An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Integrated self-management programme.
- Who it may be relevant to
- Registry conditions: Hand Osteoarthritis. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hand OsteoArthritis Self-management and Integrated Scheme (OASIS-H) to Improve Outcomes in Patients With Hand Osteoarthritis
Overview
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.
Interventions
- Behavioral Integrated self-management programme
8 weeks integrated management programme with three educational sessions. Group therapy sessions (6-8 participants per group) delivered by occupational therapists and rheumatology nurses. 1. Disease pathology and Pain management 2. Joint protection and stretching exercise 3. Psychosocial education 4. Aids prescription Each session will consist of education session, exercise session and group sharing sessions.
Primary outcome measures
- Change in Pain visual analogue scale (VAS) [Time frame: 26 weeks]
Secondary outcome measures (8)
- Change in pain Visual Analogue Scale (VAS) [Time frame: 12weeks, 52 weeks]
- Change in Functional index hand osteoarthritis (FIHOA) [Time frame: 12 weeks, 26 weeks, 52 weeks]
- Change in Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score [Time frame: 12 weeks, 26 weeks, 52 weeks]
- Change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 [Time frame: 12 weeks, 26 weeks, 52 weeks]
- Change in Short-form 36 items health survey [Time frame: 26 weeks, 52 weeks]
- Change in hand grip strength [Time frame: 26 weeks, 52 weeks]
- Change in hand dexterity measurement [Time frame: 26 weeks, 52 weeks]
- Radiographic changes [Time frame: 52 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06264908 · 20240125-010-000