Protocol summary

Study aim
Comparison the effect of patient and family center education on quality of life and HbA1C in type 2 diabetic patients referring to diabetes clinic of Rafsanjan, 2018
Design
Parallel group randomised trial, no blinded
Settings and conduct
The research population are patients with type 2 diabetes referred to the Diabetes Clinic of Rafsanjan. Sampling will be convenience. Allocation of samples will be done randomly by stratified method (minimization) and patients will assigned to three groups: patient-centered education groups (presence of the patient in educational sessions), family-centered education group (the presence of the patient and one of the family members in the training sessions) and control group. Educational intervention will conducted in two intervention groups for 12 weeks (6 session in first 6 weeks and 3 session in second 6 week).
Participants/Inclusion and exclusion criteria
Residents in Rafsanjan, type 2 diabetes, age over 40 years old and consent to participate in study are inclusion criteria. Having other forms of illness, in addition to diabetes and mental illness, are exclusion criteria.
Intervention groups
1. Family-centered education group 2. Patient-centered education group 3. Control group
Main outcome variables
Quality of life HbA1C

General information

Acronym
IRCT registration information
IRCT registration number: IRCT20150713023190N5
Registration date: 2018-08-18, 1397/05/27
Registration timing: prospective

Last update: 2018-08-18, 1397/05/27
Update count: 0
Registration date
2018-08-18, 1397/05/27
Registrant information
Name
Tabandeh Sadeghi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.sadeghi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment the effect of patient and family center education on quality of life and HbA1C in type 2 diabetic patients referring to diabetes clinic of Rafsanjan, 2018
Public title
Comparison the effect of patient and family center education on quality of life and HbA1C in type 2 diabetic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Residents in Rafsanjan. Having type II diabetes. Age over 40 years old. Inform consent for participate in study.
Exclusion criteria:
Participate in another research project. Having other physical illnesses in addition to diabetes. Having psychiatric diseases.
Age
To 40 years old
Gender
Both
Phase
3
Groups that have been masked
None
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified Randomization by minimization method based on quality of life and HbA1C variables.
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
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7717933777
Approval date
2018-08-01, 1397/05/10
Ethics committee reference number
IR.RUMS.REC.1397.088

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Quality of life score
Timepoint
Pre intervention and 12 weeks post intervention
Method of measurement
SF36 questionnaire

2

Description
Mean of HBA1C
Timepoint
Pre intervention and 12 weeks post intervention
Method of measurement
Spectrophotometer device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patient-centered education group: patient will received educational intervention for 12 weeks (6 sessions in first 6 weeks and 3 sessions in second 6 weeks)
Category
Other

2

Description
Intervention group: family-centered education group: patient and one of family members will received educational intervention for 12 weeks (6 sessions in first 6 weeks and 3 sessions in second 6 weeks)
Category
Other

3

Description
Control group: no receive any intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes clinic of Ali Ebn Abitaleb Hospital
Full name of responsible person
Parisa Balaei
Street address
Mofateh Blvd
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7717933777
Phone
+98 34 3428 0001
Email
aliebn@rums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7717933777
Phone
+98 34 3428 0097
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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

Person responsible for general inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.sadeghi@rums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.sadeghi@rums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.sadeghi@rums.ac.ir

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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