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CELESTE: Telepharmacy on Patients With Arterial Hypertension

Sponsor
Federal University of Bahia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06108674
Collaborator
(none)
194
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pharmaceutical care via telepharmacy and usual care
  • Other: Pharmaceutical care in-person and usual care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Evaluation of the Effectiveness of Telepharmacy on Clinical Outcomes of Patients With Arterial Hypertension: Celeste Randomized Clinical Trial
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Controlling blood pressure [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

Secondary Outcome Measures

  1. Adherence to the treatment [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.

  2. Patient satisfaction [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. Level of clinical significance of interventions [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Márcio Galvão Guimarães de Oliveira, Adjunct Professor, Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT06108674
Other Study ID Numbers:
  • CELESTE2023
First Posted:
Oct 31, 2023
Last Update Posted:
Nov 3, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Márcio Galvão Guimarães de Oliveira, Adjunct Professor, Federal University of Bahia
pharmaceutical care
telepharmacy
elderly patients
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Nov 3, 2023