To determine the effectiveness of training based on Idea software on self-care behaviors of the elderly with type 2 diabetes
Design
A clinical trial with a control group and a parallel group will be randomized on 102 patients. A lottery method will be used for randomization.
Settings and conduct
The research community will be composed of elderly people with type 2 diabetes referred to Mustafavian Diabetes Clinic in Sari.
Idea software will be installed on the mobile phones of participants in the intervention group. People in the intervention group will manually record diabetes self-care data on the software and receive and implement lifestyle recommendations for better diabetes self-care for one month through it.
Participants/Inclusion and exclusion criteria
Age 60 years and above
Ability to communicate
Having a normal cognitive status based on the cognitive status assessment tool (AMT) (scoring 7 and above)
Informed consent of the patient to participate in the study
Access to a smart mobile phone and the ability to work with it
Internet access
Literacy for reading and writing
Not using care software before entering the study
Diagnosed with diabetes by a doctor who has been diagnosed for at least 6 months
Intervention groups
Intervention group: installing Idea software, recording data related to diabetes self-care (nutritional information, blood sugar recording, insulin and medication recording, physical activity recording, emotion recording) manually on Idea software and receiving related trainings To self-care diabetes through the software for a month.
Control group: They will receive all the recommendations in a printed file when they enter the study, but no interactive training such as question and answer will be given to them.
Main outcome variables
Self-care of diabetic patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170611034454N5
Registration date:2023-08-15, 1402/05/24
Registration timing:registered_while_recruiting
Last update:2023-08-15, 1402/05/24
Update count:0
Registration date
2023-08-15, 1402/05/24
Registrant information
Name
Ehteram Sadat Ilali
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.arab1388@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To assess the effectiveness of the education based on the Idia application on the self-care behaviors of the elderly with type 2 diabetes
Public title
Mobile phone-based self-care in diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 years and above
Ability to communicate
Having a normal cognitive status based on the cognitive status assessment tool (AMT) (scoring 7 and above)
Informed consent of the patient to participate in the study
Access to a smart mobile phone and the ability to work with it
Internet access
Literacy for reading and writing
Diagnosed with diabetes by a doctor who has been diagnosed for at least 6 months
Exclusion criteria:
using care software before entering the study
Unwillingness to participate in the study
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly assigned into two intervention and control groups. Based on this, all people are numbered from 1 to 102. Then 51 cards with white color and 51 cards with red color without numbers are prepared and placed in a container. Then, one card for each person is randomly selected from the container and assigned to each number. If the color of the card is red, the person is assigned to the intervention group, and if it is white, the person is assigned to the control group.
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 Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Siences (Vice chanchellor for research), Moallem Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
IR.MAZUMS.REC.1402.193
Health conditions studied
1
Description of health condition studied
diabetic
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Self-care score in the Summary of Diabetes Self Care Activities questionnaire
Timepoint
Measuring the self-care score at the beginning of the study (before the start of the intervention) and 1 and 3 months after the start of the intervention
Method of measurement
Summary of Diabetes Self Care Activities questionnaire
Secondary outcomes
1
Description
HbA1c
Timepoint
At the beginning of the study (before the start of the intervention) and 1 and 3 months after the start of the intervention
Method of measurement
It will be measured by Tobi Sari laboratory kits
2
Description
fasting blood sugar
Timepoint
At the beginning of the study (before the start of the intervention) and 1 and 3 months after the start of the intervention
Method of measurement
Glucometer brand DIABAN and model SMM1000 made in Iran
Intervention groups
1
Description
Intervention group: After selecting the participants of the intervention group, they are invited to visit the Mustafavian diabetes clinic in Sari. In this meeting, the researcher will first introduce himself, explain the objectives of the study and obtain written informed consent. Then the desired questionnaires are completed with the help of the researcher. FBS and HbA1c tests will be taken from patients. At the end of the session, Idea software is installed for the participants of the intervention group and its performance is controlled on the phone, and with the cooperation of the patient, how to use and use it by an experienced expert (with education and experience in the field of planning and development) It will be given. If possible, it is suggested to the participants of the intervention group that a family member accompanies them in face-to-face and non-face-to-face training sessions to facilitate the process of working with Idea software. Also, along with the installed program, a pamphlet will be presented to the users, which is a guide for using the program, and it will be explained to the participants that whenever they encounter a problem during the intervention period, they can contact the researcher (a number that is available 24 hours a day). It is provided to the elderly to answer their questions. This software will allow patients to manually record diabetes self-care data (nutritional information, blood sugar records, insulin and medication records, physical activity records, emotion records) on the mobile phone, and trainings Receive information related to diabetes self-care through the software. Also, once a week, along with measuring blood sugar by the researcher, the weight of the patients will be measured using a scale and recorded in the program. The training of the participants in the intervention group will be in the form of two sessions in person and 8 sessions in person. It will be held twice a week (Mondays and Wednesdays) in the period of 15-18 on the chat page of the Idea program as a group. In this way, the educational content in the form of PDF, the recorded voice of the researcher and the educational video will be sent to the participants at 15:00 and they are requested to read the content. The researcher will have access to all the information recorded by the participants through the Idea software database and will be informed indirectly about the treatment plan and lifestyle of the patients. Also, the researcher will follow up the participants during their participation in the training sessions.
Category
Lifestyle
2
Description
Control group: After selecting the participants of the control group, they are invited to visit the Mustafavian diabetes clinic in Sari. In this meeting, the researcher will first introduce himself, explain the objectives of the study and obtain written informed consent. Then the desired questionnaires are completed with the help of the researcher. FBS and HbA1c tests will be taken from patients. At the end of the session, they will receive all the recommendations related to diabetes self-care in the form of a printed file. But no interactive training such as question and answer is given to them.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafavian Diabetes Center
Full name of responsible person
Akbardokht
Street address
Mostafavian Diabetes Center, Razi St., Amir Mazandarani St., Tabarsi District,Sari