The effect of family-centered education on treatment adherence and glycosylated hemoglobin in patients with type 1 diabetes
Design
In a quasi-experimental clinical trial with pretest-posttest design, 60 patients with type 1 diabetes who met the inclusion criteria will be allocated into intervention and control groups using random allocation software.
Settings and conduct
This study will be conducted in Urmia Diabetes Association. The researcher will meet the patients in an introductory session. After sufficient explanations about the study, patients and active family members who sign the consent form will enter the study and receive family-centered education for 12 sessions. The intervention group (active family member) will be divided into three small groups of 10 patients, and according to their educational needs, four sessions will be performed for each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria were:
1. Diagnosis of type 1 diabetes,
2. Not having mental illness,
3. Age between 15 and 30 years,
4. Willingness to participate in the study,
5. Lack of early and late complications,
6. Living with family,
7. Not having a private nurse
Exclusion criteria included:
1. Unwillingness to participate in the study,
2. Having family member as a medical staff,
3. Having physical disability,
4. Inability to read and write of patient or family member.
Intervention groups
Receiving family-centered education by 30 patients in the intervention group and receiving the routine care of the Urmia Diabetes Association by the control group
Effect of family Centered_Education on Treatment Adherence and Glycosylated Hemoglobin in Patients with Type 1 Diabetes
Public title
The effect of family-centered education on treatment adherence and glycosylated hemoglobin
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of type 1 diabetes for at least one year by a specialist
Lack of mental illness with the approval of a specialist
Age between 15-30 years
Willingness to participate in the study
Not having early or late side effects
Living with family
Not having a private nurse
Exclusion criteria:
Unwillingness to participate to the study
Having an active family member as a medical staff
Having a physical disability
Inability to read and write of a patient or active family member
Age
From 15 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomly divided into two intervention (n=30) and control (n=30) groups through simple random allocation. Randomization was performed according to the numbers randomly selected by Random Allocation Software ( Version 1.0.0) in the computer, and participants were divided into intervention or control groups based on pre-designated numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences Headquarters, Emergency Alley, Resalat Street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.UMSU.REC.1398.408
Health conditions studied
1
Description of health condition studied
Type 1 Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Mean scores of adherence to treatment
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Modanloo Adherence to Treatment Questionnaire (MATQ)
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
Before intervention and four months of intervention
Method of measurement
Laboratory blood samples
2
Description
Glycosylated hemoglobin
Timepoint
Before intervention and four months after intervention
Method of measurement
Laboratory blood samples
Intervention groups
1
Description
The patients in the intervention group will be asked to introduce an immediate family member (spouse, parents, child, or sibling) with whom they have the most interaction. Then their educational needs will be assessed and determined using a checklist prepared in advance. The needs assessment will be performed to design and implement the best intervention method and ensure the intervention's effectiveness in achieving the study's objectives. After the needs assessment, the educational program's content will be prepared using a literature review and valid books and articles according to the educational needs of patients and family members and the approval of an endocrinologist. The educational sessions will be held based on need assessment checklists and the needs of patients and their active family members in each group. The intervention group (with active family members) will be divided into three small sub-groups with ten patients each. Four educational sessions will be held for each sub-group. Then, 12 training sessions will be held to empower patients and their active family members in the intervention group. Thus, one session per week will be held for groups one, two, and three on Saturdays, Mondays, and Wednesdays, respectively. Training sessions will be ended in four weeks. The first session topics will be included endocrine physiology, diabetes, types of diabetes, and its symptoms and treatment. In the second session, the importance of adherence to treatment, the reasons for not accepting treatment, and the symptoms and complications of the lack of adherence to treatment procedure will be discussed. The third session will be about diabetes care such as diet, tips to take medications, preventing complications, blood sugar self-monitoring, and foot care. In the fourth session, "Question and Answer Session," the questions and concerns of patients and their active family members will be addressed. The content of each session will be given to the patients' family members to review with their patients and write down what they will learn or the questions they might have to discuss them at the beginning of the following session. It is noteworthy that the two researchers will be presented in all 12 sessions of group discussions and will make the discussion more effective with their guidance when appropriate. After the intervention is over, the patients and family members will be given three months to take care of themselves and keep their illness under control based on the skills they will gain during educational sessions. The pre-designed care checklist will be given to the active members of the patients to fill in based on the care provided for patients and to give it to the researcher at a certain time at the beginning of each week in Urmia Diabetes Association. After four months of the family-centered empowerment education course, all patients will be called to refer to the Urmia Diabetes Association. After taking blood samples from all patients, Modanloo adherence to the treatment questionnaire will be completed again by patients in both groups. Educational packages, including booklets, DVDs, and pamphlets, will also be provided to patients in the control group at the end of the study.
Category
Other
2
Description
Control group: They will receive routine education from the Urmia Diabetes Association.Three educational sessions (one and a half hours each) per week are the routine education in the Urmia Diabetes Association. Classes on diabetes, symptoms, and treatment by an endocrinologist on Saturday, nutrition education on diabetes by a nutritionist on Monday, and anxiety reduction classes by a psychiatrist on Wednesday.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Diabetes Association
Full name of responsible person
Mahsa Mansour
Street address
Urmia Diabetes Associationin , in front of the municipal building , corner of Vesal St., Mehrab St.,Resalat St.,
City
Urmia
Province
West Azarbaijan
Postal code
۵۷۱۹۹۵۷۳۹۵
Phone
+98 44 3238 8790
Fax
+98 44 3336 6487
Email
parizad.n@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Sata Urmia University of Medical Sciences,Emergency Alley,Resalat Street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
parizad.n@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mahsa Mansour
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mahsa Mansour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 44, 4th floor,Shahid Danaeifar block,The third town of Khordad, West Yasemi Street,North Kurdistan Street
City
Tehran
Province
Tehran
Postal code
1996813461
Phone
+98 21 8862 5107
Email
parizad.n@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mahsa Mansour
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 44, 4th floor,Shahid Danaeifar block,The third town of Khordad, West Yasemi Street,North Kurdistan Street
City
Tehran
Province
Tehran
Postal code
1996813461
Phone
+98 21 8862 5107
Email
parizad.n@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mahsa Mansour
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 44, 4th floor,Shahid Danaeifar block,The third town of Khordad, West Yasemi Street,North Kurdistan Street
City
Tehran
Province
Tehran
Postal code
1996813461
Phone
+98 21 8862 5107
Email
parizad.n@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Laboratory data on fasting blood sugar and glycosylated hemoglobin and treatment adherence scores
When the data will become available and for how long
۲۰۲۰/۰۷/۲۰
To whom data/document is available
University of Medical Sciences Professors
Under which criteria data/document could be used
Statistical analysis
From where data/document is obtainable
parizad.n@umsu.ac.ir
What processes are involved for a request to access data/document