Aim: Effect of empowerment model on quality of life and metabolic control in patients with type 2 diabetes. Design: Double- Blind Clinical Trial. Method: patients will be allocated randomly to case and control groups. Data collection tools in this study includes investigation of laboratory indicators ( for investigating the metabolic control), questionnaire of demographic information, questionnaire of empowerment evaluation of diabetic patients, and quality of life questionnaire, which will be completed before and after the intervention for both groups. Study population: patients with type 2 diabetes.
Inclusion criteria: diagnosis of type 2 diabetes by doctor; minimum age of 18 and having a medical file in diabetes center of Shahroud.
Exclusion criteria: not wanting to cooperate in any part of the study; inability to cooperate due to disease severity.
In this study, with 95% confidence, power of 90% and by taking account of 10% attrition of sample units in each group, the calculated sample size for each group was 54 and consequently, a total sample size of 108 was obtained for two groups. Intervention: intervention for case group was by performing the empowerment education, and for control group was the center’s routine education. Variables with main effect: metabolic control indicators and patients’ quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082614484N1
Registration date:2014-03-17, 1392/12/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-17, 1392/12/26
Registrant information
Name
Mahdi Sadeghi
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 27 3334 1206
Email address
mahdisadeghi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council- Shahroud University of Medical Sciences
Expected recruitment start date
2013-10-30, 1392/08/08
Expected recruitment end date
2014-02-04, 1392/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of empowerment model on quality of life and metabolic control in patients with type 2 diabetes
Public title
Investigating the effect of education on quality of life and disease control in diabetic patients
Purpose
Health service research
Inclusion/Exclusion criteria
Main inclusion criteria: diagnosis of type 2 diabetes by the doctor; being at the minimum age of 18; and having a medical file in Diabetes center of Shahroud.
Main exclusion criteria: not wanting to cooperate in any part of the study; inability to cooperate due to disease severity.
Age
From 18 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
people who completed the questionnaire were blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahroud, Hafte-Tir Square, Shahroud University of Medical Sciences7th Tir Square, Shahroud, Iran. Postal Code: 361473955
City
Shahroud
Postal code
Approval date
2013-10-07, 1392/07/15
Ethics committee reference number
920/07
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E10, E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
quality of life
Timepoint
Before the intervention, three months after the intervention
Method of measurement
questionnaire of empowerment evaluation of diabetic patients, and questionnaire of quality of life specific to diabetic patients
Secondary outcomes
1
Description
metabolic control
Timepoint
befor the intervention and three months after the intervention
Method of measurement
Indicators of glycosylated hemoglobin and blood sugar, and fat
Intervention groups
1
Description
intervention will be performed by applying the empowerment method on patients (in four areas of medical regimen, nutrition, exercise and feet caring) for 3 month according to the mentioned steps in the model as follows: fist stage (understanding the threat), Second stage (problem solving) and Third stage (evaluation).
Category
Other
2
Description
The control group will receive the routine education.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes center of Imam Hosein Hospital in Shahroud
Full name of responsible person
Mahdi Sadeghi
Street address
Shahroud, Imam Hosein Hospital, Diabetes center
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hassan Emamian
Street address
Shahroud, Hafte-Tir Square, Shahroud University of Medical Sciences, Vice chancellor for research
City
Shahroud
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, Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mahdi Sadeghi
Position
instructor/M.Sc.
Other areas of specialty/work
Street address
7th Tir Square, Shahroud, Iran. Postal Code: 361473955
City
Shahroud
Postal code
Phone
+98 27 3339 5054
Fax
Email
mahdisadeghi@shmu.ac; irmimsadeghi2020@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahdi Sadeghi
Position
instructor/ M.Sc.
Other areas of specialty/work
Street address
7th Tir Square, Shahroud, Iran. Postal Code: 361473955
City
Shahroud
Postal code
Phone
+98 27 3339 5054
Fax
Email
mahdisadeghi@shmu.ac; irmimsadeghi2020@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahdi Sadeghi
Position
instructor/ M.Sc.
Other areas of specialty/work
Street address
7th Tir Square, Shahroud, Iran. Postal Code: 361473955
City
Shahroud
Postal code
Phone
00
Fax
Email
mahdisadeghi@shmu.ac; irmimsadeghi2020@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)