Protocol summary

Study aim
Comparison of the effect of self-care program training in two ways, face-to-face and smartphone application, on adherence to treatment regimen and glycosylated hemoglobin of type 2 diabetes patients.
Design
Clinical trial with two intervention groups for comparison, with parallel groups, unblinded and randomized, on 60 patients. For randomization, the random select option of spss software is used.
Settings and conduct
Patients with type 2 diabetes who were referred to Shahid Qudsi and Parsian clinics in Mashhad during the study, If they are eligible, will enter the study and will be assigned to two groups 1 (face-to-face) and 2 (smartphone application) by a simple random method.
Participants/Inclusion and exclusion criteria
The research population is all patients with type 2 diabetes referring to the mentioned clinics. Inclusion criteria: over 18 years of age, having consent to study, having at least reading and writing literacy to complete the questionnaire, patients diagnosed with type 2 diabetes for at least 6 months, diagnosed by a specialist, having a smart phone and being able to use it; Exclusion criteria: suffering from mental illness and other chronic diseases diagnosed by a doctor, suffering from complications caused by diabetes such as diabetic neuropathy
Intervention groups
Group 1: this group is trained in a face to face self-care program in 3 one-hour sessions within 3 weeks. Group 2: this group has also been trained in a self-care program using smartphones for a month, and the designed app, which has content related to type 2 diabetes patients, will be installed for patients in a 15-30 minute session and the essential instructions will be given as well.
Main outcome variables
Adherence to treatment, Glycosylated hemoglobin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221028056323N1
Registration date: 2022-12-23, 1401/10/02
Registration timing: registered_while_recruiting

Last update: 2022-12-23, 1401/10/02
Update count: 0
Registration date
2022-12-23, 1401/10/02
Registrant information
Name
Mahsa GharehGoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
gharehgm981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-06, 1401/09/15
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Effect of Self-Care Program Training in Two Ways Face-to-Face and Smartphone Application On Adherence to Treatment Regimen and Glycosylated Hemoglobin of Patients with Type 2 Diabetes
Public title
The Effect of Teaching Self-Care Program in Patients with Type 2
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years Having consent to study Having minimum reading and writing literacy to complete the questionnaire Patients diagnosed with type 2 diabetes for at least 6 months Diagnosis of the disease by a specialist Having a smartphone and being able to use it
Exclusion criteria:
Having another chronic disease as diagnosed by a doctor Mental illness diagnosed by a doctor Having a complication caused by diabetes such as diabetic neuropathy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization unit is individual and the tool being used is SPSS. In this way, all eligible patients will be randomly selected and will be divided into two groups; A and B, using SPSS 26 software. To perform randomization by SPSS, the “Data” option is selected from the toolbar. Next, in the new window, the “select cases” is selected. Then, in the “Select” box, first a click on “Random sample of cases” and then on “select” option will be done. After the “Exactly” option has been selected in the new window, the number of patients in each group and the total number of samples are respectively entered in the empty boxes ( in this study, 30 and 60 respectively). After that, a click on the “Continue” and “OK” options will be done and finally, the generated random variables are randomly divided into two equal groups with codes 1 and 0 on the “Data view” page which conventionally, code 1 is assigned to the intervention group and code 0 to the control group. Patients will be randomly placed in either the intervention or control groups by someone other than the main researcher and statistical analyst.
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 Faculty of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Qurashi Building, Near Hovaze Cinema, Daneshgah St, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-08-02, 1401/05/11
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.071

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
Adherence to the treatment regimen
Timepoint
Before and 3 months after the intervention
Method of measurement
Questionnaire of adherence to the treatment of chronic diseases

2

Description
Glycosylated hemoglobin
Timepoint
Before and 3 months after the intervention
Method of measurement
Glycosylated hemoglobin test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In this group, self-care training is done face-to-face during three one-hour sessions at intervals of one week. The patients are placed in groups of 6 to 8 people and the researcher will provide necessary information related to self-care training (nutrition management, drug management, activity management, and blood sugar check).
Category
Behavior

2

Description
Intervention group 2: In this group, self-care training conducted for three months through a smartphone application. This application includes specific training in the field of self-care for type 2 diabetes patients (nutrition and activity management, medication management, and blood sugar check). This app is a type of educational app that has self-care educational facilities (text, audio, and video) and important titles are presented in a highlighted form. It is also possible to communicate with the researcher in the form of text, and the patient will receive his answer after sending the question, and if he goes online, he will be able to learn new materials. After designing and building the above application, in a 15-20 minute session, the application will be installed on the phone and necessary explanations will be given to the patients regarding how to use it. Two weeks after the application is installed, the patients will be contacted and the ability and efficiency of the application will be evaluated.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Parsiyan Diabetes Clinic of Mashhad
Full name of responsible person
Aliakbar Raoofsaeb
Street address
Parsiyan biulding, between chamran 8 and Golestan, Chamran street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3858 4040
Email
info@parsiandiabetes.com

2

Recruitment center
Name of recruitment center
Shahid Ghodsi
Full name of responsible person
Susan Daulatabadi
Street address
Shahid Ghodsi Center , Sanabad Street , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3844 0077
Email
dolatabadis1@mums.ac.ir
Web page address
http://behdasht3.mums.ac.ir/index.php/43-persian-category/229-ghodsi

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
University of Medical Sciences, university street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Garehgholi
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street, Doctora Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Gharehgm981@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Reza Mazloum
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street, Doctora Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
05138598019-207
Email
mazlomr@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Gharehgoli
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street, Doctora Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Gharehgm981@mums.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
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
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