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

Study Overview
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Brief Summary
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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
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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. 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

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

Conditions
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Hand Osteoarthritis

Intervention / Treatment
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* Other: e-self-management intervention (Happy Hands app)
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter randomized controlled trial with a qualitative study nested within the trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e-self-management intervention<br>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)<br>* 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.<br>Other: Treatment as usual<br>* Treatment as usual may vary from no treatment at all to referral to a patient education group program, or occupational therapy.<br>|
| Active Comparator: Treatment as usual<br>Treatment as usual | Other: Treatment as usual<br>* Treatment as usual may vary from no treatment at all to referral to a patient education group program, or occupational therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: ≥50% improvement + absolute change of ≥2 in pain (numeric rating scale, NRS 0-10), OR ≥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: ≥20% improvement + absolute change of ≥1 in pain (NRS) ≥20% improvement + absolute change of ≥0.3 in function (MAP-Hand) ≥20% improvement + absolute change of ≥1 in global assessment of disease activity (NRS) | Baseline and 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OMERACT/OARSI responder criteria long-term | 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: ≥50% improvement + absolute change of ≥2 in pain (numeric rating scale, NRS 0-10), OR ≥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: ≥20% improvement + absolute change of ≥1 in pain (NRS) ≥20% improvement + absolute change of ≥0.3 in function (MAP-Hand) ≥20% improvement + absolute change of ≥1 in global assessment of disease activity (NRS) | 3 and 6 months follow-up | 
| Pain intensity | Numeric rating scale (0-10), 0=no pain, 10= worst possible pain | Baseline, 3 and 6 months follow-up | 
| Pain intensity (intervention group) | Numeric rating scale (0-10), 0=no pain, 10= worst possible pain, measured after each exercise session | 3 times weekly in the intervention period (12 weeks) | 
| Stiffness | Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness | Baseline, 3 and 6 months follow-up | 
| Stiffness (intervention group) | Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness, measured after each exercise session | 3 times weekly in the intervention period (12 weeks) | 
| Disease activity | Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity | Baseline, 3 and 6 months follow-up | 
| Disease activity (intervention group) | Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity, measured each month in the intervention period | Monthly in the intervention period (12 weeks) | 
| Measure of Activity performance (MAP-Hand) | 18 questions conserning activity performance of the hand (1=no problem, 4=cannot do the activity), mean score from 1-4. | Baseline, 3 and 6 months follow-up | 
| Measure of Activity performance (MAP-Hand) (intervention group) | 18 questions conserning activity performance of the hand (1=no problem, 4=cannot do the activity), mean score from 1-4. | Monthly in the intervention period (12 weeks) | 
| Grip strength | Measured with Jamar dynamometer (kg), mean of two measures for each hand | Baseline and 3 months follow-up | 
| Quality indicators for hand osteoarthritis treatment | Quality indicators based on the OA-QI questionnaire, adopted to fit the treatment recommendations of hand osteoarthritis. 16 questions answered with yes, no or not appriopriate/do not know. Measured as pass rate. | Baseline, 3 and 6 months follow-up | 
| eHealth literacy | Measured with the eHEALS questionnaire, Norwegian version. 8 questions conserning eHealth literacy (strongly disagree - strongly agree) | Baseline | 
| Number of painful joints | Number of painful joints on left and right hand | Baseline | 
| Change in condition | Global rating of change scale, likert scale with 7 answer options from much better to much worse | Baseline, 3 and 6 months follow-up | 
| Change in condition (intervention group) | Global rating of change scale, likert scale with 7 answer options from much better to much worse | Monthly in the intervention group (3 months) | 
| Motivation for hand exercises | Numeric rating scale (0-10), 0=no motivation, 10=best motivation | Baseline and 3 monhts follow-up | 
| Health-related quality of life | Measured with EQ5D-5L, 5 questions used to calculate an utility score (0-1, 1= best health), assessed as a total score across all timepoints | Baseline, 3 and 6 months follow-up | 
| Health care utilization | Costs related to self-reported healthcare use in primary and secondary health care. Patients will be asked if they have been seeking healthcare (yes/no), if yes, they will be asked to specify type of healthcare use and time used. | Baseline, 3 and 6 months follow-up | 
| Medication use | Medication use will be self-reported by the patient | Baseline, 3 and 6 months follow-up | 
| Adverse events | Number of adverse events, serious adverse events, and withdrawals because of adverse events. Will be self-reported | 3 and 6 months follow-up | 
| Sickleave | Sickleave due to hand osteoarthritis will be self-reported | Baseline, 3 and 6 months follow-up | 
| Fatigue | Fatigue last week measured on an 11-point NRS (0=no fatigue, 10=worst possible fatigue) | Baseline, 3 and 6 months follow-up | 
| Patient satisfaction with care | 1 item with five point response options ranging from Very satisfied to Very dissatisfied, higher value indicate better outcome | Baseline, 3 and 6 months follow-up | 
| System Usability Scale (SUS) | Questionnaire assessing the usability of the Happy Hands app, 10 questions (strongly agree - strongly disagree), index from 0-100 where 100 is best score | 3 month follow-up | 
| Adherence to exercise | Number of exercises performed (0-36 exercise sessions), collected from the app | 3 times weekly during the intervention period (3 months) | 
| Adherence to exercise long-term | Number of exercises performed after completion of intervention, collected from the app | 3 and 6 months follow-up | 
| Adherence to informational videos | Number of informational videos watched, collected from the app | During the intervention period (3 months) | 
| Adherence to informational videos long-term | Number of informational videos watched, collected from the app | 3 and 6 months follow-up | 
| Arthritis self-efficacy scale | Measured by Arthritis Self-Efficacy Scale (ASES): comprises 11 items addressing pain and symptoms (scored on a 5-point scale ranging from not confident at all to very confident). The scores are summed up to a 0-100 score where higher score indicate better self-efficacy. | Baseline | 
| Demographic variable | Age, gender, other painful joints, sivil status, education, previous hand surgery, previous treatment, comorbidities | Baseline |