Skip to content

Happy Hands E-self-management Pilot Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05150171
Enrollment
72
Registered
2021-12-08
Start date
2021-11-23
Completion date
2022-12-31
Last updated
2023-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Osteoarthritis

Brief 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. 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.

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.

Interventions

OTHERe-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.

Sponsors

The Norwegian Rheumatism Association
CollaboratorOTHER
Diakonhjemmet Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in quality indicators for hand osteoarthritis treatmentBaseline and 12 week follow-upQuality 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

MeasureTime frameDescription
StiffnessBaseline and 12 week follow-upNumeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness
Grip strengthBaseline and 12 week follow-upMeasured with Jamar dynamometer (kg), mean of two measures for each hand
Measure of Activity performance (MAP-Hand)Baseline, 4 weeks, 8 weeks, 12 weeks follow-up18 questions conserning activity performance of the hand (1=no problem, 4=cannot do the activity), mean score from 1-4.
Quality indicators for hand osteoarthritis treatmentBaseline and 12 week follow-upQuality 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.
eHealth literacyBaselineMeasured with the eHEALS questionnaire, Norwegian version. 8 questions conserning eHealth literacy (strongly disagree - strongly agree)
System Usability Scale (SUS)12 week follow-upQuestionnaire assessing the usability of the Happy Hands app, 10 questions (strongly agree - strongly disagree), index from 0-100 where 100 is best score
Pain intensityBaseline and 12 week follow-upNumeric rating scale (0-10), 0=no pain, 10= worst possible pain
Disease activityBaseline, 4 weeks, 8 weeks, 12 weeksNumeric rating scale (0-10), 0=no disease activity; 10=high disease activity
Change in condition4 weeks, 8 weeks, 12 weeksGlobal rating of change scale, likert scale with 7 answer options from much better to much worse
Demographic variablesBaselineAge, gender, other painful joints, sivil status, education, previous hand surgery, comorbidities
Motivation for hand exercisesBaselineNumeric rating scale (0-10), 0=no motivation, 10=best motivation
Adherence to app content12 weeksNumber of exercises performed (0-36 exercise sessions) and informational videos watched (0-12 weeks) during the intervention period. Collected from the app
Number of painful jointsBaselineNumber of painful joints on left and right hand

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026