NCT06108674

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. 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. 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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
194

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

October 25, 2023

Last Update Submit

August 6, 2025

Conditions

Keywords

pharmaceutical caretelepharmacyelderly patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Adherence to the treatment

    3 months

  • Patient satisfaction

    3 months

  • Level of clinical significance of interventions

    3 months

Study Arms (2)

Telepharmacy

EXPERIMENTAL

Pharmaceutical care via telepharmacy

Other: Pharmaceutical care via telepharmacy and usual care

In-person

ACTIVE COMPARATOR

In-person pharmaceutical care

Other: Pharmaceutical care in-person and usual care

Interventions

Pharmacotherapeutic monitoring via telephone consultation

Telepharmacy

Face-to-face pharmacotherapeutic monitoring

In-person

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farmácia Escola da UFBA, campus Anísio Teixeira

Vitória da Conquista, Estado de Bahia, 45028440, Brazil

RECRUITING

Related 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.

    PMID: 34007681BACKGROUND
  • 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: 28438829BACKGROUND
  • 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: 30253681BACKGROUND
  • 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: 20884286BACKGROUND
  • 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.

    PMID: 21431947BACKGROUND
  • 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: 29474713BACKGROUND
  • 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: 18577730BACKGROUND
  • 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: 25239295BACKGROUND
  • 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.

    PMID: 33341405BACKGROUND
  • 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.

    PMID: 23821088BACKGROUND
  • 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.

    PMID: 22101425BACKGROUND

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Gabriella F Magalhães

    UFOB

    STUDY CHAIR
  • Márcio Galvão Guimarães de Oliveira

    UFBA

    PRINCIPAL INVESTIGATOR
  • Igor Matheus de novais Silva

    UFBA

    STUDY CHAIR

Central Study Contacts

Gabriella F Magalhães

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations