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Completed

NCT Number: NCT05150171

Happy Hands E-self-management 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.

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Key information

Conditions

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian Rheumatology Association, Oslo, Please Select, Norway

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About this study

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.

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
  • if they do not talk or understand Norwegian,
  • if they have uncontrolled serious comorbidities.

Treatment and study plan

e-self-management intervention

Other

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.

Primary outcomes

  1. Change in quality indicators for hand osteoarthritis treatment

    Time frame: Baseline and 12 week 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.

Secondary outcomes

  1. Pain intensity

    Time frame: Baseline and 12 week follow-up

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

  2. Pain intensity

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

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

  3. Stiffness

    Time frame: Baseline and 12 week follow-up

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

  4. Stiffness

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

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

  5. Grip strength

    Time frame: Baseline and 12 week follow-up

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

  6. Measure of Activity performance (MAP-Hand)

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks follow-up

    18 questions conserning activity performance of the hand (1=no problem, 4=cannot do the activity), mean score from 1-4.

  7. Quality indicators for hand osteoarthritis treatment

    Time frame: Baseline and 12 week 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.

  8. eHealth literacy

    Time frame: Baseline

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

  9. System Usability Scale (SUS)

    Time frame: 12 week 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

  10. Number of painful joints

    Time frame: Baseline

    Number of painful joints on left and right hand

  11. Disease activity

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

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

  12. Change in condition

    Time frame: 4 weeks, 8 weeks, 12 weeks

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

  13. Demographic variables

    Time frame: Baseline

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

  14. Motivation for hand exercises

    Time frame: Baseline

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

  15. Adherence to app content

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • The Norwegian Rheumatism Association

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 8, 2021
Registry last updated
Feb 2, 2023

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.

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