Happy Hands E-self-management Pilot Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hand Osteoarthritis
• Intervention / Treatment: Other: e-self-management intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0319
    • Diakonhjemmet Hospital
  • Please Select
    • Oslo, Please Select, Norway, 0130
      • Norwegian Rheumatology Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: e-self-management intervention; Patients will receive the HAPPY Hands e-self-management intervention delivered through a smartphone app.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Numeric rating scale (0-10), 0=no pain, 10= worst possible pain	Baseline and 12 week follow-up
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)
Stiffness	Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness	Baseline and 12 week follow-up
Stiffness	Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness	After each exercise session (3 times a week for 12 weeks)
Grip strength	Measured with Jamar dynamometer (kg), mean of two measures for each hand	Baseline and 12 week follow-up
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
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
eHealth literacy	Measured with the eHEALS questionnaire, Norwegian version. 8 questions conserning eHealth literacy (strongly disagree - strongly agree)	Baseline
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
Number of painful joints	Number of painful joints on left and right hand	Baseline
Disease activity	Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity	Baseline, 4 weeks, 8 weeks, 12 weeks
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
Demographic variables	Age, gender, other painful joints, sivil status, education, previous hand surgery, comorbidities	Baseline
Motivation for hand exercises	Numeric rating scale (0-10), 0=no motivation, 10=best motivation	Baseline
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

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Collaborators: The Norwegian Rheumatism Association

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Actual): August 10, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: REK 249364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data may be made available upon reasonable request to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No