Program for Health Promotion to Improve Therapeutic Compliance in Hypertensive Patiente

NCT ID: NCT02036814

Last Updated: 2014-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-02-28

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Group A who underwent to an inter-relational strategy

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

Group Type: EXPERIMENTAL

Program Health Education

Intervention Type: BEHAVIORAL

Group B who underwent group orientation by the nurse

Group Type: EXPERIMENTAL

Program Health Education

Intervention Type: BEHAVIORAL

Interventions

Program Health Education

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

Exclusion Criteria

• Diabetes patients

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InCor Heart Institute

OTHER

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Grazia Maria Guerra

Grazia M. Guerra

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heno Ferreira Lopes, PhD

Role: STUDY_CHAIR

Heart Institute of Medicine School of University of São Paulo

Other Identifiers

CAPPesq779/05

Identifier Type: -

Identifier Source: org_study_id