An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis
NCT ID: NCT06264908
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2024-04-30
2028-04-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Early intervention arm
8 weeks integrated self-management programme delivered by occupational therapists and rheumatology nurse
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.
Routine Clinical care (Control)
Patients will receive routine clinical care for hand osteoarthritis for 26 weeks, then cross-over to the integrated programme after 26 weeks.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* Receive systemic corticosteroids (other than topical or inhalational) within 6 months of study entry
* Inability to sign informed consent
40 Years
80 Years
ALL
No
Sponsors
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Hospital Authority, Hong Kong
OTHER_GOV
Dr Iris Tang Yan Ki
OTHER
Responsible Party
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Dr Iris Tang Yan Ki
Clinical Assistant Professor
Central Contacts
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Other Identifiers
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20240125-010-000
Identifier Type: -
Identifier Source: org_study_id
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