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IRCT20180105038224N1 IRCT 2018-12-02 Iran University of Medical Sciences Designing Occupation-Centered Self-management interventions and investigating its effect on Performance, Satisfaction and self- efficacy of people diagnosed with type 2 diabetes Designing Occupation-Centered Self-management interventions and investigating its effect on Performance, Satisfaction and self- efficacy of people diagnosed with type 2 diabetes 2019-10-23 anticipated 30 Complete https://irct.ir/trial/31633 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: The random allocation is done using random cards, Blinding description: All assessments in both groups will be done by an unaware examiner of the random allocation method. All assessments will be done 3 times: before the first intervention session, after the end of the intervention and three months thereafter. N/A Type 2 diabetes. Intervention 1: Intervention group: Occupation- centered self-management intervention will be conducted in the intervention group. Intervention sessions will be hold using various methods such as education, counseling, coaching, feedback, and discussion among members by group format to facilitate performance in different areas of self-management. At intervals between sessions, the therapist will check the attendance rate through a phone call or SMS. Also, participants can ask their questions one day of per week in person or by phone. In order to generalize the skills to real life, the logbook is available to each participant and homework assignments are set for individuals. At the beginning of the meetings, people will talk about the experience of generalizing their real life skills. Details and schedules of the various intervention sessions will be determined after the expert panel sessions and a preliminary study. Initially, nine sessions of intervention, once a week, are scheduled for 60 minutes per session. Intervention 2: Control group: The control group will receive the current self-management program implemented through the existing educational booklet at Endocrinology and Metabolism Research Center of Iran University of Medical Sciences. The booklet will be explained to the participants in a 15-minute session. Also, the rate of tracking the program by individuals and answering their questions will be done by the research team using telephone at regular intervals. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Afsoon Hassani Mehraban
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Mother's Square, Mirdamad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 afsoonmehraban@hotmail.com Iran University of Medical Sciences scientific Afsoon Hassani Mehraban
Faculty of Rehabilitation Sciences of Iran University of Medical Sciences, Shah Nazari St, Mother's Square, Mirdamad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 afsoonmehraban@hotmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of type 2 diabetes for at least 1 year No co-morbidity based on patient's report and doctor's diagnosis Age range of 30 to 60 years Being literate Occupational balance score of less than 2.5 according to Life Balance Inventory Interested in participating in study-related activities Ability to use cellphone or short message system 30 years 60 years Both Unwillingness to continue working with the research team Severe injury or illness during the implementation of the program No referral for gathering blood sample Two consecutive absence or four absentee sessions throughout the treatment sessions E10-E14 E11.8 Type 2 diabetes mellitus with unspecified complications Rehabilitation Behavior Intervention group: Occupation- centered self-management intervention will be conducted in the intervention group. Intervention sessions will be hold using various methods such as education, counseling, coaching, feedback, and discussion among members by group format to facilitate performance in different areas of self-management. At intervals between sessions, the therapist will check the attendance rate through a phone call or SMS. Also, participants can ask their questions one day of per week in person or by phone. In order to generalize the skills to real life, the logbook is available to each participant and homework assignments are set for individuals. At the beginning of the meetings, people will talk about the experience of generalizing their real life skills. Details and schedules of the various intervention sessions will be determined after the expert panel sessions and a preliminary study. Initially, nine sessions of intervention, once a week, are scheduled for 60 minutes per session Control group: The control group will receive the current self-management program implemented through the existing educational booklet at Endocrinology and Metabolism Research Center of Iran University of Medical Sciences. The booklet will be explained to the participants in a 15-minute session. Also, the rate of tracking the program by individuals and answering their questions will be done by the research team using telephone at regular intervals. Satisfaction. Timepoint: Before the intervention, after the end of the intervention, 3 months later. Method of measurement: The Canadian Occupational Performance Measure. Performance. Timepoint: Before the intervention, after the end of the intervention, 3 months later. Method of measurement: The Canadian Occupational Performance Measure. Self Efficacy. Timepoint: Before the intervention, after the end of the intervention, 3 months later. Method of measurement: The diabetes empowerment scale. Fasting Blood Sugar. Timepoint: Before the intervention, after the end of the intervention, 3 months later. Method of measurement: Blood samples. Hemoglobin A1c. Timepoint: Before the intervention, after the end of the intervention, 3 months later. Method of measurement: Blood samples. Lipid Profile. Timepoint: Before the intervention, after the end of the intervention, 3 months later. Method of measurement: Blood samples. Creatinine. Timepoint: Before the intervention, after the end of the intervention, 3 months later. Method of measurement: Blood samples. Distress. Timepoint: Before the intervention, after the end of the intervention, 3 months later. Method of measurement: The diabetes distress scale. Self care. Timepoint: Before the intervention, after the end of the intervention, 3 months later. Method of measurement: The summary of diabetes self care activities measure. Iran University of Medical Sciences Approved 2018-01-20 Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)