Investigation of the effect of drug reminder application on drug adherence in primary hypertensive Patients
Design
randomized trial with parallel group , blinded postoperative care, include 76 participants (38 in the intervention group and 38 controls)
Settings and conduct
Referring to the Yazd Cardiovascular research center, the researchers will provide a list of middle-aged people with hypertension and make contacts with eligible individuals. Morisky Medication Adherence Questionnaire is completed on the phone and those who score poorly are invited to visit the center.The participants will then complete the written consent form in the center and their demographic data form and Morisky questionnaire will be completed by the researcher through an interview.Samples will be assigned to one of the groups using random numbers table. Prior to and three months after the intervention, the degree of adherence to drug therapy is measured by the Morisky questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having cognitive-psychological ability to participate in the study
Having a smartphone
The ability to use of the application
Diagnosis of primary blood pressure by a physician
Having at least 6 months of history of the disease
the age of 25 to 65 years
Obtain an Undesirable Score from drug adherence Questionnaire
Exclusion criteria:
Hospitalization during the study
Change location to another city
Intervention groups
In the first group, “Drug Reminder” application is installed on patients’ mobile phones and the necessary training will be provided to use the application. No action is taken in the control group
Main outcome variables
drug adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160503027736N4
Registration date:2018-07-18, 1397/04/27
Registration timing:retrospective
Last update:2018-07-18, 1397/04/27
Update count:0
Registration date
2018-07-18, 1397/04/27
Registrant information
Name
shahin heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 5351
Email address
sh.heidari@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-04, 1396/07/12
Expected recruitment end date
2018-01-15, 1396/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of drug reminder application on drug adherence in primary hypertensive Patients
Public title
the effect of drug reminder application on drug adherence in hypertensive Patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All middle-aged patients with primary hypertension
and have been diagnosed with a primary blood pressure diagnosis physician.
Exclusion criteria:
Mental diseases such as Alzheimer's and other types of dementia
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization; Individual; Samples will be assigned to one of the groups(drug reminder application group and control group ) using random numbers table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that samples are assigned into the groups with the use of random numbers table, the author will be blinded regarding the assignments.
Placebo
Not used
Assignment
Parallel
Other design features
drug reminder application that it had used in this research"Daro Yab"is that an optic and easy program for using to remind pills and management of drugs
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences., Imam Ali Blvd., Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717643373
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.RUMS.REC.1396.68
Health conditions studied
1
Description of health condition studied
drug adherence in primary hypertensive Patients
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
obtain weak score of Morisky Medication Adherence Questionnaire
Timepoint
before intervention - three months after the intervention
Method of measurement
Morisky Medication Adherence Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: . In the intervention group, “drug Reminder” application is installed on patients’ mobile phones and the necessary training will be provided to use the application
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Cardiovascular research center
Full name of responsible person
Dr.Seyed mostafa seyedhosseini
Street address
Jomhouri Boulevard., Afshar Hospital
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3523 1421
Fax
+98 35 3525 3335
Email
m.seyedhossaini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahin Heidari
Street address
Mofateh Street
City
Rafsanjan
Province
Kerman
Postal code
7717643373
Phone
+98 34 3425 5900
Email
sh.heidari@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Sajedeh Mohammadi
Position
Critical Care Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
20 Alley., Imam Khomeini Ave., Turk Abad
City
Ardakan
Province
Yazd
Postal code
8953137318
Phone
+98 35 3227 3440
Email
sajedemohammady@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Sajedeh Mohammadi
Position
Critical Care Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
20 Alley., Imam Khomeini Ave., Turk Abad
City
Ardakan
Province
Yazd
Postal code
8953137318
Phone
+98 35 3227 3440
Email
sajedemohammady@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahin Heidari
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mofateh Street
City
Rafsanjan
Province
Kerman
Postal code
7717643373
Phone
+98 34 3425 5900
Email
sh.heidari@rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD