Determining the impact of a comprehensive remote empowerment program on the quality of life and medication adherence of patients with psoriasis
Design
The clinical trial has a control group, with parallel, randomized groups, on 52 patients and is used for block randomization.
Settings and conduct
Psoriasis patients referred to Razi Hospital are included Convenient sampling
sampling and then randomized block method is used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The individual's personal consent to participate in the program; Adults 18 to 65 years old; Medical diagnosis of psoriasis according to the patient's medical record; Being in a stable state of illness; Having minimum reading and writing literacy; Ability to communicate; Access and ability to use a smartphone and the Internet. Exclusion criteria:
Diagnosed mental and cognitive disorders; Previous participation in similar empowerment programs; History of suicide
Intervention groups
during 7 weeks, the control group will receive the usual care (treatment and individual care methods that have been carried out so far will continue), while the intervention group patients will receive a comprehensive remote empowerment program in addition to the usual care.
Main outcome variables
Treatment adherence; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230219057453N1
Registration date:2023-03-27, 1402/01/07
Registration timing:prospective
Last update:2023-03-27, 1402/01/07
Update count:0
Registration date
2023-03-27, 1402/01/07
Registrant information
Name
sayede Sara Mirhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4633 7314
Email address
saramirhosseini1400@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-02, 1402/01/13
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of a comprehensive remote empowerment program on the quality of life and medication adherence of patients with psoriasis
Public title
Investigating the impact of the empowerment program on psoriasis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Personal consent of the person to participate in the program
Adults 18 to 65 years old
Medical diagnosis of psoriasis according to the patient's medical record
Being in a stable state of illness
Having at least reading and writing literacy
Ability to communicate
Access and ability to use a smart phone and the Internet
Exclusion criteria:
Diagnosed mental and cognitive disorders
Previous participation in similar empowerment programs
History of suicide
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
during two stages; The first step is the convenience sampling. In the second stage, patients will be allocated in two intervention and control groups by random block allocation method. The samples are randomly assigned to quadruple blocks A, A, B, B in random groups. So that 16 blocks of 4 letters A and B are made up.Then a block is randomly selected. RAS random allocation software will be used to randomly select blocks. A indicates sample placement in intervention group and B indicates sample placement in control group. First, a block will be randomly identified by RAS software and then the first eligible sample will be entered into the intervention or control group according to the order of the letters A or B. Sampling will continue until all samples are selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Shahvarz Blvd., corner of Qods St., Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶-۱۴۵۳۵
Approval date
2023-02-17, 1401/11/28
Ethics committee reference number
IR.TUMS.FNM.REC.1401.179
Health conditions studied
1
Description of health condition studied
psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Treatment compliance
Timepoint
Before the intervention, 2 weeks and 4 weeks after the intervention
Method of measurement
Moriski medication adherence questionnaire
2
Description
Quality of life
Timepoint
Before the intervention, 2 weeks and 4 weeks after the intervention
Method of measurement
Questionnaire of quality of life of World Health Organization,
Secondary outcomes
1
Description
stigma
Timepoint
Before starting the intervention, 2 weeks and 4 weeks after the intervention
Method of measurement
Geisenberg et al.'s questionnaire
Intervention groups
1
Description
Intervention group: At the beginning of the study, the study questionnaires including demographic information questionnaire, perceived stigma, quality of life and medication adherence were completed by the patients of both control and intervention groups. This study will be conducted for 7 weeks and the control group will receive the usual care, while the patients of the intervention group will also receive the comprehensive empowerment program in addition to the usual care. In this way, the intervention group will be joined by the researcher in virtual groups of 10 to 15 people in the WhatsApp social network and will receive the comprehensive empowerment program. In this research, a 7-week empowerment program will be held online and on the platform of virtual networks according to the patients' conditions, and each week will address a specific topic to promote self-care. The content of each of the sessions will be provided to all patients of the intervention group in the same way as a combination of online and offline sessions (4 online sessions and 3 offline sessions) with an interval of one week for 7 weeks. Or the training video will be sent in the virtual network groups and in the online meetings, the Skyroom link will be placed in the virtual network group to hold online group meetings. Online group meetings with members of groups of 10 to 15 people will be held on the virtual network for 10 minutes and through the Skyroom platform. became.
Category
Other
2
Description
Control group: Control group: study questionnaires including demographic information questionnaire, perceived stigma, quality of life and drug treatment adherence are completed by patients of both control and intervention groups. This study will be conducted in 7 weeks and the control group will receive the usual care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Arezoo Rasti
Street address
Tehran Vahdat Islami Square - Razi Dead End - Hospital...
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱.
Phone
+98 21 5563 0553
Email
razihospital@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Arezoo Rasti
Street address
Tehran, Tawheed Square, Nosrat St., Tehran School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@tums.ac.ir
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
50
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
Tehran University of Medical Sciences
Full name of responsible person
sayede Sara Mirhosseini
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, Kargarshamali Street, Amirabad, Dormitory of Medical Sciences for Girls
City
tehran
Province
Tehran
Postal code
1439955975
Phone
+98 930 264 4173
Email
saramirhosseini1400@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
dr Arezoo Rasti
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tawheed Square, Nosrat St., Faculty of Nursing and Midwifery, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
arasti@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
sayede Sara Mirhosseini
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, Kargarshamali Street, Amirabad, Medical Sciences Dormitory for Girls
City
tehran
Province
Tehran
Postal code
1439955975
Phone
+98 930 264 4173
Email
saramirhosseini@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after de-identifying the participants
When the data will become available and for how long
Start access after receiving information and data forever
To whom data/document is available
All applicants working in academic and scientific institutions
Under which criteria data/document could be used
The use of data and documents in scientific research is unimpeded.
From where data/document is obtainable
ایمیل arasti@tums.ac.ir
What processes are involved for a request to access data/document
Apply by email and after receiving the email up to 2 months later