This study is done to determine the effect of self-care program on the quality of life of patients with psoriasis
Design
This study is a Single-arm trials with a before and after study design
Settings and conduct
A self-care education program will be held at the Razi Skin Hospital, Tehran, including discussion groups, providing booklet and telephone follow up along with a presentation of educational pamphlets. 1 And 2 months after the discharge, the intervention group will be contacted to answer questions that may be asked about the training given and Compliance with the given training should be considered
Participants/Inclusion and exclusion criteria
Inclusion criteria: confirming the diagnosis of psoriasis by doctor, age 18 years old and older, at least 3 months before the study had a history of psoriasis; Exclusion criteria: Not participate in one of the training sessions for the intervention group and Unwillingness to cooperate.
Intervention groups
Intervention group: Self-care education in groups of 10 patients in 4 sessions of 40 minutes, then followed up for 2 months.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181119041699N1
Registration date:2019-01-27, 1397/11/07
Registration timing:registered_while_recruiting
Last update:2019-01-27, 1397/11/07
Update count:0
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
nasrin rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3187 2200
Email address
sadeghi-ha@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-12, 1397/10/22
Expected recruitment end date
2019-04-11, 1398/01/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of self- care program on quality of life in patients with psoriasis
Public title
Assessing the effect of self- care program on quality of life in patients with psoriasis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirming the diagnosis of psoriasis by doctor
Age of 45-18 years old
At least 3 months before the study had a history of psoriasis
The ability to read and write in Persian
Willingness to participate in the study
Was not pregnant
Exclusion criteria:
Unwilling to continue collaboration in study
Dying during the study
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Tehran Medical Branch ethics committee
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
IR.IAU.TMU.REC.1397.235
Health conditions studied
1
Description of health condition studied
psoriasis
ICD-10 code
L40.1
ICD-10 code description
Generalized pustular psoriasis
Primary outcomes
1
Description
Quality of life
Timepoint
Before and 2 months after intervention
Method of measurement
Dermatology Life Quality Index and 36-Item Short Form Survey
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: self-care training in groups of 10 people at 4 sessions of 40 minutes, then followed up for 2 months.
Category
Lifestyle
2
Description
Control group: the routine training, follow-up after 2 months
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Robabe Abedini
Street address
Razi Alley, Islamic Unity Square
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0174
Fax
+98 21 5562 0300
Email
razihospital@sina.tums.ac.ir
Web page address
http://razihos.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemiyan
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2248 1754
Fax
+98 21 2248 1754
Email
info@iauctb.ac.ir
Web page address
http://iauctb.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Moshtagh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2248 1754
Fax
+98 21 2248 1754
Email
z.moshtagh@yahoo.com
Web page address
http://iauctb.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Moshtagh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 21 2248 1754
Fax
+98 21 2248 1754
Email
z.moshtagh@yahoo.com
Web page address
http://iauctb.ac.ir/fa
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zhahra Moshtagh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2248 1754
Fax
+98 21 2248 1754
Email
z.moshtagh@yahoo.com
Web page address
http://iauctb.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