Telepharmacy on Patients With Arterial Hypertension (CELESTE)

February 22, 2024 updated by: Márcio Galvão Guimarães de Oliveira, Federal University of Bahia

Evaluation of the Effectiveness of Telepharmacy on Clinical Outcomes of Patients With Arterial Hypertension: Celeste Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Bahia
      • Vitória Da Conquista, Bahia, Brazil, 45028440
        • Recruiting
        • Farmácia Escola da UFBA, campus Anísio Teixeira
        • Contact:
          • Marcio Galvão Oliveira, PhD
          • Phone Number: 55 77 988280954
          • Email: mgalvao@ufba.br
        • Principal Investigator:
          • Márcio Galvão Oliveira, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telepharmacy
Pharmaceutical care via telepharmacy
Other: Pharmaceutical care via telepharmacy and usual care
Pharmacotherapeutic monitoring via telephone consultation
Active Comparator: In-person
In-person pharmaceutical care
Other: Pharmaceutical care in-person and usual care
Face-to-face pharmacotherapeutic monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Controlling blood pressure
Time Frame: 3 months
Rate of patients reaching the blood pressure target for healthy elderly people: systolic pressure of 130-139 mmHg and diastolic pressure of 70-79 mmHg; and for frail elderly people: systolic pressure of 140-149 mmHg and diastolic pressure of 70-79mmHg according to guidelines from the Brazilian Society of Cardiology of 2020
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the treatment
Time Frame: 3 months
Patients who score higher than eight points on the adherence scale will be considered to have high adherence, those who score between six and seven points will be classified as medium adherence and those who score less than 6 points will be classified as low adherence.
3 months
Patient satisfaction
Time Frame: 3 months
The score will be calculated by the sum of the user's answers divided by the number of corresponding questions. Thus, the closer to 5, the greater the satisfaction with the service and the closer to 1, the greater the dissatisfaction.
3 months
Level of clinical significance of interventions
Time Frame: 3 months
Clinical significance of the intervention as described by the DOCUMENT, which classifies interventions into four levels of clinical significance: low; light; moderate and high.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Bahia

Investigators

  • Study Chair: Gabriella F Magalhães, UFOB
  • Principal Investigator: Márcio Galvão Guimarães de Oliveira, UFBA
  • Study Chair: Igor Matheus de novais Silva, UFBA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELESTE2023

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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