Protocol summary
-
Study aim
-
Determining the effectiveness of a family-oriented intervention program on treatment adherence in patients with type 2 diabetes
-
Design
-
The clinical trial will have a control group, randomized, on 110 patients, and randomization will be done by a statistician using the Balanced Blocked randomization method.
-
Settings and conduct
-
The intervention group will receive the family-oriented intervention program under the application for 8 weeks, and the control group will receive the usual diabetes programs in the center.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: proven type 2 diabetes; HbA1c level equal to or greater than 7; age range of 18 to 60 years old; literate in reading and writing; have a mobile phone personally or in the family in order to participate in the program; do not have debilitating diseases (such as liver failure, psychological diseases, kidney failure, etc.).
Exclusion criteria: hospitalization during the study for any reason; suffering from serious diseases such as diabetic ketoacidosis or hyperglycemic non-ketogenic hyperosmolar syndrome.
-
Intervention groups
-
The intervention group: the group of diabetic patients under family-oriented intervention and the control group: the group of diabetic patients receiving the usual programs of the diabetes center
-
Main outcome variables
-
Adherence to treatment
General information
-
Reason for update
-
Due to illness and knee injury, my start of work was delayed for a while. Furthermore, since my place of study is in Isfahan, it was not agreed to start and conduct research outside of Isfahan. On the other hand, my place of work and life is in Karaj, and my leave was not agreed to at work due to my previous sick leave and severe shortage of staff. Therefore, due to the problems that have arisen, the start of my research work and sampling has been delayed. Given the tacit agreement of my place of work to take leave, I will start my research work in Isfahan.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20220907055909N1
Registration date:
2022-10-03, 1401/07/11
Registration timing:
prospective
Last update:
2025-12-23, 1404/10/02
Update count:
1
-
Registration date
-
2022-10-03, 1401/07/11
-
Registrant information
-
-
Recruitment status
-
recruiting
-
Funding source
-
-
Expected recruitment start date
-
2026-02-27, 1404/12/08
-
Expected recruitment end date
-
2027-03-11, 1405/12/20
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Design, implementation and evaluation of family-centered intervention program on adherence to treatment in Type 2 Diabetic patients
-
Public title
-
Investigating the effect of family-centered intervention on adherence to diabetes treatment
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Have type 2 diabetes and their diabetes has been diagnosed and confirmed by a doctor before registration
Have diabetes for at least 6 months
HbA1c level equal to or greater than 7
Be in the age range of 18 to 60 years old
Be literate in reading and writing
Have a phone at home
Have a mobile phone personally or in the family in order to participate in the program
Do not have disabling physical problems and diseases
Are not pregnant and do not intend to become pregnant during the study period
Do not suffer from known psychological diseases
Do not suffer from serious diseases (such as liver failure, kidney failure, etc.)
Willing to participate in the study and complete the informed consent form
Do not currently participate in other research studies.
Family member entry criteria:
Be over 18 years old
Do not have diabetes
Be a First degree family member (wife, child, parent, sister or brother)
Be literate in reading and writing
Willing to participate in the study
Can use a smartphone
Exclusion criteria:
Being hospitalized during the study for any reason
Suffering from diabetic ketoacidosis or hyperglycemic hyperosmolar Nonketotic syndrome
Suffering from serious diseases such as advanced form of cardiovascular diseases, uncontrolled high blood pressure, psychological disorders, severe vision disorders, psychiatry diseases or suffering from physical or mental problems preventing participation in the research
Unwillingness of the patient or family member to participate or continue cooperation
-
Age
-
From 18 years old to 60 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Care provider
- Data analyser
- Data and Safety Monitoring Board
-
Sample size
-
Target sample size:
110
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
In this study, research samples are first selected based on the available criteria and then randomly (Block Randomization) are divided into intervention and control groups.
In this method, block randomization is used; Blocking is used in order to balance the number of samples allocated to each of the studied groups, so that since we have two groups under study, we use equal blocks of 4 and create all possible states of 4. Then, the sequence of the blocks is determined with the simple randomization service software, and since the sample size in this study is 110 people (55 people in each group), 28 blocks of 4 are used.
Blocked randomization method Balanced and using Sealed Envelope Ltd web software. It is 2020. The method of random allocation is using blocks of size 4. Randomization will be performed by a statistician, who will have no contact with the patients. Researchers and study participants are unaware of the randomization sequence. After confirming the patient's entry into the study, the clinical researcher places the patient in the intervention groups by registering the patient's code based on the determined random sequence.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Randomization will be performed by a statistician, who will have no contact with the patients. Researchers and study participants are unaware of the randomization sequence. After confirming the patient's entry into the study, the clinical researcher places the patient in the intervention groups by registering the patient's code based on the determined random sequence.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
The studied patients will be examined and compared in 2 groups. A control group is diabetic patients who receive routine care. The family members are present with the patient and in this group the patient and the family member are considered as an intervention unit, the training is provided to the patient himself and the families do not participate in educating and informing the patient and play a passive role or They have a patio. In the intervention group, the family member will participate directly in the clinical care processes. Family members are considered as independent units and direct contributors. In this group, the intervention is done on the family members and the family member plays the main role. In this group, the application is installed on the family member's mobile phone or tablet, the family member is taught how to perform the intervention and how to use it (receiving training and compliance programs for family-oriented treatment through the application) and answers to the existing problems. It will be given. In this group, patients will receive the usual care and family members (not patients) as patient supporters, will receive the necessary training in the field of diabetes control through the installation of the designed application. All educational programs using the application with Various methods such as text, images, videos, listening profile and multimedia are presented to the intervention group and the convenience of family members to receive information is also considered and patients and their family members are advised to Ask any questions or problems regarding how to use the application. In addition to that, training on how to use the application is sent in the form of video and text in the application, and one day after receiving the application, the training will be sent weekly in the application. Submissions will be based on the constructs of awareness, perceived threat, perceived benefits, perceived barriers, perceived self-efficacy, outcome expectations (positive outcomes), self-regulation, and perceived social support. For example, for the perceived threat regarding the complications caused by diabetes, an educational video on foot injury and diabetic foot ulcer will be shown, and the statistics related to leg amputation due to diabetes and lack of blood sugar control will be displayed as a message. Or for self-efficacy in the field of how to perform a daily foot examination by the person himself, it is taught step by step through the video so that the person is able to perform the foot examination alone. Data collection will be done at the beginning of the study and 3 months after the intervention.
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2022-08-22, 1401/05/31
-
Ethics committee reference number
-
IR.MUI.RESEARCH.REC.1401.189
Health conditions studied
1
-
Description of health condition studied
-
Type 2 diabetes
-
ICD-10 code
-
E11.9
-
ICD-10 code description
-
Type 2 diabetes mellitus without complications
Primary outcomes
1
-
Description
-
Medication compliance score
-
Timepoint
-
Before the intervention and 3 months after the intervention
-
Method of measurement
-
Morisky Medication Adherence Scale
2
-
Description
-
Physical activity score
-
Timepoint
-
Before the intervention and 3 months after the intervention
-
Method of measurement
-
International Physical Activity Questionnaire (IPAQ )
3
-
Description
-
Self-Efficacy Scale
-
Timepoint
-
Before the intervention and 3 months after the intervention
-
Method of measurement
-
Diabetes Management Self-Efficacy Scale(DMSES)
4
-
Description
-
Self-care behaviors score
-
Timepoint
-
Before the intervention and 3 months after the intervention
-
Method of measurement
-
Summary of Diabetes Self Care Activities (SDSCA)
5
-
Description
-
Perceived family social support score
-
Timepoint
-
Before the intervention and 3 months after the intervention
-
Method of measurement
-
Diabetes Specific Family Support Scale
6
-
Description
-
Self-regulation score in treatment
-
Timepoint
-
Before the intervention and 3 months after the intervention
-
Method of measurement
-
Treatment Self-Regulation Questionnaire (TSRQ)
Secondary outcomes
1
-
Description
-
Glycosylated hemoglobin
-
Timepoint
-
Before the intervention and 3 months after the intervention
-
Method of measurement
-
Blood sample test
Intervention groups
1
-
Description
-
Intervention group: This group will receive the intervention under the application on the mobile phone for 8 weeks, and all educational programs will be presented to the intervention group using the application in various ways, including text, images, videos, audio profiles, and multimedia.
-
Category
-
Behavior
2
-
Description
-
Control group: This group will receive the usual programs at the diabetes center.
-
Category
-
N/A
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Esfahan 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
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