The aim of this study was to investigate the effects of self-care program with a multimedia software support on quality of life in patients with diabetes type II. This study was a randomized controlled clinical trial in which 60 patients with diabetes type II referred to diabetes clinic at Arak city were divided randomly into experiment (n=30) and control (n=30) groups.Inclusion criteria included: diabetes patients type II; age between 20 to 60 years; personal access or one of the family members to computer for using from software; ability of self-care; lack of previous using from multimedia training methods about diabetes. Exclusion criteria included: unwillingness to continue participation in the study; failure to complete the questionnaire; lack of using from software. Diabetes Quality of Life Brief Clinical Inventory (DQOL-BCI) was used in Persian language for determining of life quality. Data were collected before and 2 months after the intervention in the both groups. Educational program with equal content was applied for both experiment group (Self-care program with multimedia software support in two sessions) & control group (lecture and presentation with PowerPoint in one session).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072410713N3
Registration date:2014-08-04, 1393/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-04, 1393/05/13
Registrant information
Name
Moloud Farmahani Farahani
Name of organization / entity
Arak University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3524
Email address
farahani91@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of self-care program with multimedia software support on quality of life in patients with diabetes type II
Public title
Effects of self-care program with multimedia software support on quality of life in patients with diabetes type II
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included: diabetes patients type II; age between 20 to 60 years; personal access or one of the family members to computer for using from software; ability of self-care; lack of previous using from multimedia training methods about diabetes. Exclusion criteria included: unwillingness to continue participation in the study; failure to complete the questionnaire; lack of using from software.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Arak University of Medical Siences
Street address
Arak Univercity of Medical Siences, Arak, Iran
City
Arak
Postal code
Approval date
2013-08-21, 1392/05/30
Ethics committee reference number
92-151-7
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Quality of Life
Timepoint
before and 2 months after the intervention
Method of measurement
Diabetes Quality of Life Brief Clinical Inventory (DQOL-BCI)
Secondary outcomes
empty
Intervention groups
1
Description
control group: lecture and presentation with PowerPoint in one session.
Category
N/A
2
Description
experiment group: Self-care program with multimedia software support in two sessions
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic at Arak City
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Siences
Full name of responsible person
Dr. Ali Asghar Yaghoubi
Street address
Arak University of Medical Sciences, Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Siences
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
Arak university of Medical Siences
Full name of responsible person
Molud Farmahini Farahani
Position
MSc Nursing
Other areas of specialty/work
Street address
Arak university of Medical Siences, Arak, Iran
City
Arak
Postal code
Phone
00
Fax
Email
farahani91@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Siences
Full name of responsible person
Molud Farmahini Farahani
Position
MSc Nursing Education
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Arak , Iran
City
Arak
Postal code
Phone
00
Fax
Email
farahani91@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak university of Medical Siences
Full name of responsible person
Molud Farmahini Farahani
Position
MSc Nursing
Other areas of specialty/work
Street address
Arak university of Medical Siences, Arak, Iran
City
Arak
Postal code
Phone
00
Fax
Email
farahani91@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)