Clinical Trials Logo

Clinical Trial Summary

The main aim of this project is to assess the effect, cost-effectiveness and user experiences with using an e-self-management intervention in addition to treatment as usual compared to treatment as usual alone in patients with hand osteoarthritis. The study is an RCT comprising approx 400 participants with hand osteoarthritis recruited from primary and secondary healthcare in all four health regions in Norway.


Clinical Trial Description

Hand osteoarthritis (OA) is a highly prevalent rheumatic joint disease, and the number of people living with debilitating hand OA will continue to rise in the coming decades due to increased life expectancy. Research shows that patients with hand OA have poor access to recommended treatment, and in Norway, they are increasingly referred to surgical consultation before having received recommended first-line treatment. Thus, there is a need to develop easily viable models of care for patients with hand OA that make recommended treatment available across different healthcare levels. Our hypotheses are that an e-self-management intervention for people with hand OA will improve pain and function and be more cost-effective compared to treatment as usual, and that this app can easily be implemented in both specialist and primary healthcare. The hypotheses will be tested and explored in a randomized controlled trial, with a qualitative study nested within this trial. The main research questions are: 1. To evaluate whether a 12-week e-self-management intervention is more effective in improving pain and function (according to the OMERACT-OARSI responder criteria26) compared to usual care in patients with hand OA (randomized controlled trial). 2. To determine the cost-effectiveness of the e-self-management intervention compared to usual care after 6 months (randomized controlled trial). 3. To explore patients' experience of barriers and facilitators for adopted and continued use of a e-self-management intervention for treatment of hand OA (qualitative interviews). Secondary research questions will also be assessed. Approx 400 patients will be recruited in this multicenter randomized controlled trial where patients with hand OA are allocated to either usual care or a 12-week e-self-management intervention delivered through a smartphone app (the HAPPY Hands app). Outcome measures are collected at baseline, 3 months (=end of intervention) and 6 months ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05568875
Study type Interventional
Source Diakonhjemmet Hospital
Contact
Status Completed
Phase N/A
Start date November 8, 2022
Completion date February 29, 2024

See also
  Status Clinical Trial Phase
Completed NCT01910116 - Efficacy of Shinabro in Hand Osteoarthritis Phase 2/Phase 3
Completed NCT02612233 - Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin Phase 4
Completed NCT01249391 - Splinting to Treat Hand Osteoarthritis Phase 2
Recruiting NCT04402047 - Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis N/A
Completed NCT03911570 - Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis
Completed NCT04576403 - Heated Mittens for Patients With Hand Osteoarthritis N/A
Completed NCT01874067 - C-GLOVES: the Effectiveness of Compression Gloves in Arthritis
Completed NCT02528630 - Progressive Strength in Hand Osteoarthritis Phase 4
Suspended NCT03703934 - Central Pain Mechanisms in Patients With Hand-Osteoarthritis, Psoriatic Arthritis and Healthy Controls
Completed NCT04585113 - Diagnostic Accuracy of Dual-energy CT
Completed NCT03693833 - CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. Phase 2
Completed NCT05150171 - Happy Hands E-self-management Pilot Study N/A
Completed NCT02667145 - Assistive Device for Hand Osteoarthritis N/A
Completed NCT02477059 - Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis Phase 3
Recruiting NCT04611347 - Topical CBD in Joint Arthritis Phase 2
Completed NCT04036929 - Can we Use Estrogen-containing Therapy to Improve Pain in Women After Menopause With Hand Osteoarthritis? N/A
Completed NCT03919279 - Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation N/A
Recruiting NCT06329219 - Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis N/A
Not yet recruiting NCT05216757 - Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO) Phase 2/Phase 3
Completed NCT02771860 - RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints Phase 2