To determine the effect of peer group support on psychological well-being, fatigue, and self-efficacy of patients with rheumatoid arthritis
Design
A two-arm parallel group randomized clinical trial without blinding on 78 patients. The permutation blocking method is used for randomization.
Settings and conduct
Eligible samples will be selected using convenience sampling from patients with rheumatoid arthritis referring to the rheumatology clinic affiliated with Birjand University of Medical Sciences. They will be randomly assigned to an intervention or a control group using permutation blocking. The intervention group will participate in one-and-a-half-hour online sessions for 6 weeks. The control group will not receive the above intervention. The study will be performed without blinding.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: definite diagnosis of rheumatoid arthritis, willingness to participate in research, and ability to read and write. Exclusion criterion: Individuals who have previously received peer group intervention.
Intervention groups
Intervention group: Sessions for the intervention group will take place online for approximately 1.5 hours per week for six weeks.
Control group: This group will receive only the routine care of the patient recruitment center.
Main outcome variables
Psychological well-being, fatigue, and self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017756N49
Registration date:2023-10-14, 1402/07/22
Registration timing:prospective
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of peer group presence and absence on psychological well-being, fatigue, and self-efficacy among rheumatoid arthritis patients
Public title
The effect of peer group on mental well-being, fatigue, and self-efficacy of patients with rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 70 years
A definitive diagnosis of rheumatoid arthritis
Willingness for participation
Ability to read and write
Non-dependence on drugs
Exclusion criteria:
Individuals who have previously received peer group intervention.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be recruited for the study using the convenience sampling method. Subsequently, patients will be assigned to intervention and control groups using permutation blocking. This will continue until the required number of study participants is recruited.
The limited randomization method will be used using the principle of random allocation. First, 39 sealed cards related to the intervention group and 39 sealed cards related to the control group will be prepared. These cards will be placed in the draw container. Then, the cards will be randomly removed from the container without replacement, and the created sequence will be recorded. Each of the generated random sequences will be recorded on a card, and each card will be placed inside opaque envelopes. In order to maintain the random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the lids of the envelopes will be glued and placed in a box in sequence. For each participant, one of the envelopes will be opened in order, and the assigned group of that participant will be determined.
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 Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2023-03-06, 1401/12/15
Ethics committee reference number
IR.BUMS.REC.1401.442
Health conditions studied
1
Description of health condition studied
rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
Psychological well-being
Timepoint
Before and after the intervention
Method of measurement
Ryff’s scale of psychological well-being- short form
2
Description
Fatigue
Timepoint
Before and after the intervention
Method of measurement
Fatigue Severity Scale
3
Description
Self-efficacy
Timepoint
Before and after the intervention
Method of measurement
Arthritis self-efficacy scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Peer support sessions for the intervention group will take place online for approximately 1.5 hours per week for six weeks. Peer group support will be presented in six sessions. The content comprises two dimensions: informational support (learning coping skills, effective communication skills, familiarity with rheumatoid arthritis and associated problems, and the expression of experiences by each person, and the sharing of other people in these experiences) and emotional support (reducing the sense of isolation and strengthening and encouraging people).
Category
Other
2
Description
Control group: This group will receive only the routine care of the patient recruitment center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Clinic affiliated with Birjand University of Medical Sciences
Full name of responsible person
Maryam Davoodifard
Street address
Taleghani Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3253 1761
Email
marydavoodi786@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellery for Research, Birjand University of Medical Sciences
Full name of responsible person
Dr. Masoud Yousefi
Street address
Vice chancellor for research, Birjand University of Medical Sciences, Ayatollah Ghafari Street,
City
Birjand,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
masoud.yousefi@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery for Research, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Maryam Davoodifard
Position
Master Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3253 1761
Email
marydavoodi786@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Davoodifard
Position
Master Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3253 1761
Email
marydavoodi786@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Street address
Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
+98 56 3244 0447
Email
mbroozgar@bums.ac.ir
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
Not applicable
Title and more details about the data/document
Unidentified individual participant data
When the data will become available and for how long
Since the publication of the article extracted from the research for 6 months
To whom data/document is available
Researchers
Under which criteria data/document could be used
Research purposes
From where data/document is obtainable
First author of the article
What processes are involved for a request to access data/document