Protocol summary

Summary
It is a Clinical trial study with the Telenursing care program as the dependent variable and the recurrence of PTSD and quality of life as dependent variables. Research population is the veterans with PTSD who refer to the veterans hospitals in Tehran for psychiatric treatment or follow-up. Inclusion criteria: male gender, diagnosis of posttraumatic stress disorder in cases, dual diagnosis with depression or substance abuse or both, have a cell phone , willingness to participate in research, Not under Nursing care remotely via mobile phone Exclusion criteria: patients identified above who also have other major problems, those covered by other types of tracking applications (mobile, remote consulting, internet, etc) and those that are out of our care plan earlier than 6 months Care program simultaneously with a mobile phone with text messaging and asynchronous training and support will be implemented and the number of samples goes to completion. There are two groups; One under the designed telenursing care program, the others are not received this program. Available and easy sampling distribution of the sample is randomly divided into two groups. Then the samples will be homogeneous. Questionnaires included demographic details, post traumatic stress disorder and quality of life at the beginning and end of the study will be completed and statistical analysis will be done.

General information

Acronym
PTSD
IRCT registration information
IRCT registration number: IRCT2013101214983N1
Registration date: 2013-12-04, 1392/09/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-12-04, 1392/09/13
Registrant information
Name
Asieh Darvish
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4302
Email address
adarvish@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research , TEhran University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2015-10-31, 1394/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Telenursing through Mobile Health on Recurrence of Post Traumatic Stress Disorder and Quality of Life in Veterans with post traumatic stress disorder
Public title
Telenursing on Veterans with Post Traumatic Stress Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: male gender, diagnosis of posttraumatic stress disorder in cases, dual diagnosis with depression or substance abuse or both, have a cell phone , willingness to participate in research, Not under Nursing care remotely via mobile phone Exclusion criteria: patients identified above who also have other major problems, those covered by other types of tracking applications (mobile, remote consulting, internet, etc) and those that are out of our care plan earlier than 6 months.
Age
From 40 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of TUMS
Street address
Tehran-Gods Street, Keshavars Blvd, Headquarters Building of Tehran University of Medical Sciences- Fifth Floor- Room 501
City
Tehran
Postal code
1417653761
Approval date
2013-11-27, 1392/09/06
Ethics committee reference number
92-02-28-23508-99591

Health conditions studied

1

Description of health condition studied
PTSD
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder

Primary outcomes

1

Description
Recurrence
Timepoint
6 months after starting the intervention (after the end of intervention)
Method of measurement
The number of refers to the health center-questionnaire

2

Description
Quality of Life
Timepoint
Before the intervention and 6 months after starting the intervention
Method of measurement
Quality of life questionnaire, Persion version of standard ُّ-36

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group:Telenursing Program will be designed by the researcher and co-workers, and will recieve mobile care and SMS messages. Telenursing care covers : acceptance of illness , self-control , relaxation, how to deal with suicidal thoughts , encouraging adherence to medication instructions , how to deal with insomnia, anxiety and intrusive thoughts ; awareness of the importance of proper diet and appropriated environmental changes
Category
Other

2

Description
Control Group: will nor recieve telenursing care and mobile care and SMS.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sadr Psychiatry Hospital
Full name of responsible person
Street address
Sadr Highway- Pirooz Square- Delpazir End Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Asieh Darvish
Street address
Tohid Square- Nosrat St.- School of Nursing and Midwifery
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Asieh Darvish
Position
MSc of information technology management in medicine/ Lecturer and responsile of IT courses
Other areas of specialty/work
Street address
Tohi Square- Nosrat St-School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6105 4302
Fax
Email
sedarvish@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Asieh Darvish
Position
MSc in information technology management in medicine- Honor Diploma information Technology- BSc in n
Other areas of specialty/work
Street address
Tohid Square- Nosrat St. - School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6105 4302
Fax
Email
sedarvish@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Asieh Darvish
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
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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