Telepharmacy on Patients With Arterial Hypertension

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Pharmaceutical care via telepharmacy and usual care
  Pharmacotherapeutic monitoring via telephone consultation
• Другое Pharmaceutical care in-person and usual care
  Face-to-face pharmacotherapeutic monitoring

Первичные конечные точки

• Controlling blood pressure [Срок оценки: 3 months]

Вторичные конечные точки (3)

• Adherence to the treatment [Срок оценки: 3 months]
• Patient satisfaction [Срок оценки: 3 months]
• Level of clinical significance of interventions [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Бразилия · 1 центр

• Farmácia Escola da UFBA, campus Anísio Teixeira — Vitória da Conquista

Публикации

• 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. PMID 34007681
• 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. PMID 28438829
• 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. PMID 30253681
• 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. PMID 20884286
• 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 sy PMID 21431947
• 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. PMID 29474713
• 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. PMID 18577730
• 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. PMID 25239295

Идентификаторы

NCT: NCT06108674 · CELESTE2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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