- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02551926
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
Unknown
Conditions
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
Interventional
Enrollment (Anticipated)
600
Phase
- 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
-
-
-
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:
- Amir H pakpour, PhD
- Phone Number: 02833239259
- Email: sdh@qums.ac.ir
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: mobile text messaging
Patients will receive some SMS in a regular interval.
|
|
|
Experimental: virtual communities
Patients will receive some messages by a virtual community in a regular interval.
|
|
|
Experimental: brochures
Patients will receive some messages by as a printed media
|
|
|
Active Comparator: Control
control group will be included without any intervention
|
What is the study measuring?
Primary Outcome Measures
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
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.
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
August 1, 2015
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
August 27, 2015
First Submitted That Met QC Criteria
September 15, 2015
First Posted (Estimate)
September 16, 2015
Study Record Updates
Last Update Posted (Estimate)
September 16, 2015
Last Update Submitted That Met QC Criteria
September 15, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Cardiovascular Diseases
-
Hull University Teaching Hospitals NHS TrustNot yet recruitingCardiovascular Surgery | Cardiovascular Diseases (CVD)United Kingdom
-
Weill Medical College of Cornell UniversityAmerican Heart AssociationRecruitingCardiovascular | Cardiovascular Health | Cardiovascular (CV) Risk | Cardiovascular Disease (CVD) Risk FactorsUnited States
-
Fu Jen Catholic UniversityRecruitingCardiovascular Disease | Cardiovascular SurgeryTaiwan
-
Medical College of WisconsinNational Center for Complementary and Integrative Health (NCCIH)CompletedCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
IRCCS Policlinico S. DonatoIRCCS San Raffaele; Fondazione Policlinico Universitario Agostino Gemelli IRCCS and other collaboratorsRecruitingCardiovascular Risk | Genetic Cardiovascular RiskItaly
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
Children's Hospital Medical Center, CincinnatiRecruitingCardiovascular Diseases (CVD)United States
Clinical Trials on Usual care
-
Charite University, Berlin, GermanyCompletedMultiple Sclerosis | FatigueGermany
-
Charite University, Berlin, GermanyMammazentrum Hamburg am Krankenhaus Jerusalem, Germany; Dorit und Alexander...Completed
-
European Institute for Evidence Based Osteopathic...Unknown
-
Suzanna ZickUniversity of MichiganTerminatedQuality of Life | Fatigue | Lupus Erythematosus, Systemic | Sleep | Pain, ChronicUnited States
-
Centers for Disease Control and PreventionCompleted
-
University Hospital, MontpellierCompletedOsteoarthritis | Mindfulness | MBSRFrance
-
Gachon University Gil Oriental Medical HospitalKorea Health Industry Development InstituteCompletedKnee Replacement | AcupunctureKorea, Republic of
-
Mayo ClinicCompleted
-
The Miriam HospitalNational Institute on Aging (NIA)CompletedHeart FailureUnited States
-
Lawson Health Research InstituteUnknownDepression | Quality of Life | Sleep | Anxiety | Dry EyeCanada