Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 386
- Locations
- 19
- Primary Endpoint
- OMERACT/OARSI responder criteria
Study Overview
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:
- 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).
- To determine the cost-effectiveness of the e-self-management intervention compared to usual care after 6 months (randomized controlled trial).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
Only investigator conduction the analyses will be blinded to group allocation
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
OMERACT/OARSI responder criteria
Time Frame: Baseline and 3 months follow-up
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)
Secondary Outcomes
- Disease activity (intervention group)(Monthly in the intervention period (12 weeks))
- Pain intensity (intervention group)(3 times weekly in the intervention period (12 weeks))
- OMERACT/OARSI responder criteria long-term(3 and 6 months follow-up)
- Measure of Activity performance (MAP-Hand)(Baseline, 3 and 6 months follow-up)
- Pain intensity(Baseline, 3 and 6 months follow-up)
- Disease activity(Baseline, 3 and 6 months follow-up)
- Grip strength(Baseline and 3 months follow-up)
- Change in condition(Baseline, 3 and 6 months follow-up)
- Health care utilization(Baseline, 3 and 6 months follow-up)
- Fatigue(Baseline, 3 and 6 months follow-up)
- Adherence to exercise long-term(3 and 6 months follow-up)
- Adherence to informational videos(During the intervention period (3 months))
- Stiffness(Baseline, 3 and 6 months follow-up)
- Stiffness (intervention group)(3 times weekly in the intervention period (12 weeks))
- Measure of Activity performance (MAP-Hand) (intervention group)(Monthly in the intervention period (12 weeks))
- eHealth literacy(Baseline)
- Health-related quality of life(Baseline, 3 and 6 months follow-up)
- Medication use(Baseline, 3 and 6 months follow-up)
- Motivation for hand exercises(Baseline and 3 monhts follow-up)
- Adverse events(3 and 6 months follow-up)
- Sickleave(Baseline, 3 and 6 months follow-up)
- Adherence to exercise(3 times weekly during the intervention period (3 months))
- Quality indicators for hand osteoarthritis treatment(Baseline, 3 and 6 months follow-up)
- Number of painful joints(Baseline)
- Change in condition (intervention group)(Monthly in the intervention group (3 months))
- Patient satisfaction with care(Baseline, 3 and 6 months follow-up)
- Arthritis self-efficacy scale(Baseline)
- System Usability Scale (SUS)(3 month follow-up)
- Adherence to informational videos long-term(3 and 6 months follow-up)
- Demographic variable(Baseline)
Investigators
Anne Therese Tveter
Professor
Diakonhjemmet Hospital