The effect of Behzi mobile application on drug adherence and self-care in patients with type 2 diabetes
Design
Samples are selected by Convenience method from patients referred to Tehran University hospitals. Then, the subjects will be randomly assigned to the control and intervention groups (65 people each).
Settings and conduct
Behzi application will be installed on the phones of people in both groups and its application will be explained by an expert person. Then demographic, self-care questionnaires for diabetics, Moriski drug compliance, informed consent form will be completed by samples in both groups and HbA1C will be checked. The intervention group will receive lifestyle recommendations within 3 months. But the control group does not have any interactive training such as questions and answers and enters the application only to answer the questions of the questionnaires. At the end of 3 months, both groups will be complete the above-mentioned questionnaires as well as the amount of HbA1C will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age>18 years, literacy, HgA1C level higher or equal to 8%, ability to use cell phones, Internet access and diagnosis of the disease up to one year.
Exclusion criteria: Unwillingness to continue participation, not received more than two sessions of training, and hospitalization.
Intervention groups
The intervention group will receive and implement the ADEA's lifestyle recommendations in seven main areas.
Main outcome variables
This study intends to implement a care program for people with type 2 diabetes using this application and evaluate its effectiveness on drug adherence, improving self-care, physical activity and improving the status of diabetes indicators as a secondary outcome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210416050992N1
Registration date:2021-05-30, 1400/03/09
Registration timing:prospective
Last update:2021-05-30, 1400/03/09
Update count:0
Registration date
2021-05-30, 1400/03/09
Registrant information
Name
Mohammad Salehpoor Emran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3533 9265
Email address
ms_82820@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of BEHZEE diabetic mobile application on medical adherence and self-care in patients with diabetes mellitus type 2
Public title
Effect of BEHZEE APP on medical adherence and self-care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
HgA1C level higher or equal to 8%
Be literate
Ability to use cell phone
Diagnosed type 2 diabetes at least one year ago
Exclusion criteria:
Not intention to continue participation
Absence in more than two educational sessions
hospitalization due to new complication during the intervention
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected by available method from diabetic patients referred to the hospitals of Tehran University of Medical Sciences. Selected samples with random allocation will be divided into two intervention and control groups . This method is used to prevent significant imbalances in the number of participants assigned to each group. Block randomization ensures that no significant imbalance is established between groups at any time during randomization, and at certain points the number of participants in each group is equal. Blocks of 4 will be considered to complete the sample size. Then the list of blocks will be written and the numbers will be assigned to them: AABB (1) - ABAB (2) -ABBA (3) - BBAA (4) - BABA (5) - BAAB (6). For this purpose, all possible modes for quadruple blocks will be determined as 2 items in the test group and 2 items in the control group (6 modes in total). Then the numbers will be selected from a table of random numbers and the allocation of individuals in the test and control groups will be done as follows. Dark envelopes will be used to conceal the allocation.
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
Joint Organizational Ethics Committee of the School of Nursing, Midwifery and Rehabilitation, Tehran
Street address
School of Nursing and Midwifery, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.TUMS.FNM.REC.1399.139
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Self-care of diabetic patients
Timepoint
Before the intervention and 3 months after it
Method of measurement
Diabetes self-care questionnaire
2
Description
Drug adherence
Timepoint
Before the intervention and 3 months after it
Method of measurement
Morisky Drug Adherence Questionnaire
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
Before the intervention and three months after
Method of measurement
Mg / dl
2
Description
HbA1C
Timepoint
Before and 3 months after intervention
Method of measurement
Blood Sample
Intervention groups
1
Description
Intervention group: Within 3 months, the intervention team will receive and implement lifestyle recommendations in 7 key areas recommended for better diabetes self-care recommended by the American Diabetes Educators Association:1. Recommendations for type 2 diabetes management training, 2. Adequate mobility and use of all muscles in the body 3. Proper nutrition in this disease 4. Proper and continuous use of drugs prescribed by a doctor and adaptation to them 5. Sleep and rest in type 2 diabetes 6. Management of interaction with the environment and reduction of high-risk behaviors, appropriate to the disease 7. How to manage and promote mental health in this disease.
Category
Lifestyle
2
Description
Control group: The control group receives all the recommendations as a printed file when they go to the hospital and enter the study, but no interactive training such as questions and answers is done with them and only to answer questions Logs in to complete the questionnaires through the application.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Rheumatology Department of Imam Khomeini Hospital, Tehran
Full name of responsible person
Sarieh Poortaghi
Street address
School of Nursing and Midwifery, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4148
Email
s-poortaghi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dean of Research deputy, TUMS
Street address
Research Deputy, 6th Floor, Main house, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?