Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis
- Conditions
- Hand Osteoarthritis
- Registration Number
- NCT05568875
- Lead Sponsor
- Diakonhjemmet Hospital
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 386
- People diagnosed with hand osteoarthritis
- Possessing a smartphone
- cognitive deficits
- are scheduled for hand surgery within the next 3 months
- do not talk or understand Norwegian,
- have uncontrolled serious comorbidities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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)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.
Pain intensity Baseline, 3 and 6 months follow-up Numeric rating scale (0-10), 0=no pain, 10= worst possible pain
Disease activity Baseline, 3 and 6 months follow-up Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity
Grip strength Baseline and 3 months follow-up Measured with Jamar dynamometer (kg), mean of two measures for each 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
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.
Fatigue Baseline, 3 and 6 months follow-up Fatigue last week measured on an 11-point NRS (0=no fatigue, 10=worst possible fatigue)
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
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
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.
eHealth literacy Baseline Measured with the eHEALS questionnaire, Norwegian version. 8 questions conserning eHealth literacy (strongly disagree - strongly agree)
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
Medication use Baseline, 3 and 6 months follow-up Medication use will be self-reported by the patient
Motivation for hand exercises Baseline and 3 monhts follow-up Numeric rating scale (0-10), 0=no motivation, 10=best motivation
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
Adherence to exercise 3 times weekly during the intervention period (3 months) Number of exercises performed (0-36 exercise sessions), collected from the app
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.
Number of painful joints Baseline Number of painful joints on left and right hand
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
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
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.
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 informational videos long-term 3 and 6 months follow-up Number of informational videos watched, collected from the app
Demographic variable Baseline Age, gender, other painful joints, sivil status, education, previous hand surgery, previous treatment, comorbidities
Trial Locations
- Locations (19)
Arendal sykehus
🇳🇴Arendal, Norway
Haukeland Universitetssykehus
🇳🇴Bergen, Norway
Aurskog Fysikalske Institutt
🇳🇴Bjørkelangen, Norway
Nordlandssykehuset
🇳🇴Bodø, Norway
Lærdal Sjukehus
🇳🇴Førde, Norway
Finnmarkssykehuset, Kirkenes Sykehus
🇳🇴Kirkenes, Norway
Kongsvinger sykehus
🇳🇴Kongsvinger, Norway
Kristiansand sykehus
🇳🇴Kristiansand, Norway
Levanger sykehus
🇳🇴Levanger, Norway
Revmatismesykehuset Lillehammer
🇳🇴Lillehammer, Norway
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