Determining effect of education based on the extended parallel process model on adherence to treatment and self-care of type 2 diabetic elderly
Design
Clinical trial with control group, with parallel groups, single blind , Random Allocation on 70 patients, random number table was used for randomization.
Settings and conduct
Sampling will begin among the type 2 diabetic elderly referred to the diabetes clinic who have the conditions to participate in the study. First, randomization will be performed and then individuals will be randomly divided into 2 groups. The study will be single blind. Adherence to treatment and Self-care is measured by questionnaire, in both groups before the intervention. The intervention group will receive 5 training sessions based on the extended parallel process model and the control group will receive routine training. Four weeks after training, the level of adherence to treatment and self-care is assessed by a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Type 2 diabetic Elderly over the age of 60 who have not a known psychiatric illness based on a medical record . Be aware of the time and place and have the ability to understand educational content. Have a minimum literacy rate. Exclusion criteria: The patient's unwillingness to participate in the research. Participate in a similar training program that coincides with the intervention.
Intervention groups
The intervention group consisting of 35 patients, based on the extended parallel process model, will receive training in 5 sessions, each session lasting 45 minutes. There will be 1 training session every week. The control group of 35 patients will receive the usual training in these 5 weeks.
Main outcome variables
Adherence to treatment, self-care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220522054962N1
Registration date:2022-06-09, 1401/03/19
Registration timing:prospective
Last update:2022-06-09, 1401/03/19
Update count:0
Registration date
2022-06-09, 1401/03/19
Registrant information
Name
Malihe Kabusi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3232 3662
Email address
kabusi.m@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-27, 1401/05/05
Expected recruitment end date
2022-08-10, 1401/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on the extended parallel process model (EPPM) on adherence to treatment and self-care of type 2 diabetic elderly
Public title
Impact of training extended parallel process model on adherence to treatment and self-care of type 2 diabetic elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic elderly over 60 years of age who are diagnosed with no psychiatric illness based on medical records.
All units participating in this study should be aware of the time and place and have the ability to understand the educational content.
Have a minimum literacy.
Exclusion criteria:
The patient's unwillingness to participate in the research.
Participating in a similar educational program that coincides with the implementation of the intervention.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The names of the type 2 diabetic elderly who are eligible for the study will be received from the diabetes clinic and will be numbered based on the medical record number and placed in an envelope. We will use a random number table for randomization. In order to use a random number table, it will first be pre-set to read the table numbers. Then odd numbers are assigned to group A and even numbers are assigned to group B. Hand will be on one of the numbers and move in the predetermined direction and the numbers are recorded in one of the groups A and B according to being even and odd. The intervention and control groups are then randomly assigned.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be single blind. The data analyzer who does the data analysis will be blinded to the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Deputy of Research and Technology- Golestan University of Medical Sciences and Health Services- Hyrkan Blvd-Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2022-05-08, 1401/02/18
Ethics committee reference number
IR.GOUMS.REC.1401.046
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Adherence to treatment
Timepoint
Before training, 4 weeks after training
Method of measurement
Questionnaire of adherence to the treatment of chronic diseases
2
Description
Self-care
Timepoint
Before training, 4 weeks after training
Method of measurement
Elderly self-care questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive trainings based on the extended parallel process model , in 5 sessions By Lectures, questions and answers, educational booklets and pamphlets. The educational content includes Familiarity with diabetes and its complications, Complications of non-adherence to treatment and lack of self-care, Benefits of self-care and adherence to treatment in diabetes control and prevention of complications of this disease, removing the wrong barriers in the field of diabetes and Diabetes control methods. One session per week, each session will be 45 minutes and the duration of the training course will be 5 weeks.
Category
Lifestyle
2
Description
Control group: The control group does not receive any intervention, they are only under normal treatment and training.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Dezyani Specialized and Sub-Specialized Clinic
Full name of responsible person
Fateme Maghsodlo
Street address
Dezyani Specialized and Sub-Specialized Clinic.,in front of Behesht 17., Shahid Beheshti St.,Gorgan
City
Gorgan
Province
Golestan
Postal code
4916694667
Phone
+98 17 3224 2714
Email
fateme_maghsodlo_51@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Deputy of research and technology, Golestan University of Medical Sciences, Hyrkan Blvd.,Gorgan.
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
mrhonarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Gholamreza Mahmoudi Shan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Golestan University of Medical Sciences, Hyrkan Blvd., Gorgan.
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0319
Email
mahmoodigh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Gholamreza Mahmoudi Shan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Golestan University of Medical Sciences, Hyrkan Blvd., Gorgan.
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0319
Email
mahmoodigh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Malihe Kabusi
Position
Master of Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mirfanderski One, Azar One, 5 Azar Street, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917634586
Phone
+98 17 3232 3662
Email
malihekabusi987@gmail.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