This study aims to determine the effect of self-management training on medication adherence and quality of life of patients with Behçet's syndrome.
Design
The experimental study is of the clinical trial type, randomly assigned to two groups and four permutation blocks without blinding.
Settings and conduct
This study will be conducted on Behjat's patients referred to the rheumatology clinic and rheumatologist's personal office in Ahvaz city. The sampling method will be random and permutation block of four and without blinding. The intervention group consists of 30 patients with Behcet, who will be presented with a self-management program in a room in the rheumatology subspecialty clinic or the amphitheater hall of Golestan Hospital and in a calm and suitable environment in terms of temperature and light. The control group will only receive the usual care and training In the common way, they receive visits through the doctor, and the researcher will not have any intervention in their education.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients with Behcet's disease who have been definitively diagnosed by a rheumatology doctor
Age above 18 years
Having informed written consent to enter the research
exclusion criteria
Having any history of mental problems
Intervention groups
In the intervention group, the self-management program will be presented for 2 consecutive weeks.
The control group will receive only the usual care and education that they receive in the usual way through the doctor during the visit, and the researcher will not have any intervention in their education.
Main outcome variables
Medication adherence, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240731062607N1
Registration date:2024-08-15, 1403/05/25
Registration timing:prospective
Last update:2024-08-15, 1403/05/25
Update count:0
Registration date
2024-08-15, 1403/05/25
Registrant information
Name
Marzie Rabiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5237 8300
Email address
nurse93_rb@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management education on medication adherence and quality of life of patients with behcet’s syndrome
Public title
Self-management training in Behcet's syndrome patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Behcet's disease who have been definitively diagnosed by a rheumatology doctor
Age above 18 years
Having informed written consent to enter the research
Exclusion criteria:
Having any history of mental problems
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
It will be divided equally and randomly into two intervention and control groups through a four permutation block.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-07-20, 1403/04/30
Ethics committee reference number
IR.AJUMS.REC.1403.165
Health conditions studied
1
Description of health condition studied
Behcet's disease
ICD-10 code
M35.2
ICD-10 code description
Behcet's disease
Primary outcomes
1
Description
Medication adherence
Timepoint
Before and a month later
Method of measurement
Medication adherence questionnaire
2
Description
Quality of life
Timepoint
Before and a month later
Method of measurement
SF-36 quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The self-management program will be presented in a room in the rheumatology subspecialty clinic or the amphitheater hall of Golestan Hospital and in a calm and suitable environment in terms of temperature and light. The contents of the prepared training manual will be taught to the clients of the intervention group in simple and understandable language and without using specific medical terms, and after the end of the training of each subject, if there is any ambiguity, the questions will be answered. At the beginning of each session, the contents of the previous sessions will be reviewed. The training sessions are held for 2 consecutive weeks, in one session of 45 to 60 minutes each week at the rheumatology subspecialty clinic and the amphitheater hall of Ahvaz Golestan Hospital in the form of PowerPoint and counseling sessions. Lectures and questions and answers will be conducted face-to-face by the researcher for the intervention group.
Category
Lifestyle
2
Description
Control group: The control group will receive only the usual care and education that they receive in the usual way through the doctor during the visit, and the researcher will not have any intervention in their education.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz golestan hospital
Full name of responsible person
Mofid Hosseinzade
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135733117
Phone
+98 61 3320 4501
Email
golestan-hospital@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8383
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
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
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Sayadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8383
Email
sayadi_neda@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Sayadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8383
Email
sayadi_neda@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzie Rabiee
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.77, East Milad 3 Alley, 218 Devices
City
Mahshahr
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 5237 8300
Fax
Email
Nurse93_rb@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD