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

NCT ID: NCT05568875

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-08
• Study Completion Date: 2024-02-29

Brief 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.

Detailed 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

Conditions

Hand Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

e-self-management intervention

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

Group Type: EXPERIMENTAL

e-self-management intervention (Happy Hands app)

Intervention Type: OTHER

The 12-week intervention consists of 30 short informational videos addressing the themes prioritized by the patient research partners. These themes are further operationalized into the following categories: "Information on hand OA", "Hand exercises", "Use of assistive devices and orthoses", "Medication and surgical alternatives", and "Self-management of the disease". Additionally, the intervention includes a hand exercise program consisting of 8 videos providing instructions on warm up, exercises to improve mobility, strength and coordination, and a stretching exercise. The intervention group will additionally receive treatment as usual.

Treatment as usual

Intervention Type: OTHER

Treatment as usual may vary from no treatment at all to referral to a patient education group program, or occupational therapy.

Treatment as usual

Treatment as usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

Treatment as usual may vary from no treatment at all to referral to a patient education group program, or occupational therapy.

Interventions

e-self-management intervention (Happy Hands app)

The 12-week intervention consists of 30 short informational videos addressing the themes prioritized by the patient research partners. These themes are further operationalized into the following categories: "Information on hand OA", "Hand exercises", "Use of assistive devices and orthoses", "Medication and surgical alternatives", and "Self-management of the disease". Additionally, the intervention includes a hand exercise program consisting of 8 videos providing instructions on warm up, exercises to improve mobility, strength and coordination, and a stretching exercise. The intervention group will additionally receive treatment as usual.

Intervention Type: OTHER

Treatment as usual

Treatment as usual may vary from no treatment at all to referral to a patient education group program, or occupational therapy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Dam Foundation

OTHER

Sponsor Role: collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Therese Tveter

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Therese Tveter, PhD

Role: PRINCIPAL_INVESTIGATOR

Diakonhjemmet Hospital

Locations

Arendal sykehus

Arendal, , Norway

Ålesund sjukehus

Ålesund, , Norway

Haukeland Universitetssykehus

Bergen, , Norway

Aurskog Fysikalske Institutt

Bjørkelangen, , Norway

Nordlandssykehuset

Bodø, , Norway

Lærdal Sjukehus

Førde, , Norway

Finnmarkssykehuset, Kirkenes Sykehus

Kirkenes, , Norway

Kongsvinger sykehus

Kongsvinger, , Norway

Kristiansand sykehus

Kristiansand, , Norway

Levanger sykehus

Levanger, , Norway

Revmatismesykehuset Lillehammer

Lillehammer, , Norway

Meråker kurbad

Meråker, , Norway

Nøtterøy Fysioterapi

Nøtterøy, , Norway

Diakonhjemmet Hospital

Oslo, , Norway

Humana Helse

Sandvika, , Norway

Universitetssykehuset Nord-Norge

Tromsø, , Norway

St.Olavs Hospital

Trondheim, , Norway

Helsehuset Stokke

Tønsberg, , Norway

Vikersund bad

Vikersund, , Norway

Countries

Norway

References

Tveter AT, Fjeldstad KA, Varsi C, Maarnes MK, Pedersen SJ, Christensen BS, Blanck T, Nyheim SB, Prior Y, Bjork M, Pelle T, Kjeken I. Evaluation of an e-self-management intervention (Happy Hands app) for hand osteoarthritis: Study protocol for a multicentre randomised controlled trial. Rheumatol Int. 2025 Jan 16;45(1):30. doi: 10.1007/s00296-025-05787-6.

Reference Type: DERIVED

PMID: 39820549 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

REK 477746

Identifier Type: -

Identifier Source: org_study_id