Hand Osteoarthritis Clinical Trial
Official title:
Usability of an E-self-management Program for Treatment of Hand Osteoarthritis - the Happy Hands Pilot Study
Verified date | February 2023 |
Source | Diakonhjemmet Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Diakonhjemmet Hospital | Oslo | |
Norway | Norwegian Rheumatology Association | Oslo | Please Select |
Lead Sponsor | Collaborator |
---|---|
Diakonhjemmet Hospital | The Norwegian Rheumatism Association |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline and 12 week follow-up | |
Secondary | Pain intensity | Numeric rating scale (0-10), 0=no pain, 10= worst possible pain | Baseline and 12 week follow-up | |
Secondary | Pain intensity | Numeric rating scale (0-10), 0=no pain, 10= worst possible pain | After each exercise session (3 times a week for 12 weeks) | |
Secondary | Stiffness | Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness | Baseline and 12 week follow-up | |
Secondary | Stiffness | Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness | After each exercise session (3 times a week for 12 weeks) | |
Secondary | Grip strength | Measured with Jamar dynamometer (kg), mean of two measures for each hand | Baseline and 12 week follow-up | |
Secondary | 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. | Baseline, 4 weeks, 8 weeks, 12 weeks follow-up | |
Secondary | 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. | Baseline and 12 week follow-up | |
Secondary | eHealth literacy | Measured with the eHEALS questionnaire, Norwegian version. 8 questions conserning eHealth literacy (strongly disagree - strongly agree) | Baseline | |
Secondary | 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 | 12 week follow-up | |
Secondary | Number of painful joints | Number of painful joints on left and right hand | Baseline | |
Secondary | Disease activity | Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity | Baseline, 4 weeks, 8 weeks, 12 weeks | |
Secondary | Change in condition | Global rating of change scale, likert scale with 7 answer options from much better to much worse | 4 weeks, 8 weeks, 12 weeks | |
Secondary | Demographic variables | Age, gender, other painful joints, sivil status, education, previous hand surgery, comorbidities | Baseline | |
Secondary | Motivation for hand exercises | Numeric rating scale (0-10), 0=no motivation, 10=best motivation | Baseline | |
Secondary | 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 | 12 weeks |
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