1. Home
  2. Approved trials
  3. » فارسی

The effect of interactive intervention in the platform of social messengers according to protection motivation theory on medication adherence and blood pressure control in adults with hypertension

Protocol summary

Study aim
The effect of interactive intervention in the platform of social messengers according to protection motivation theory on medication adherence and blood pressure control in adults with hypertension
Design
A randomized,single-blind, parallel-group controlled clinical trial on 142 patients with primary hypertension.Randomization will be done by quadruple block random assignment method.
Settings and conduct
Place Of Study:Comprehensive Health centers under the coverage of Tehran University of Medical Sciences; Research population: Adults with primary hypertension; Blinding:Single-Blinded; Blinding description: The statistical analyst will be blinded to the allocation of participants to intervention and control group by providing participant data in coded form (for example:letter A and B)
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Diagnosis of primary hypertension; Currently on at least one prescribed blood pressure medication; Literacy (ability to read and write); Ownership and ability to use a smartphone with internet access; Proficiency in using social networking platforms; Active participation in at least one social network. Exclusion Criteria: Prior participation in similar projects;Current involvement in other research or interventions; Use of special, rare, or costly drugs; Use of injectable blood pressure medication; Presence of sensory disorders (vision, hearing, touch); History of drug addiction; Presence of concurrent diseases
Intervention groups
Intervention group:An interactive intervention based on protection motivation theory will be implemented for 3 months on social messaging platforms for individuals.The control group will receive the usual care.At the end of the implementation of the program,the content designed based on the protection motivation theory will be provided to the control group.
Main outcome variables
Medication Adherence; Blood pressure control

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231202060239N1
Registration date: 2024-01-14, 1402/10/24
Registration timing: prospective

Last update: 2024-01-14, 1402/10/24
Update count: 0
Registration date
2024-01-14, 1402/10/24
Registrant information
Name
Mehdi Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 1685
Email address
051mehdijafari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of interactive intervention in the platform of social messengers according to protection motivation theory on medication adherence and blood pressure control in adults with hypertension
Public title
The effect of interactive intervention taking place in social messenger platforms on medication adherence and blood pressure control
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of primary hypertension by a physician Minimum use of one anti-hypertensive medication prescribed by a physician Age between 18 to 65 years Ability to read and write (being literate) Possession of a smartphone and ability to use it and access the internet The ability to use the facilities of social messaging platforms (the person should have the minimum ability to send and receive messages in any possible form (text, voice, etc.) Have an account in at least one social messaging platform such as Whats App, Telegram, Eitaa, Soroush)
Exclusion criteria:
Participation in previous similar studies Concurrent involvement in other research or interventions Use of special or expensive medications Use of injectable anti hypertensive drugs Having sensory impairments including vision, hearing, and touch Addiction to drugs,narcotics presence of comorbidities (such as diabetes, asthma, cancer, and renal disorders)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 142
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be allocated into two groups: intervention and control, using a block randomization method with a block size of 4. The supervisor will handle the generation of the random sequence and allocation concealment, while the student will conduct the sampling. To maintain concealment, dark envelopes, equal to the sample size, will be used. These envelopes will contain papers with random sequences. Upon joining the study, each participant will receive an envelope from the researcher. The paper inside the envelope will determine the participant’s group assignment.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, only the statistical analyst will not be informed about the allocation of the participants to the intervention and control groups. In this way, the data related to the participants will be delivered to the statistical analyst in coded form (for example, the intervention group with the letter A and the control group with the letter B). After the completion of the data analysis and evaluation of the relevant consequences after the completion of the implementation of the intervention, each code will be finally determined so that after comparing the data, the final result of the effectiveness of the intervention or its absence will be realized.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee, School of Medicine, Tehran University of Medical Sciences
Street address
Ethics Committee, Faculty of Medicine, Poursina St. , Ghods St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.472

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
Medication Adherence
Timepoint
Before intervention and 97 days after the intervention
Method of measurement
Hill-Bone Medication Adherence Scale (HB-MAS9) ,Kim et al. 2000

Secondary outcomes

1

Description
Controlled blood pressure: In this study, blood pressure less than 140 mm Hg (systolic) and 90 mm Hg (diastolic) will be considered as controlled blood pressure.
Timepoint
Before implementing the intervention at the beginning of the study (baseline) and then 97 days after the onset of interactive intervention
Method of measurement
In this study, blood pressure measurements will be taken from the participants after they’ve rested for five minutes in a seated position. A calibrated sphygmomanometer will be used on the patient’s right arm for these measurements. This process will be repeated twice, with a 10-minute interval between the measurements.

Intervention groups

1

Description
Intervention group: After establishing communication between the researcher and the people of the intervention group in messengers selected from the previously announced priorities (Soroush, Eitaa, Telegram, WhatsApp), an intervention within 3 months for the people of the intervention group by sending a daily message reminding them to take medicine and a message with multimedia content prepared based on the constructs of the protection motivation theory will be sent on the social messenger platform of their choice. A reminder message to take the medicine according to the list prepared according to the demographic questionnaire (name of the medicine, usual time of taking the medicine) and five minutes before the time of taking the medicine in the corresponding messaging platform with a message containing the name of the medicine, the dose of the medicine, the exact time of taking the medicine and the word "time of taking the medicine" "Your medicine has arrived. Do not delay taking your medicine." Along with the drug usage tips, including: 1) blood pressure control and after taking blood pressure medication, and 2) tips related to the drug used, are sent to the person and they are asked to send a message for feedback and confirmation in case of taking the drug. They should also declare the use of medication and medication errors in order to register.The people of the intervention group can send their questions to the researcher to be answered in the relevant messengers. A message prepared according to the constructs of the protection motivation theory is also sent one number per day and at a random hour between 10 am and 8 pm. All feedbacks from peoples in the intervention group will be recorded and their questions about the submitted content will be answered. All the questions asked will be recorded and part of the content of the message sent every three days will be non-repeating questions asked by patients and their answers. At the end of each week of the implementation of the intervention, people are requested to send a message to inform the researcher of any change in the type or dosage of the drug used.
Category
Behavior

2

Description
Control group: The people of the control group will also receive the usual care during three months and no intervention will be done. Just to attend for blood pressure measurement, they will receive the same message as the people in the intervention group at the same time and under the same conditions. After 97 days (7 days after the completion of sending the intervention), the people of both groups will come to the center for the final blood pressure measurement and recording, and after the blood pressure control, the medication compliance questionnaire will be provided to both the intervention and control groups for completion. At the end of the implementation of the program, the content designed based on the protection motivation theory will be provided to the control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
South Tehran Health Centers
Full name of responsible person
Mohammad Reza Salmani Nadushan
Street address
South Health Center, Abbas Shafiee Alley, Vasal Shirazi St. , Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
66419881
Phone
+98 21 6695 0069
Fax
+98 21 6697 8050
Email
Behdasht_Jonoob_Tehran@sina.tums.ac.ir
Web page address
https://sthn.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Negarandeh
Position
Professor of Nursing Education Department of Community Health Nursing, School of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Care Research Center, School of Nursing Midwifery, Tehran University of Medical Sciences , Dr. Mirkhani St. (East Nusrat), Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Fax
Email
negarandeh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Negarandeh
Position
Professor of Nursing Education Department of Community Health Nursing, School of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Care Research Center, School of Nursing Midwifery, Tehran University of Medical Sciences , Dr. Mirkhani St. (East Nusrat), Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Fax
Email
negarandeh@gmail.com
Web page address
https://isid.research.ac.ir/Reza_Negarandeh

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Jafari
Position
Msc student of Community Health Nursing / Tehran University of Medical sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery, Tehran University of Medical Sciences , Dr. Mirkhani St. (East Nusrat), Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Fax
Email
051mehdijafari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...