Protocol summary

Study aim
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
En 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: IRCT20221011056146N2
Registration date: 2023-01-03, 1401/10/13
Registration timing: prospective

Last update: 2023-01-03, 1401/10/13
Update count: 0
Registration date
2023-01-03, 1401/10/13
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
2023-02-22, 1401/12/03
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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 No visual problems The ability to read the line of a magazine or newspaper from a distance of 30 cm No movement problems Having at least reading and writing literacy Not suffering from severe and debilitating complications caused by diabetes, such as kidney failure, etc. Able to speak and communicate Absence of cognitive problems
Exclusion criteria:
Reluctance to continue cooperation in the study - - Participation in similar training sessions - Failure to participate in even one training session Having an education in the field of medical sciences
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
From among 93 comprehensive health service centers of Mashhad with the help of random number software, one center was selected, then from the entire list of diabetic patients in the Sina system using random sampling method with Using the software, a number of 104 diabetic patients will be selected. These people will enter the study randomly and will be placed in one of the training or control groups as an uninformed strain. After checking that these people meet the conditions for entering the study. In order for the studied subjects to be homogeneous in terms of gender and education in two groups, stratified randomization method was used and the studied subjects were stratified according to these variables, then the required sample in each group (52 people) was An equal form of classification is done by simple random allocation method (randomization will be done using a computer) or according to the conditions after classifying the samples using block random allocation with two groups A (training group) and B ( control group) samples will be allocated in two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each selected diabetic patient was contacted and the work steps were explained to all patients and the patient will be informed that there is a possibility of being placed in any training or control group for the patient and that the patient will be placed in which group. is unaware
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
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Medication compliance
Timepoint
Before training and six sessions after training
Method of measurement
En 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
En 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.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, the contents (diabetes disease, drug therapy in diabetes, diet in diabetes, exercise activity in diabetes, blood sugar measurement methods, effect of stress on diabetes disease) are presented in the form of feedback training, which is taught by the teacher who is a researcher. is responsible for education; 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 content for the client. The number of sessions is 6, twice a week, each session is 20 minutes, which will be completed within 3 weeks.
Category
Lifestyle

2

Description
Control group: Teaching subjects: diabetes disease, 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
آدرس خیابان 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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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