Measurement of the effect of sending short text messages as reminders on medication adherence in patients with chronic hyperlipidemia
Design
A clinical trial with a control group of 60 patients, with parallel groups
Settings and conduct
This research will be carried out at Imam Hossein Health Services Center in Borazjan.
The consent form is completed by the patients and their mobile phone number. 60 people are randomly divided into 2 groups. A daily reminder message is sent to the intervention group to follow the follow-up schedule for a period of 6 weeks. No messages will be sent to the control group. Blood lipids are measured in both groups at the start and end of the study and recorded in the patient's case. At the end of this study, changes in blood lipids in both groups of patients are analyzed. Morissky questionnaire is completed at the beginning and end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria : age group of 30 - 65 years , mobile ownership
Exclusion criteria : the development of diseases that involve the administration of drugs other than lipid profile, such as blood pressure, supplementary treatments such as herbal medicines, the individual's desire not to continue to collaborate in the research
Intervention groups
the intervention group receive a short message remind about the use of the drug for six weeks.
the control group will not receive a message and will follow their usual treatment.
Main outcome variables
The primary outcome is a study of increased adherence to drug use in patients with high blood lipids.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180703040317N1
Registration date:2019-01-31, 1397/11/11
Registration timing:retrospective
Last update:2019-01-31, 1397/11/11
Update count:0
Registration date
2019-01-31, 1397/11/11
Registrant information
Name
Seyedeh Zeinab Mahdian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 4301
Email address
sz_mahdian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-08, 1397/06/17
Expected recruitment end date
2018-10-19, 1397/07/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of sending short text messages as reminders on medication adherence in patients with chronic hyperlipidemia
Public title
the effect of sending short text messages as reminders on medication adherence in patients with chronic hyperlipidemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the age group of 30 to 65 years, owning at least one mobile phone that has the ability to receive and send text messages, have reading and writing skills, the ability to send and receive text messages over mobile phones, and that the prescription for Patients only include oral medications
Exclusion criteria:
Diseases requiring drugs other than lipid metabolism, such as blood pressure, supplementary treatments such as herbal medicines, individual tendency to non-cooperation in research
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat Highway,
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.IUMS.REC.1397.040
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
Increased adherence to drug use in patients with high blood lipids
Timepoint
At the beginning and end of the study
Method of measurement
Morisky questionnaire
Secondary outcomes
1
Description
cholesterol,
Timepoint
The beginning and the end of the study
Method of measurement
Using the results of biochemical tests to determine the serum cholesterol level in mg / dl
2
Description
triglycerides
Timepoint
The beginning and the end of the study
Method of measurement
Using the results of biochemical tests to determine the serum triglyceride level in mg / dl
3
Description
LDL
Timepoint
The beginning and the end of the study
Method of measurement
Using the results of biochemical tests to determine the serum LDL level in mg / dl
Intervention groups
1
Description
Intervention group: Patients in the intervention group receive a short message remind about the use of the drug for six weeks
Category
Other
2
Description
Control group: Patients in the control group will not receive a message and will follow their usual treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Health Services Center
Full name of responsible person
Bahareh HosseinAbadi
Street address
HosseinAbad Ave
City
Borazjan
Province
Boushehr
Postal code
7561969187
Phone
+98 77 3422 3104
Email
HealthNetworkDashtestan@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Iran Uni Med Science, Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8879 4301
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Zeinab Mahdian
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Health Information Technology
Street address
No. 8, Rashidyasemi Ave, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1995614111
Phone
+98 21 8879 4302
Email
sz_mahdian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Ahmadi
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Health Information Systems
Street address
No. 8, Rashidyasemi Ave, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1995614111
Phone
+98 21 8879 4302
Email
hosseinis3007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Zeinab Mahdian
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Health Information Technology
Street address
No. 8, Rashidyasemi Ave, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1995614111
Phone
+98 21 8879 4302
Email
sz_mahdian@yahoo.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