Plain English Summary
Background and study aims
Hand osteoarthritis is one of the most common rheumatic diseases, concerning 60-70% of the population over 65 years. The small finger joints are affected in particular. This causes pain and swelling. In addition, people often have problems using their hands, which makes everyday activities more difficult.
There are drug and non-drug treatments for hand osteoarthritis. Treatments are provided by various health professionals, such as rheumatologists, nurses, occupational therapists and physiotherapists.
The aim of this study is to assess how well an interdisciplinary intervention works (when the various health professionals work together and learn from one another).
Who can participate?
Patients with hand osteoarthritis.
What does the study involve?
Participants will be randomly allocated to one of two groups: standard treatment group or interdisciplinary intervention group.
The interdisciplinary intervention group will have access to: exercise programs, products and tools (called assistive devices) that can make life with hand osteoarthritis easier, splints, weight reduction advice, information about exercise, self-management, when to consider surgery, pain and pain management, and telephone follow-up.
What are the possible benefits and risks of participating?
Participants will have consultations with different health professionals.
There are no risks involved and participants can contact health professionals immediately and directly in case of adverse events.
Where is the study run from?
The study will be done by researchers of the Medical University of Vienna/ Department for Rheumatology (Austria). Participant consultations will take place there.
When is the study starting and how long is it expected to run for?
May 2012 to May 2014.
Who is funding the project?
Physio Austria Professional Association of Physiotherapists (Austria)
Ergo Austria Professional Association of Occupational Therapists (Austria)
FH Campus Wien, University of Applied Sciences (Austria)
Medical University Vienna, Department of Rheumatology (Austria)
Who is the main contact?
Michaela Stoffer
michaela.stoffer@meduniwien.ac.at
Trial website
Contact information
Type
Scientific
Primary contact
Dr Tanja Stamm
ORCID ID
Contact details
Währinger Gürtel 18-20
Vienna
1090
Austria
+43 1 40400 4381
tanja.stamm@meduniwien.ac.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9/2/2012
Study information
Scientific title
An Interdisciplinary Innovative model of care for people with Hand OsteoArthritis (IIHOA) :a randomised controlled trial
Acronym
IIHOA
Study hypothesis
An interdisciplinary innovative model of care significantly improves grip strength in people with hand osteoarthritis (OA) compared to routine clinical care.
Ethics approval
Ethics Committee of the Medical University of Vienna, 27 March 2012, ref: EK Nr: 1083/2012
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hand Osteoarthritis
Intervention
Patients will be randomised into two groups. Each group receives an intervention, either the standard treatment in agreement with the rheumatologist or the interdisciplinary intervention. Patients randomised into the standard treatment group will be given the offer to receive the interdisciplinary intervention after two months if they wish to.
Interdisciplinary intervention includes:
1. Exercise program
2. Information about physical activity
3. Assistive devices for daily living
4. Splints if needed
5. Weight reduction if needed
6. Information for self management to increase self-efficacy
7. Physical methods
8. Information about when to consider surgery
9. Information about pain and pain management
10. Telephone follow-up
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Grip strength measured using a vigorimeter at baseline and two months later
Secondary outcome measures
1. Hand function measured by a test (sub-test of the Jebsen-Taylor-Hand-Function-Test) and a self-report questionnaire (AUSCAN)
2. Self-reported assessment of pain and satisfaction of patients with their health care and health status (on a 11-point Likert scale)
Measured at baseline and two months later.
Overall trial start date
31/05/2012
Overall trial end date
31/05/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients meeting the American College of Rheumatology (ACR) criteria for hand OA
2. In order not to exclude patients with hand osteoarthritis in an early stage, patients will also be eligible to participate in this study if they have bony swelling of at least one interphalangeal (IP) joint of the 2nd to 5th finger and/ or pain or bony swelling of at least one carpometacarpal (CMC) 1 joint
3. To have a potential for improvement (and motivation for adherence to the treatment), eligible patients have to be above or equal to an 11- point Likert scale of hand pain of at least 3 at two time points
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Patients with evidence of rheumatoid arthritis or any rheumatic disease other than OA
2. Furthermore, persons with elevated C-reactive protein levels (>0.5 mg/dl) as a sign of active inflammation at the test visit and/ or with soft tissue swelling of any of the finger joints on either hand
3. Patients who have received steroid injections within the last four weeks
4. Patients who have undergone hand surgery within the last year
5. Patients who plan to receive steroid injections or hand surgery during the study period
Recruitment start date
31/05/2012
Recruitment end date
31/05/2014
Locations
Countries of recruitment
Austria
Trial participating centre
Währinger Gürtel 18-20
Vienna
1090
Austria
Sponsor information
Organisation
Medical University of Vienna (Austria)
Sponsor details
Währinger Gürtel 18-20
Vienna
1090
Austria
+43 1 40400 4381
tanja.stamm@meduniwien.ac.at
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Physio Austria (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ergo Austria (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
FH Campus Wien, University of Applied Sciences (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medical University Vienna, Department of Rheumatology (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary