TelePharmaceutical Care Diabetes Trial

NCT05380596 | Unknown

• 1 other identifier: RioGrandeSulSHD
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Keywords

Telehealth; Pharmaceutical care; Diabetes mellitus; Pharmaceutical services; Tele-interventions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Adherence to treatment

  3 months

• Variation in blood pressure levels

  3 months

• Variation in lipid profile

  3 months

• Hospitalizations

  3 months

• Medical consultations

  3 months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

ACTIVE COMPARATOR

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

Interventions

Telepharmaceutical Care 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Rio Grande do Sul State Health Department - SES/RS

Porto Alegre, Rio Grande do Sul, 90110-150, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)