Health Education Using Text Messaging Prevents Hypertension in High Risk People

September 15, 2015 updated by: Amir H Pakpour, Qazvin University Of Medical Sciences

Health Education Using Text Messaging Prevents Hypertension in High Risk People: a Comparison Between Effectiveness of Electronic Text Messaging and Printed Material

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Qazvin, Iran, Islamic Republic of, 3419759811
        • Recruiting
        • 22 Bahman Hospital
        • Contact:
          • Mehran Alijanzadeh, Msc
          • Phone Number: 02833239259
          • Email: sdh@qums.ac.ir
        • Principal Investigator:
          • Amir H Pakpour, PhD
      • Qazvin, Iran, Islamic Republic of
        • Recruiting
        • Qazvin University of Medical Sciences, Shahid Rajaei Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: mobile text messaging
Patients will receive some SMS in a regular interval.
Behavioral: mobile text messages
Device: mobile phone
Experimental: virtual communities
Patients will receive some messages by a virtual community in a regular interval.
Behavioral: virtual community
Experimental: brochures
Patients will receive some messages by as a printed media
Behavioral: brochures
Active Comparator: Control
control group will be included without any intervention
Other: Usual care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Blood pressure
Time Frame: Changes from baseline and 1 Months after the intervention
Changes from baseline and 1 Months after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes in self-reported physical activity
Time Frame: Changes from baseline and 1 Months after the intervention
Physical activity will be measured using a self-reported scale examining participants' self- reported physical activity for the past seven days. Six items
Changes from baseline and 1 Months after the intervention
Changes in self-reported healthy eating
Time Frame: Changes from baseline and 1 Months after the intervention
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 from baseline and 1 Months after the intervention
Changes in self-reported Self-efficacy
Time Frame: Changes from baseline and 1 Months after the intervention
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
Changes from baseline and 1 Months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qazvin University Of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QUMS25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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