TelePharmaceutical Care Diabetes Trial

Telemedicine Clinical Trial

— TPCDT  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05380596
• Other study ID #: RioGrandeSulSHD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: January 2023

Study information

• Verified date: May 2022
• Source: Rio Grande do Sul State Health Department - SES/RS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabete Mellitus
• Diabete Type 2
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Telehealth
• Telemedicine

Intervention

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.

Locations

Country	Name	City	State
Brazil	Rio Grande do Sul State Health Department - SES/RS	Porto Alegre	Rio Grande Do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Rio Grande do Sul State Health Department - SES/RS	Agnes Nogueira Gossenheimer, Ana Paula Rigo, Roberto Eduardo Schneiders

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in HbA1c levels	The patient'S blood glucose level	3 months
Primary	Adherence to treatment - Brief Medication Questionnaire (BMQ)	Assessment of treatment adherence through the BMQ.	3 months
Secondary	Adherence to treatment	Assessed by the Self-Care Inventory - revised (SCI-R).	3 months
Secondary	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
Secondary	Variation in lipid profile	Will be obtained from medical records and laboratory tests that patients report at the beginning of tele calls.	3 months
Secondary	Hospitalizations	Number of hospitalizations in the period.	3 months
Secondary	Medical consultations	Number of medical consultations performed.	3 months
Secondary	Emergency visits	Number of emergency visits.	3 months
Secondary	Drug-related problems	Number of drug-related problems found and resolved.	3 months
Secondary	Service-related cost	Service-related cost	3 months
Secondary	Quality of life measured by DQOL-Brazil;	Quality of life measured by Diabetes Quality of Life Measure (DQOL-Brasil).	3 months