TelePharmaceutical Care Diabetes Trial

NCT ID: NCT05380596

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-01-31

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.

Conditions

Diabete Mellitus; Diabete Type 2; Telemedicine; Telehealth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Telepharmaceutical Care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agnes Nogueira Gossenheimer

UNKNOWN

Sponsor Role: collaborator

Ana Paula Rigo

UNKNOWN

Sponsor Role: collaborator

Roberto Eduardo Schneiders

UNKNOWN

Sponsor Role: collaborator

Rio Grande do Sul State Health Department - SES/RS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rio Grande do Sul State Health Department - SES/RS

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Facility Contacts

Agnes ANG Nogueira Gossenheimer, Doctor

Role: primary

agnes-gossenheimer@saude.rs.gov.br

55 51 32887922

Other Identifiers

RioGrandeSulSHD

Identifier Type: -

Identifier Source: org_study_id