Protocol summary

Summary
This study is a randomized control trial to determine the The effect of self-care program education on Adherence to treatment regimen and self-efficacy in veteran with spinal cord injury. All of the Veteran spinal cord injury patients, who were referred to Khatamalanbia hospital were our statistical research community. Of them, 60 patients were selected based on inclusion criteria included not participated in previous training programs about self-care in the last three months, history of spinal cord injury for 6 months and more and no history of diabetes, hypertension, congestive heart failure, coronary heart disease and chronic obstructive pulmonary disease, they were randomly divided into two experimental and control groups using table of random numbers. The experimental group will be received 6 sessions of 60-45 minutes once in every two days. Patients will complete morong self-efficacy and researcher make adherence to treatment before and after the intervention.In this study blindness will be performed only for subjects (patients).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050222311N2
Registration date: 2017-07-23, 1396/05/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-23, 1396/05/01
Registrant information
Name
Naser Sedghi Goyaghaj
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3640 0459
Email address
sedghi.nurse@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Aja University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care program education on Adherence to treatment regimen and self-efficacy in veteran with spinal cord injury
Public title
The effect of self-care program education on Adherence to treatment regimen and self-efficacy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: not participated in previous training programs about self-care in the last three months; history of spinal cord injury for 6 months and more and no history of diabetes, hypertension, congestive heart failure, coronary heart disease and chronic obstructive pulmonary disease. Exclusion criteria:Cancel the continued cooperation; Not Participate in all meetings of intervention; patient died and Partially completed questionnaires.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers will be used For randomization

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Aja University of Medical Sciences
Street address
Etemadzadeh Street, West fatemi Street, Tehran
City
Tehran
Postal code
Approval date
2017-06-22, 1396/04/01
Ethics committee reference number
IR.AJAUMS.REC.1396.44

Health conditions studied

1

Description of health condition studied
Spinal cord Injury
ICD-10 code
M84.1
ICD-10 code description
Injury to nerves and spinal cord

Primary outcomes

1

Description
Adherence to treatment regimen
Timepoint
before, after and one month after intervention
Method of measurement
Researcher maked Adherence to treatment regimen questionnare

2

Description
self efficacy
Timepoint
before, after and one month after intervention
Method of measurement
moorong self efficacy scale

Secondary outcomes

1

Description
---
Timepoint
---
Method of measurement
---

Intervention groups

1

Description
For Patients in the intervention group, self-care education by face to face method and over the 6 sessions of 60-45 minutes every other day, will be trained in by researchers.
Category
Treatment - Other

2

Description
Control group: No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam-Al-anbia Hospital
Full name of responsible person
Naser Sedghi Goyaghaj
Street address
Rashid Yasemi Street, Above Mirdamad Blvd, Vali-Ye-Asr Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Naser Sedghi Ghoyaghaj
Street address
Etemadzadeh Street, West fatemi Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Aja University of Medical Sciences
Full name of responsible person
Naser Sedghi Ghoyaghaj
Position
Master of Sciences in nursing
Other areas of specialty/work
Street address
Etemadzadeh Street, West fatemi Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8355 3970
Fax
Email
Sedghi.nurse@yahoo.com
Web page address
http://ajaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Aja University of Medical Sciences
Full name of responsible person
Amir Hossein Pishgooie
Position
PhD of nursing
Other areas of specialty/work
Street address
Etemadzadeh Street, West fatemi Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8802 8350
Fax
Email
apishgooie@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Aja University of Medical Sciences
Full name of responsible person
Naser Sedghi Goyaghaj
Position
Master of Sciences in Nursing
Other areas of specialty/work
Street address
Etemadzadeh Street, West fatemi Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8355 3970
Fax
Email
sedghi.nurse@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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