Inclusion Criteria:
- diabetes
Exclusion Criteria:
- non diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
control
|
|
|
2
treated
|
patients will be oriented
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
differences in glycemic control
Time Frame: 1 year
|
Evaluation of the glycemic indices
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 5, 2021
Primary Completion (Anticipated)
January 5, 2022
Study Completion (Anticipated)
February 15, 2022
Study Registration Dates
First Submitted
November 28, 2019
First Submitted That Met QC Criteria
December 7, 2019
First Posted (Actual)
December 10, 2019
Study Record Updates
Last Update Posted (Actual)
November 6, 2020
Last Update Submitted That Met QC Criteria
November 4, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Diabetes mellitus
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
none information will be shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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