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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04124263
Other study ID # 332/2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2021
Est. completion date November 10, 2022

Study information

Verified date December 2022
Source Federal University of Bahia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

OBJECTIVE: To evaluate the effect of intervention by sending short text messages with a reminder of the time of medication use, compared to sending educational messages, on adherence to drug treatment in patients with hypertension. METHODOLOGY: Prospective, randomized, controlled, double-blind, parallel group study that will be performed in patients with hypertension seen at a community pharmacy in Brazil. The following groups will be compared: a) intervention group 1: 70 hypertensive patients registered for access to medication associated with usual care, in addition to text messages via mobile phone with educational information b) intervention group 2: 70 hypertensive patients registered for access to medications that will additionally receive text messages at the times indicated in the prescription for use of each indicated medication, in addition to educational information. After the washout period, the groups will have the active interventions changed for an additional 90 days. The proportion of adherent and non-adherent patients with and without controlled BP in both groups will be compared after the periods of application of the different interventions.


Recruitment information / eligibility

Status Completed
Enrollment 157
Est. completion date November 10, 2022
Est. primary completion date November 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: hypertension diagnosis, age, availability of mobile phone with short message texts access and ability to read and access short message texts - Exclusion Criteria: visual, hearing or mental disabilities that disables receiving short message texts , being pregnant, recently delivered or breastfeeding -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational short message texts
Educational messages for patient engagement
Adherence short message texts
Reminder messages of medication use time

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Federal University of Bahia Medtronic Foundation

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment adherence Measurement of medication usage through Brief Medication Questionnaire: low to high adherence Seven months (including one month of washout period)
Secondary Blood pressure Measurement of blood pressure Seven months (including one month of washout period)
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