The effect of empowerment program on quality of life, self-efficacy and glycemic control in type 2 diabetic patient. The study is single blinded (for patient group).The study’s population includes patients with type 2 diabetes that aged between 30-65 years; they have a history of diabetes for more than a year, they are educated and have the ability to attend meetings . Absence more than two sessions and complications during the study will be excluded. Considering the possibility to loss some participants, the sample size is estimated 100 people. They divide to control and Intervention groups. The intervention is implementation eight sessions of training empowerment in case group. The questionnaires are completed and HbA1C test is done once before intervention and once one month after intervention in both groups. Quality of life, self-efficacy and blood glucose in the patients will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070818400N1
Registration date:2014-10-17, 1393/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-17, 1393/07/25
Registrant information
Name
Maryam Moein
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3267 0762
Email address
mmoein@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kashan University of Medical Sciences
Expected recruitment start date
2014-09-01, 1393/06/10
Expected recruitment end date
2014-10-12, 1393/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of empowerment program on quality of life , self- efficacy and blood glucose in type 2 diabetic patient
Public title
Empowering effect on diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Patients with type 2 diabetes who have been diagnosed by a physician, aged 30 to 65 years, history of diabetes for more than a year, having the physical and mental ability to participate in training sessions, having the ability to read and writing, a person's willingness to participate in the study. Exclusion criteria: absence of more than two training sessions ,acute and chronic complications Occur during the study.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Parastar Street, Ravand, Kashan
City
Kashan
Postal code
8715981151
Approval date
2014-06-25, 1393/04/04
Ethics committee reference number
9350
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E10,E11,E1
ICD-10 code description
Diabetes Mellitus
Primary outcomes
1
Description
Quality of life
Timepoint
Once before intervention and once one month after it
Method of measurement
Questionnair
2
Description
Self efficacy
Timepoint
Once before intervention and once one month after it
Method of measurement
Questionnair
Secondary outcomes
1
Description
blood glucose
Timepoint
Once before intervention and once one month after it
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group:The diabetes empowerment held 8 sessions per month.
Completing questionnaires and HbA1C
test once before intervention and once one month after it.
Category
Lifestyle
2
Description
Control group: HbA1C test and Completing questionnaires once before and once after control time, without empowerment sessions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Golabchi Center
Full name of responsible person
Maryam Moein
Street address
Diabetes unit, Golabchi Center, Emam Street, Kashan
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Sciences
Full name of responsible person
Dr.Hamidi
Street address
Kashan University of Medical Sciences, Parastar Street, Ravand, Kashan
City
Kashan
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 of Kashan University of Medical Sciences