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Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory

Primary Purpose

Blood Pressure, Adhesion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
App hypercross group
without App hypercross group
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Blood Pressure focused on measuring software, hypertension, technology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hypertensive patients admitted to the hypertension clinic at Instituto de Cardiologia
  • older 18 years

Exclusion Criteria:

  • Patients without a mobile phone compatible with the App

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    hypertensive patients using HyperCrossApp

    hypertensive patients without using HyperCrossApp

    Arm Description

    Interdisciplinary health care + HyperCross App

    Interdisciplinary health care

    Outcomes

    Primary Outcome Measures

    Blood pressure value
    systolic Blood pressure and dyastolic Blood pressure

    Secondary Outcome Measures

    Morisky scale
    Medication adherence. The Morisky scale condition and medication specific assessment: 1) measures the level of adherence an medication, 2) measures the severity of Major Depressive Disorder, a determinant of non-adherence 3) identifies why the patient is not taking their medication, 4) determines the risk between non-adherence to BP measures of disease control. 0-1 = Low motivation; 2-3 = High motivation / 0-1 = Low knowledge; 2-3 = High knowledge

    Full Information

    First Posted
    May 29, 2020
    Last Updated
    July 18, 2020
    Sponsor
    Instituto de Cardiologia do Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04475367
    Brief Title
    Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory
    Official Title
    Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 10, 2020 (Anticipated)
    Primary Completion Date
    December 20, 2021 (Anticipated)
    Study Completion Date
    December 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto de Cardiologia do Rio Grande do Sul

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Brief Summary: Through the App, the user will have the opportunity to connect directly with the health professional, clarify doubts and manage the treatment of their hypertension.
    Detailed Description
    To evaluate treatment adherence and blood pressure reduction, through the HiperCross App, between two groups of hypertensive patients in a Hypertension Public Ambulatory in Porto Alegre. The investigators hope to identify better adherence to treatment, as well as a significant reduction in blood pressure, all of these results will be better evaluated using the HiperCross application.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Pressure, Adhesion
    Keywords
    software, hypertension, technology

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The participants will be randomized into 2 intervention groups
    Masking
    Outcomes Assessor
    Masking Description
    blind research assistant
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    hypertensive patients using HyperCrossApp
    Arm Type
    Experimental
    Arm Description
    Interdisciplinary health care + HyperCross App
    Arm Title
    hypertensive patients without using HyperCrossApp
    Arm Type
    Active Comparator
    Arm Description
    Interdisciplinary health care
    Intervention Type
    Other
    Intervention Name(s)
    App hypercross group
    Intervention Description
    hypertensive patients using HyperCrossApp
    Intervention Type
    Other
    Intervention Name(s)
    without App hypercross group
    Intervention Description
    Interdisciplinary health care
    Primary Outcome Measure Information:
    Title
    Blood pressure value
    Description
    systolic Blood pressure and dyastolic Blood pressure
    Time Frame
    15 minutes
    Secondary Outcome Measure Information:
    Title
    Morisky scale
    Description
    Medication adherence. The Morisky scale condition and medication specific assessment: 1) measures the level of adherence an medication, 2) measures the severity of Major Depressive Disorder, a determinant of non-adherence 3) identifies why the patient is not taking their medication, 4) determines the risk between non-adherence to BP measures of disease control. 0-1 = Low motivation; 2-3 = High motivation / 0-1 = Low knowledge; 2-3 = High knowledge
    Time Frame
    15 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: hypertensive patients admitted to the hypertension clinic at Instituto de Cardiologia older 18 years Exclusion Criteria: Patients without a mobile phone compatible with the App
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ana Paula Reis, Nurse
    Phone
    +555132303600
    Email
    areis9874@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bruna Eibel, PhD
    Phone
    +555132303600
    Email
    brunaeibel@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bruna Eibel, PhD
    Organizational Affiliation
    Post Graduation professor - Cardiology Foundation
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory

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