Telepharmacy on Patients With Arterial Hypertension

Hypertension Clinical Trial

— CELESTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108674
• Other study ID #: CELESTE2023
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Federal University of Bahia
• Contact: Gabriella F Magalhães
• Phone: 77999062525
• Email: gabimagalhaes[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: November 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Brazil	Farmácia Escola da UFBA, campus Anísio Teixeira	Vitória Da Conquista	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2009 Nov 11;302(18):1972. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Controlling blood pressure	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	Adherence to the treatment	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
Secondary	Patient satisfaction	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
Secondary	Level of clinical significance of interventions	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

External Links

•   BRASIL, Ministério da Saúde. O que é Prontuário Eletrônico do Cidadão?
•   Diretrizes Brasileiras de Hipertensão Arterial - 2020. Arq Bras Cardiol.
•   ORGANIZATION OF THE TELE-PHARMACEUTICAL CARE SERVICE AS AN EMERGING IN THE FIGHT AGAINST COVID-19 IN RIO GRANDE DO SUL
•   Patient satisfaction with pharmacy services: translation and validation of the Pharmacy Services Questionnaire for Brazil
•   PORTARIA GM/MS Nº 1.348, DE 2 DE JUNHO DE 2022
•   Telepharmacy shows it worth in Cancer Setting.
•   Vigitel Brasil 2014: vigilância de fatores de risco e proteção para doenças crônicas por inquérito telefônico.