Program for Health Promotion to Improve Therapeutic Compliance in Hypertensive Patiente

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Program Health Education

• Registration Number: NCT02036814
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The aim was to test if interpersonal relationships group strategies provided by nursing can promote an additional benefit on blood pressure (BP) control and quality of life (QoL) in hypertensive patients. Methods: 21 treated patients were randomized into two groups: Group A 10 patients (8 women), underwent to a health educational orientation program (inter-relational strategy), with group meetings every 15 days during 4 months(8 meetings). Group B 11 patients (7 women), who underwent group orientation by the nurse every 40 days during 4 months (3 meetings). Both groups received the same content guidelines (healthy lifestyle and prevention of risk factors). The patients had 2 visits by nurses at baseline (15 days) and at the final study (120 days). BP was measured by auscultatory method and QoL questionnaire (WHOQoL-Brief)was applied. The dispensing and pill counts were done every 30 days. Ambulatory blood pressure monitoring (ABPM) was performed at baseline and after 120 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-03
• Study Completion: 2011-02
• Study First Submitted: 2013-10-11
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-14
• Last Update Submitted: 2014-01-14
• Study First Posted: 2014-01-15
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

• Diabetes patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A who underwent to an inter-relational strategy	Program Health Education	Group A who underwent to a health educational orientation program (inter-relational strategy)
Group B who underwent group orientation by the nurse	Program Health Education	-

Primary Outcome Measures

Name	Time	Method
measure blood pressure arterial	4 months	At the first nurse interview (day 0: randomization) three consecutive measurements of BP were taken after the patient had rested for 5 min in the supine position.Ambulatory BP monitoring was recorded at 15 and 180 days of follow-up for 24 h with a noninvasive ABPM (Space Labs 90207 monitor; Space Labs, Redmond, WA) with an appropriate-sized cuff. The monitor was placed on the nondominant arm and was set to take BP readings every 10 min during the day and every 20 min at night

Secondary Outcome Measures

Name	Time	Method
QoL questionnaire (WHOQoL-Brief)	4 months	At the first nurse interview (day 0: randomization), a questionnaire was used to obtain information related to general data, habits, history of disease, other risk factors for cardiovascular disease, and prescribed medications. This questionnaire was used only to characterize the adherence behavior and the risk factors at the beginning the study, but was not used to evaluate modifications of behavior during the study.