The effect of self-management programs based on 5A model on self efficacy and quality of life in the elderly patients with diabetic mellitus
Design
Samples will be chosen from the patients admitted to Razi hospital affiliated with Mazandaran University of Medical Sciences. In this randomized controlled clinical trial, 90 patients will be randomly assigned to the experimental and control groups.The research is single blinded.
Settings and conduct
This study will be done in diabetic clinic of Razi hospital affiliated with Mazandaran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria included: the desire to participate in the study; age over 60 years old; history of diabetes mellitus at least one year; listening and speaking ability for the relationship; the absence of cognitive impairment; ability to perform daily activities independently; ability of reading and writing; lack of malignant diseases, kidney failure, thyroid disorders, psychiatric disorders; the absence of severe crises in the last three months. Exclusion criteria included: unwillingness to cooperate; exposure to extreme crisis situations; hospitalization during the study; absence more than two sessions.
Intervention groups
In the test group: this group will be educated based on 5A self-management model through giving lecture, question and answer and group discussion. The self-management program performs for each patient in 5 steps during 6 weeks.
In the control group no intervention will be done for the patients.
Main outcome variables
In both groups, self-efficacy and quality of life are measured before, immediately after intervention and 4 weeks after intervention Is measured
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110912007529N19
Registration date:2018-10-22, 1397/07/30
Registration timing:registered_while_recruiting
Last update:2018-10-22, 1397/07/30
Update count:0
Registration date
2018-10-22, 1397/07/30
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of of self-management program based on 5A model on self efficacy and quality of life in the elderly patients with diabetic mellitus
Public title
The effect of of self-management program on elderly patients with diabetic mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
the desire to participate in the study;
age over 60 years old;
history of diabetes mellitus at least one year;
listening and speaking ability for the relationship ;
the absence of cognitive impairment;
ability to perform daily activities independently;
ability of reading and writing;
lack of malignant diseases, kidney failure, thyroid disorders, psychiatric disorders;
the absence of severe mental health crises in the last three months.
Exclusion criteria:
unwillingness to cooperate;
exposure to extreme crisis situations;
hospitalization during the study;
absence more than two sessions
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly assigned into two groups using permuted block randomization.Random allocation sequence will be determined using the numbers table. Opaque sealed sequentially numbered envelopes from number 1 to 90 will be used for allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyzer and data collector will be blind of the allocation of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Eligible patients will be selected through convenience sampling and will be randomly assigned into 2 groups using permuted block randomization with allocation ratio of 2:2. Random allocation sequence will be determined using a computerized program. Opaque sealed sequentially numbered envelopes from number 1 to 90 will be used for allocation concealment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.SHAHED.REC.1397.051
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
self-efficacy
Timepoint
before intervention, after intervention, and 4 weeks after intervention
Method of measurement
self-efficacy scale
Secondary outcomes
1
Description
quality of life
Timepoint
before intervention, after intervention, and 4 weeks after intervention
Method of measurement
Lipad Questionnaire
2
Description
self-efficacy
Timepoint
before intervention, after intervention, and 4 weeks after intervention
Method of measurement
self-efficacy scale
3
Description
Mental statuse
Timepoint
Before intervention
Method of measurement
Abbreviated Mental Test Score
4
Description
Activity Daily Living
Timepoint
before intervention, after intervention, and 4 weeks after intervention
Method of measurement
Activity Daily Living Scale
5
Description
self-efficacy for managing chronic disease
Timepoint
before intervention, after intervention, and 4 weeks after intervention
Method of measurement
self-efficacy for managing chronic disease questionnaire
6
Description
Diabestes Management Self –Efficacy
Timepoint
before intervention, after intervention, and 4 weeks after intervention
Method of measurement
Diabestes Management Self –Efficacy Scale
Intervention groups
1
Description
Intervention group: Educational sessions will be held in elderly people with diabetes in 5 steps during 6 weeks and each session will be 45-60 minutes. Based on the training, the A-5- self-management program will be taught with the help of family members for possible and actual problems.
Category
Lifestyle
2
Description
Control group: Apart from routine interventions, no other intervention will be received. At parallel intervals, self-efficacy and quality of life will be measured with the test group. The questionnaires will be completed and recorded at three levels before and after the intervention and then 4 weeks after the intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Maedeh Sadeghigolafshanl
Street address
Razi hospital, Reza St, Ghaemshahr
City
Ghaemshahr
Province
Mazandaran
Postal code
4765686743
Phone
+98 11 4331 8018
Email
razi-ghh@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Vice chancellor for research, Shahed University, Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3071
Email
Kiasalari@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Nahid Rejeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3071
Email
nrejeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nahid Rejeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3071
Email
nrejeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nahid Rejeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3071
Email
nrejeh@yahoo.com
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