Determining the effect of education based on the Leventhal model on understanding the disease, adherence to treatment and glycemic control in patients with diabetes
Design
This clinical trial study was designed with pretest-posttest design in two experimental and control groups
Settings and conduct
The population of this study included all diabetic patients (including type 1 and type 2 diabetes) with a medical record in the diabetes clinic of Musa bin Jaafar Hospital in Quchan, affiliated to Mashhad University of Medical Sciences
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
- Age aged 18-65 years
- At least one year have passed since their diagnosis of diabetes.
- HbA1C≥7
- The absence of any mental illness that interferes with the intervention
- Lack of participation in similar educational programs
- Ability to understand conversation in Persian language
- - Communication problems (such as loss of hearing and vision)
- Lack of severe and severe underlying disease (such as metastatic cancer, severe heart failure, etc.)
Non-inclusion criteria:
- Absence in the curriculum
- Unwilling to continue reading
Intervention groups
The teaching according to cognitive environment (identity, cause, time lines, outcomes, odrman) discussed in its regulatory model to better understand diabetes lontal, treatment adherence and improve indicators of گلیسمیک, by a nurse researcher in two 45-minute training session is offered to patients and using A questionnaire comply with treatment of the disease, understand and measure گلیسمیک (HbA1C) after 3 months, the impact of training investments.
Main outcome variables
Patient perception, compliance with treatment and HbA1C levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180409039251N1
Registration date:2018-04-20, 1397/01/31
Registration timing:registered_while_recruiting
Last update:2018-04-20, 1397/01/31
Update count:0
Registration date
2018-04-20, 1397/01/31
Registrant information
Name
Mansure Sadeh tabarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 4368
Email address
hoseinirz9@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on Leventhal Model on perception of disease , adherence to treatment and glycemic control in diabetic patients
Public title
The effect of education based on Leventhal Model on perception of disease , adherence to treatment and glycemic control in diabetic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-65 years
At least one year have passed since their diagnosis of diabetes
The absence of any mental illness that interferes with the intervention
Lack of participation in similar educational programs
Ability to understand conversation in Persian language
Communication problems (such as loss of hearing and vision)
Lack of severe and severe underlying disease (such as metastatic cancer, severe heart failure, etc.)
HbA1C≥7
Exclusion criteria:
Absence in the training session
Unwillingness to attend meetings
Age
From 18 years old to 65 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
This is a randomized clinical trial with two groups of test and control. Eligible patients are selected as case study from among the records in the clinic, randomly selected from the sample (random number table) to the sample size calculated for the research, the patient is selected and after obtaining their consent To participate in the pre-test study, we used questionnaires and HbA1C measurements.Afterwards, the samples are divided into two groups of intervention and control. Contact groups will be contacted for training sessions, and training sessions will be held at the clinic. Therefore, the control and intervention group have the least amount of meeting and the contamination of the information does not occur.
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 the Faculty of Nursing and Midwifery, Tehran University
Street address
Nosrat st. Tohid sq. Tehran I.IRAN 141973317
City
Tehran
Province
Tehran
Postal code
141973317
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3291
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type 1 and 2
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
perception of disease
Timepoint
Before the start of the intervention and 3 months after training perception of disease
Method of measurement
Understanding of disease questionnaire (IPQ-R), a questionnaire comply with treatment, laboratory measurement of glycated hemoglobin
Secondary outcomes
empty
Intervention groups
1
Description
The teaching according to cognitive environment (identity, cause, time lines, outcomes, odrman) discussed in its regulatory model to better understand diabetes lontal, adherence to the treatment and improvement of HbA1c, by the nurse researcher in two 45-minute training session is offered to patients and A questionnaire comply with treatment of the disease, understanding and measurement of glycated hemoglobin after 3 months, the impact of training investments.
Category
Behavior
2
Description
Control group: No do not receive the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Musa bin Ja'far Hospital Quchan
Full name of responsible person
Ali Ansari
Street address
parastar st,Musa Ibn Jafar Hospital
City
Quchan
Province
Razavi Khorasan
Postal code
00985147233412
Phone
+98 51 4723 3412
Email
sadeh.4005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yonesian
Street address
Keshavarz Blvd., Qods Street, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1417863181
Phone
+98 21 6640 5666
Email
sadeh.4005@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mansureh Sadeh Tabarian
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
sadeh.4005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Ghiyasvandian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq. Tehran
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 912 130 3833
Email
shghiyas@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansureh adeh Tabarian
Position
master student nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq. TehranSchool of Nursing Midwifery ,Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
sadeh.4005@yahoo.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