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Completed

NCT Number: NCT07273578

HOME BLOOD PRESSURE MONITORING IN PATIENTS WITH UNCONTROLLED HYPERTENSION: A RANDOMIZED CLINICAL TRIAL

This study aimed to test Home Blood Pressure Monitoring (HBPM) in reducing blood pressure (BP) levels in individuals with uncontrolled hypertension. Data collection was conducted in 5 stages: 1) recruitment; 2) inclusion in the study and collection of baseline data, including information on sociodemographic issues, anthropometric and clinical profile, and adherence to medication treatment; 3) randomization; 4) intervention; and 5) Reassessment of adherence to medication treatment. All participants will be monitored by the research team in three follow-up visits at the unit. The intervention consisted of HBPM being performed by participants in the IG, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month. Participants in the CG did not perform HBPM, but were also monitored by the research team in their follow-up visits. In these follow-up visits, for both groups, the researchers performed new BP measurements using the oscillometric method.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Ceará

Fortaleza, Ceará/BRASIL, Brazil

About this study

The outcome was the reduction in mean SBP and DBP values over time within and between groups, consisting of a reduction with a significant difference between the baseline and the post-intervention period.

The Omron HEM-1100® automatic clinical monitor was used to perform oscillometric BP measurement in the unit.

The HEM 7122 automatic BP monitor was made available to IG participants for self-measurement of BP at home. The following were included:

  • Patients diagnosed with hypertension associated or not with DM, CAD or RI;
  • Time since diagnosis greater than 6 months;
  • BP > 140/90 mmHg obtained in triplicate during an initial clinical consultation conducted by the researchers, immediately after the invitation to participate in the study;
  • They had been following the same antihypertensive drug treatment for at least 4 weeks, according to the participant's self-report;
  • They were able to move around and attend follow-up appointments at the health unit. The random allocation of participants into the two groups (G1 and CG) was performed proportionally (1:1) using Research Randomizer 1, which generated the sequence of entry by sets (set 01: G1, Set 02: CG). The numbers generated were previously recorded in sealed envelopes, which were opened in the presence of the participants immediately after collecting the variables at baseline and completing the data collection instrument. After randomization, the researcher informed the IG participant that he would undergo the intervention with HBPM during the follow-up period of three consecutive appointments scheduled by the unit. To this end, he would be loaned an automatic BP monitor provided by the researcher for the duration of the study and that it should be returned at the end. The CG participant was also informed by the researcher about the monitoring by the research team, which would include taking BP measurements using the oscillometric method during the period of three consecutive return appointments scheduled by the unit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

a) Patients diagnosed with hypertension, whether or not associated with DM, CAD or RI; b) Time since diagnosis greater than 6 months; c) BP > 140/90 mmHg obtained in triplicate during the initial clinical consultation conducted by the researchers, immediately after the invitation to participate in the study; d) Having been following the same antihypertensive drug treatment for at least 4 weeks, according to the participant's self-report; e) Having mobility conditions to attend follow-up consultations at the health unit.

Exclusion criteria

a) Pregnant women or women actively seeking to become pregnant; b) Have physical incapacity (represented by the presence of tetraplegia, tetraparesis, triplegia, triparesis, hemiplegia, hemiparesis, amputation or cerebral palsy), cognitive incapacity (represented by the presence of dementia, depression, delirium and mental illnesses, such as schizophrenia, oligophrenia and paraphrenia), and have undergone surgical procedures, accidents, amputation, oncological treatment that prevents self-monitoring of BP; c) Inability to maintain the monitor at home, represented by the participant's refusal to receive and/or keep the device; d) Acute cardiovascular event (myocardial infarction and stroke) in the last three months; e) Have a medical diagnosis of arrhythmia, as per the participant's self-report and confirmation in the medical record. f) Perform home BP measurement, represented by the participant's report. -

Treatment and study plan

Home Blood Pressure Monitoring

Procedure

The intervention consisted of HBPM being performed by IG participants, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month.

Primary outcomes

  1. Reduction in average Systolic and Diastolic Blood Pressure values

    Time frame: 9 months

    Reduction in mean SBP and DBP values over time within and between groups, consisting of a reduction with a significant difference between the baseline and the post-intervention period.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Ceara

Other

Collaborators

  • Coordination for the Improvement of Higher Education Personnel

Registry information

Acronym: HP-HBMP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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