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Comparing the effect of self-management education with and without phone calls and the use of mobile social networking follow-up on self_management behavior in patients with hypertension

Protocol summary

Summary
In this Clinical trial, randomized study to Compare the effect of self-management education with and without phone calls and the use of mobile social networking follow-up on self_management behavior in patients in the two Isfahan hospitals performed on 200 patients. The study population are the patients with primary hypertension admitted to hospital a Inclusion criteria are essential hypertension, the exact diagnosis by a doctor and having blood pressure greater than 85 / 140 mmgh, phone access, non-hospitalized treatment and make phone calls in less than four times during the study in groups training management track, participating in one of the training sessions in the intervention group or the death of a person, not study. Patients into four groups (control, self-management training without follow-up, self-management education with telephone follow-up and pursuit of self-management education using mobile-based social networking) groups and the control group will receive common training, patients in the second group, self-education will participate in two sessions of 30-45 minutes. A third group self-management training similar to the training methods and content are without telephone follow-up. After 6 weeks, each week a phone call by the researcher to learn and impart information and health tips and reminders need to be patient and answer questions. The fourth group self-management training will be like previous groups. In this type of track on a weekly basis through the cable connection is established. Self-management behaviors, by students in all 4 groups 6 weeks after the implementation of the training program is completed. The primary outcome self-management behaviors blood pressure is secondary outcome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016012426173N1
Registration date: 2016-04-16, 1395/01/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-16, 1395/01/28
Registrant information
Name
Sanaz Sharifian
Name of organization / entity
Iran University of Medical Sciences, School of International Campus, Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 31 3662 3234
Email address
sharifiyan.s@takiums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of self-management education with and without phone calls and the use of mobile social networking follow-up on self_management behavior in patients with hypertension
Public title
Telephone and mobile phone-based social network tracing the self_management behavior in hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: There are definite diagnosis of essential hypertension by a doctor and having blood pressure greater than mmgh85/140; age between 35-85 years; Unemployment patient with family members of the medical team; Non-hospitalized patients referred to emergency medical departments after completion of therapy (range up to 24 hours of stay in the emergency department); No problem auditory, visual and cognitive; ability to read and write, having access to the phone; The ability to use mobile phones; Take advantage of mobile-based social network (Telegram); Internet access Exclusion criteria: Make phone calls less than four times during the telephone follow-up study in self-management training or the use of mobile phone-based social network; Failure to attend one of the training sessions in the intervention group; mortality
Age
From 35 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples were randomly allocated block of four (24 mode) will be without permutation. In this method, different modes of four, written on 24 cards, each will be placed in a sealed envelope. These envelopes are placed in a box and researcher does not know before selecting cards that will be the subjects in each group. Pre-exposure research units, nurses (unaware of the study and groups) by removing an envelope from the box indicates that four patients who were enrolled in the study will be under one group.will. This process continues until all 24 cards out of the box, and then returned the cards to the box and the random selection is repeated until the desired sample size provided.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences, School of International Campus
Street address
Martyr Hemmat Highway
City
Tehran
Postal code
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
IR.IUMS.REC.1394.9313677003

Health conditions studied

1

Description of health condition studied
HYPERTENSION
ICD-10 code
I10
ICD-10 code description
High blood pressure

Primary outcomes

1

Description
Self-managemant behavior
Timepoint
Before and 6 weeks after intervention
Method of measurement
self-managemant behavior questionnaire(HSMBQ)

Secondary outcomes

1

Description
Blood Pressure
Timepoint
Before the intervention, 6 weeks after intervention
Method of measurement
Pressure gauge, in millimeters of mercury

Intervention groups

1

Description
Patients in four groups (control and intervention) are divided.The patients in self-management training with follow-up phone , in time proportional with the convenience and patient request and in coordination with him, in two sessions self-management training, now taken 30-45 minutes.The training by the researcher, for face to face training with a question and answer booklets will be The training by the researcher, for face to face training with a question and answer booklets with educational content include defining normal blood pressure, hypertension definition, causes of disease, risk factors, symptoms, hypertension self-management behaviors such as adherence diet, proper exercise, medication adherence, side effects and blood pressure measurements will be teaching.researcher followed this group in six weeks with telephon .Call time up to 15 minutes between the hours of 8 am to 8 pm and time to be determined in agreement with the patient. If you have questions or problems can be patient for 24 hours in contact with the researcher.In this type of track on a weekly basis about the patient's health status and health behaviors strengthen asked to adhere to treatment regimens and the need for referral is examined.on your daily monitoring available to researchers and the feedback he has received.
Category
Other

2

Description
control group The control group will receive common training and if the problem can be single refer to "Patient Education" in the hospital
Category
Other

3

Description
Invertion group (1) Group self-management training without follow-up phone and use social networks, in time proportional to patient comfort and harmony with His will, self-management training company in two sessions are 30-45 minutes. The training by the researcher, for face to face training with a question and answer booklets with educational content include defining normal blood pressure, hypertension definition, causes of disease, risk factors, symptoms, hypertension self-management behaviors such as adherence diet, proper exercise, medication adherence, side effects and blood pressure measurements will be teaching. Informing patients of this group is that if the problem can be single refer to "Patient Education" in hospital.
Category
Other

4

Description
Intervention group(3) Group self-management training with follow-up with use social networks, in time proportional to patient comfort and harmony with His will, self-management training company in two sessions are 30-45 minutes. The training by the researcher, for face to face training with a question and answer booklets with educational content include defining normal blood pressure, hypertension definition, causes of disease, risk factors, symptoms, hypertension self-management behaviors such as adherence diet, proper exercise, medication adherence, side effects and blood pressure measurements will be teaching.In this type of track on a weekly basis about the patient's health status and health behaviors strengthen asked to adhere to treatment regimens and the need for referral is examined.researcher sends informations and educations with pictures and videoes on a weekly for patients. the patient can be conect if he has any questions.Information on your daily monitoring available to researchers and the feedback he has received.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Sharifian Sanaz
Street address
Isfahan,Sofeh Avenue
City
Isfahan

2

Recruitment center
Name of recruitment center
Noor & Ali_Asghar Hospital
Full name of responsible person
Sharifian Sanaz
Street address
Isfahan,Ostandari Avenue
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
International Assistance
Full name of responsible person
Ghasemi Mohamad Sadegh
Street address
Tehran, martyr Hemmat Highway, Tehran University of Medical Sciences, International Assistance
City
Teharn
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Assistance
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
Iran University of Medical Sciences, School of Nursing and Midwifery, International Campus
Full name of responsible person
Sharifian Sanaz
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
Isfahan, Shiraz Gate, Saadat Abad streets, alleys martyr Nvranyan
City
Isfahan
Postal code
Phone
+98 31 3662 3234
Fax
Email
sharifian_sanaz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Tahereh Najafi Ghezeljeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran, Vali Asr Avenue, Street Rashid Yassami
City
Tehran
Postal code
Phone
+98 21 4365 1000
Fax
Email
najafi.t@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery, International Campus
Full name of responsible person
Sharifian Sanaz
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
Isfahan, Shiraz Gate, Saadat Abad streets, alleys martyr Nvranyan
City
Isfahan
Postal code
Phone
+98 31 3662 3234
Fax
Email
sharifian_sanaz@yahoo.com
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
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Analytic Code
empty
Data Dictionary
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