NCT04124263

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 7, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

October 9, 2019

Last Update Submit

December 19, 2022

Conditions

Keywords

HypertensionPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • Treatment adherence

    Measurement of medication usage through Brief Medication Questionnaire: low to high adherence

    Seven months (including one month of washout period)

Secondary Outcomes (1)

  • Blood pressure

    Seven months (including one month of washout period)

Study Arms (2)

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.

Other: Educational short message textsOther: 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.

Other: Educational short message textsOther: Adherence short message texts

Interventions

Educational messages for patient engagement

Educational Short MessagesMedication Time Short Messages

Reminder messages of medication use time

Educational Short MessagesMedication Time Short Messages

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

HypertensionTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 11, 2019

Study Start

January 7, 2021

Primary Completion

November 10, 2022

Study Completion

November 10, 2022

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations