The aim of this study is to determine the effect of counseling on self-care and quality of life in postmenopausal diabetes women. This study is a randomized clinical trial study that implement in the experimental and control groups . Population of this study are postmenopausal diabetes women attending to Diabetes Research Center in Hamadan. Sampling is done through random permutation block. A sample of 40 patients in the intervention group and 40 in the control group will determined. Inclusion criteria are: age over 45 years, patients with type II diabetes, lack of women with premature menopause (menopause before 40 years). Exclusion criteria are: absence in more than one session of counseling session and no intention to continue the study. Intervention consists of four sessions of counseling on self-care that will conduct every week by a researcher. Control group only receive routine care. Comparison will done between two groups on the self- care and quality of life among diabetes women. Outcome of this research may improve post- menopausal diabetes' women' self-care and quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120910426N9
Registration date:2016-01-18, 1394/10/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-18, 1394/10/28
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Research Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling on self-care and quality of life in postmenopausal diabetes women
Public title
The effect of counseling on self-care and quality of life in postmenopausal diabetes women attending to Diabetes Research Center in Hamadan in 2015 -2016
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age over 45 years;
Patients with type II diabetes; The lack of women with premature menopause (menopause before 40 years); passed at least one year and up to 10 years of menstruation (the physiological); After at least one year of diabetes diagnosis;
No history of myocardial infarction, liver diseases, mental health, thyroid or kidney;
Failure Patients with advanced diabetes complications such as kidney failure, stroke, myocardial infarction, malignant tumor patients; The drug-treated diabetes (tablets or insulin).
Exclusion criteria: not participate in more than one session of counseling class and wanting to continue to cooperate with investigation; The occurrence of stress-inducing events (such as near death, accident) during the study.
Age
From 45 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Avenue, Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Approval date
2015-07-27, 1394/05/05
Ethics committee reference number
IR.UMSHA.REC.1394.207
Health conditions studied
1
Description of health condition studied
Diabetes Type II
ICD-10 code
E12
ICD-10 code description
Malnutrition-related diabetes mellitus
Primary outcomes
1
Description
Self care in Diabetes Type II
Timepoint
Before and 3 months after intervention
Method of measurement
Questionnaire of self-care
Secondary outcomes
1
Description
Quality of life
Timepoint
Before, immediately after and two months after intervention
Method of measurement
Questionare for quality of lifeof menopause women (MENQL)
Intervention groups
1
Description
Intervention group will receive self-care counseling for four sessions (one session a week)
Category
Lifestyle
2
Description
Control group have not receive any intervention during study however they will receive educational materials after the end of study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center of Hamadan
Full name of responsible person
Roya Ahmadi
Street address
Madani, Azadegan Street, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanslor of Research in Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Shahid Fahmideh Street, Hamadan University of Medical Sciences, Vice Chanslor of Research
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanslor of Research in Hamadan University of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street, Counterpoint of Mardom Park, Hamadan, Iran
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medicine Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)