Program for Health Promotion to Improve Therapeutic Compliance in Hypertensive Patiente

NCT02036814 | Completed DMC

• 1 other identifier: CAPPesq779/05
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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

Keywords

Hypertension; Nursing; Therapeutic compliance; Quality of life; Health education

Outcome Measures

Primary Outcomes (1)

• measure blood pressure arterial

  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

  4 months

Secondary Outcomes (1)

• QoL questionnaire (WHOQoL-Brief)

  4 months

Study Arms (2)

Group A who underwent to an inter-relational strategy

EXPERIMENTAL

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

Behavioral: Program Health Education

Group B who underwent group orientation by the nurse

EXPERIMENTAL

Behavioral: Program Health Education

Interventions

Program Health Education BEHAVIORAL

Group A who underwent to an inter-relational strategy; Group B who underwent group orientation by the nurse

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diabetes patients

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• InCor Heart Institute: collaborator

MeSH Terms

Conditions

Hypertension; Patient Compliance; Health Education

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Adherence Interventions; Medication Adherence

Study Officials

• Heno Ferreira Lopes, PhD

  Heart Institute of Medicine School of University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Grazia M. Guerra

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: January 15, 2014
• Study Start: March 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: February 1, 2011
• Last Updated: January 15, 2014

Record last verified: 2014-01