The effect of self care education on disease outcomes in patients with osteoarthritis referring to Rheumatology Clinic of Tabriz University of Medical Sciences 2011:A Randomized controlled trial study
Purpose of this double blind randomized controlled trial study is evaluation the effectiveness of self care education on disease outcomes in patients with osteoarthritis referring to Rheumatology Clinic of Tabriz, Iran. After convenience sampling, 80 participants will be randomly assigned to two group using Random.org Website. Self care’s demands will determine with individualized interview for intervention group. Two intervention sessions include an individualized self care education session and group exercise training session. Educational materials will be distributed in booklet form in intervention group. Program adherence will be follow with a phone calling once a week for six weeks. The control group will receive usual treatment and the study materials will be provided for them at the end of study. Data were collected at baseline, six weeks, and 12 weeks. Western Ontario and McMaster Universities) WOMAC (questionnaire with five dimensions will used for data collection, that include pain, stiffness, physical function, social function and emotional function. These five dimensions are primary outcomes. Inclusion criteria of this study include age over 35; having primary osteoarthritis and having Primary education, and also exclusion criteria included having other diseases that may effect on pain and physical activity and having history of surgery on joints.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106156810N1
Registration date:2011-07-11, 1390/04/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-11, 1390/04/20
Registrant information
Name
Alireza Mohajjel Aghdam
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mohajjela@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self care education on disease outcomes in patients with osteoarthritis referring to Rheumatology Clinic of Tabriz University of Medical Sciences 2011:A Randomized controlled trial study
Public title
The effect of self care education on disease outcomes in patients with osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age over 35; having primary osteoarthritis and having Primary education. Exclusion criteria: having other diseases that may effect on pain and physical activity and having history of surgery on joints.
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Golgasht St
City
Tabriz
Postal code
Approval date
2011-06-22, 1390/04/01
Ethics committee reference number
5/4/2586
Health conditions studied
1
Description of health condition studied
Osteoartheritise
ICD-10 code
M15-M19
ICD-10 code description
arthrosis
Primary outcomes
1
Description
pain
Timepoint
3 month
Method of measurement
womac
2
Description
stiffness
Timepoint
3 month
Method of measurement
womac
3
Description
Physical function
Timepoint
3 month
Method of measurement
womac
4
Description
Social function
Timepoint
3 month
Method of measurement
womac
5
Description
Emotional function
Timepoint
3 month
Method of measurement
womac
Secondary outcomes
1
Description
The amount and frequency of analgesics
Timepoint
3 mounth
Method of measurement
Questionnaire
Intervention groups
1
Description
self care education
Category
Lifestyle
2
Description
no intervention in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Golgasht clinic
Full name of responsible person
Street address
Dr Susan Kolahi (Rheumatologist)
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
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?