Evaluation of the Effect of Self-management Education in Teach Back Method on Medication and Nutritional Adherence of Elderly Patients with Type 2 Diabetes
Determining the impact of self-management training in a retrospective manner on the level of medication and dietary compliance of the elderly referring to selected comprehensive health service centers in Mashhad in 2022
Design
From among 93 comprehensive health service centers in Mashhad, with the help of random number software, one center was selected, then from the entire list of diabetic patients in Sina system, 104 members of the sample were divided into two groups using random sampling method.
Settings and conduct
After randomly selecting people and obtaining written consent, demographic information questionnaires, medication compliance questionnaires and dietary compliance questionnaires will be completed for both groups of the elderly and training will be conducted during six sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age older thanr 60 years old; having type 2 diabetes for at least one year since diagnosis; obtaining written consent; being literate and not suffering from debilitating complications caused by diabetes; able to speak and communicate; absence of cognitive problems.
Exclusion criteria: unwillingness to continue cooperation in the study; failure to participate even in a training session; participation in similar training sessions; having education in the field of medical sciences.
Intervention groups
In the feedback training intervention group, the trainer uses simple and understandable language; He teaches the client individually and after the end of teaching each topic, he asks the client to repeat the content in his own language as he understood it. If the client does not repeat the contents well, the trainer repeats the contents for the client until he fully understands
Main outcome variables
Medication compliance; food compliance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221011056146N1
Registration date:2022-12-18, 1401/09/27
Registration timing:prospective
Last update:2022-12-18, 1401/09/27
Update count:0
Registration date
2022-12-18, 1401/09/27
Registrant information
Name
Afsaneh Garshad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3272 4459
Email address
garshad@Nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-05, 1401/12/14
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
2023-03-05, 1401/12/14
Actual recruitment end date
2023-07-22, 1402/04/31
Trial completion date
2023-10-23, 1402/08/01
Scientific title
Evaluation of the Effect of Self-management Education in Teach Back Method on Medication and Nutritional Adherence of Elderly Patients with Type 2 Diabetes
Public title
Evaluation of the Effect of Self-management Education in Teach Back Method on Medication and Nutritional Adherence of Elderly Patients with Type 2 Diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years
Having type 2 diabetes, at least one year has passed since the definitive diagnosis of the disease by a doctor
Not having visual problems (able to read the line of a magazine or newspaper from a distance of 30 cm)
Not having movement problems and having minimal reading and writing literacy and not suffering from severe and debilitating complicationsCaused by diabetes such as kidney failure and...
able to speak and communicate; Absence of cognitive problems
Random allocation: At first, the patients who met the criteria for entering the study were divided into two intervention and control groups according to the table of random numbers(even odd)
Exclusion: variables that could not be controlled and could have a strong effect on the research resultswere included in the entry and exit criteria.
Consideration and homogenization: variables that cannot be eliminated, with the help of statistical testsChi-square, Fisher, independent t, will be analyzed and homogenized. These variablesThey include: level of education, income, marital status, insurance status and use of other drugs.Community Verified icon
No cognitive problems
Exclusion criteria:
Reluctance to continue cooperation in the study
Failure to participate in even one training session
Participation in similar training sessions
Having education in the field of medical sciences
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
Actual sample size reached:
104
Randomization (investigator's opinion)
Randomized
Randomization description
The patients who met the conditions for entering the study were divided into two intervention and control groups according to the random number table.
We will try to select patients as much as possible, until two groups are homogeneous in terms of age, sex, education and other variables.
to be selected and also to check the homogeneity of the demographic variables in the two training and control groups, from the detailed test
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 North Khorasan University of Medical Sciences
Street address
Shahyar St
City
Boujnurd
Province
North Khorasan
Postal code
9418636595
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.NKUMS.REC.1398.122
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E16.4
ICD-10 code description
Type 2 diabetes
Primary outcomes
1
Description
Return training
Timepoint
Food compliance
Method of measurement
Medication compliance
Secondary outcomes
1
Description
Medication compliance
Timepoint
Before training and six sessions after training
Method of measurement
Questionnaires for demographic information, Moriski medication adherence questionnaire for the elderly in both groups of return education and education in the usual way
2
Description
Food compliance
Timepoint
Before training and six sessions after training
Method of measurement
Questionnaire of demographic information, dietary compliance questionnaire (Mediterranean diet adherence tool) for the elderly in both groups of return education and education in the usual way.
Intervention groups
1
Description
Intervention group In this group, the content is presented in the form of feedback training, where the trainer, who is a researcher himself, is responsible for the training; content in simple and understandable language; without using specific medical terms, he teaches the client individually and after the end of the training, he asks the client to understand the content; to tell in his own language; If the client has not understood and narrated the content well; person teaching until full understanding; He will repeat the contents for the client. Number of sessions: 6 sessions, twice a week, each session is 20 minutes, which will be completed within 3 weeks. Session topics: diabetes, drug therapy in diabetes, diet in diabetes. Exercise activity in diabetes. Blood sugar measurement methods. The effect of stress on diabetes
Category
Lifestyle
2
Description
Control group: Control group: teacher, subjects: diabetes, drug therapy in diabetes, diet in diabetes. Exercise activity in diabetes. Blood sugar measurement methods. The effect of stress on diabetes. The number of sessions is 6 sessions, twice a week, each session is 20 minutes, which will be completed within 3 weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Health Service Center
Full name of responsible person
Marzie Seyedi
Street address
Ansar 8, Payambar Azam Highway, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
36200329
Phone
+98 915 120 5545
Email
seyedimr3@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Amir Ali Ghahremani
Street address
Vice President of Research and Technology, North Khorasan University of Medical Sciences, Shahriar St.
City
bojnurd
Province
North Khorasan
Postal code
9418636595
Phone
+98 58 3151 1420
Email
modiriat.pajoheshi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Afsaneh Garshad
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahriar Street
City
Bojnourd
Province
North Khorasan
Postal code
9418636595
Phone
+98 58 3272 4459
Email
Garshsad@NKUMS.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Afsaneh Garshad
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahriar Street
City
Bojnourd
Province
North Khorasan
Postal code
9418636595
Phone
+98 58 3272 4459
Email
Garshsad@NKUMS.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Afsaneh Garshad
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahriar Street
City
Bojnourd
Province
North Khorasan
Postal code
9418636595
Phone
+98 58 3272 4459
Email
Garshsad@NKUMS.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available