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Health Education Using Text Messaging Prevents Hypertension in High Risk People

Primary Purpose

Hypertension, Cardiovascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
mobile text messages
virtual community
brochures
Usual care
mobile phone
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • be >18 years
  • have a diagnosis of prehypertension based on definition
  • own a cell phone capable of receiving and sending text messages
  • be a member of virtual communities
  • Persian speaking
  • willing to attend two data collection visits in Qazvin

Exclusion Criteria:

  • admits to planning to terminate cell phone contract or excite form virtual communities during the next one month
  • education less than primary school
  • other major health problems (e.g., terminal stage of cancer, advanced liver disease)

Sites / Locations

  • 22 Bahman HospitalRecruiting
  • Qazvin University of Medical Sciences, Shahid Rajaei HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

mobile text messaging

virtual communities

brochures

Control

Arm Description

Patients will receive some SMS in a regular interval.

Patients will receive some messages by a virtual community in a regular interval.

Patients will receive some messages by as a printed media

control group will be included without any intervention

Outcomes

Primary Outcome Measures

Blood pressure

Secondary Outcome Measures

changes in self-reported physical activity
Physical activity will be measured using a self-reported scale examining participants' self- reported physical activity for the past seven days. Six items
Changes in self-reported healthy eating
Healthy eating behavior will be measured using the Diet Guidelines Index (DGI). The DGI is a food-based dietary index that measures adherence to healthy eating recommendations over the previous month. It consists of 15 items that reflect current dietary guidelines,including consumption of vegetable and legumes, fruit, total cereals, meat, total dairy, beverages, sodium, saturated fat, alcoholic beverages, and added sugars. A diet quality score is obtained by summing the indicators of wholegrain cereals, lean meat, low-fat dairy, and dietary variety, and is informed by age- and sex-specific recommendations. Scores range from 0 to 150, with higher scores representing higher levels of healthy eating. Serving portions are described in the questionnaire, and participants were directed to refer to the healthy eating guidelines26 provided for further details.
Changes in self-reported Self-efficacy
Self-efficacy will be measured using the Medication Adherence Self-Efficacy Scale (MASES).he MASES is a patient-centered and self-administered questionnaire that consists of 26 items. The patient were asked to rate their confidence of taking antihypertensive medications in different conditions using a three-point scale

Full Information

First Posted
August 27, 2015
Last Updated
September 15, 2015
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02551926
Brief Title
Health Education Using Text Messaging Prevents Hypertension in High Risk People
Official Title
Health Education Using Text Messaging Prevents Hypertension in High Risk People: a Comparison Between Effectiveness of Electronic Text Messaging and Printed Material
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
Prehypertension is a predisposing condition for morbidity inhypertension and cardiovascular diseases. Health education via electronic pathways such as mobile text messaging or virtual communities may provide more availability and adherence than printed media. Regarding lower costs of such electronic resources and continuity of interventions through these ways, assessing their effectiveness compared to a printed material may help health educators to choose proper methods for improve their educational attempts. Therefore, the current study aims to compare different tools for health education about healthy lifestyle in people with prehypertension. For this, educational interventions with similar content among 3 groups of people will be conducted (i.e., first group via mobile text messaging, second group using virtual communities, and third group by brochures as a printed media). A control group also will be considered without any intervention. Several phases are considered in the study. In phase 1 using health centers located in Qazvin city, people would be invited to a free screening program of prehypertension. Then, an eligible sample will be divided in three groups using a random allocation process (each one including 100-150 people with prehypertension). The blood pressure and health promotion lifestyle profile II (HPLP II) will be measured before intervention. A standard educational content using approaches of lifestyle promotion defined in HPLP II would be available for intervention groups during a time period of 1 month concurrently. At final phase, one month after termination of intervention blood pressure as primary outcome and lifestyle changes along with self-efficacy for lifestyle modification as secondary outcomes will be measured. This study may suggest effective ways for health education which is applicable by health care professionals to promote health status among peopleat risk of hypertension.
Detailed Description
Prehypertension is a predisposing condition for morbidity in hypertension and cardiovascular diseases. This has been defined as a systolic pressure from 120 to 139 mmHg or a diastolic pressure of 80-89 mm hg. The prevalence of this condition estimated to be at least 2 times higher than hypertension and those who have prehypertension 4 times more likely to progress to hypertension than normotensive people. Although, hypertension is a multi-factorial disease, lifestyle is associated mainly to its development. According to information, lifestyle changes may prevent more than 70% of primary hypertension and health education is a key strategy to promote lifestyle modification. Health education via electronic pathways such as mobile text messaging or virtual communities may provide more availability and adherence than printed media. Regarding lower costs of such electronic resources and continuity of interventions through these ways, assessing their effectiveness compared to a printed material may help health educators to choose proper methods for improve their educational attempts. Therefore, the current study aims to compare different tools for health education about healthy lifestyle in people with prehypertension. For this, educational interventions with similar content among 3 groups of people will be conducted (i.e., first group via mobile text messaging, second group using virtual communities, and third group by brochures as a printed media). A control group also will be considered without any intervention. Several phases are considered in the study. In phase 1 using health centers located in Qazvin city, people would be invited to a free screening program of prehypertension. Then, an eligible sample will be divided in three groups using a random allocation process (each one including 100-150 people with prehypertension). The blood pressure and health promotion lifestyle profile II (HPLP II) will be measured before intervention. A standard educational content using approaches of lifestyle promotion defined in HPLP II would be available for intervention groups during a time period of 1 month concurrently. At final phase, one month after termination of intervention blood pressure as primary outcome and lifestyle changes along with self-efficacy for lifestyle modification as secondary outcomes will be measured. This study may suggest effective ways for health education which is applicable by health care professionals to promote health status among people at risk of hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mobile text messaging
Arm Type
Experimental
Arm Description
Patients will receive some SMS in a regular interval.
Arm Title
virtual communities
Arm Type
Experimental
Arm Description
Patients will receive some messages by a virtual community in a regular interval.
Arm Title
brochures
Arm Type
Experimental
Arm Description
Patients will receive some messages by as a printed media
Arm Title
Control
Arm Type
Active Comparator
Arm Description
control group will be included without any intervention
Intervention Type
Behavioral
Intervention Name(s)
mobile text messages
Intervention Type
Behavioral
Intervention Name(s)
virtual community
Intervention Type
Behavioral
Intervention Name(s)
brochures
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Type
Device
Intervention Name(s)
mobile phone
Primary Outcome Measure Information:
Title
Blood pressure
Time Frame
Changes from baseline and 1 Months after the intervention
Secondary Outcome Measure Information:
Title
changes in self-reported physical activity
Description
Physical activity will be measured using a self-reported scale examining participants' self- reported physical activity for the past seven days. Six items
Time Frame
Changes from baseline and 1 Months after the intervention
Title
Changes in self-reported healthy eating
Description
Healthy eating behavior will be measured using the Diet Guidelines Index (DGI). The DGI is a food-based dietary index that measures adherence to healthy eating recommendations over the previous month. It consists of 15 items that reflect current dietary guidelines,including consumption of vegetable and legumes, fruit, total cereals, meat, total dairy, beverages, sodium, saturated fat, alcoholic beverages, and added sugars. A diet quality score is obtained by summing the indicators of wholegrain cereals, lean meat, low-fat dairy, and dietary variety, and is informed by age- and sex-specific recommendations. Scores range from 0 to 150, with higher scores representing higher levels of healthy eating. Serving portions are described in the questionnaire, and participants were directed to refer to the healthy eating guidelines26 provided for further details.
Time Frame
Changes from baseline and 1 Months after the intervention
Title
Changes in self-reported Self-efficacy
Description
Self-efficacy will be measured using the Medication Adherence Self-Efficacy Scale (MASES).he MASES is a patient-centered and self-administered questionnaire that consists of 26 items. The patient were asked to rate their confidence of taking antihypertensive medications in different conditions using a three-point scale
Time Frame
Changes from baseline and 1 Months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: be >18 years have a diagnosis of prehypertension based on definition own a cell phone capable of receiving and sending text messages be a member of virtual communities Persian speaking willing to attend two data collection visits in Qazvin Exclusion Criteria: admits to planning to terminate cell phone contract or excite form virtual communities during the next one month education less than primary school other major health problems (e.g., terminal stage of cancer, advanced liver disease)
Facility Information:
Facility Name
22 Bahman Hospital
City
Qazvin
ZIP/Postal Code
3419759811
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehran Alijanzadeh, Msc
Phone
02833239259
Email
sdh@qums.ac.ir
First Name & Middle Initial & Last Name & Degree
Amir H Pakpour, PhD
Facility Name
Qazvin University of Medical Sciences, Shahid Rajaei Hospital
City
Qazvin
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir H pakpour, PhD
Phone
02833239259
Email
sdh@qums.ac.ir

12. IPD Sharing Statement

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Health Education Using Text Messaging Prevents Hypertension in High Risk People

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