Interdisciplinary Innovative model of care for people with Hand OsteoArthritis

ISRCTN	ISRCTN62513257
DOI	https://doi.org/10.1186/ISRCTN62513257
Secondary identifying numbers	9/2/2012

Submission date: 02/05/2012
Registration date: 17/05/2012
Last edited: 12/11/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Tanja Stamm
Scientific

Währinger Gürtel 18-20
Vienna
1090
Austria

Phone	+43 1 40400 4381
Email	tanja.stamm@meduniwien.ac.at

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	An Interdisciplinary Innovative model of care for people with Hand OsteoArthritis (IIHOA) :a randomised controlled trial
Study acronym	IIHOA
Study objectives	An interdisciplinary innovative model of care significantly improves grip strength in people with hand osteoarthritis (OA) compared to routine clinical care.
Ethics approval(s)	Ethics Committee of the Medical University of Vienna, 27 March 2012, ref: EK Nr: 1083/2012
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	31/05/2012
Completion date	31/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	140
Key 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
Key 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
Date of first enrolment	31/05/2012
Date of final enrolment	31/05/2014

Locations

Countries of recruitment

Austria

Study participating centre

Währinger Gürtel 18-20

Vienna
1090
Austria

Sponsor information

Medical University of Vienna (Austria)
University/education

Währinger Gürtel 18-20
Vienna
1090
Austria

Phone	+43 1 40400 4381
Email	tanja.stamm@meduniwien.ac.at
"ROR"	https://ror.org/05n3x4p02

Funders

Funder type

Industry

Physio Austria (Austria)

No information available

Ergo Austria (Austria)

No information available

FH Campus Wien, University of Applied Sciences (Austria)

No information available

Medical University Vienna, Department of Rheumatology (Austria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/11/2018		Yes	No

Editorial Notes

12/11/2018: Publication reference added.