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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05150171
Other study ID # REK 249364
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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