An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis

NCT06264908 | Not Yet Recruiting

• 1 other identifier: 20240125-010-000
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hand Osteoarthritis

Keywords

hand osteoarthritis; self-management programme

Outcome Measures

Primary Outcomes (1)

• 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.

  26 weeks

Secondary Outcomes (8)

• Change in pain Visual Analogue Scale (VAS)

  12weeks, 52 weeks

• Change in Functional index hand osteoarthritis (FIHOA)

  12 weeks, 26 weeks, 52 weeks

• Change in Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score

  12 weeks, 26 weeks, 52 weeks

• Change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) 3.1

  12 weeks, 26 weeks, 52 weeks

• Change in Short-form 36 items health survey

  26 weeks, 52 weeks

Other Outcomes (2)

• Adverse events

  up to 52 weeks

• Use of rescue pain medication

  up to 52 weeks

Study Arms (2)

Early intervention arm

EXPERIMENTAL

8 weeks integrated self-management programme delivered by occupational therapists and rheumatology nurse

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.

Interventions

Integrated self-management programme BEHAVIORAL

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.

Early intervention arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Iris Tang Yan Ki: lead
• Hospital Authority, Hong Kong: collaborator

Central Study Contacts

Iris Tang, MBBS

CONTACT

+852-22555999; tykiris@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 20, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share