TelePharmaceutical Care Diabetes Trial

Not Applicable

• Conditions: Diabete Mellitus; Telehealth; Telemedicine; Diabete Type 2
• Interventions: Behavioral: Telepharmaceutical Care

• Registration Number: NCT05380596
• Lead Sponsor: Rio Grande do Sul State Health Department - SES/RS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-13
• Last Update Submitted: 2022-05-13
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Study Start: 2022-06-01
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• People aged 18 years or older, with a previous diagnosis of type 2 diabetes mellitus and who take dapagliflozin at the Special Medicines Pharmacy of the State of Rio Grande do Sul, Brazil, will be selected. In addition, it will be considered an inclusion criterion that the person is available to receive phone calls.

Exclusion Criteria

• Do not present a telephone record registered in the system;
• Be participating in another diabetes education program;
• Pregnancy;
• Severe cognitive problems;
• Communication difficulties;
• Presence of other injuries;
• Patients who are hospitalized at the time of recruitment will also be excluded from participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Telepharmaceutical Care	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.

Primary Outcome Measures

Name	Time	Method
Adherence to treatment - Brief Medication Questionnaire (BMQ)	3 months	Assessment of treatment adherence through the BMQ.
Variation in HbA1c levels	3 months	The patient'S blood glucose level

Secondary Outcome Measures

Name	Time	Method
Adherence to treatment	3 months	Assessed by the Self-Care Inventory - revised (SCI-R).
Variation in blood pressure levels	3 months	Will be obtained from medical records and laboratory tests that patients report at the beginning of tele calls.
Variation in lipid profile	3 months	Will be obtained from medical records and laboratory tests that patients report at the beginning of tele calls.
Hospitalizations	3 months	Number of hospitalizations in the period.
Medical consultations	3 months	Number of medical consultations performed.
Emergency visits	3 months	Number of emergency visits.
Quality of life measured by DQOL-Brazil;	3 months	Quality of life measured by Diabetes Quality of Life Measure (DQOL-Brasil).
Drug-related problems	3 months	Number of drug-related problems found and resolved.
Service-related cost	3 months	Service-related cost

Trial Locations

Locations (1)

Rio Grande do Sul State Health Department - SES/RS; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil