Comparison the effects of an educational program based on stage of change theory with drug therapy on health related quality of life, pain reduction and disability improvement of patients living with knee osteoarthritis.
This controlled clinical trial study was designed to examin the effects of a developed theory based multidisciplinary educational program on quality of life of patients suffering from knee osteoartritis. This study will be conducted on 146 eligible participants who have key criteria such as being aged > 35 years, having definitive diagnosis of knee osteoartritis, not suffering from any infection or malignancy on vertebra. This patients will be randomly divided to control or intervention group with 73 patients with each one. Patients in the control group will receive just oral drug treatment while patients in the intervention group will receive oral drug treatment plus multidisciplinary rehabilitation program. The primary outcomes of the study will be quality of life and secondary outcome will be pain and physical function of the patients that will be assessed up to 6- month follow up. Data on three standard scales regarding quality of life, pain and physical function will be collected at 3-, and 6 - month follow ups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102110603N1
Registration date:2012-11-07, 1391/08/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-11-07, 1391/08/17
Registrant information
Name
Sedigheh Sadat Tavafian
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4547
Email address
tavafian@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of an educational program based on stage of change theory with drug therapy on health related quality of life, pain reduction and disability improvement of patients living with knee osteoarthritis.
Public title
The effects of designed educational program on health related quality of life of knee osteoarthritis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: aged ≥35 years; suffering from knee osteoarthritis for at least 3 months. Exclusion criteria: rheumatoid arthritis or other inflammatory joint disease; serious co-morbidities; having knee surgery within 6 months of commencing the study; having physical impairments that preclude fulfillment of the requirements of either program
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
Ethics Committee of Tehran University of Medical Sciences, Poursina St., Keshavarz Ave, Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-07-31, 1391/05/10
Ethics committee reference number
61553
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee
Primary outcomes
1
Description
quality of life
Timepoint
3 and 6 months after intervention
Method of measurement
The short Form Health Survey (SF- 36)
2
Description
Pain
Timepoint
3 and 6 montha after intervention
Method of measurement
Visual Analog Scale (VAS)
3
Description
physical function
Timepoint
3 and 6 montha after intervention
Method of measurement
(HAQ) Health Assessment Questionnair
Secondary outcomes
empty
Intervention groups
1
Description
There is no intervention for control group. Throughout the study medications such as analgesics, NSAIDs, and antidepressant drugs will be prescribed for participants in control group as necessary.
Category
N/A
2
Description
The intervention in intervention group is a group–based multidisciplinary rehabilitation program which involves relevant specialists to educate for 9 hours . The different specialists would be physiotherapist ( 1 - hour theory class and 2 - hour practical class), Rheumatologist (1- hour theory class), nutritionist (1- hour theory class), psychologist (2 - hour theory class) and health education specialist (2 - hour theory class).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Research Center of Tehran Uiversity of Medical Sciences
Full name of responsible person
Sedigheh Sadat Tavafian
Street address
No 212, Health Education Department, Faculty of Sciences, Tarbiat Modares University, Jalale Ale Ahmad Ave, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rheumatology Research Center of Tehran University of Medical Sciences
Full name of responsible person
Ahmad Reza Jamshidi
Street address
Rheumatology Research Center, Shariati Hosital, Jalale Ale Ahmad Ave, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rheumatology Research Center of Tehran 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
Tarbiat Modares University
Full name of responsible person
Sedigheh sadat Tavafian
Position
Faculty member/ Associate prof.
Other areas of specialty/work
Street address
No 212, Health Education Deparetment, Faculty of Medical Sciences, Tarbiat Modares University
City
Tehran
Postal code
14115331
Phone
+98 21 8288 4547
Fax
+98 21 8288 4555
Email
tavafian@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedigheh Sadat Tavafian
Position
Faculty member/ Associate prof/ PHD
Other areas of specialty/work
Street address
No 212, Health Education Deparetment, Faculty of Medical Sciences, Tarbiat Modares University
City
Tehran
Postal code
14115331
Phone
+98 21 8288 4547
Fax
+98 21 8288 4555
Email
tavafian@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedigheh Sadat Tavafian
Position
Associate Prof/ PHD
Other areas of specialty/work
Street address
No 212, Health Education Deparetment, Faculty of Medical Sciences, Tarbiat Modares University
City
Tehran
Postal code
15115331
Phone
+82 82884547
Fax
+98 21 8288 4555
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)