An interventional study of Telepharmaceutical Care in Diabete Mellitus, Diabete Type 2 and Telemedicine, sponsored by Rio Grande do Sul State Health Department - SES/RS. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-19.
Sponsored by Rio Grande do Sul State Health Department - SES/RS · Not applicable, Interventional, and Health services research
The prevalence of Diabetes Mellitus (DM) in the world is currently around 9.3% of adults aged between 20 and 79 years, which corresponds to 463 million people living with DM, and about 80% of these people are found in developing countries. In Brazil, fourth in the number of patients with Type 2 Diabetes Mellitus (DM2) in the world, the prevalence of DM is around 12%, with a significant increase in the last three decades. Non-adherence to DM treatment is known as a problem in the scenario and internationally, as it impairs the physiological response to the disease, increasing the direct and indirect cost of treatment. Pharmaceutical care is a practice model characterized by the provision of pharmaceutical services that optimize treatment, improve the process of medicines used, and aim at their best use. With the calamity situation arising from the COVID-19 pandemic created in the state of Rio Grande do Sul, the Pharmaceutical Telecare service was implemented. Dapagliflozin was recently incorporated into the Brazilian public system for the treatment of type 2 DM. Considering that there are no studies in Brazil to date on the use, treatment adherence, and problems related to pharmacotherapy (PRM) associated with dapagliflozin, and also considering that the guidance and monitoring of patients remotely have become more frequent and necessary, the purpose of this protocol is to describe a clinical trial that will evaluate the impact of a pharmaceutical telecare service in aspects related to treatment adherence, disease control, and costs, offered to people with DM2 using dapagliflozin. The hypothesis that will be tested is that Pharmaceutical Telecare can be as effective as standard care for type 2 diabetes and assess the associated costs related to teleconsultation in public health settings.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 124 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with Rio Grande do Sul State Health Department - SES/RS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the control group will remain out of contact with the research group and will receive usual care, which consists of receiving medications without additional information. After completion of the project, the control group will receive educational materials related to the care of people with diabetes and, if the effectiveness of the Pharmaceutical Telecare service is proven, this possibility of care will be offered to users.
The intervention will be carried out through three teleconsultations, one per month, with a pharmacist (Times 0, 1, 2 and 3), via cell phone. Each consultation will address an aspect of health education for DM2.
Behavioral: Telepharmaceutical Care
The intervention will be carried out through three teleconsultations, one per month, with a pharmacist (Times 0, 1, 2 and 3). In the opportunities, aspects related to pharmacotherapy and health status, non-pharmacological approaches, treatment adherence and evaluation of problems related to pharmacotherapy (PRM) will be discussed.
Variation in HbA1c levels
The patient'S blood glucose level
Time frame: 3 months
Adherence to treatment - Brief Medication Questionnaire (BMQ)
Assessment of treatment adherence through the BMQ.
Time frame: 3 months
Adherence to treatment
Assessed by the Self-Care Inventory - revised (SCI-R).
Time frame: 3 months
Variation in blood pressure levels
Will be obtained from medical records and laboratory tests that patients report at the beginning of tele calls.
Time frame: 3 months
Variation in lipid profile
Will be obtained from medical records and laboratory tests that patients report at the beginning of tele calls.
Time frame: 3 months
Hospitalizations
Number of hospitalizations in the period.
Time frame: 3 months
Medical consultations
Number of medical consultations performed.
Time frame: 3 months
Emergency visits
Number of emergency visits.
Time frame: 3 months
Drug-related problems
Number of drug-related problems found and resolved.
Time frame: 3 months
Service-related cost
Service-related cost
Time frame: 3 months
Quality of life measured by DQOL-Brazil;
Quality of life measured by Diabetes Quality of Life Measure (DQOL-Brasil).
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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