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

NCT ID: NCT07273578

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2023-09-30

Brief Summary

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.

Detailed Description

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:

1. Patients diagnosed with hypertension associated or not with DM, CAD or RI;

2. Time since diagnosis greater than 6 months;

3. 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;

4. They had been following the same antihypertensive drug treatment for at least 4 weeks, according to the participant's self-report;

5. 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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Grupo intervenção (GI)

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.

Group Type: ACTIVE_COMPARATOR

Home Blood Pressure Monitoring

Intervention Type: 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.

Grupo controle (GC)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home Blood Pressure Monitoring

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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. -

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordination for the Improvement of Higher Education Personnel

OTHER

Sponsor Role: collaborator

Universidade Federal do Ceara

OTHER

Sponsor Role: lead

Responsible Party

Antonia Fabiana Rodrigues da Silva

Doutora

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal do Ceará

Fortaleza, Ceará/BRASIL, Brazil

Countries

Brazil

Other Identifiers

nº 5.769.427

Identifier Type: -

Identifier Source: org_study_id