to compare the effect of one-way and interactive SMS reminders on medication compliance in the elderly with hypertension.
Design
A randomized clinical trial, without blinding, on the elderly with high blood pressure under oral drug treatment, selecting 114 patients with easy primary sampling based on the purpose and dividing into three equal groups of 38 people randomly.
Settings and conduct
The study was done without blinding in Shahrekord blood pressure clinic. After completing the initial forms and the questionnaire, the average sitting and lying blood pressure are recorded. A text message is sent to the intervention groups daily for a month. Unlike group 1, group 2 is able to send messages. Group 3 do not receive messages and cannot send messages. The blood pressure of the three groups will be measured one and two months later and the questionnaire will be completed again.
Participants/Inclusion and exclusion criteria
Entry criteria: having a mobile phone and the ability to read text messages, consent, diagnosis of hypertension, age 60 years and older, taking oral hypertension medication
Exclusion criteria: taking blood pressure injection drugs, having coronary artery disease, chronic kidney disease, controlled hypertension during previous visits, participation in other research projects.
Intervention groups
The one-way interactive group (1) receives a daily text message after completing the treatment compliance questionnaire and blood pressure measurement for one month. One and two months later, blood pressure is measured and the questionnaire is completed.
Two-way interactive group (2) can send SMS in addition to receiving SMS.
Control group (3) do not receive messages and cannot send SMS.
Main outcome variables
high blood pressure control; Improving adherence to drug therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231122060136N1
Registration date:2023-12-27, 1402/10/06
Registration timing:registered_while_recruiting
Last update:2023-12-27, 1402/10/06
Update count:0
Registration date
2023-12-27, 1402/10/06
Registrant information
Name
Nasrin Malekmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3452 3853
Email address
nasrin215malekmohammadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of one-way and interactive SMS reminder on adherence to treatment regimen in the elderly with hypertension
Public title
The effect of SMS on the use of blood pressure medication in the elderly with high blood pressure
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Having a mobile phone and the ability to read text messages
Willingness to cooperate in the study
Diagnosis of hypertension
Age 60 years and older
Taking at least one medication to control hypertension
Exclusion criteria:
Use of blood pressure injection drugs
Having coronary artery disease
chronic kidney disease
Having controlled hypertension during previous visits
Participation in other research projects
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
114 selected samples are divided into 3 groups of 38 people, one-way, two-way and control interaction with the help of random allocation software. In this software, numbers between 1 and 114 are entered and then selected by this program in groups of 9. The first 9 numbers are in the one-way interaction group, the second 9 numbers are in the two-way interaction group, and the third 9 numbers are in the control group, and this is repeated again, and at the end, the remaining 6 numbers are grouped in pairs and in the same order in Groups are placed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
No. 31, 75 Alley, West Saadi , Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817845645
Approval date
1981-08-11, 1360/05/20
Ethics committee reference number
IR.SSU.REC.1402.079
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I15.8
ICD-10 code description
Secondary hypertension, unspecified
Primary outcomes
1
Description
The treatment adherence score is based on Moriski questionnaire, whose total score range is between 0 and 8. The lower the score, the more people will adhere to medication.
Timepoint
Completing the questionnaire at the beginning of work and two months after
Method of measurement
Morisky questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The one-way interaction group, after completing the treatment compliance questionnaire and blood pressure measurement, will receive daily text messages for one month. One and two months later, blood pressure is measured and the questionnaire is completed again.
Category
N/A
2
Description
Intervention group: The two-way interaction group will receive a daily SMS after completing the treatment compliance questionnaire and blood pressure measurement for one month. In addition to receiving text messages, this group can also send text messages to the researcher. One or two months later, the blood pressure will be measured and the questionnaire will be completed again.
Category
N/A
3
Description
Control group: In the control group, the treatment compliance questionnaire is completed and initial blood pressure is measured. This group does not receive messages during the study and cannot send SMS. One and two months later, blood pressure is measured and the questionnaire is completed again.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord blood pressure clinic
Full name of responsible person
Nasrin Malekmohammadi
Street address
No. 31, 75 Alley, West Saadi St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817845645
Phone
+98 38 3452 3853
Email
nasrin215malekmohammadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Yazd University of Medical Sciences
Street address
No. 31, 75 Alley, West Saadi St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817845645
Phone
+98 38 3452 3853
Email
nasrin215malekmohammadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd University of Medical Sciences (Faculty of Nursing and Midwifery)
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
Yazd University of Medical Sciences
Full name of responsible person
Nsrin Malekmohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 31, 75 Alley, West Saadi St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817845645
Phone
+98 38 3452 3853
Email
nasrin215malekmohammadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nasrin Malekmohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 31, 75 Alley, West Saadi St
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817845645
Phone
0098384523853
Email
nasrin215malekmohammadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nasrin Malekmohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 31, 75 Alley, West Saadi Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817845645
Phone
+98 38 3452 3853
Email
nasrin215malekmohammadi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome or similar
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
For all
Under which criteria data/document could be used
Yazd University of Medical Sciences website
Personal email: nasrin215malekmohammadi@gmail.com
Phone 09132815336
From where data/document is obtainable
Yazd University of Medical Sciences website
Personal email: nasrin215malekmohammadi@gmail.com
Phone 09132815336
What processes are involved for a request to access data/document