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Hand OsteoarthritisNCT05150171

Happy Hands E-self-management Pilot Study

A study testing e-self-management intervention in people with Hand Osteoarthritis, run by Diakonhjemmet Hospital at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot study will assess usability of a e-self-management program for patients with hand osteoarthritis through the Happy Hands app. People with hand osteoarthritis will be recruited for the study. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Hand Osteoarthritis
What is being tested?
e-self-management intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesNorway
Study dates
23 Nov 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • People diagnosed with hand osteoarthritis
  • Possessing a smartphone

Who cannot join

  • cognitive deficits
  • are scheduled for hand surgery within the next 3 months
  • if they do not talk or understand Norwegian,
  • if they have uncontrolled serious comorbidities.

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Norwegian Rheumatology Association

    Oslo, Please Select, 0130

  • Diakonhjemmet Hospital

    Oslo, 0319

Other trials in Norway

About this study

Official title: Usability of an E-self-management Program for Treatment of Hand Osteoarthritis - the Happy Hands Pilot Study

This pilot study will assess usability of a e-self-management program for patients with hand osteoarthritis through the Happy Hands app. People with hand osteoarthritis will be recruited for the study. The e-self-management intervention consists of informational videos and videos of hand exercises and has a duration of 12 weeks. Patient-reported outcomes and grip strength will be collected before and after the 12 week intervention period. Change in pain, stiffness, grip strength, disease activity and quality indicators will be assessed after 12 weeks.

Read the detailed description

Patients diagnosed with hand osteoarthritis will be recuited from The Norwegian Rheumatism Association, Diakonhjemmet Hospital and Ankerløkka Legesenter (general practitioner). Patients will be summoned for an appointment at Diakonhjemmet or another suitable place for testing of grip strength and instructions on how to download the app. The e-self-management intervention is a 12 week intervention delivered through the Happy Hands app.

The app is developed based on a combination of behavioural change techniques informed by Social cognitive theory and the EULAR recommendations on management of hand OA. The 12-week intervention consists of 25 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 informational videos and exercise program are delivered in a progressive order across the 12 weeks. When downloading the app, participants are asked to specify when they plan to use the app (three days a week with time points). Thereafter, patients get a notification on their smartphone with that week's informational videos and hand exercises on the specified days.

After each exercise session patients are asked to rate their pain and stiffness, and these answers are put into graphs visualising the development over the 12-week intervention period. Each month, patients also answer questions about hand function, which they can use to self-monitor their development across the intervention period. Encouragement and motivational messages are provided each week to enhance continued adherence to the intervention. Additionally, at the end of each week the patients are asked questions related to the informational videos the paticipants have seen that week for the purpose of promoting self-efficacy.

The primary aim is to assess the change in quality indicators from baseline to 12 weeks follow-up. Secondary aims are to assess the change in pain, stiffness, activity performance and grip strength from baseline to follow-up, and to assess the use of and adherence to the content of the app.

Being tested
e-self-management intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-self-management interventionOther

    The app is developed based on a combination of behavioural change techniques informed by Social cognitive theory and the EULAR recommendations on management of hand osteoarthritis. The 12-week intervention consists of 25 short informational videos addressing the themes prioritized by the patient research partners. 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 informational videos and exercise program are delivered in a progressive order across the 12 weeks. Encouragement and motivational messages are provided each week to enhance continued adherence to the intervention.

Study groups in NCT05150171
Study groupRoleWhat they receive
e-self-management interventionExperimentalPatients will receive the HAPPY Hands e-self-management intervention delivered through a smartphone app.
Receives: Other: e-self-management intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 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.

    Measured: Baseline and 12 week follow-up

Secondary outcomes (15)

  1. Pain intensity

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

    Measured: Baseline and 12 week follow-up

  2. Pain intensity

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

    Measured: After each exercise session (3 times a week for 12 weeks)

  3. Stiffness

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

    Measured: Baseline and 12 week follow-up

  4. Stiffness

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

    Measured: After each exercise session (3 times a week for 12 weeks)

  5. Grip strength

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

    Measured: Baseline and 12 week follow-up

  6. 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.

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks follow-up

  7. 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.

    Measured: Baseline and 12 week follow-up

  8. eHealth literacy

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

    Measured: Baseline

  9. 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

    Measured: 12 week follow-up

  10. Number of painful joints

    Number of painful joints on left and right hand

    Measured: Baseline

  11. Disease activity

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

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

  12. Change in condition

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

    Measured: 4 weeks, 8 weeks, 12 weeks

  13. Demographic variables

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

    Measured: Baseline

  14. Motivation for hand exercises

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

    Measured: Baseline

  15. Adherence to app content

    Number of exercises performed (0-36 exercise sessions) and informational videos watched (0-12 weeks) during the intervention period. Collected from the app

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2021
  2. Study start23 Nov 2021
  3. Primary completion10 Aug 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
An e-self-management intervention consisting of videos informing patients with hand osteoarthritis about recommended treatment (information, hand exercises, use of assistive devices and orthoses, information about pharmacological and surgical treatment).
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05150171
Sponsor's protocol ID
REK 249364
Status last verified
Feb 2023
First submitted
26 Nov 2021
Last updated
2 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data may be made available upon reasonable request to the principal investigator.

Publications

  • Tveter AT, Varsi C, Maarnes MK, Pedersen SJ, Christensen BS, Blanck TB, Nyheim SB, Pelle T, Kjeken I. Development of the Happy Hands Self-Management App for People with Hand Osteoarthritis: Feasibility Study. JMIR Form Res. 2024 Oct 29;8:e59016. doi: 10.2196/59016.

    PubMed 39470716

Questions about this trial

What is this clinical trial studying?

A study testing e-self-management intervention in people with Hand Osteoarthritis, run by Diakonhjemmet Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in quality indicators for hand osteoarthritis treatment (time frame: Baseline and 12 week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05150171, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.

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