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

NCT07273578 | Completed

• 1 other identifier: nº 5.769.427
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Blood Pressure Determination; UNCONTROLLED HYPERTENSION

Outcome Measures

Primary Outcomes (1)

• Reduction in average Systolic and Diastolic Blood Pressure values

  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.

  9 months

Study Arms (2)

Grupo intervenção (GI)

ACTIVE COMPARATOR

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.

Procedure: Home Blood Pressure Monitoring

Grupo controle (GC)

NO INTERVENTION

Interventions

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.

Grupo intervenção (GI)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidade Federal do Ceara: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator

Study Sites (1)

Universidade Federal do Ceará

Fortaleza, Ceará/BRASIL, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The final data was anonymized before being made available to the statistician.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doutora

Model Details: The intervention consisted of implementing HBPM to individuals with uncontrolled hypertension who were allocated to the IG, where they performed four measurements per day, two in the morning and two at night, before meals, for 5 consecutive days each month during follow-up, during three follow-up appointments at the unit. They also received a monthly telephone call to remind them to perform the measurements.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: December 9, 2025
• Study Start: December 12, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data de inicio ainda não foi prevista
• Access Criteria: Those who request

Locations

BR (1)