TelePharmaceutical Care Diabetes Trial

Study Overview
=================
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.

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)

Conditions
-----------------
Diabete Mellitus, Diabete Type 2, Telemedicine, Telehealth

Intervention / Treatment
-----------------
* Behavioral: Telepharmaceutical Care


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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. | |
| Active Comparator: Intervention<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telehealth, Pharmaceutical care, Diabetes mellitus, Pharmaceutical services, Tele-interventions