Protocol summary

Summary
Objective: Determine the effect of group discussion on self-management ability in patients with type 2 diabetes. Inclusion criteria: Diagnosis of type 2 diabetes after at least on year; aged between 30 to 70 years; absence of psychological illness. Exclusion criteria: Having serious physical or mental disease during the intervention; participating in similar training and research sessions during the study; more than two sessions of absence. The sample size in this study is 90 patients (45 in each group). Researcher will be provided for patients in the intervention group self-management training on the different topics. Time taken for each meeting is one hour. Distance between training sessions will be a week. Meanwhile the control group will be receiving routine interventions. Then the Lin self-management questionnaire will be evaluated before and three months after the intervention by both the control and intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051717509N2
Registration date: 2016-12-26, 1395/10/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-26, 1395/10/06
Registrant information
Name
Akbar Sofyani
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3625 3908
Email address
sofyani.a@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Scinces
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group discussion on the ability of self-management in patients with Type 2 diabetes
Public title
The impact of education on self-management of diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: At least one year after diagnosis of type 2 diabetes; aged between 30 to 70 years; absence of psychological illness Exclusion criteria: Having serious physical or mental disease during the intervention; participating in similar training and research sessions during the study; more than two sessions of absence
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
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
Urmia University of Medical Scinces
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Postal code
Approval date
2013-03-21, 1392/01/01
Ethics committee reference number
1392.164

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
E12
ICD-10 code description
Malnutrition-related diabetes mellitus

Primary outcomes

1

Description
self-management
Timepoint
befor intervention, Three months after the intervention.
Method of measurement
Lin self-management questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Self-management education is given through group discussion. The number of sessions are eight session in one-hour session will be done in eight weeks.
Category
Other

2

Description
Control group: Will be received routine educational program.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Madani Hospital of Khoy
Full name of responsible person
Nasrin Badrkhany
Street address
Vali Asr Square
City
Khoy

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Science
Full name of responsible person
Iraj Mohebbi
Street address
Urmia University of Medical Science
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Urmia University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery Urmia University of Medical Sciences
Full name of responsible person
Akbar Sofyani
Position
MSN
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Road Nazloo
City
Urmia
Postal code
Phone
+98 44 3275 4961
Fax
Email
sofyani.a@umsu.ac
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery Urmia University of Medical Sciences
Full name of responsible person
Hossein Habibzadeh
Position
PHD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Road Nazloo
City
Urmia
Postal code
Phone
+98 44 3275 4961
Fax
Email
habibzadeh.h@umsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery Urmia University of Medical Sciences
Full name of responsible person
Akbar Sofyani
Position
MSN
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Road Nazloo
City
Urmia
Postal code
Phone
+98 44 3275 4961
Fax
Email
sofyani.a@umsu.ac
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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