Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis

Hand Osteoarthritis Clinical Trial

— HappyHands  

Official title:

Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05568875
• Other study ID #: REK 477746
• Status: Completed
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: April 2024
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of this project is to assess the effect, cost-effectiveness and user experiences with using an e-self-management intervention in addition to treatment as usual compared to treatment as usual alone in patients with hand osteoarthritis. The study is an RCT comprising approx 400 participants with hand osteoarthritis recruited from primary and secondary healthcare in all four health regions in Norway.

Description:

Hand osteoarthritis (OA) is a highly prevalent rheumatic joint disease, and the number of people living with debilitating hand OA will continue to rise in the coming decades due to increased life expectancy. Research shows that patients with hand OA have poor access to recommended treatment, and in Norway, they are increasingly referred to surgical consultation before having received recommended first-line treatment. Thus, there is a need to develop easily viable models of care for patients with hand OA that make recommended treatment available across different healthcare levels.

Our hypotheses are that an e-self-management intervention for people with hand OA will improve pain and function and be more cost-effective compared to treatment as usual, and that this app can easily be implemented in both specialist and primary healthcare. The hypotheses will be tested and explored in a randomized controlled trial, with a qualitative study nested within this trial.

The main research questions are:

1. To evaluate whether a 12-week e-self-management intervention is more effective in improving pain and function (according to the OMERACT-OARSI responder criteria26) compared to usual care in patients with hand OA (randomized controlled trial).

2. To determine the cost-effectiveness of the e-self-management intervention compared to usual care after 6 months (randomized controlled trial).

3. To explore patients' experience of barriers and facilitators for adopted and continued use of a e-self-management intervention for treatment of hand OA (qualitative interviews).

Secondary research questions will also be assessed.

Approx 400 patients will be recruited in this multicenter randomized controlled trial where patients with hand OA are allocated to either usual care or a 12-week e-self-management intervention delivered through a smartphone app (the HAPPY Hands app). Outcome measures are collected at baseline, 3 months (=end of intervention) and 6 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: February 29, 2024
• Est. primary completion date: September 1, 2023
• 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

• do not talk or understand Norwegian,

• have uncontrolled serious comorbidities

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

Intervention

Other:
• e-self-management intervention (Happy Hands app)
The 12-week intervention consists of 30 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 intervention group will additionally receive treatment as usual.
• Treatment as usual
Treatment as usual may vary from no treatment at all to referral to a patient education group program, or occupational therapy.

Locations

Country	Name	City	State
Norway	Ålesund sjukehus	Ålesund
Norway	Arendal sykehus	Arendal
Norway	Haukeland Universitetssykehus	Bergen
Norway	Aurskog Fysikalske Institutt	Bjørkelangen
Norway	Nordlandssykehuset	Bodø
Norway	Lærdal Sjukehus	Førde
Norway	Finnmarkssykehuset, Kirkenes Sykehus	Kirkenes
Norway	Kongsvinger sykehus	Kongsvinger
Norway	Kristiansand sykehus	Kristiansand
Norway	Levanger sykehus	Levanger
Norway	Revmatismesykehuset Lillehammer	Lillehammer
Norway	Meråker kurbad	Meråker
Norway	Nøtterøy Fysioterapi	Nøtterøy
Norway	Diakonhjemmet Hospital	Oslo
Norway	Humana Helse	Sandvika
Norway	Helsehuset Stokke	Tønsberg
Norway	Universitetssykehuset Nord-Norge	Tromsø
Norway	St.Olavs Hospital	Trondheim
Norway	Vikersund bad	Vikersund

Sponsors (2)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	The Dam Foundation

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OMERACT/OARSI responder criteria	Combined score of change in pain, function and disease activity. Patients are categorized into responders or non-responders according to the following: High improvement on pain or function: =50% improvement + absolute change of =2 in pain (numeric rating scale, NRS 0-10), OR; =50% improvement + absolute change of =0.6 in function (Measure of Activity Performance of the Hand, MAP-Hand); Improvement in at least two of the three following: =20% improvement + absolute change of =1 in pain (NRS); =20% improvement + absolute change of =0.3 in function (MAP-Hand); =20% improvement + absolute change of =1 in global assessment of disease activity (NRS)	Baseline and 3 months follow-up
Secondary	OMERACT/OARSI responder criteria long-term	Combined score of change in pain, function and disease activity. Patients are categorized into responders or non-responders according to the following: High improvement on pain or function: =50% improvement + absolute change of =2 in pain (numeric rating scale, NRS 0-10), OR; =50% improvement + absolute change of =0.6 in function (Measure of Activity Performance of the Hand, MAP-Hand); Improvement in at least two of the three following: =20% improvement + absolute change of =1 in pain (NRS); =20% improvement + absolute change of =0.3 in function (MAP-Hand); =20% improvement + absolute change of =1 in global assessment of disease activity (NRS)	3 and 6 months follow-up
Secondary	Pain intensity	Numeric rating scale (0-10), 0=no pain, 10= worst possible pain	Baseline, 3 and 6 months follow-up
Secondary	Pain intensity (intervention group)	Numeric rating scale (0-10), 0=no pain, 10= worst possible pain, measured after each exercise session	3 times weekly in the intervention period (12 weeks)
Secondary	Stiffness	Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness	Baseline, 3 and 6 months follow-up
Secondary	Stiffness (intervention group)	Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness, measured after each exercise session	3 times weekly in the intervention period (12 weeks)
Secondary	Disease activity	Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity	Baseline, 3 and 6 months follow-up
Secondary	Disease activity (intervention group)	Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity, measured each month in the intervention period	Monthly in the intervention period (12 weeks)
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, 3 and 6 months follow-up
Secondary	Measure of Activity performance (MAP-Hand) (intervention group)	18 questions conserning activity performance of the hand (1=no problem, 4=cannot do the activity), mean score from 1-4.	Monthly in the intervention period (12 weeks)
Secondary	Grip strength	Measured with Jamar dynamometer (kg), mean of two measures for each hand	Baseline and 3 months 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, 3 and 6 months follow-up
Secondary	eHealth literacy	Measured with the eHEALS questionnaire, Norwegian version. 8 questions conserning eHealth literacy (strongly disagree - strongly agree)	Baseline
Secondary	Number of painful joints	Number of painful joints on left and right hand	Baseline
Secondary	Change in condition	Global rating of change scale, likert scale with 7 answer options from much better to much worse	Baseline, 3 and 6 months follow-up
Secondary	Change in condition (intervention group)	Global rating of change scale, likert scale with 7 answer options from much better to much worse	Monthly in the intervention group (3 months)
Secondary	Motivation for hand exercises	Numeric rating scale (0-10), 0=no motivation, 10=best motivation	Baseline and 3 monhts follow-up
Secondary	Health-related quality of life	Measured with EQ5D-5L, 5 questions used to calculate an utility score (0-1, 1= best health), assessed as a total score across all timepoints	Baseline, 3 and 6 months follow-up
Secondary	Health care utilization	Costs related to self-reported healthcare use in primary and secondary health care. Patients will be asked if they have been seeking healthcare (yes/no), if yes, they will be asked to specify type of healthcare use and time used.	Baseline, 3 and 6 months follow-up
Secondary	Medication use	Medication use will be self-reported by the patient	Baseline, 3 and 6 months follow-up
Secondary	Adverse events	Number of adverse events, serious adverse events, and withdrawals because of adverse events. Will be self-reported	3 and 6 months follow-up
Secondary	Sickleave	Sickleave due to hand osteoarthritis will be self-reported	Baseline, 3 and 6 months follow-up
Secondary	Fatigue	Fatigue last week measured on an 11-point NRS (0=no fatigue, 10=worst possible fatigue)	Baseline, 3 and 6 months follow-up
Secondary	Patient satisfaction with care	1 item with five point response options ranging from "Very satisfied" to "Very dissatisfied", higher value indicate better outcome	Baseline, 3 and 6 months follow-up
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	3 month follow-up
Secondary	Adherence to exercise	Number of exercises performed (0-36 exercise sessions), collected from the app	3 times weekly during the intervention period (3 months)
Secondary	Adherence to exercise long-term	Number of exercises performed after completion of intervention, collected from the app	3 and 6 months follow-up
Secondary	Adherence to informational videos	Number of informational videos watched, collected from the app	During the intervention period (3 months)
Secondary	Adherence to informational videos long-term	Number of informational videos watched, collected from the app	3 and 6 months follow-up
Secondary	Arthritis self-efficacy scale	Measured by Arthritis Self-Efficacy Scale (ASES): comprises 11 items addressing pain and symptoms (scored on a 5-point scale ranging from not confident at all to very confident). The scores are summed up to a 0-100 score where higher score indicate better self-efficacy.	Baseline
Secondary	Demographic variable	Age, gender, other painful joints, sivil status, education, previous hand surgery, previous treatment, comorbidities	Baseline