TelePharmaceutical Care Diabetes Trial (TPCDT)

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Telemedicine; Diabete Mellitus; Diabete Type 2; Telehealth
• Intervention / Treatment: Behavioral: Telepharmaceutical Care

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-150
      • Rio Grande do Sul State Health Department - SES/RS
      • Contact: Agnes ANG Nogueira Gossenheimer, Doctor; Phone Number: 55 51 32887922; Email: agnes-gossenheimer@saude.rs.gov.br
      • Principal Investigator: Agnes ANG Nogueira Gossenheimer, Doctor
      • Sub-Investigator: Ana Paula APR Rigo, Master
      • Sub-Investigator: Roberto Eduardo RES Schneiders, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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; 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.

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

Collaborators and Investigators

• Sponsor: Rio Grande do Sul State Health Department - SES/RS
• Collaborators: Agnes Nogueira Gossenheimer; Ana Paula Rigo; Roberto Eduardo Schneiders

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Telehealth; Diabetes mellitus; Pharmaceutical care; Pharmaceutical services; Tele-interventions
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RioGrandeSulSHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes