Hand OsteoarthritisOASIS-HNCT06264908
An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis
A study testing Integrated self-management programme in people with Hand Osteoarthritis, run by Dr Iris Tang Yan Ki.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Integrated self-management programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hand OsteoArthritis Self-management and Integrated Scheme (OASIS-H) to Improve Outcomes in Patients With Hand Osteoarthritis
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.
Read the 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.
- Conditions
- Hand Osteoarthritis
- Being tested
- Integrated self-management programme
- Keywords
- hand osteoarthritis, self-management programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated self-management programmeBehavioural
8 weeks integrated management programme with three educational sessions. Group therapy sessions (6-8 participants per group) delivered by occupational therapists and rheumatology nurses.
- Disease pathology and Pain management
- Joint protection and stretching exercise
- Psychosocial education
- Aids prescription Each session will consist of education session, exercise session and group sharing sessions.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention arm | Experimental | 8 weeks integrated self-management programme delivered by occupational therapists and rheumatology nurse Receives: Behavioral: Integrated self-management programme |
| Routine Clinical care (Control) | No intervention | Patients will receive routine clinical care for hand osteoarthritis for 26 weeks, then cross-over to the integrated programme after 26 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain visual analogue scale (VAS)
Pain VAS reflects the severity of pain in a score of 0-100. A lower score indicates less pain.
Measured: 26 weeks
Secondary outcomes (8)
Change in pain Visual Analogue Scale (VAS)
Pain VAS reflects the severity of pain in a score of 0-100. A lower score indicates less pain.
Measured: 12weeks, 52 weeks
Change in Functional index hand osteoarthritis (FIHOA)
FIHOA reflects hand function with a score of 0 to 30. A lower score indicates better hand function
Measured: 12 weeks, 26 weeks, 52 weeks
Change in Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score
QuickDASH is a self-reported 11-itemed questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability)
Measured: 12 weeks, 26 weeks, 52 weeks
Change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) 3.1
AUSCAN 3.1 hand osteoarthritis index is a self-administered questionnaire that assesses the three dimensions of pain, disability and joint stiffness in hand osteoarthritis using a battery of 15 questions. The score is expressed in 3 subscores: AUSCAN pain score (0 (least painful)-100 (most painful), the AUSCAN stiffness score (0: least stiffness-100: most stiffness), the AUSCAN function score (0: least function impairment-100: most severe function impairment)
Measured: 12 weeks, 26 weeks, 52 weeks
Change in Short-form 36 items health survey
Short-form 36 items health survey measures 8 domains of health related quality of life. The score is expressed in 0 - 100. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 26 weeks, 52 weeks
Change in hand grip strength
Hand grip strength measured by dynamometer
Measured: 26 weeks, 52 weeks
Change in hand dexterity measurement
Hand dexterity measurement
Measured: 26 weeks, 52 weeks
Radiographic changes
Measured by hand plain radiographs
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Iris Tang Yan Ki
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Sponsor-investigator, Dr Iris Tang Yan Ki, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264908
- Sponsor's protocol ID
- 20240125-010-000
- Acronym
- OASIS-H
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand OsteoArthritis Self-management and Integrated Scheme (OASIS-H) to Improve Outcomes in Patients With Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT06264908
- Acronym / sponsor ID
- OASIS-H / 20240125-010-000
- Conditions
- Hand Osteoarthritis
- Keywords
- hand osteoarthritis, self-management programme
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dr Iris Tang Yan KiUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early intervention arm | Experimental | Behavioral: Integrated self-management programme8 weeks integrated self-management programme delivered by occupational therapists and rheumatology nurse |
| Routine Clinical care (Control) | No intervention | –Patients will receive routine clinical care for hand osteoarthritis for 26 weeks, then cross-over to the integrated programme after 26 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated self-management programme8 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. | Behavioural | Early intervention arm |
Primary outcome
Change in Pain visual analogue scale (VAS)
Time frame: 26 weeks
Pain VAS reflects the severity of pain in a score of 0-100. A lower score indicates less pain.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated self-management programme in people with Hand Osteoarthritis, run by Dr Iris Tang Yan Ki.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Tang, MBBS (+852-22555999, tykiris@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain visual analogue scale (VAS) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.