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The design and effectiveness of self-care training package based on cultural educational needs of patients with type II diabetes on some health indicators

Protocol summary

Study aim
- The design and effectiveness of self-care educational package based on the educational-cultural needs of patients with type 2 diabetes and its effect on health indicators such as HA1C and quality of life, health literacy and self-care behaviors
Design
In this study, 70 patients with type 2 diabetes were selected randomly from the diabetic patient referred to Valiasr clinic in the city of Darreh. Four groups were randomly divided into two groups of 35 experimental and control groups
Settings and conduct
Clinical trial - Clinic of Vali Asr Hospita
Participants/Inclusion and exclusion criteria
Entry requirements: 40 years of age and over-six months longer than their diabetes - no mental, mental or hearing impairment
Intervention groups
In this study, the intervention would be face-to-face group training and lecture using a booklet, a pamphlet, a poster. The content of the patient's package of education based on assessing the needs of patients and the problems of diabetic patients, as well as the content of the self-care program of the patient in diabetic patients (Correct and timely delivery of insulin, dietary observation, regular exercise activities, identification of signs of hyperglycemia, Regular use of medications, foot care, communication skills, problem solving, emotional management and excitement) In Six sessions for 45 minutes. the intervention group will be provided.For the control group during the intervention will not be any training. After finishing the third stage and collecting final data, the control group will be awarded a booklet
Main outcome variables
Diabetic Patients' Health Literacy, Diabetic Patients' Quality, Diabetic Patients' Awareness, Self-Efficacy of Patients with Diabetes, Self-care behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170819035769N3
Registration date: 2018-07-14, 1397/04/23
Registration timing: retrospective

Last update: 2018-07-14, 1397/04/23
Update count: 0
Registration date
2018-07-14, 1397/04/23
Registrant information
Name
Behnaz Amozadeh
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3522 9119
Email address
behnaz1079@yahoo.com
Recruitment status
Recruitment complete
Funding source
Supply by student
Expected recruitment start date
2017-12-04, 1396/09/13
Expected recruitment end date
2018-02-02, 1396/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The design and effectiveness of self-care training package based on cultural educational needs of patients with type II diabetes on some health indicators
Public title
Self-care education for diabetics
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Six months after the diagnosis of diabetes The age group is 40 years and older
Exclusion criteria:
There are sensory and perceptual problems, and visual, hearing and communication disorders
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized block design with four blocks has been used to randomly assign to the control and experimental groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Interviews with diabetic patients to meet the educational needs of the region's culture

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Tehran, Vanak, Vanak Square, Mullasadra Street
City
Tehran
Province
Tehran
Postal code
Iran
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
IR.BMSU.REC.1395.342

Health conditions studied

1

Description of health condition studied
Diabet
ICD-10 code
E10
ICD-10 code description
E10-E14

Primary outcomes

1

Description
Diabetic Patients' Awareness,
Timepoint
Before the intervention, immediately after the intervention, three months after the intervention
Method of measurement
knowledge questionnaire of diabetes

2

Description
Efficacy
Timepoint
Before the intervention - one month later and three months later
Method of measurement
Self-efficacy questionnaire

3

Description
Self-care behaviors
Timepoint
Before the intervention - one month later and three months later
Method of measurement
Self-care behaviors questionnaire

4

Description
Quality of Life
Timepoint
Before the intervention - one month later and three months later
Method of measurement
Quality of Life Questionnaire

5

Description
Health literacy
Timepoint
Before the intervention - one month later and three months later
Method of measurement
Health literacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Initially, training packages and educational pamphlets based on educational needs were provided for the intervention groupThen, they will be taught in questions and answers and face-to-face in groups of 5 or 6 in six 45-minute sessions. Immediately after training, and three months later, the questionnaires will be completed and analyzed again.
Category
Lifestyle

2

Description
The control group did not receive any intervention and will receive only the final instruction booklet.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Behnaz amozadeh
Street address
Ilam - Darreshahr - Health Center Darrehshahr
City
Darrehshahr
Province
Ilam
Postal code
6961743178
Phone
+98 84 3522 4545
Fax
+98 84 3522 4991
Email
behnaz1079@yahoo.com
Web page address
http://dareshahr.medilam.ac.ir

2

Recruitment center
Name of recruitment center
Taleghani koye Center - Shaheed Mo'airi Center
Full name of responsible person
Behnaz amozadeh
Street address
Ilam - Darreshahr - Health Center Darrehshahr
City
Darrehshahr
Province
Ilam
Postal code
6961743178
Phone
+98 84 3522 9119
Fax
+98 84 3522 4991
Email
behnaz1079@yahoo.com
Web page address
http://dareshahr.medilam.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Vice chancellor for research,baqiyatallah University of Medical Sciences.Dr. Mohammad Alishiri
Street address
baqiyatallah (AJ) University, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak, Tehran
City
tehran
Province
Tehran
Postal code
+9819575-174
Email
behnaz1079@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Darreshahr Health Center
Full name of responsible person
behnaz amozadeh
Position
Graduate
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Darrehshahr- shahid jafari street- dareeshahr health center
City
Darrehshahr
Province
Ilam
Postal code
69618-34655
Phone
+98 84 3522 4545
Fax
+98 84 3522 4991
Email
Behnazamozadeh1079@yahoo.com
Web page address
http://dareshahr.medilam.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Akram parandeh
Position
doctorial
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vank Square, Mulla Sadra Ave., Sheikh Bahaee Avenue, next to Baqiyatallah (AS) Mosque - Shahid Nasrati Alley - Baqiyatallah University of Medical Sciences (AJ) - Faculty Building - Faculty of Nursing - Sixth Class.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3580
Fax
+98 21 8860 0047
Email
Akramparandeh@bmsu.ac.ir
Web page address
http://www.bmsu.ac.ir/Services/Departments/?ObjId=193&PageId=785

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
behnaz amozadeh
Position
nurs
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ilam-darreshahr-Health center darrehshahr
City
dareshar
Province
Tehran
Postal code
69618-34655
Phone
+98 84 3522 4545
Fax
+98 84 3522 4991
Email
behnaz1079@yahoo.com
Web page address
http://daresharhr.medilam.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
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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