An interventional study of e-self-management intervention in Hand Osteoarthritis, sponsored by Diakonhjemmet Hospital. Completed at 2 sites in Norway. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by Diakonhjemmet Hospital · Not applicable, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 72 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Diakonhjemmet Hospital is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive the HAPPY Hands e-self-management intervention delivered through a smartphone app.
Other: e-self-management intervention
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.
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.
Time frame: Baseline and 12 week follow-up
Pain intensity
Numeric rating scale (0-10), 0=no pain, 10= worst possible pain
Time frame: Baseline and 12 week follow-up
Pain intensity
Numeric rating scale (0-10), 0=no pain, 10= worst possible pain
Time frame: After each exercise session (3 times a week for 12 weeks)
Stiffness
Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness
Time frame: Baseline and 12 week follow-up
Stiffness
Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness
Time frame: After each exercise session (3 times a week for 12 weeks)
Grip strength
Measured with Jamar dynamometer (kg), mean of two measures for each hand
Time frame: Baseline and 12 week follow-up
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks follow-up
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.
Time frame: Baseline and 12 week follow-up
eHealth literacy
Measured with the eHEALS questionnaire, Norwegian version. 8 questions conserning eHealth literacy (strongly disagree - strongly agree)
Time frame: Baseline
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
Time frame: 12 week follow-up
Number of painful joints
Number of painful joints on left and right hand
Time frame: Baseline
Disease activity
Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in condition
Global rating of change scale, likert scale with 7 answer options from much better to much worse
Time frame: 4 weeks, 8 weeks, 12 weeks
Demographic variables
Age, gender, other painful joints, sivil status, education, previous hand surgery, comorbidities
Time frame: Baseline
Motivation for hand exercises
Numeric rating scale (0-10), 0=no motivation, 10=best motivation
Time frame: Baseline
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
Time frame: 12 weeks
Plan to share: No — Individual participant data may be made available upon reasonable request to the principal investigator.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Diakonhjemmet Hospital