Clinical trial NCT05380596: TelePharmaceutical Care Diabetes Trial
Official title: Impact of TelePharmaceutical Care on People With Type 2 Diabetes Melitus, Seen at the Special Medicines Pharmacy of the State of Rio Grande do Sul: a Randomized Clinical Trial (TelePharmaceutical Care Diabetes Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabete Mellitus
Diabete Type 2
Telemedicine
Telehealth
Keywords: Telehealth
Pharmaceutical care
Diabetes mellitus
Pharmaceutical services
Tele-interventions
Lead sponsor: Rio Grande do Sul State Health Department - SES/RS
Sponsor class: OTHER_GOV
Collaborators: name: Agnes Nogueira Gossenheimer
name: Ana Paula Rigo
name: Roberto Eduardo Schneiders
First posted: 2022-05-19
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an unblinded randomized clinical trial comparing the outcomes between a group that will receive a Pharmaceutical Telecare intervention (pharmaceutical consultation via telephone), and the control group that will receive only the usual care. All steps of this study will follow the recommendations of the CONSORT guideline for clinical trials (SCHULZ, 2010)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Variation in HbA1c levels
timeFrame: 3 months
measure: Adherence to treatment - Brief Medication Questionnaire (BMQ)
timeFrame: 3 months
Secondary outcomes:
measure: Adherence to treatment
timeFrame: 3 months
measure: Variation in blood pressure levels
timeFrame: 3 months
measure: Variation in lipid profile
timeFrame: 3 months
measure: Hospitalizations
timeFrame: 3 months
measure: Medical consultations
timeFrame: 3 months
measure: Emergency visits
timeFrame: 3 months
measure: Drug-related problems
timeFrame: 3 months
measure: Service-related cost
timeFrame: 3 months
measure: Quality of life measured by DQOL-Brazil;
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Rio Grande do Sul State Health Department - SES/RS
state: Rio Grande Do Sul
Study officials:
References: