Self management after shoulder replacement Musculoskeletal Diseases
Conditions
Interventions
Phase 1: Separate small co-design group meetings (healthcare professionals and people with shoulder replacement)
At least 2 weeks before the co-design meetings, after written consent has been receive
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People with shoulder replacement: 1. Have experienced a total shoulder replacement either anatomical or reverse because of osteoarthritis, rotator cuff arthropathy or inflammatory arthritis 2. >=18 years of age 3. English speaker or have access to someone who can act as a translator. Healthcare professionals: 1. Work in NHS shoulder replacement surgery or rehabilitation services as allied healthcare professionals, nurses, surgeons, consultants, support workers or have personal experience of shoulder replacement e.g., family members/friends
Exclusion criteria
Exclusion criteria: People with shoulder replacement: 1. Have experienced a revision joint replacement or total shoulder replacement because of malignancy, avascular necrosis, fracture or dislocation, where the surgical procedure precludes early rehabilitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain and disability is measured using the Total Shoulder Pain and Disability Index (SPADI) at baseline, 3-month follow-up post randomisation 1, 6-week follow-up post randomisation 2, 12-month follow-up post randomisation 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global Impression of change is measured using the Patient Global Impression of Change Scale (PGI-C) at baseline, 3-month follow-up post randomisation 1, 6-week follow-up post randomisation 2, 6-month follow-up post randomisation 2, and 12-month follow-up post randomisation 2. 2. Pain is measured using the SPADI pain subscale at baseline, 3-month follow-up post randomisation 1, 6-week follow-up post randomisation 2, and 12-month follow-up post randomisation 2. 3. Disability is measured using the SPADI disability subscale at baseline, 3-month follow-up post randomisation 1, 6-week follow-up post randomisation 2, and 12-month follow-up post randomisation 2. 4. Pain self-efficacy is measured using the Pain Self-Efficacy Questionnaire (PSEQ) at baseline, 3-month follow-up post randomisation 1, 6-week follow-up post randomisation 2, and 12-month follow-up post randomisation 2. 5. Sleep is measured using the Patient Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance Short Form at baseline, 3-month follow-up post randomisation 1, 6-week follow-up post randomisation 2, and 12-month follow-up post randomisation 2. 6. Beliefs and priorities are measured using an in-house designed beliefs and priorities measure at baseline. 7. Length of stay is measured by calculating length of hospital stay at 6-week follow-up post randomisation 2. 8. Surgical complications are measured using an in-house designed measure at 6-week, 6-month, and 12-month follow-up post randomisation 2. 9. Surgical (in-hospital) outcomes are measured using an in-house designed measure at the time of surgery. 10. Serious adverse events (related and unrelated) and trial-specific adverse events are measured throughout the trial. 11. Quality of life is measured using the EQ-5D-5L health utility and EQ-5D-5L VAS at baseline, 3-month follow-up post randomisation 1, 6-week, 6-month, and 12-month follow-up post randomisation 2. 12. Healthcare resource use and costs are me | — |
Countries
United Kingdom, Wales
Contacts
Public ContactGwenllian Moody
Outcome results
None listed