Protocol summary

Summary
Type 2 diabetes mellitus is a chronic disease with severe late complications and high mortality. The prevalence of type 2 diabetes in Iran is 4-4.5% and in population aged above 30 years is greater than 14%. Further, although glycemic control, the development of complications and mortality represent critical outcomes in people with type 2 diabetes, quality of life (QOL) outcomes are also important. Quality of life represents a broad, multi-dimensional concept that reflects an individual’s sense of well-being or satisfaction with life circumstances, and self concept is one’s image of oneself. Individuals with a positive self concept are better able to develop and maintain inter personal relationship and resist psychological and physical illness. The aim o f this study is determine the effect of quality of life education on self concept of patients with type 2 diabetes. This investigation is a clinical trial study on 123 patients with type 2 diabetes that referred to clinic of diabetes in Emam Khomeini hospital of Ardebil. These participants were known or newly diagnosed type 2 diabetes with range age 30-70, and divided randomly in two groups :case (61 persons) and control group(62 persons). The information was gathered using 4 questionnaires. The first one was socio-demographics , second one was Beck’s self concept questionnaire, third one Rosenberg’s self esteem questionnaire, and the last one was body image questionnaire. The quality of life education as intervention factor was performed using face-to-face , group teaching methods, and handout to case group. The quality of life education program consist of one weekly group session of 45 minutes for 6 weeks, limited to 8 patients per group. A nurse, a physiotherapist, a dietician, and a psychologist run the sessions. Then, the patients will be evaluated 1 month after the final intervention program by filling the same questionnaires.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904084256N2
Registration date: 2010-06-29, 1389/04/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-29, 1389/04/08
Registrant information
Name
Nasrin Samadi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 3057
Email address
na.samadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2010-01-20, 1388/10/30
Expected recruitment end date
2010-06-20, 1389/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Quality of Life Education on Self-concept in patients with type 2 diabees
Public title
Effect of Quality of Life Education on Self-concept in patients with type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria were: • being 30 years of age or older • having cognitive ability to answer the questions in the research instruments and agreement to take part in the study • Known or newly diagnosed type 2 diabetes • Both genders The exclusion criteria were: • Prior quality of life intervention during the last year • Severe heart, liver, or kidney disease or any incurable cancer • Chronic mental disease history
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: 123
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
Tehran's Azad university of medical science
Street address
Tehran,shariati street,gholhak
City
Tehran
Postal code
Approval date
2009-04-03, 1388/01/14
Ethics committee reference number
88/3898

Health conditions studied

1

Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
non-insullin-dependent diabetes mellitus

Primary outcomes

1

Description
self concept
Timepoint
3monthes
Method of measurement
Beck's self-concept test

Secondary outcomes

1

Description
self steem
Timepoint
3monthes
Method of measurement
Rosenberg's questionnaire

2

Description
Body image
Timepoint
3 months
Method of measurement
Body image questionnaire

Intervention groups

1

Description
Case group: The quality of life education programme (physical , Social and Emotional/Spiritual dimention) consist of one weekly group session of 45 minutes for 6 weeks, limited to 8 patients per group by lecture, face to face and handout.
Category
Prevention

2

Description
Control group: Routine care and educational hand outs after the time of intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Emem Khomeini Hospital in Ardebil
Full name of responsible person
Nasrin Samadi
Street address
Ardebil university of medical sciences
City
Ardebil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Nasrin Samadi
Street address
Ardebil university of Medical Science
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Azad Uiversity of Medical Sciences, Tehran's branch
Full name of responsible person
Nasrin Samadi
Position
MSc
Other areas of specialty/work
Street address
Golhak, shariati st., Tehran
City
Tehran
Postal code
Phone
+98 21 2200 6660
Fax
Email
na.samadi@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran's Azad University of Medical Sciences
Full name of responsible person
Nasrin Samadi
Position
MSc of Nursing
Other areas of specialty/work
Street address
Gholhak, Shariati st., Tehran
City
Tehran
Postal code
Phone
+98 914 453 8943
Fax
Email
na.samadi@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Azad University of Medical Sciences, Tehran's branch
Full name of responsible person
Nasrin Samadi
Position
MSc
Other areas of specialty/work
Street address
Golhak, shariati st., Tehran
City
Tehran
Postal code
Phone
+98 21 2200 6660
Fax
Email
na.samadi@arums.ac.ir
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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