Objective: Determine the effect of self-management education on quality of life in patients with type 2 diabetes.
Inclusion criteria: Patients who can understand and state Persian language; a definitive diagnosis of diabetes (type II) given by a doctor endocrinologist; similar research has not previously participated; there is a possibility of direct contact with the patient's home; disease is not known psychological and psychiatric drug use is not effective.
Exclusion criteria: For some reason the patient needs to be hospitalized or emergency intervention so that the conditions of work with the researcher to los; during the study, the disease progresses in a manner that cannot work or if the patient dies; patients with physical limitations that prevent her colleagues is new. The sample size in this study, 98 patients (49 in each group) is. Patients in the intervention group self-management educational of four sessions on the topics of drug regimens, nutrition, physical activity, self-monitoring of blood glucose and foot care will be by researcher. Each session will be one hour. The intervals between training sessions a week. Training for ten-man group discussion with questions and answers, pamphlets and booklets will be provided training package includes. Diabetes quality of life brief clinical inventory questionnaire (DQOL- BCI) before and two months after the intervention by both the control and intervention is completed and evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040721637N1
Registration date:2015-06-08, 1394/03/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-06-08, 1394/03/18
Registrant information
Name
Asghar Salimi
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
a-salimi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University Of Medical sciences
Expected recruitment start date
2015-07-12, 1394/04/21
Expected recruitment end date
2015-11-12, 1394/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of self-management education on quality of life of patients with type 2 diabetes
Public title
The impact of education on quality of life of diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients who can understand and state Persian language; a definitive diagnosis of diabetes (type II) given by a doctor endocrinologist; similar research has not previously participated; there is a possibility of direct contact with the patient's home; disease is not known psychological and psychiatric drug use is not effective.
Exclusion criteria: For some reason the patient needs to be hospitalized or emergency intervention so that the conditions of work with the researcher to los; during the study, the disease progresses in a manner that cannot work or if the patient dies; patients with physical limitations that prevent her colleagues is new.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
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 Tehran University of Medical Science
Street address
The central building of Tehran university of medical sciences, Qods street, Keshavarz street, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-04-15, 1394/01/26
Ethics committee reference number
9111196031-1
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Quality of life
Timepoint
Before of intervention and two month after intervention
Method of measurement
Diabetes quality of life brief clinical inventory questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-management education is given through group discussion. The number of sessions, four one-hour sessions will be four weeks.
Category
Other
2
Description
Control group: Will receive routine educational program of center.