Design, implementation and evaluation of an intervention based on the Pender health promotion model to improve the medication adherence of type 2 diabetes patients
Design, implementation and evaluation of an intervention based on the Pender health promotion model to improve medication adherence of patients withT2D
Design
the sample size is 166 people in a total of two groups (83 people in each group). For randomization with systematic sampling method, the selection of individuals according to the list of 1500 people registered in the diabetes clinic from the participants who meet the inclusion criteria through systematic random sampling from the list using the sampling distance (k), [k = N / n = 1500/166 = 9] are selected. From 1 to 9, the number 2 is randomly selected as the first sample and the list of 166 people is completed by adding the number 9 in each step.
To randomize this final list, by drawing lots, the first name out of these 166 people will be selected as the second intervention group, and so on.
Settings and conduct
The intervention is designed and implemented based on Pender's health promotion model in face-to-face and online training sessions in Hormoz Diabetes Clinic. Blinding will not be performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in research, file registration in diabetes clinic as a patient with type 2 diabetes, living in Bandar Abbas
Non-entry condition: Alzheimer's disease based on patient records
Intervention groups
The intervention will be based on the constructs of Pender's health promotion model (Suitable tools for any structure, such as: video clips or posters) for the intervention group and the control group will use the normal services of the clinic.
Main outcome variables
medication adherence score ; hemoglobin A1C test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211228053558N1
Registration date:2022-03-17, 1400/12/26
Registration timing:prospective
Last update:2022-03-17, 1400/12/26
Update count:0
Registration date
2022-03-17, 1400/12/26
Registrant information
Name
nahid shahabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 8583
Email address
nahid.shahabi@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-17, 1401/01/28
Expected recruitment end date
2022-07-24, 1401/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation of an intervention based on the Pender health promotion model to improve the medication adherence of type 2 diabetes patients
Public title
Pender's health promotion model on medication adherence of type 2 diabetes patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in research
Registration of a case in the diabetes clinic of Shahid Mohammadi hospital as a type 2 diabetic patient
Living in Bandar Abbas
Exclusion criteria:
Not participating in regular training sessions (absence of more than 2 sessions)
Not going to the diabetes clinic of Shahid Mohammadi Hospital
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
166
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible samples are selected through systematic random sampling from Hormoz Diabetes Clinic (Bandar Abbas Diabetes Reference Clinic). Based on the information recorded in the center files (taking into account the inclusion criteria) to achieve the required sample size of 83 people in the intervention group and 83 control people, individuals through systematic random sampling from the list using sampling distance ( k), [k = N / n (1500 ÷ 166 = 9)] will be selected. From 1 to 9, a number will be randomly selected as the first sample and then the second sample will be selected by adding the number 9 to the first patient and this process will continue until the end. After identifying the samples, a lottery will be drawn between the two intervention and control groups. The first lottery will be called the intervention group and then the next names will be placed one by one in the control and intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is performed in three phases: qualitative, cross-sectional and intervention, and the effect can be measured through a questionnaire and a1c test.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of hormozgan University of Medical Sciences
Street address
Iran, Hormozgan, Bandar Abbas, Shahid Chamran Boulevard
City
bandarabbas
Province
Hormozgan
Postal code
7916613885
Approval date
2022-01-22, 1400/11/02
Ethics committee reference number
IR.HUMS.REC.1400.377
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 score
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
medication adherence questionnaire
2
Description
Hemoglobin A1C test
Timepoint
At the beginning of the study (before the intervention) and 3 months after the end of the intervention
Method of measurement
The hemoglobin A1C listed in the test result
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hormoz Diabetes Clinic of Shahid Mohammadi Hospital in Bandar Abbas as the place of intervention and using educational services will be 10-12 sessions in person or online or a combination of both depending on the university conditions during the Covid-19 epidemic. The use of educational clips, posters and pamphlets will be in the training process and the main content of the sessions on promoting and improving adherence to treatment in the areas of drug therapy, physical activity and nutrition (content according to Pender's health promotion model to promote self-efficacy, related emotions By adhering to and reducing benefits, etc.) it will be that face-to-face meetings will be set with an average time of 45 minutes and online meetings of 15 minutes. The control group will not receive training and will receive the clinic's routine care services. Then the changes in the results of the hemoglobin A1C test in both groups will be examined.
Category
Behavior
2
Description
Control group: does not receive any intervention and uses the normal services of the clinic.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hormoz Clinic of Shahid Mohammadi Hospital
Full name of responsible person
Mohammad Tamaddondar
Street address
Bandar Abbas - Islamic Republic of Iran Boulevard
City
bandarabbas
Province
Hormozgan
Postal code
7919916753
Phone
+98 76 3334 7000
Email
tamaddondar491@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
دکتر تیمور آقا ملایی
Street address
Bandar Abbas - Imam Hossein Boulevard - in front of Kargaran Sports Club - Nabout Town - Campus of University of Medical Sciences
City
bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3371 0393
Email
teaghamolaei@gmail.com
Grant name
Grant code / Reference number
4000362
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Nahid Shahabi
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Bandar Abbas, Jomhuri Eslami Blvd., Bustan Alley 10, Faculty of Health
City
Bandarabbas
Province
Hormozgan
Postal code
7919916753
Phone
+98 76 3333 8583
Fax
Email
nahid.shahabi@hums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Nahid Shahabi
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Bandar Abbas, Jomhuri Eslami Blvd., Bustan Alley 10, Faculty of Health
City
Bandarabbas
Province
Hormozgan
Postal code
7919916753
Phone
+98 76 3333 8583
Fax
Email
nahid.shahabi@hums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Nahid Shahabi
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Bandar Abbas, Jomhuri Eslami Blvd., Bustan Alley 10, Faculty of Health
City
Bandarabbas
Province
Hormozgan
Postal code
7919916753
Phone
+98 76 3333 8583
Fax
Email
nahid.shahabi@hums.ac.ir
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
Yes - There is 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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If the request is kept confidential and reasonable
From where data/document is obtainable
Nahid Shahabi Student
nahid.shahabi@hotmail.com
Zahra Hosseini First Supervisor
hosseinishirin@ymail.com
Teamur Aghamolaei Second Supervisor
teaghamolaei@gmail.com
What processes are involved for a request to access data/document
After sending the request via email and obtaining permission from the professors, information will be sent to the applicant.