Clinical trial NCT05150171: Happy Hands E-self-management Pilot Study
Official title: Usability of an E-self-management Program for Treatment of Hand Osteoarthritis - the Happy Hands Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Osteoarthritis
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: The Norwegian Rheumatism Association
First posted: 2021-12-08
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in quality indicators for hand osteoarthritis treatment
timeFrame: Baseline and 12 week follow-up
Secondary outcomes:
measure: Pain intensity
timeFrame: Baseline and 12 week follow-up
measure: Pain intensity
timeFrame: After each exercise session (3 times a week for 12 weeks)
measure: Stiffness
timeFrame: Baseline and 12 week follow-up
measure: Stiffness
timeFrame: After each exercise session (3 times a week for 12 weeks)
measure: Grip strength
timeFrame: Baseline and 12 week follow-up
measure: Measure of Activity performance (MAP-Hand)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks follow-up
measure: Quality indicators for hand osteoarthritis treatment
timeFrame: Baseline and 12 week follow-up
measure: eHealth literacy
timeFrame: Baseline
measure: System Usability Scale (SUS)
timeFrame: 12 week follow-up
measure: Number of painful joints
timeFrame: Baseline
measure: Disease activity
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in condition
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Demographic variables
timeFrame: Baseline
measure: Motivation for hand exercises
timeFrame: Baseline
measure: Adherence to app content
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Rheumatology Association
state: Please Select
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Anne Therese Tveter, PhD
role: PRINCIPAL_INVESTIGATOR
References: