PHPTCHP: Program for Health Promotion to Improve Therapeutic Compliance in Hypertensive Patiente

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02036814

Collaborator

InCor Heart Institute (Other)

Enrollment

Arms

47.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: Program Health Education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Health Services Research

Official Title:

A PROGRAM OF HEALTH EDUCATION PROMOTION BY NURSING CAN IMPROVE BLOOD PRESSURE CONTROL AND QUALITY OF LIFE IN HYPERTENSIVE PATIENTS?

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A who underwent to an inter-relational strategy Group A who underwent to a health educational orientation program (inter-relational strategy)	Behavioral: Program Health Education
Experimental: Group B who underwent group orientation by the nurse	Behavioral: Program Health Education

Arm

Intervention/Treatment

Experimental: Group A who underwent to an inter-relational strategy

Group A who underwent to a health educational orientation program (inter-relational strategy)

Behavioral: Program Health Education

Experimental: Group B who underwent group orientation by the nurse

Behavioral: Program Health Education

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Hypertensive patients under treatment regimen;
Pressure levels greater than or equal to 90 mmHg diastolic blood pressure (DBP), and
Pressure level greater than or equal to 140 mmHg systolic blood pressure (SBP)
Age limit between 25 to 75 years, for both female and male.