Clinical trial NCT06108674: Telepharmacy on Patients With Arterial Hypertension
Official title: Evaluation of the Effectiveness of Telepharmacy on Clinical Outcomes of Patients With Arterial Hypertension: Celeste Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: pharmaceutical care
telepharmacy
elderly patients
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 194
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to compare the effectiveness of a pharmaceutical care protocol via teleconsultation in the management of uncontrolled hypertension with pharmaceutical care carried out in elderly patients assisted in primary health care. The main questions it aims to answer are:

1. How effective is a pharmaceutical care protocol via teleconsultation on the clinical outcomes of elderly people with uncontrolled hypertension, when compared to in-person pharmaceutical care?
2. How effective is a pharmaceutical care protocol via teleconsultation in adherence to the treatment of elderly people with hypertension, when compared to in-person pharmaceutical care?

Participants will undergo four visits. Two visits will be for the application of instruments and measurement of clinical parameters to be carried out at the beginning and end of follow-up (visits 1 and 4). These will be carried out in a pharmacist's office at the pharmacy by previously trained pharmacists and pharmacy students. Visits 2 and 3 will be pharmaceutical consultations to be carried out in person and/or via telepharmacy.

Researchers will compare pharmaceutical care via telepharmacy with in-person pharmaceutical care to see how effective these services are in controlling blood pressure in elderly patients with uncontrolled blood pressure.

Detailed description: Specific objectives

* Characterize the clinical and socio-demographic profile of the studied population.
* Compare the acceptance and clinical importance of interventions carried out by the pharmacist between the telepharmacy and in-person (control) groups.
* Evaluate patient adherence to medication treatment in the teleconsultation group and in person
* Evaluate patient satisfaction in the teleconsultation group and in-person consultation.
* Compare satisfaction between the telepharmacy and in-person (control) groups.

Eligibility criteria: Inclusion Criteria:

* Elderly patients admitted to the service with a diagnosis of systemic arterial hypertension made by a physician based on a patient report, report or medical prescription.
* Patients who present uncontrolled blood pressure at the time of assessment based on the average of three measurements using a standardized protocol at the pharmacy will be included;
* Patients must have a cell phone and know how to use it;
* Patient not have previously received pharmaceutical care.

Exclusion Criteria:

* Elderly people who are unable to use their cell phones due to cognitive impairments (Mini Mental State Examination (MMSE).
* Elderly person considered unable of using a telephone (Instrumental Activities of Daily Living)
* Elderly with controlled blood pressure according to home monitoring.

Primary outcomes:
measure: Controlling blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: Adherence to the treatment
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 3 months
measure: Level of clinical significance of interventions
timeFrame: 3 months
Other outcomes:
Locations:
city: Vitória Da Conquista
country: Brazil
facility: Farmácia Escola da UFBA, campus Anísio Teixeira
state: Bahia
Study officials:
affiliation: UFOB
name: Gabriella F Magalhães
role: STUDY_CHAIR
affiliation: UFBA
name: Márcio Galvão Guimarães de Oliveira
role: PRINCIPAL_INVESTIGATOR
affiliation: UFBA
name: Igor Matheus de novais Silva
role: STUDY_CHAIR
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