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

About this trial
This is an interventional screening trial for Blood Pressure focused on measuring software, hypertension, technology
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
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
NCT ID
NCT04475367
First Posted
May 29, 2020
Last Updated
July 18, 2020
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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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