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

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Program Health Education
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Hypertension, Nursing, Therapeutic compliance, Quality of life, Health education

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Exclusion Criteria:

  • Diabetes patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A who underwent to an inter-relational strategy

    Group B who underwent group orientation by the nurse

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    QoL questionnaire (WHOQoL-Brief)
    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.

    Full Information

    First Posted
    October 11, 2013
    Last Updated
    January 14, 2014
    Sponsor
    University of Sao Paulo General Hospital
    Collaborators
    InCor Heart Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02036814
    Brief Title
    Program for Health Promotion to Improve Therapeutic Compliance in Hypertensive Patiente
    Acronym
    PHPTCHP
    Official Title
    A PROGRAM OF HEALTH EDUCATION PROMOTION BY NURSING CAN IMPROVE BLOOD PRESSURE CONTROL AND QUALITY OF LIFE IN HYPERTENSIVE PATIENTS?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo General Hospital
    Collaborators
    InCor Heart Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    Hypertension, Nursing, Therapeutic compliance, Quality of life, Health education

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A who underwent to an inter-relational strategy
    Arm Type
    Experimental
    Arm Description
    Group A who underwent to a health educational orientation program (inter-relational strategy)
    Arm Title
    Group B who underwent group orientation by the nurse
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Program Health Education
    Primary Outcome Measure Information:
    Title
    measure blood pressure arterial
    Description
    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
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    QoL questionnaire (WHOQoL-Brief)
    Description
    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.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heno Ferreira Lopes, PhD
    Organizational Affiliation
    Heart Institute of Medicine School of University of São Paulo
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Program for Health Promotion to Improve Therapeutic Compliance in Hypertensive Patiente

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