Universidade Federal do Ceará
Fortaleza, Ceará/BRASIL, Brazil
NCT Number: NCT07273578
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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Interventional
Not applicable
Fortaleza, Ceará/BRASIL, Brazil
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:
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. -
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.
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.
Universidade Federal do Ceara
Other
Acronym: HP-HBMP
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