Skip to main content
OpenTrials
Completed

NCT Number: NCT05568875

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hand Osteoarthritis

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arendal sykehus, Arendal, Norway

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

e-self-management intervention (Happy Hands app)

Other

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.

Treatment as Usual

Other

Treatment as usual may vary from no treatment at all to referral to a patient education group program, or occupational therapy.

Primary outcomes

  1. 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:

    • ≥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)

Secondary outcomes

  1. OMERACT/OARSI responder criteria long-term

    Time frame: 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:

    • ≥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)

  2. Pain intensity

    Time frame: Baseline, 3 and 6 months follow-up

    Numeric rating scale (0-10), 0=no pain, 10= worst possible pain

  3. Pain intensity (intervention group)

    Time frame: 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

  4. Stiffness

    Time frame: Baseline, 3 and 6 months follow-up

    Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness

  5. Stiffness (intervention group)

    Time frame: 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

  6. Disease activity

    Time frame: Baseline, 3 and 6 months follow-up

    Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity

  7. Disease activity (intervention group)

    Time frame: 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

  8. Measure of Activity performance (MAP-Hand)

    Time frame: 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.

  9. Measure of Activity performance (MAP-Hand) (intervention group)

    Time frame: 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.

  10. Grip strength

    Time frame: Baseline and 3 months follow-up

    Measured with Jamar dynamometer (kg), mean of two measures for each hand

  11. Quality indicators for hand osteoarthritis treatment

    Time frame: 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.

  12. eHealth literacy

    Time frame: Baseline

    Measured with the eHEALS questionnaire, Norwegian version. 8 questions conserning eHealth literacy (strongly disagree - strongly agree)

  13. Number of painful joints

    Time frame: Baseline

    Number of painful joints on left and right hand

  14. Change in condition

    Time frame: Baseline, 3 and 6 months follow-up

    Global rating of change scale, likert scale with 7 answer options from much better to much worse

  15. Change in condition (intervention group)

    Time frame: Monthly in the intervention group (3 months)

    Global rating of change scale, likert scale with 7 answer options from much better to much worse

  16. Motivation for hand exercises

    Time frame: Baseline and 3 monhts follow-up

    Numeric rating scale (0-10), 0=no motivation, 10=best motivation

  17. Health-related quality of life

    Time frame: 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

  18. Health care utilization

    Time frame: 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.

  19. Medication use

    Time frame: Baseline, 3 and 6 months follow-up

    Medication use will be self-reported by the patient

  20. Adverse events

    Time frame: 3 and 6 months follow-up

    Number of adverse events, serious adverse events, and withdrawals because of adverse events. Will be self-reported

  21. Sickleave

    Time frame: Baseline, 3 and 6 months follow-up

    Sickleave due to hand osteoarthritis will be self-reported

  22. Fatigue

    Time frame: Baseline, 3 and 6 months follow-up

    Fatigue last week measured on an 11-point NRS (0=no fatigue, 10=worst possible fatigue)

  23. Patient satisfaction with care

    Time frame: 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

  24. System Usability Scale (SUS)

    Time frame: 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

  25. Adherence to exercise

    Time frame: 3 times weekly during the intervention period (3 months)

    Number of exercises performed (0-36 exercise sessions), collected from the app

  26. Adherence to exercise long-term

    Time frame: 3 and 6 months follow-up

    Number of exercises performed after completion of intervention, collected from the app

  27. Adherence to informational videos

    Time frame: During the intervention period (3 months)

    Number of informational videos watched, collected from the app

  28. Adherence to informational videos long-term

    Time frame: 3 and 6 months follow-up

    Number of informational videos watched, collected from the app

  29. Arthritis self-efficacy scale

    Time frame: 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.

  30. Demographic variable

    Time frame: Baseline

    Age, gender, other painful joints, sivil status, education, previous hand surgery, previous treatment, comorbidities

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • The Dam Foundation

Registry information

Acronym: HappyHands

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 6, 2022
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.