Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05568875
Other study ID # REK 477746
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01910116 - Efficacy of Shinabro in Hand Osteoarthritis Phase 2/Phase 3
Completed NCT02612233 - Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin Phase 4
Completed NCT01249391 - Splinting to Treat Hand Osteoarthritis Phase 2
Recruiting NCT04402047 - Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis N/A
Completed NCT03911570 - Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis
Completed NCT04576403 - Heated Mittens for Patients With Hand Osteoarthritis N/A
Completed NCT02528630 - Progressive Strength in Hand Osteoarthritis Phase 4
Completed NCT01874067 - C-GLOVES: the Effectiveness of Compression Gloves in Arthritis
Suspended NCT03703934 - Central Pain Mechanisms in Patients With Hand-Osteoarthritis, Psoriatic Arthritis and Healthy Controls
Completed NCT04585113 - Diagnostic Accuracy of Dual-energy CT
Completed NCT03693833 - CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. Phase 2
Completed NCT05150171 - Happy Hands E-self-management Pilot Study N/A
Completed NCT02667145 - Assistive Device for Hand Osteoarthritis N/A
Completed NCT02477059 - Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis Phase 3
Recruiting NCT04611347 - Topical CBD in Joint Arthritis Phase 2
Completed NCT04036929 - Can we Use Estrogen-containing Therapy to Improve Pain in Women After Menopause With Hand Osteoarthritis? N/A
Completed NCT03919279 - Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation N/A
Recruiting NCT06329219 - Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis N/A
Not yet recruiting NCT05216757 - Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO) Phase 2/Phase 3
Completed NCT02771860 - RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints Phase 2