- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04124263
Use of Short Text Messages to Promote Medication Adherence in Hypertensive Patients
December 19, 2022 updated by: Márcio Galvão Guimarães de Oliveira, Federal University of Bahia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
157
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bahia
-
Vitória Da Conquista, Bahia, Brazil, 45028440
- Farmácia Escola da UFBA, campus Anísio Teixeira
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Medication Time Short Messages
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.
|
Educational messages for patient engagement
Reminder messages of medication use time
|
Experimental: Educational Short Messages
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.
|
Educational messages for patient engagement
Reminder messages of medication use time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment adherence
Time Frame: Seven months (including one month of washout period)
|
Measurement of medication usage through Brief Medication Questionnaire: low to high adherence
|
Seven months (including one month of washout period)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Seven months (including one month of washout period)
|
Measurement of blood pressure
|
Seven months (including one month of washout period)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2021
Primary Completion (Actual)
November 10, 2022
Study Completion (Actual)
November 10, 2022
Study Registration Dates
First Submitted
October 9, 2019
First Submitted That Met QC Criteria
October 10, 2019
First Posted (Actual)
October 11, 2019
Study Record Updates
Last Update Posted (Actual)
December 21, 2022
Last Update Submitted That Met QC Criteria
December 19, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 332/2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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