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Investigating the effect of family-centered intervention on adherence to diabetes treatment

Not Applicable
Recruiting
Conditions
Type 2 diabetes.
E11.9
Type 2 diabetes mellitus without complications
Registration Number
IRCT20220907055909N1
Lead Sponsor
Esfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
110
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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Medication compliance score. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Morisky Medication Adherence Scale.;Physical activity score. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: International Physical Activity Questionnaire (IPAQ ).;Self-Efficacy Scale. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Diabetes Management Self-Efficacy Scale(DMSES).;Self-care behaviors score. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Summary of Diabetes Self Care Activities (SDSCA).;Perceived family social support score. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Diabetes Specific Family Support Scale.;Self-regulation score in treatment. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Treatment Self-Regulation Questionnaire (TSRQ).
Secondary Outcome Measures
NameTimeMethod
Glycosylated hemoglobin. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Blood sample test.
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