Clinical trial NCT05568875: Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis
Official title: Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Osteoarthritis
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: The Dam Foundation
First posted: 2022-10-06
Enrollment: 386
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter randomized controlled trial with a qualitative study nested within the trial
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: OMERACT/OARSI responder criteria
timeFrame: Baseline and 3 months follow-up
Secondary outcomes:
measure: OMERACT/OARSI responder criteria long-term
timeFrame: 3 and 6 months follow-up
measure: Pain intensity
timeFrame: Baseline, 3 and 6 months follow-up
measure: Pain intensity (intervention group)
timeFrame: 3 times weekly in the intervention period (12 weeks)
measure: Stiffness
timeFrame: Baseline, 3 and 6 months follow-up
measure: Stiffness (intervention group)
timeFrame: 3 times weekly in the intervention period (12 weeks)
measure: Disease activity
timeFrame: Baseline, 3 and 6 months follow-up
measure: Disease activity (intervention group)
timeFrame: Monthly in the intervention period (12 weeks)
measure: Measure of Activity performance (MAP-Hand)
timeFrame: Baseline, 3 and 6 months follow-up
measure: Measure of Activity performance (MAP-Hand) (intervention group)
timeFrame: Monthly in the intervention period (12 weeks)
measure: Grip strength
timeFrame: Baseline and 3 months follow-up
measure: Quality indicators for hand osteoarthritis treatment
timeFrame: Baseline, 3 and 6 months follow-up
measure: eHealth literacy
timeFrame: Baseline
measure: Number of painful joints
timeFrame: Baseline
measure: Change in condition
timeFrame: Baseline, 3 and 6 months follow-up
measure: Change in condition (intervention group)
timeFrame: Monthly in the intervention group (3 months)
measure: Motivation for hand exercises
timeFrame: Baseline and 3 monhts follow-up
measure: Health-related quality of life
timeFrame: Baseline, 3 and 6 months follow-up
measure: Health care utilization
timeFrame: Baseline, 3 and 6 months follow-up
measure: Medication use
timeFrame: Baseline, 3 and 6 months follow-up
measure: Adverse events
timeFrame: 3 and 6 months follow-up
measure: Sickleave
timeFrame: Baseline, 3 and 6 months follow-up
measure: Fatigue
timeFrame: Baseline, 3 and 6 months follow-up
measure: Patient satisfaction with care
timeFrame: Baseline, 3 and 6 months follow-up
measure: System Usability Scale (SUS)
timeFrame: 3 month follow-up
measure: Adherence to exercise
timeFrame: 3 times weekly during the intervention period (3 months)
measure: Adherence to exercise long-term
timeFrame: 3 and 6 months follow-up
measure: Adherence to informational videos
timeFrame: During the intervention period (3 months)
measure: Adherence to informational videos long-term
timeFrame: 3 and 6 months follow-up
measure: Arthritis self-efficacy scale
timeFrame: Baseline
measure: Demographic variable
timeFrame: Baseline
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Arendal sykehus
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Bjørkelangen
country: Norway
facility: Aurskog Fysikalske Institutt
city: Bodø
country: Norway
facility: Nordlandssykehuset
city: Førde
country: Norway
facility: Lærdal Sjukehus
city: Kirkenes
country: Norway
facility: Finnmarkssykehuset, Kirkenes Sykehus
city: Kongsvinger
country: Norway
facility: Kongsvinger sykehus
city: Kristiansand
country: Norway
facility: Kristiansand sykehus
city: Levanger
country: Norway
facility: Levanger sykehus
city: Lillehammer
country: Norway
facility: Revmatismesykehuset Lillehammer
city: Meråker
country: Norway
facility: Meråker kurbad
city: Nøtterøy
country: Norway
facility: Nøtterøy Fysioterapi
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Sandvika
country: Norway
facility: Humana Helse
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge
city: Trondheim
country: Norway
facility: St.Olavs Hospital
city: Tønsberg
country: Norway
facility: Helsehuset Stokke
city: Vikersund
country: Norway
facility: Vikersund bad
city: Ålesund
country: Norway
facility: Ålesund sjukehus
Study officials:
affiliation: Diakonhjemmet Hospital
name: Anne Therese Tveter, PhD
role: PRINCIPAL_INVESTIGATOR
References: