Protocol summary

Summary
The aim of this study was to investigate the effect of group education on self-management in patient with rheumatoid arthritis .Inclusion criteria: diagnosis of rheumatoid arthritis by Rheumatologist ; willingness to participate in the study; ability to do exercises two sessions in week. Exclusion criteria:Suffering from other diseases such as osteoarthritis or other associated diseases (cardio-pulmonary diseases or psychological disturbances) ؛ being absent in more than two training sessions. 64 patients from rheumatology clinic in Shiraz-Iran were enrolled in the study. participants were randomly assigned into two group(case and control) .intervention in this study was 16 sessions of educational-exercise for 2 months( two session 70 min per week). Primary outcome was self management in patients

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201308187531N3
Registration date: 2013-11-30, 1392/09/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-30, 1392/09/09
Registrant information
Name
Iran Jahanbin
Name of organization / entity
University of Medical Sciences Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 917 313 7399
Email address
jahanbii@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-09-01, 1392/06/10
Expected recruitment end date
2013-11-01, 1392/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group education on self-management in patient with rheumatoid arthritis reffring to the Rheumatoid Arthritis clinic Shiraz-IRAN
Public title
The effect of group education on self-management in patient with rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of rheumatoid arthritis by Rheumatologist based on ACR 2010 ; willingness to participate in the study; ability to do exercises two sessions in week. Exclusion criteria:Suffering from other diseases such as osteoarthritis or other associated diseases (cardio-pulmonary diseases or psychological disturbances) ؛ being absent in more than two training sessions.
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: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Bld.Vice chancellor of Shiraz university of medical sciences
City
shiraz
Postal code
Approval date
2013-08-05, 1392/05/14
Ethics committee reference number
926620

Health conditions studied

1

Description of health condition studied
rheumatoid arthritis
ICD-10 code
M05.8
ICD-10 code description
Other seropositive rheumatoid arthritis

Primary outcomes

1

Description
self management
Timepoint
Immediately and 2month after the intervention
Method of measurement
using of AIMS2-SF and ASES questionnaire

Secondary outcomes

1

Description
pain
Timepoint
Immediately and 2month after the intervention
Method of measurement
using of VAS questionnaire

Intervention groups

1

Description
Teaching self management and group exercise program to experiment group for 8 weeks and two sessions 70 min in week .No intervention for control group.
Category
Lifestyle

2

Description
control group no intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Rheumatology Clinic
Full name of responsible person
Hoseini Moghadam Mahboobe
Street address
N0. 16, Salman Rezaei alley, Imam Hossein St.
City
Behbahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Shiraz University of Medical Sciense
Full name of responsible person
Dr Gholam Reza Hattam
Street address
Zand Bld, 7th Floor Research Deputy of Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Shiraz University of Medical Sciense
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
Shiraz University of Medical Sciences
Full name of responsible person
Iran Jahanbin
Position
MS Nursing
Other areas of specialty/work
Street address
Square Namazi, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4250
Fax
Email
jahanbii@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Iran Jahanbin
Position
MSc in Nursing
Other areas of specialty/work
Street address
Namazi Square,School of Nursing & Midwifery
City
Shiraz
Postal code
Phone
+98 71 1647 4250
Fax
Email
jahanbii@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mahboobe Hoseini Moghadam
Position
Graduate nursing student of nursing
Other areas of specialty/work
Street address
N0. 16, Salman Rezaei alley, Imam Hossein St.
City
Behbahan
Postal code
6361657613
Phone
+98 67 1222 7510
Fax
Email
hoseini_mahboobe@yahoo.com
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
Loading...