Condition category
Musculoskeletal Diseases
Date applied
02/05/2012
Date assigned
17/05/2012
Last edited
29/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes