Telepharmacy on Patients With Arterial Hypertension

NCT ID: NCT06108674

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Telepharmacy

Pharmaceutical care via telepharmacy

Group Type EXPERIMENTAL

Pharmaceutical care via telepharmacy and usual care

Intervention Type OTHER

Pharmacotherapeutic monitoring via telephone consultation

In-person

In-person pharmaceutical care

Group Type ACTIVE_COMPARATOR

Pharmaceutical care in-person and usual care

Intervention Type OTHER

Face-to-face pharmacotherapeutic monitoring

Interventions

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Pharmaceutical care via telepharmacy and usual care

Pharmacotherapeutic monitoring via telephone consultation

Intervention Type OTHER

Pharmaceutical care in-person and usual care

Face-to-face pharmacotherapeutic monitoring

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Bahia

OTHER

Sponsor Role lead

Responsible Party

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Márcio Galvão Guimarães de Oliveira

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabriella F Magalhães

Role: STUDY_CHAIR

UFOB

Márcio Galvão Guimarães de Oliveira

Role: PRINCIPAL_INVESTIGATOR

UFBA

Igor Matheus de novais Silva

Role: STUDY_CHAIR

UFBA

Locations

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Farmácia Escola da UFBA, campus Anísio Teixeira

Vitória da Conquista, Estado de Bahia, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Gabriella F Magalhães

Role: CONTACT

77999062525

Facility Contacts

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Marcio Galvão Oliveira, PhD

Role: primary

55 77 988280954

References

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Afreen N, Padilla-Tolentino E, McGinnis B. Identifying Potential High-Risk Medication Errors Using Telepharmacy and a Web-Based Survey Tool. Innov Pharm. 2021 Feb 12;12(1):10.24926/iip.v12i1.3377. doi: 10.24926/iip.v12i1.3377. eCollection 2021.

Reference Type BACKGROUND
PMID: 34007681 (View on PubMed)

Alexander E, Butler CD, Darr A, Jenkins MT, Long RD, Shipman CJ, Stratton TP. ASHP Statement on Telepharmacy. Am J Health Syst Pharm. 2017 May 1;74(9):e236-e241. doi: 10.2146/ajhp170039. No abstract available.

Reference Type BACKGROUND
PMID: 28438829 (View on PubMed)

Amkreutz J, Lenssen R, Marx G, Deisz R, Eisert A. Medication safety in a German telemedicine centre: Implementation of a telepharmaceutical expert consultation in addition to existing tele-intensive care unit services. J Telemed Telecare. 2020 Jan-Feb;26(1-2):105-112. doi: 10.1177/1357633X18799796. Epub 2018 Sep 25.

Reference Type BACKGROUND
PMID: 30253681 (View on PubMed)

Ekeland AG, Bowes A, Flottorp S. Effectiveness of telemedicine: a systematic review of reviews. Int J Med Inform. 2010 Nov;79(11):736-71. doi: 10.1016/j.ijmedinf.2010.08.006.

Reference Type BACKGROUND
PMID: 20884286 (View on PubMed)

Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, Cheshire WP, Chelimsky T, Cortelli P, Gibbons CH, Goldstein DS, Hainsworth R, Hilz MJ, Jacob G, Kaufmann H, Jordan J, Lipsitz LA, Levine BD, Low PA, Mathias C, Raj SR, Robertson D, Sandroni P, Schatz I, Schondorff R, Stewart JM, van Dijk JG. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011 Apr;21(2):69-72. doi: 10.1007/s10286-011-0119-5. No abstract available.

Reference Type BACKGROUND
PMID: 21431947 (View on PubMed)

Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):237-244. doi: 10.1093/ehjqcco/qcw018.

Reference Type BACKGROUND
PMID: 29474713 (View on PubMed)

Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857.

Reference Type BACKGROUND
PMID: 18577730 (View on PubMed)

Al Hamid A, Ghaleb M, Aljadhey H, Aslanpour Z. A systematic review of qualitative research on the contributory factors leading to medicine-related problems from the perspectives of adult patients with cardiovascular diseases and diabetes mellitus. BMJ Open. 2014 Sep 19;4(9):e005992. doi: 10.1136/bmjopen-2014-005992.

Reference Type BACKGROUND
PMID: 25239295 (View on PubMed)

Diedrich L, Dockweiler C. Video-based teleconsultations in pharmaceutical care - A systematic review. Res Social Adm Pharm. 2021 Sep;17(9):1523-1531. doi: 10.1016/j.sapharm.2020.12.002. Epub 2020 Dec 13.

Reference Type BACKGROUND
PMID: 33341405 (View on PubMed)

Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549.

Reference Type BACKGROUND
PMID: 23821088 (View on PubMed)

Williams M, Peterson GM, Tenni PC, Bindoff IK, Stafford AC. DOCUMENT: a system for classifying drug-related problems in community pharmacy. Int J Clin Pharm. 2012 Feb;34(1):43-52. doi: 10.1007/s11096-011-9583-1. Epub 2011 Nov 19.

Reference Type BACKGROUND
PMID: 22101425 (View on PubMed)

Related Links

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http://aps.saude.gov.br/noticia/2300

BRASIL, Ministério da Saúde. O que é Prontuário Eletrônico do Cidadão?

http://bvsms.saude.gov.br/bvs/publicacoes/vigitel_brasil_2014.pdf

Vigitel Brasil 2014: vigilância de fatores de risco e proteção para doenças crônicas por inquérito telefônico.

http://doi.org/10.1590/S0102-311X2009000100009

Patient satisfaction with pharmacy services: translation and validation of the Pharmacy Services Questionnaire for Brazil

http://www.scielo.br/j/read/a/HxkCrtpx6qkCt7JWzgT4Yxr/

ORGANIZATION OF THE TELE-PHARMACEUTICAL CARE SERVICE AS AN EMERGING IN THE FIGHT AGAINST COVID-19 IN RIO GRANDE DO SUL

Other Identifiers

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CELESTE2023

Identifier Type: -

Identifier Source: org_study_id

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