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Clinical Trials/NCT05150171
NCT05150171
Completed
Not Applicable

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

Diakonhjemmet Hospital2 sites in 1 country72 target enrollmentNovember 23, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hand Osteoarthritis
Sponsor
Diakonhjemmet Hospital
Enrollment
72
Locations
2
Primary Endpoint
Change in quality indicators for hand osteoarthritis treatment
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 23, 2021
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Diakonhjemmet Hospital
Responsible Party
Principal Investigator
Principal Investigator

Anne Therese Tveter

Senior researcher

Diakonhjemmet Hospital

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.

Outcomes

Primary Outcomes

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

  • Stiffness(After each exercise session (3 times a week for 12 weeks))
  • Grip strength(Baseline and 12 week follow-up)
  • Measure of Activity performance (MAP-Hand)(Baseline, 4 weeks, 8 weeks, 12 weeks follow-up)
  • Motivation for hand exercises(Baseline)
  • Pain intensity(After each exercise session (3 times a week for 12 weeks))
  • Change in condition(4 weeks, 8 weeks, 12 weeks)
  • Quality indicators for hand osteoarthritis treatment(Baseline and 12 week follow-up)
  • Number of painful joints(Baseline)
  • Adherence to app content(12 weeks)
  • Demographic variables(Baseline)
  • eHealth literacy(Baseline)
  • System Usability Scale (SUS)(12 week follow-up)
  • Disease activity(Baseline, 4 weeks, 8 weeks, 12 weeks)

Study Sites (2)

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