Diabete Mellitus, Diabete Type 2, Telehealth, Telemedicine
Conditions
Keywords
Telehealth, Pharmaceutical care, Diabetes mellitus, Pharmaceutical services, Tele-interventions
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.
Interventions
BEHAVIORALTelepharmaceutical 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.
Sponsors
Agnes Nogueira Gossenheimer
Ana Paula Rigo
Roberto Eduardo Schneiders
Rio Grande do Sul State Health Department - SES/RS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation in HbA1c levels | 3 months | The patient'S blood glucose level |
| Adherence to treatment - Brief Medication Questionnaire (BMQ) | 3 months | Assessment of treatment adherence through the BMQ. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Adherence to treatment | 3 months | Assessed by the Self-Care Inventory - revised (SCI-R). |
| Drug-related problems | 3 months | Number of drug-related problems found and resolved. |
| Service-related cost | 3 months | Service-related cost |
| Quality of life measured by DQOL-Brazil; | 3 months | Quality of life measured by Diabetes Quality of Life Measure (DQOL-Brasil). |
| Emergency visits | 3 months | Number of emergency visits. |
| 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. |
Countries
Brazil
Outcome results
None listed