The purpose of this study was to determine the effect of education based on self-management empowerment model on the ability of elderly people with type 2 diabetes.
Design
Clinical trial with intervention and control group, with parallel groups, random sampling in intervention and control group, sample size 60.
Settings and conduct
The study is an educational / counseling intervention in Mashhad health centers. In the intervention group, the educational package is based on the concepts of self-management empowerment model and in the routine care and routine control group. One blind blind with a lack of expert knowledge of statistics.
Participants/Inclusion and exclusion criteria
Having a 60 year old age, having diabetes for at least 6 months
Intervention groups
The intervention group receive a 12-week Intervention in 5 stages based on self-management empowerment model.
The control group receives routine care/
Main outcome variables
The ability of elderly people with type II diabetes
General information
Reason for update
Acronym
EED
IRCT registration information
IRCT registration number:IRCT20110728007143N5
Registration date:2018-05-22, 1397/03/01
Registration timing:registered_while_recruiting
Last update:2018-05-22, 1397/03/01
Update count:0
Registration date
2018-05-22, 1397/03/01
Registrant information
Name
Hamid Chamanzari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1605 8548
Email address
chamanzarih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on self-management empowerment model on empowerment level of elderly patients with type 2 diabetes
Public title
The effect of education based on self-management empowerment model on empowerment level of elderly patients with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Up 60 age
Not having cognitive impairment based on Abbreviated Mental Test
The history of type 2 diabetes for at least six months
Use of diabetes medications
Non-acute complications of diabetes (dialysis and diabetic foot ulcers)
Ability to speak Persian
Not having severe visual impairment
Not having severe hearing impairment
Exclusion criteria:
Acute illness
Unwilling to participate in the study
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the research units, randomized assignment was done in two groups by lottery method. In this way, on the same two tabs, the word "intervention and control" is written and the research unit is asked to select one of these two leaves. According to the selection, the research unit is assigned to the intervention and control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data was provided to the statistician without any knowledge of the research units.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
University Street,Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
ir.mums.rec.1396.226
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
The empowerment of diabetes
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Short form diabetes empowerment scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: The intervention group intervenes in self-management empowerment in 5 stages (self-awareness of the level of performance and expectations by the client-the desired goal-setting by the client-planning-intervention-evaluation) based on the model of self-management empowerment. Strategies are provided within one or two full-time 45-minute empowerment sessions. Elders use one-month approaches and the researcher will follow through on the phone. Meanwhile, solutions are provided to the elderly in the form of a booklet in the second session of empowerment for use in a one-month period.
Category
Lifestyle
2
Description
Control group: During the research, control group will not receive any educational intervention and will receive the usual care and education at the health center. However, after the end of the study (after the end of stage 3), the training booklet is provided to the elderly of the control group Will be placed.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Danesh Amooz Center
Full name of responsible person
Shahin Marhamati
Street address
Farhang Square.,Danesh Amooz Blvd.,Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188994864
Phone
+98 51 3893 2322
Email
marhamatish1@mums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Hashemi Nejad Center
Full name of responsible person
Hashem Hosseini
Street address
Gas crossroads,Tabarsi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
917752365
Phone
+98 51 3273 5905
Email
hoseinih3@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqodi
Street address
University Street,21/5000 Deputy of Research and Technology,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Phone
+98 51 3841 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atiyeh Haddad Alizadeh
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University Street,Faculity Nursing,Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Haddadaa931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Chamanzari
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University Street,Faculity Nursing,Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ChamanzariH@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atiyeh Haddad Alizadeh
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University Street,Faculity Nursing,Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Haddadaa931@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available