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

NCT05568875 | Completed

• 1 other identifier: REK 477746
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 19

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.

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• OMERACT/OARSI responder criteria

  Combined score of change in pain, function and disease activity. Patients are categorized into responders or non-responders according to the following: High improvement on pain or function: 1. ≥50% improvement + absolute change of ≥2 in pain (numeric rating scale, NRS 0-10), OR 2. ≥50% improvement + absolute change of ≥0.6 in function (Measure of Activity Performance of the Hand, MAP-Hand) Improvement in at least two of the three following: 1. ≥20% improvement + absolute change of ≥1 in pain (NRS) 2. ≥20% improvement + absolute change of ≥0.3 in function (MAP-Hand) 3. ≥20% improvement + absolute change of ≥1 in global assessment of disease activity (NRS)

  Baseline and 3 months follow-up

Secondary Outcomes (30)

• OMERACT/OARSI responder criteria long-term

  3 and 6 months follow-up

• Pain intensity

  Baseline, 3 and 6 months follow-up

• Pain intensity (intervention group)

  3 times weekly in the intervention period (12 weeks)

• Stiffness

  Baseline, 3 and 6 months follow-up

• Stiffness (intervention group)

  3 times weekly in the intervention period (12 weeks)

Study Arms (2)

e-self-management intervention

EXPERIMENTAL

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

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

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual

Other: Treatment as usual

Interventions

e-self-management intervention (Happy Hands app) 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.

e-self-management intervention

Treatment as usual 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; e-self-management intervention

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Most women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People diagnosed with hand osteoarthritis
• Possessing a smartphone

You may not qualify if:

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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• The Dam Foundation: collaborator

Study Sites (19)

Arendal sykehus

Arendal, Norway

Location

Ålesund sjukehus

Ålesund, Norway

Location

Haukeland Universitetssykehus

Bergen, Norway

Location

Aurskog Fysikalske Institutt

Bjørkelangen, Norway

Location

Nordlandssykehuset

Bodø, Norway

Location

Lærdal Sjukehus

Førde, Norway

Location

Finnmarkssykehuset, Kirkenes Sykehus

Kirkenes, Norway

Location

Kongsvinger sykehus

Kongsvinger, Norway

Location

Kristiansand sykehus

Kristiansand, Norway

Location

Levanger sykehus

Levanger, Norway

Location

Revmatismesykehuset Lillehammer

Lillehammer, Norway

Location

Meråker kurbad

Meråker, Norway

Location

Nøtterøy Fysioterapi

Nøtterøy, Norway

Location

Diakonhjemmet Hospital

Oslo, Norway

Location

Humana Helse

Sandvika, Norway

Location

Universitetssykehuset Nord-Norge

Tromsø, Norway

Location

St.Olavs Hospital

Trondheim, Norway

Location

Helsehuset Stokke

Tønsberg, Norway

Location

Vikersund bad

Vikersund, Norway

Location

Related Publications (2)

• Fjeldstad KA, Tveter AT, Rasmussen E, Olden L, Nyheim S, Blanck T, Killingmo RM, Kjeken I. Changing Habits With the Happy Hands App: Qualitative Focus Group Study of a Hand Osteoarthritis Self-Management Intervention. J Med Internet Res. 2026 Feb 2;28:e82773. doi: 10.2196/82773.

  PMID: 41628446 DERIVED

• 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.

  PMID: 39820549 DERIVED

MeSH Terms

Interventions

Therapeutics

Study Officials

• Anne Therese Tveter, PhD

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Only investigator conduction the analyses will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multicenter randomized controlled trial with a qualitative study nested within the trial

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: November 8, 2022
• Primary Completion: September 1, 2023
• Study Completion: February 29, 2024
• Last Updated: April 13, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol will be available from 1.11.22. SAP will be available before initation of analyses.
• Access Criteria: E-mail the principal investigator for access to supporting information.

Locations

NO (19)