The impact of mobile health intervention based on Information-Motivation-Behavioral Skills Model on the health outcomes of patients with type 2 diabetes : a randomized clinical study
Determining the effect of mobile health intervention based on information-motivation-behavioral skills model on the health outcomes of patients with type 2 diabetes
Design
Randomized, parallel-group, single-blind, controlled clinical trial on 90 patients
Settings and conduct
This study will be conducted at Hamadan Diabetes Center affiliated to Hamadan University of Medical Sciences in Hamadan.
Participants/Inclusion and exclusion criteria
The inclusion criteria include patients who have received a definitive diagnosis of type 2 diabetes in the last six months according to the opinion of an endocrinologist, have a smart cell phone, are literate, are at least 18 years old, have psychiatric problems and acute musculoskeletal problems, Do not suffer from severe complications of diabetes, consent to participate in the study.
Intervention groups
Intervention group: In addition to the center's usual interventions, the patients received the necessary training for three months using an application designed by the researchers and the IT team based on the information-motivation model and behavioral skills and installed on the patients' mobile phones and will be followed up. Control group: patients will receive training according to the current program of the diabetes center and will not receive any additional training.
Main outcome variables
Quality of life, physical activity, self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240504061643N1
Registration date:2024-06-19, 1403/03/30
Registration timing:registered_while_recruiting
Last update:2024-06-19, 1403/03/30
Update count:0
Registration date
2024-06-19, 1403/03/30
Registrant information
Name
Ashkan Allahverdy Eznav
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3225 5238
Email address
ashkanallahverdy7900@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-11, 1403/02/22
Expected recruitment end date
2024-09-12, 1403/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of mobile health intervention based on Information-Motivation-Behavioral Skills Model on the health outcomes of patients with type 2 diabetes : a randomized clinical study
Public title
The impact of mobile health intervention on the health outcomes of patients with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of type 2 diabetes during the last six months according to the opinion of an endocrinologist
Having a smart mobile phone with the Android operating system and the ability to use it
Having minimum literacy
Being at least 18 years old
Complete the informed consent form
Exclusion criteria:
Acute psychiatric problems
Acute musculoskeletal problems
Suffering from severe medical complications of diabetes
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
First of all, from patients with type 2 diabetes and having inclusion criteria, a sample is selected according to the convenience sampling method and based on balance block randomization method will be placed in cardiac rehabilitation group with education based on therapeutic engagement model and the cardiac rehabilitation group. For this purpose, four sheets of paper are provided by the researcher, writing on two sheets “1” for “first” and on two “2” for second”. The paper sheets will be pooled, placed in a container, and randomly will be drawn one at a time for each patient without replacement until all four sheets are drawn. Then, the four paper sheets will be placed back into the container and this action will be repeated until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
A diabetes nurse will perform assessments at each stage, blinded to random allocation. Also, the statistical analysis and outcome assessment will not know about the assignment of patients to two intervention and control groups during the analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Approval date
2024-04-25, 1403/02/06
Ethics committee reference number
IR.UMSHA.REC.1403.028
Health conditions studied
1
Description of health condition studied
Patients with type 2 diabetes mellitus without complications
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Quality of life
Timepoint
Before and after the end of the intervention
Method of measurement
Using the summary of the World Health Organization quality of life questionnaire: The summary of the World Health Organization quality of life questionnaire includes 26 questions that evaluate the quality of life of patients in order to check the health status of patients and determine the health care results. The first two questions are designed to examine the overall quality of life and the individual's perception of the quality of life, and the following questions evaluate the four areas of physical health, psychological health, social relationships, and the physical environment of the individual. The scoring of the questionnaire is based on a five-point Likert scale, and each answer is assigned a score of 1-5 (not at all, low, medium, high, very high).
Secondary outcomes
1
Description
Physical activity
Timepoint
Before and after the end of the intervention
Method of measurement
Using the short form of the International Physical Activity Questionnaire: The short form of the International Physical Activity Questionnaire includes 7 questions in four parts: intense activity, moderate activity, walking and sitting activity during the last 7 days to check the level of compliance with physical activity. Using this tool, the intensity of physical activity can be calculated based on the quantitative measure of energy consumption and the qualitative measure of physical activity (favorable and unfavorable physical activity).
2
Description
self-efficacy
Timepoint
Before and after the end of the intervention
Method of measurement
Using the Diabetes Self-Efficacy Questionnaire: The self-efficacy questionnaire for diabetic patients was designed by the Stanford University Research Center to measure the self-efficacy of people with diabetes. This questionnaire contains 8 questions with a range of scores from 1 to 10 on a Likert scale, and the answers are classified as 1 (not sure at all) to 10 (completely sure). By calculating the total scores of 8 items, the self-efficacy score is obtained. In the whole range of scores between 8-80, higher scores indicate greater self-efficacy.
Intervention groups
1
Description
Intervention group: In the first intervention group, the type of intervention will be as follows: after introducing the study and stating its objectives, patients will complete the informed consent form, demographic information form, questionnaires related to quality of life, physical activity and self-efficacy. For 3 months, they will receive the necessary training using an application designed by researchers and the IT team based on the information-motivation and behavioral skills model and installed on the patients' mobile phones, and they will be followed up. For each model part, a part will be seen in this application. Using this application, patients can improve their knowledge and behavioral skills related to diabetes control by reading texts, watching videos and images, and listening to audio files, as well as communicating with experts. Also, by using this application, they can record their blood sugar and daily physical activity and view it as a line graph and send it to the expert on a weekly basis, and in this way, this application can influence the motivation of the patients. After the intervention, questionnaires related to quality of life, physical activity and self-efficacy will be completed by this group.
Category
Prevention
2
Description
Control group: This group receives the usual interventions of the diabetes center, so that if they feel the need, they go to the diabetes center, the doctor in the center examines them, and the doctor and the treatment staff of the center provide the necessary health and treatment tips. They teach them. There is no written training program for individuals in this center.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Diabetes Center affiliated to Hamedan University of Medical Science
Full name of responsible person
Ashkan Allahverdy Eznav
Street address
Jihad St., Be'sat underpass
City
همدان
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
ashkanallahverdy7900@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ashkan Allahverdy Eznav
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
ashkanallahverdy7900@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Pakrad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
f_pakrad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ashkan Allahverdy Eznav
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Blvd., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Email
ashkanallahverdy7900@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I must provide all information for the sponsoring institution.