HypertensionNCT04124263
Use of Short Text Messages to Promote Medication Adherence in Hypertensive Patients
A study testing Educational short message texts and Adherence short message texts in people with Hypertension and Adherence, Treatment, run by Federal University of Bahia at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension, Adherence, Treatment
- What is being tested?
- Educational short message texts and Adherence short message texts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jan 2021to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Farmácia Escola da UFBA, campus Anísio Teixeira
Vitória da Conquista, Estado de Bahia, 45028440
About this study
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.
- Conditions
- Hypertension, Adherence, Treatment
- Being tested
- Educational short message texts, Adherence short message texts
- Keywords
- Hypertension, Primary Health Care
- Medical subject headings
- Hypertension, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational short message textsOther
Educational messages for patient engagement
Adherence short message textsOther
Reminder messages of medication use time
| Study group | Role | What they receive |
|---|---|---|
| Medication Time Short Messages | Experimental | 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. Receives: Other: Educational short message texts; Other: Adherence short message texts |
| Educational Short Messages | Experimental | 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. Receives: Other: Educational short message texts; Other: Adherence short message texts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence
Measurement of medication usage through Brief Medication Questionnaire: low to high adherence
Measured: Seven months (including one month of washout period)
Secondary outcomes (1)
Blood pressure
Measurement of blood pressure
Measured: Seven months (including one month of washout period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start7 Jan 2021
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Foundation
- Responsible party
- Principal investigator, Márcio Galvão Guimarães de Oliveira, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124263
- Sponsor's protocol ID
- 332/2016
- Status last verified
- Dec 2022
- First submitted
- 9 Oct 2019
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Short Text Messages to Promote Medication Adherence in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04124263
- Acronym / sponsor ID
- 332/2016
- Conditions
- Hypertension, Adherence, Treatment
- Keywords
- Hypertension, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Collaborators
- Medtronic Foundation
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication Time Short Messages | Experimental | Other: Educational short message texts, Other: Adherence short message texts70 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 Short Messages | Experimental | Other: Educational short message texts, Other: Adherence short message texts70 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational short message textsEducational messages for patient engagement | Other | Educational Short Messages, Medication Time Short Messages |
| Adherence short message textsReminder messages of medication use time | Other | Educational Short Messages, Medication Time Short Messages |
Primary outcome
Treatment adherence
Time frame: Seven months (including one month of washout period)
Measurement of medication usage through Brief Medication Questionnaire: low to high adherence
1 secondary outcome
Blood pressure
Time frame: Seven months (including one month of washout period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational short message texts and Adherence short message texts in people with Hypertension and Adherence, Treatment, run by Federal University of Bahia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment adherence (time frame: Seven months (including one month of washout period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.