Protocol summary

Summary
This study will be conducted with the goal of designing and developing Self-management education & support package for hypertensive patients, in the form of a mobile app. Moreover, it aims to evaluate its effectiveness against the usual care. The study will be conducted as a controlled clinical trial. The participants will be selected from the patients attending the Tehran Heart Center Clinic and will be randomly assigned to two groups of intervention and control. Inclusion criteria: The diagnosis of essential hypertension –without its complications, patients aged 30 – 60 years, having a Smartphone and/or tablet, the ability to read Persian, inclination to participate in the study, being medically treated for hypertension, intention to reside in the site of the study for the next 6 months. Exclusion criteria: presence of other cardiovascular diseases, diabetes mellitus, physical disability. The intervention consists of an educational – support package in the form of a mobile app for controlling the determinant factors of hypertension and adherence to treatment. The content of this application has been developed based on a ‘needs assessment’ performed on hypertensive patients receiving medical treatment. The participants of the intervention group will keep receiving their medical treatment as well as being given the package. The outcomes of this study include adherence to hypertensive drug therapy, adherence to the DASH diet and sodium reduction, regular monitoring of blood pressure, predisposing –enabling & reinforcing factors of adherence to the treatment of primary hypertensive patients, hypertension, the usability of the application, rate of satisfaction of the application.

General information

Acronym
Blood Pressure Management application(BPMap)
IRCT registration information
IRCT registration number: IRCT2015111712211N2
Registration date: 2016-01-01, 1394/10/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-01, 1394/10/11
Registrant information
Name
Mahnaz Ashoorkhani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 5660
Email address
ashoorkhani@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
The study will be conducted with the financial support of Tehran University of Medical Sciences and Tehran Heart Center..
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing a mobile app for the control of essential hypertension, based on the PRECEDE-PROCEED model, and evaluation of its effectiveness on patients’ self-management compared to the usual care
Public title
Evaluation of the effectiveness of a mobile app for self-management of hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:The diagnosis of essential hypertension, without its complications, such as cardiovascular accidents etc ; Being medically treated for hypertension ; Age of patients between 30 and 60 years ; Having a Smartphone and/or tablet ; The ability to read Persian ; Inclination to participate in the study ; Intention to reside in the site of study for the next 6 months Exclusion criteria: Presence of other cardiovascular diseases ; Diabetes mellitus ; Physical disability
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Central Building, Qods St., Keshavarz Blvd., Tehran, Iran.
City
tehran
Postal code
Approval date
2015-10-04, 1394/07/12
Ethics committee reference number
IR.TUMS.REC.1394.872

Health conditions studied

1

Description of health condition studied
primary hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Adherence to hypertensive drug use
Timepoint
Before the intervention – two months after the intervention – 6 months after the intervention
Method of measurement
Hill bone questionnaire

2

Description
adherence to the DASH diet and sodium reduction
Timepoint
Before the intervention – two months after the intervention – 6 months after the intervention
Method of measurement
questionnaire

3

Description
hypertension
Timepoint
Before the intervention and upon every visit – the blood pressures recorded in the application
Method of measurement
Mercury sphygmomanometer

4

Description
regular monitoring of blood pressure
Timepoint
three times in week
Method of measurement
register in application

5

Description
predisposing –enabling & reinforcing factors of adherence to treatment of primary hypertensive patients
Timepoint
Before the intervention – two months after the intervention – 6 months after the intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Interventions: Intervention group: Intervention group one, in addition to the usual care, the educational – supportive intervention (usual care plus intervention) will be carried out by installing the software on the Smartphone. This application has been developed with the goal of allowing self-management for the optimum detection and control of the determinant factors of hypertension and overcoming the barriers to adherence (BPMap=blood pressure management application). The items available in the application are: reminder for drug use, the doctor’s appointment, physical activity, blood pressure measurement • Reminder for drug use, doctor’s appointment, physical activity, blood pressure measurement • Knowledge information on the disease, its etiology, causes of disease, influential factors of disease control • Knowledge information, encouragement and reminders for quitting and reduction of smoking • Guidance and provision of a healthy nutritional diet (DASH and low-salt diet) and a weight reduction diet based on BMI and other personal characteristics • The recording of blood pressure in the application and provision of advice appropriate to the recorded rate • Delivery of data to the physician and researcher A session will be held during which the intervention group’s participants will be briefed on the goals of the study and the research team’s expectations. The application will be installed on their mobile phones and they will be taught how to operate it. Based on their drugs and individual characteristics, the patients will then set their applications accordingly. They will operate the application in the presence of the research team, so that, if any problem arises it may be resolved by the research team. The patients will then be examined at the clinic once every two weeks. Control group: The second group will receive the usual care. The usual care consists of blood pressure measurement, responding to the patient’s questions, prescription of earlier drugs or changing the drug used and explaining its method of use, in accordance with the patient’s circumstances and the specialist’s opinion.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center Hospital
Full name of responsible person
Dr. Ali Bozorgi
Street address
Tehran Heart Center Hospital- North Kargar-Ave , Tehran-Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud yunesian
Street address
Deputy of Research and Technology, Tehran University of Medical Sciences, 6th floor, Central Building, Qods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Health-Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Ashoorkhani
Position
PhD Candidate in Health Education and promotion
Other areas of specialty/work
Street address
Faculty of Health-Tehran University of Medical Sciences, Poorsina St, Qods St, Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 4293 3333
Fax
Email
ashoorkhani1392@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Health-Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Ashoorkhani
Position
PhD Candidate in Health Education and promotion
Other areas of specialty/work
Street address
Faculty of Health-Tehran University of Medical Sciences, Poorsina St, Qods St, Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 4293 3333
Fax
Email
ashoorkhani1392@yahoo.com- ashoorkhani@farabi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Health-Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Ashoorkhani
Position
PhD Candidate in Health Education and promotion
Other areas of specialty/work
Street address
Faculty of Health-Tehran University of Medical Sciences, Poorsina St, Qods St, Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 4293 3333
Fax
Email
ashoorkhani1392@yahoo.com- ashoorkhani@farabi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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