Clinical trial NCT06264908: An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis
Official title: Hand OsteoArthritis Self-management and Integrated Scheme (OASIS-H) to Improve Outcomes in Patients With Hand Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hand Osteoarthritis
Keywords: hand osteoarthritis
self-management programme
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2024-02-20
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be randomized into early intervention and routine clinical care (control) group. Patients in control group will crossover to receive the intervention at week 26.
Primary purpose: TREATMENT

Brief summary: The goal of this trial is to evaluate the efficacy of an integrated self-management programme in improving clinical outcomes in patients with hand osteoarthritis (OA).

This is an open-labelled, randomized controlled trial with an objective to determine the efficacy of an integrated self-management programme versus routine clinical care for participants with symptomatic hand OA.

Participants will be randomized into early intervention group and routine clinical care groups in a 1:1 ratio. Patients who randomized into early intervention group will receive 8 week integrated self-management programme delivered by occupational therapists and rheumatology nurse on hand OA management. Patients who randomized into routine clinical care group will receive usual clinical care for OA for 26 weeks and then receive an identical 8 weeks integrated self-management programme. The primary outcome is the improvement in pain at 26 weeks between the two groups.

Detailed description: Background: Osteoarthritis (OA) of the hand is a common and potentially disabling condition with increasing prevalence in Hong Kong due to an aging population. The direct and indirect economic burden due to OA are substantial and this calls for an unmet need for more effective management for hand OA. Hand OsteoArthritis Self-management and Integrated Scheme (OASIS-H) is a self-management programme integrated with occupational therapy and rheumatology nurse education with an aim to improve outcomes in patients with hand osteoarthritis.

Objective: This is an open-labelled, randomized controlled trial to determine the efficacy of an integrated self-management programme versus routine clinical care for participants with symptomatic hand OA.

Hypothesis: The integrated programme will be more efficacious than routine clinical care in reducing pain and improving function in symptomatic OA hand in 6 months.

Methods: Consecutive patients who fulfilled the American College of Rheumatology Classification Criteria for hand OA with a pain score of ≥40 out of 100mm on visual analogue scale (VAS) will be included. Patient with secondary OA hand, unable to sign consent and with the use of systemic corticosteroid within 6 months will be included. Participants will be randomized in a 1:1 ratio into early intervention and routine clinical care groups. In the early intervention group, patients will participate in an eight-week integrated hand OA management programme within 1 month from randomization. The programme will consist of three self-management education sessions conducted by the occupational therapists and rheumatology nurses on pain management strategy, joint protection, group sharing and exercise, one telemedicine session, aids prescription and splintage fabrication. For patients randomized into the routine clinical care group, they will continue to receive routine medical care from the rheumatology clinic. At 6 months after randomization, patients in the routine clinical care group will crossover and receive an identical 8-week integrated hand OA management programme as the early intervention group. The primary endpoint is the change in finger pain in pain VAS at 6 months from baseline. Secondary endpoints include change in function measured by the functional index for functional index for hand OA, Short form health survey and health assessment questionnaire disability index, change in hand grip strength and dexterity at 6 months and 12 months. The primary endpoint will be analyzed by linear mixed models and the differences in pain over time between the two groups will be compared using linear regression model.

Eligibility criteria: Inclusion Criteria:

* Fulfil the American College of Rheumatology hand osteoarthritis classification criteria
* Symptomatic hand osteoarthritis with a pain visual analogue score (VAS) equal to or more than 40/100mm within 2 weeks of study entry

Exclusion Criteria:

* Secondary hand osteoarthritis from inflammatory arthritis including rheumatoid arthritis, spondyloarthropathy, psoriatic arthritis, gouty arthropathy or connective tissue diseases;
* Receive systemic corticosteroids (other than topical or inhalational) within 6 months of study entry
* Inability to sign informed consent

Primary outcomes:
measure: Change in Pain visual analogue scale (VAS)
timeFrame: 26 weeks
Secondary outcomes:
measure: Change in pain Visual Analogue Scale (VAS)
timeFrame: 12weeks, 52 weeks
measure: Change in Functional index hand osteoarthritis (FIHOA)
timeFrame: 12 weeks, 26 weeks, 52 weeks
measure: Change in Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score
timeFrame: 12 weeks, 26 weeks, 52 weeks
measure: Change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) 3.1
timeFrame: 12 weeks, 26 weeks, 52 weeks
measure: Change in Short-form 36 items health survey
timeFrame: 26 weeks, 52 weeks
measure: Change in hand grip strength
timeFrame: 26 weeks, 52 weeks
measure: Change in hand dexterity measurement
timeFrame: 26 weeks, 52 weeks
measure: Radiographic changes
timeFrame: 52 weeks
Other outcomes:
measure: Adverse events
timeFrame: up to 52 weeks
measure: Use of rescue pain medication
timeFrame: up to 52 weeks
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