Happy Hands E-self-management Pilot Study

Hand Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05150171
• Other study ID #: REK 249364
• Status: Completed
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo
Norway	Norwegian Rheumatology Association	Oslo	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	The Norwegian Rheumatism Association

Country where clinical trial is conducted

Norway, 

Outcome

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