Hand Osteoarthritis
Conditions
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
Interventions
OTHERe-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.
OTHERTreatment as usual
Treatment as usual may vary from no treatment at all to referral to a patient education group program, or occupational therapy.
Sponsors
The Dam Foundation
Diakonhjemmet Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Only investigator conduction the analyses will be blinded to group allocation
Intervention model description
Multicenter randomized controlled trial with a qualitative study nested within the trial
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OMERACT/OARSI responder criteria | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Baseline, 3 and 6 months follow-up | Numeric rating scale (0-10), 0=no pain, 10= worst possible pain |
| Pain intensity (intervention group) | 3 times weekly in the intervention period (12 weeks) | Numeric rating scale (0-10), 0=no pain, 10= worst possible pain, measured after each exercise session |
| Stiffness | Baseline, 3 and 6 months follow-up | Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness |
| Stiffness (intervention group) | 3 times weekly in the intervention period (12 weeks) | Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness, measured after each exercise session |
| Disease activity | Baseline, 3 and 6 months follow-up | Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity |
| Disease activity (intervention group) | Monthly in the intervention period (12 weeks) | Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity, measured each month in the intervention period |
| Measure of Activity performance (MAP-Hand) | Baseline, 3 and 6 months follow-up | 18 questions conserning activity performance of the hand (1=no problem, 4=cannot do the activity), mean score from 1-4. |
| Measure of Activity performance (MAP-Hand) (intervention group) | Monthly in the intervention period (12 weeks) | 18 questions conserning activity performance of the hand (1=no problem, 4=cannot do the activity), mean score from 1-4. |
| Grip strength | Baseline and 3 months follow-up | Measured with Jamar dynamometer (kg), mean of two measures for each hand |
| Quality indicators for hand osteoarthritis treatment | Baseline, 3 and 6 months follow-up | 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. |
| eHealth literacy | Baseline | Measured with the eHEALS questionnaire, Norwegian version. 8 questions conserning eHealth literacy (strongly disagree - strongly agree) |
| Number of painful joints | Baseline | Number of painful joints on left and right hand |
| Change in condition | Baseline, 3 and 6 months follow-up | Global rating of change scale, likert scale with 7 answer options from much better to much worse |
| Change in condition (intervention group) | Monthly in the intervention group (3 months) | Global rating of change scale, likert scale with 7 answer options from much better to much worse |
| OMERACT/OARSI responder criteria long-term | 3 and 6 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) |
| Health-related quality of life | Baseline, 3 and 6 months follow-up | 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 |
| Health care utilization | Baseline, 3 and 6 months follow-up | 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. |
| Medication use | Baseline, 3 and 6 months follow-up | Medication use will be self-reported by the patient |
| Adverse events | 3 and 6 months follow-up | Number of adverse events, serious adverse events, and withdrawals because of adverse events. Will be self-reported |
| Sickleave | Baseline, 3 and 6 months follow-up | Sickleave due to hand osteoarthritis will be self-reported |
| Fatigue | Baseline, 3 and 6 months follow-up | Fatigue last week measured on an 11-point NRS (0=no fatigue, 10=worst possible fatigue) |
| Patient satisfaction with care | Baseline, 3 and 6 months follow-up | 1 item with five point response options ranging from Very satisfied to Very dissatisfied, higher value indicate better outcome |
| System Usability Scale (SUS) | 3 month follow-up | Questionnaire assessing the usability of the Happy Hands app, 10 questions (strongly agree - strongly disagree), index from 0-100 where 100 is best score |
| Adherence to exercise | 3 times weekly during the intervention period (3 months) | Number of exercises performed (0-36 exercise sessions), collected from the app |
| Adherence to exercise long-term | 3 and 6 months follow-up | Number of exercises performed after completion of intervention, collected from the app |
| Adherence to informational videos | During the intervention period (3 months) | Number of informational videos watched, collected from the app |
| Adherence to informational videos long-term | 3 and 6 months follow-up | Number of informational videos watched, collected from the app |
| Arthritis self-efficacy scale | Baseline | 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. |
| Demographic variable | Baseline | Age, gender, other painful joints, sivil status, education, previous hand surgery, previous treatment, comorbidities |
| Motivation for hand exercises | Baseline and 3 monhts follow-up | Numeric rating scale (0-10), 0=no motivation, 10=best motivation |
Countries
Norway
Outcome results
None listed