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Investigating the effect of educational intervention based on Pender's health promotion model on the level of treatment compliance in elderly people with type 2 diabetes referring to health care centers.

Protocol summary

Study aim
Determining the effect of educational intervention based on Pender's health promotion model on the level of treatment compliance in the elderly with type 2 diabetes.
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, on 80 patients, Excel software is used for randomization.
Settings and conduct
First, the samples will be selected from the elderly diabetics of Bojnord with the help of a statistical consultant. If you have consent to participate in the study and meet the entry criteria, you will be registered as part of the study units. Then, the elderly selected by a person outside the study are randomly assigned to two groups using assigned codes. Randomization and random sequence will be determined by a statistician as a block randomization of 4 or 6 using Excel software in the form of A, B. A written informed consent will be obtained from them to participate in the study.
Participants/Inclusion and exclusion criteria
1- Obtain written informed consent 2- Age 60 and above 3- Diagnosing type 2 diabetes by a specialist doctor based on the patient's file and under medical treatment (pills or insulin). 4- At least 6 months have passed since the diagnosis of diabetes 5- The elderly should be able to physically attend classes. 6- The elderly should be aware of the person, time and place. 7- Persistence of diabetes 8- HbA1c level between 6.5 and 8.5
Intervention groups
Ten groups of four people, eight training sessions, each session is 45 minutes, are trained by lectures, film screenings, group discussions, questions and answers, and role playing. The program will be adjusted and implemented based on the variables of Pender's health promotion model and the Iran-American Diabetes Association. 40 people in the control group do not receive the training.
Main outcome variables
Improving the health of Pender Medication compliance Hemoglobin A1c level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221013056162N1
Registration date: 2022-11-02, 1401/08/11
Registration timing: registered_while_recruiting

Last update: 2022-11-02, 1401/08/11
Update count: 0
Registration date
2022-11-02, 1401/08/11
Registrant information
Name
Zahra Salehee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 547 1634
Email address
z.salehee@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-01, 1401/08/10
Expected recruitment end date
2022-12-01, 1401/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of educational intervention based on Pender's health promotion model on the level of treatment compliance in elderly people with type 2 diabetes referring to health care centers.
Public title
Investigation of educational intervention on adherence to treatment of diabetic patients.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Obtain written informed consent Age 60 and above Diagnosing type 2 diabetes by a specialist doctor based on the patient's file and under medical treatment (pills or insulin). At least 6 months have passed since the diagnosis of diabetes The elderly should be able to physically attend classes. The elderly should be aware of the person, time and place. Persistence of diabetes HbA1c level between 6.5 and 8.5
Exclusion criteria:
Withdrawal from the study Death of the participant Having another underlying disease mental disorder Patients who, for any reason, cannot attend more than 4 alternating sessions or two consecutive sessions. Having type 1 diabetes Not doing homework Participation in other educational programs
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization and random sequence will be determined by a statistician in the form of block randomization of 4 or 6 using Excel software in the form of A, B.
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
Vice President of Research and Information Technology University of Medical Sciences, next to Imam Ali Hospital, Shahryar St., Bojnord
City
BOJNORD
Province
North Khorasan
Postal code
9417694780
Approval date
2022-09-28, 1401/07/06
Ethics committee reference number
4000278

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E10-E14
ICD-10 code description
With other specified complicationsDiabetic arthropathy (M14.2*)Neuropathic diabetic arthropathy (M14.6*).7 With multiple complications.8 With unspecified complications.9 Without complications

Primary outcomes

1

Description
Medication adherence score based on Moriski questionnaire
Timepoint
Measurement of medication adherence before the start of the intervention, immediately after the last training session and three months after the last training session.
Method of measurement
Questionnaire

2

Description
Health promotion score based on Pender health promotion model questionnaire.
Timepoint
The health improvement score is checked at the beginning of the study (before the start of the intervention), after the end of the last training session and three months after the end of the last training session.
Method of measurement
Pender Health Promotion Questionnaire

3

Description
Age according to birth certificate
Timepoint
The beginning of the study
Method of measurement
Demographic questionnaire

4

Description
gender
Timepoint
The beginning of the study
Method of measurement
Demographic questionnaire

5

Description
marital status
Timepoint
The beginning of the study
Method of measurement
Demographic questionnaire

6

Description
Level of education
Timepoint
The beginning of the study
Method of measurement
Demographic questionnaire

7

Description
Average body mass
Timepoint
The average body mass is checked at the beginning of the study (before the intervention), after the end of the last training session and three months after the end of the last training session.
Method of measurement
Digital meters and scales

8

Description
The amount of monthly income
Timepoint
The beginning of the study
Method of measurement
Demographic questionnaire

9

Description
place of income
Timepoint
The beginning of the study
Method of measurement
Demographic questionnaire

10

Description
Employment status
Timepoint
The beginning of the study
Method of measurement
Demographic questionnaire

11

Description
Living condition
Timepoint
The beginning of the study
Method of measurement
Demographic questionnaire

12

Description
Drug treatments prescribed by the attending physician
Timepoint
The beginning of the study
Method of measurement
Demographic questionnaire

13

Description
blood pressure
Timepoint
Blood pressure measurement is checked at the beginning of the study (before the intervention), after the end of the last training session and three months after the end of the last training session.
Method of measurement
Mercury sphygmomanometer

Secondary outcomes

1

Description
Glycosylated blood sugar
Timepoint
At the beginning and three months after the study
Method of measurement
blood sample

Intervention groups

1

Description
Intervention group: The first intervention group
Category
Lifestyle

2

Description
Control group: The first control group
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Mrs. Dr. Shakri's diabetes clinic
Full name of responsible person
Dr. Habiba Shakri
Street address
Dr. Hekmati Doctors Building, South Shariati St., Bojnord
City
Bojnord
Province
North Khorasan
Postal code
9417814035
Phone
+98 58 3222 6606
Email
Saleheez1365@gmail.com

2

Recruitment center
Name of recruitment center
Bojnoord Health Center
Full name of responsible person
Dr. Ibrahim Bazkhane
Street address
Bojnoord Health Center, 19 Chamran St
City
Bojnord
Province
North Khorasan
Postal code
7487794149
Phone
+98 58 3223 3341
Email
saleheez1365@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Vice Chancellor of Research and Information Technology of the University
Street address
Shahyar St., Bojnord
City
Bojnord
Province
North Khorasan
Postal code
9417814035
Phone
+98 58 3229 7010
Email
Saleheez1365@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
Zahra salehee
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jannet Complex, Jannet St., Khorramshahr Square, Bojnord
City
Bognord
Province
North Khorasan
Postal code
9417814035
Phone
+98 58 3224 8001
Email
Saleheez1365@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Fateme Khorashadizadeh
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bojnoord School of Nursing and Midwifery, Shahriar St
City
Bojnord
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7097
Email
khorashadizadehf891@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Zahra Salehi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Genat Complex, Khorramshahr Square
City
Bojnord
Province
North Khorasan
Postal code
9417814035
Phone
+98 58 3224 8001
Email
Saleheez1365@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It is possible to share the entire data.
When the data will become available and for how long
one year later.
To whom data/document is available
All people and especially researchers.
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Websites and my phone number. 05832248001
What processes are involved for a request to access data/document
During a written request or visiting the site.
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