The effect of educational intervention based on social marketing on medication adherence of patients with type 2 diabetes referred to health centers of Qazvin, year 1398
The effect of educational intervention based on social marketing on medication adherence of patients with type 2 diabetes referred to health centers of Qazvin, year 1398
Design
A randomized controlled trial with experimental and control groups
Settings and conduct
Study in health centers of Qazvin including 5 90-60 minute training sessions based on social marketing goals for experimental group with questionnaire
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
1. havingType 2 diabetes
2. Ability to speak
3- At least 6 months have passed since the diagnosis of type 2 diabetes
4-History of drug treatment of type 2 diabetes
5. Residence in Qazvin
6. Voluntary participation
7. Failure to participate in similar educational interventions in the past year
8. Mobile phone use
9- Age 30-65 years
Exclusion criteria
1-Patients' dissatisfaction with the study
2. Lack of proper physical conditions to answer questions
3. Gestational diabetes
Type 1 diabetes
5. Hospitalization during the study period
6. Having uncontrolled underlying illnesses such as hypertension with a blood pressure of 130.90 mmHg with medication
7. Missing more than one session in training will be excluded
Intervention groups
Type 2 diabetic patients aged 30-65 years old in Qazvin Health Centers will be assigned a random number after random allocation based on random numbers Then, using the formula 1 + 2 k (k = 3), one of the patients will be assigned to the control group and one to the experimental group . One of the numbers will be assigned to the control group and the other to the experimental group. The intervention group will consist of lecture, pamphlet, texting and hands-on training sessions.
Main outcome variables
medication adherence, awareness, perceived barriers and benefits, abstract norms, self-efficacy, intention to behave
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190927044901N1
Registration date:2019-12-20, 1398/09/29
Registration timing:prospective
Last update:2019-12-20, 1398/09/29
Update count:0
Registration date
2019-12-20, 1398/09/29
Registrant information
Name
zahra najafpour dobakhshari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5578 2455
Email address
najafpurzahra110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-26, 1398/10/05
Expected recruitment end date
2020-06-25, 1399/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on social marketing on medication adherence of patients with type 2 diabetes referred to health centers of Qazvin, year 1398
Public title
The effect of educational intervention on medication adherence of type 2 diabetic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1-having To Type 2 Diabetes
Ability to speak
At least 6 months have passed since the diagnosis of type 2 diabetes
History of drug treatment of type 2 diabetes
Residence in Qazvin
Voluntary participation
7. Failure to participate in similar educational interventions in the past year
Mobile phone use
Age 30-65 years
Exclusion criteria:
Patients' dissatisfaction with the study
Lack of proper physical conditions to answer questions
Gestational diabetes
Type 1 diabetes
Hospitalization during the study period
Having uncontrolled underlying illness such as hypertension with 130/90 mm Hg with medication
Missing more than one session in training will be excluded
Age
From 30 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:
110
Randomization (investigator's opinion)
Randomized
Randomization description
In this two-stage cluster randomization study, we first select 4 centers from 12 health centers and then assign a number to each patient based on random numbers, then using the formula (k 2 + 1 (k = 3) Among the patients, one will be assigned to the control group and the other to the experimental group
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double-blind. The outcome is blinded by outcome assessor and data analyzer (double blind). Outcome assessors and data analysts are not aware of grouping. The outcome assessor and the data analyzer identify the groups as A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Approval date
2019-11-20, 1398/08/29
Ethics committee reference number
IR.QUMS.REC.1398.190
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Medication adherence
Timepoint
Before and 3 months after intervention
Method of measurement
Questionnaire based on variables of social marketing approach including 16 questions of awareness, 4 questions of perceived benefits, 7 questions of perceived barriers, 19 questions of self-efficacy, 8 questions of drug compliance, 4 questions of abstract norms, 7 questions of behavior intention, questions of demographic information
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Intervention group consisting of 55 diabetic patients. Social marketing based training (including awareness, perceived barriers and benefits, abstract norms, self-efficacy, behavioral intention) will be conducted in 5 to 60-90 minute sessions in group. In the first session, your doctor will give a lecture to inform patients about diabetes and the symptoms and complications of diabetes. The second session is a group discussion with patients, where the perceived benefits and benefits of diabetes are understood and the appropriate solution is given. In the third session of the call for patients' families, the extent of family support is examined and the importance of family support is discussed. The fourth session examines the patient's skills needed to control the disease. In the fifth session, the patient is re-trained and practiced by a patient. Patients will be reminded of text messages and symptoms and symptoms of the disease. The educational pamphlet also includes information on diabetes, symptoms, complications, and ways to prevent and control the disease.
Category
Behavior
2
Description
Control group: There is no intervention for 55 patients in the control group and they only have routine health center training.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Health Center
Full name of responsible person
Zahra Najafpur
Street address
Qazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
najafpurzahra110@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Emam Jomeh
Street address
Shahid Beheshti Boulevard - Subway Moodat - Deputy of Research and Technology of Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3333 4308
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Najafpur
Position
MSc Student in Health Services Management
Latest degree
Bachelor
Other areas of specialty/work
Health Service Management
Street address
Faculty of Health, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
najafpurzahra110@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Ruhollah Kalhor
Position
Phd of Health Services Management
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
Faculty of Health, Qazvin University of Medical Sciences, Shahid Bahonar Street, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
r.kalhor@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Najafpur
Position
MSc Student in Health Service Management
Latest degree
Bachelor
Other areas of specialty/work
Health Service Management
Street address
Faculty of Health, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
najafpurzahra110@gmail.com
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
Because the data is confidential and work for the master thesis will eventually become a training package