Comparison of Effectiveness of self help groups versus usual care in quality of life and self efficacy in patients with osteoarthritis referring to Shohada medical center and Sheikhalraees Clinic of Tabriz, 2010:Randomized controlled trial
Purpose of this triple blind randomized controlled trial study is evaluation the Effectiveness of self help groups in quality of life and self efficacy in patients with osteoarthritis referring to two Rheumatology and Orthopedic Clinics of Tabriz, Iran. After purposive sampling, 400 participants will be randomly assigned to two groups using Random.org Website. The interviewers, participants and doctors will not be aware of samples allocation. The control group will be received usual care and the intervention group will be used group therapy sessions besides usual care.
Purpose of double blind randomized controlled trial study is evaluation the Effectiveness of self help groups in quality of life and self efficacy in patients with osteoarthritis. Having moderate or severe idiopathic osteoarthritis and having vision and hearing impairment and inability to speak are respectively important inclusion and exclusion criteria of this study.. After purposive sampling among patients referring to two Rheumatology and Orthopedic Clinics of Tabriz, Iran, 400 participants will be randomly assigned to two groups using Random.org Website. The interviewers, participants and doctors will not be aware of samples allocation. The control group will be received usual care and the intervention group will be used group therapy sessions besides usual care. Group therapy will be administrated in groups with 8-10 persons for six months which these will be administrated fortnight at first two months and then monthly. At all group therapy sessions, Nurses are responsible for managing and directing the discussions. Depending on the subject, a rheumatologist will participate in group discussions in the right direction as a facilitator. One month after completion of sessions, both intervention and control groups will be filled Quality of life questionnaire and, Arthritis self-efficacy scale of Stanford Patient Education Research Center with the help of interviewers for the second time. Quality of life and self-efficacy are primary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106036698N1
Registration date:2012-01-19, 1390/10/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-19, 1390/10/29
Registrant information
Name
Mozhgan Behshid
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hsr_co@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of self help groups versus usual care in quality of life and self efficacy in patients with osteoarthritis referring to Shohada medical center and Sheikhalraees Clinic of Tabriz, 2010:Randomized controlled trial
Public title
Effectiveness of self help groups in osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
having knee osteoarthritis; able to communicate; Living in Tabriz and suburbs.
Exclusion criteria:
having mild and traumatic osteoarthritis; having age below 40 and over 60 years; vision and hearing impairment and inability to speak; don’t have refractory disease and psychological problems; disability to travel and regular participation in group therapy sessions (intervention group); Following a treatment other than those prescribed; sever osteoarthritis in other joints (except knee).
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
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
Tabriz University of Medical Sciences
Street address
golghasht street
City
Tabriz
Postal code
Approval date
2011-01-02, 1389/10/12
Ethics committee reference number
5/4/7952
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Gonarthrosis, unspecified
Primary outcomes
1
Description
Quality of life
Timepoint
6 month
Method of measurement
SF-36 Quality of life questionnaire
2
Description
self-efficacy
Timepoint
6 month
Method of measurement
Arthritis self-efficacy scale of Stanford Patient Education Research Center
Secondary outcomes
1
Description
pain
Timepoint
6 month
Method of measurement
visual analogue scale
Intervention groups
1
Description
control group: usual care in these patients include pharmacological therapy and training which physician provides them.
Category
N/A
2
Description
intervention group: Group therapy will be administrated in groups with 8-10 persons for six months which these will be administrated fortnight at first two months and then monthly. After introduction and interaction between members in the initial group session, educational needs to be determined. Then all sessions’ themes will be determined and will be provided for intervention group members
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada medical center
Full name of responsible person
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Sheikhalraees clinic
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi(Research vice- chancellor)
Street address
Daneshgah st, Moavenate Pajhoheshi
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Mozhgan Behshid
Position
MS Nursing/Academic staff
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariaty
City
Tabriz
Postal code
Phone
+98 41 1335 8718
Fax
Email
mojganbehshid@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mozhgan Behshid
Position
MS Nursing/Academic staff
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariaty
City
Tabriz
Postal code
Phone
+98 41 1335 8718
Fax
Email
mojganbehshid@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mozhgan Behshid
Position
Ms Nursing/Academic staff
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariaty
City
Tabriz
Postal code
Phone
+98 41 1335 8718
Fax
Email
mojganbehshid@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)