Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis (HappyHands)

Diakonhjemmet Hospital

Status: Completed

Conditions: Hand Osteoarthritis

Treatments: Other: e-self-management intervention (Happy Hands app); Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05568875

REK 477746

Details and patient eligibility

About

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.

Full 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

Enrollment: 386 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People diagnosed with hand osteoarthritis
• Possessing a smartphone

Exclusion criteria

• cognitive deficits
• are scheduled for hand surgery within the next 3 months
• do not talk or understand Norwegian,
• have uncontrolled serious comorbidities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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386 participants in 2 patient groups

e-self-management intervention

Experimental group

Description:

12-week e-self-management intervention consisting of exercise videos and videos with information about recommended treatment

Treatment:

Other: Treatment as usual

Other: e-self-management intervention (Happy Hands app)

Treatment as usual

Active Comparator group

Description:

Treatment as usual

Treatment:

Other: Treatment as usual