OsteoarthritisDigiOANCT04767854
Digital Osteoarthritis Care
A study testing OA school and Virtual Training mobile health application in people with Osteoarthritis, run by Diakonhjemmet Hospital at 13 sites in Norway.
Trial summary
Osteoarthritis (OA) is among the most prevalent and costly diseases, with an estimate of $460 billion in all-cause medical costs. It causes pain and reduced physical function, and with no existing cure, the recommended first-line treatment is information, exercise and weight management if indicated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- OA school and Virtual Training mobile health application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 13 sitesNorway
- Study dates
- 1 Jun 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Activity-related hip and/or knee pain/complaints and clinical signs and symptoms corresponding to hip and/or knee OA
- Access to smartphone or tablet
Who cannot join
- Neurological disorders
- Contraindication to physical activity
- Total hip or knee replacement in the actual joint(s) with no pain/ complaints in the other hip or knee joint(s)
- Inflammatory rheumatic diseases (e.g. rheumatoid arthritis, spondyloarthritis)
- Malignant illness or other major conditions (e.g. unstable cardiovascular disorders or lung disease, dementia) that restrict the ability to adhere to the recommended treatment
- Not understanding the Norwegian language
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Norway13 sites
Laguneparken fysioterapi/Arna fysikalske
Bergen
Sandviken fysioterapi og trening
Bergen
Trimmen
Drammen
Sentrum Fysioterapi
Gjøvik
Ace Treningssenter
Indre Østfold
Trøgstad fysioterapi
Indre Østfold
Nittedal fysikalske institutt
Nittedal
Physiotherapist Stein Listaul
Notodden
Aktifys Institutt
Oslo
Furuset Fysioterapi
Oslo
Røa Centrum Fysioterapi og Akupunktur
Oslo
Ski Fysioterapisenter
Ski
Skiptvet Fysikalske
Skiptvet
About this study
Official title: Digital Osteoarthritis Care- DigiOA
Osteoarthritis (OA) is among the most prevalent and costly diseases, with an estimate of $460 billion in all-cause medical costs. It causes pain and reduced physical function, and with no existing cure, the recommended first-line treatment is information, exercise and weight management if indicated. As the prevalence of OA is expected to increase in the coming years, exploring innovative solutions to maintain economical sustainable treatment in the future becomes a necessity. Telerehabilitation, technology which involves providing treatment through information and communication technology, regardless of the patient's geographical location, has shown its potential within cardiac, pulmonary, neurological and musculoskeletal conditions.
Virtual Training (VT) is a generic mobile health application used to deliver digital home exercise programs with text, audio and video support. Through a novel feedback system the therapist is able monitor the patients progress and pain level during exercise. This project aims to investigate, through a randomized controlled trial (RCT), whether the use of the VT-app is as effective as supervised exercise therapy in improving pain, physical function and disease activity in patients with hip and/or knee osteoarthritis. In addition, the investigators want to investigate if the use of the app is more cost effective than supervised exercise therapy, whether the use increases adherence with first line treatment, and whether there are certain characteristics of the patients responding to the intervention.
Read the detailed description
The study is a two-armed non-inferiority randomized controlled trial (RCT) situated in the primary care setting in Norway. Participants diagnosed with hip and/or knee OA will be randomized to either exercise therapy via app or usual care. Patients aged 18 years and older presenting with activity-related hip and/or knee pain/complaints and clinical signs and symptoms corresponding to hip and/or knee OA seeking treatment at physiotherapist working in private practice, will be included if eligible for the study.
The research questions are:
- Is exercise therapy, delivered through a mobile health application (Virtual Training), as effective as supervised exercise therapy in patients with hip and/or knee OA, measured by number of patients classified as responders according to the OMERACT-OARSI responder criteria?
- Is exercise therapy delivered through Virtual Training more cost-effective regarding health care and medication use than supervised exercise therapy for patients with hip and/or knee OA?
- Will patients with hip and/or knee OA, using Virtual Training, be more adherent to exercise during the intervention period compared to patients undergoing supervised exercise therapy, and are there any demographic or clinical factors characterizing the OMERACT-OARSI responding patients using Virtual Training?
The primary analysis will be conducted on an intention-to-treat basis by comparing the proportion of responders at 6 weeks and 3 months post-intervention according to the OMERACT-OARSI responder criteria in the intervention and the control group using logistic regression analysis. Per-protocol analyses will also be conducted. Difference in secondary outcomes will be assessed using analysis of covariance (ANCOVA) on the post-intervention values, with baseline values as covariates.
Cost-effectiveness will be evaluated assessing the difference in health care and medication use and quality of life during 3-month follow-up, reporting the incremental cost-effectiveness ratio (ICER) reflecting the between-group difference in incremental cost per adjusted life years (QALYs). Between-group difference in adherence to exercise will be assessed using linear regression, while patient characteristics in the intervention group will be assessed using logistic regression. Additional analyses assessing associations between physical activity, efficacy, barriers for exercise and OA-related questions will also be assessed in secondary analyses.
- Conditions
- Osteoarthritis
- Being tested
- OA school, Virtual Training mobile health application, Usual care
- Keywords
- Osteoarthritis, Telerehabilitation, Digital care, mHealth
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OA schoolBehavioural
Patient education according to guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
Virtual Training mobile health applicationOther
Individually tailored home exercise programs delivered through a mobile health application
Usual careOther
Individually tailored exercise programs conducted in weekly supervised individual or group sessions
| Study group | Role | What they receive |
|---|---|---|
| OA school + Virtual Training mobile health application | Experimental | After a clinical examination by the physiotherapist, all patients will receive a 1-2-hour group session of patient education according to guidelines.
The intervention group will receive an individually tailored exercise program through the Virtual Training mobile health application. After each exercise the patient score his/her execution of the exercise on a Likert-scale of 1 to 5, judging their effort from very poor to very good. After the session, patients rate their pain on a Numeric Rating Scale from 0 to 10. The patients in the intervention group will be instructed to exercise 3 times per week for 6 weeks. If the patients want to exercise more than 3 times per week, the exercise program will be available in the app once every day. Receives: Behavioral: OA school; Other: Virtual Training mobile health application |
| OA school + usual care | Active comparator | After a clinical examination by the physiotherapist, all patients will receive a 1-2-hour group session of patient education according to guidelines.
The control group will receive individually tailored supervised exercise therapy by a physiotherapist individually or in a group setting, twice a week for 6 weeks. Additionally, the patients will be motivated to perform one session of home exercise a week, a total of 3 sessions per week Receives: Behavioral: OA school; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of responders according to OMERACT-OARSI responder criteria
A patient is classified as a responder if one of the following criteria is fulfilled:
- High improvement in pain or function from baseline to follow-up
- ≥50% improvement + absolute change of ≥2 in pain, OR
- ≥50% improvement + absolute change of ≥2 in function
- Improvement in at least two of the three following from baseline to follow-up:
- ≥20% improvement + absolute change ≥1 in pain
- ≥20% improvement + absolute change ≥1 in function
- ≥20% improvement + absolute change ≥1 in the patient´s global assessment of disease activity
Measured: 6 weeks (end of intervention period)
Secondary outcomes (49)
Number of responders according to OMERACT-OARSI responder criteria
A patient is classified as a responder if one of the following criteria is fulfilled:
- High improvement in pain or function from baseline to follow-up
- ≥50% improvement + absolute change of ≥2 in pain, OR
- ≥50% improvement + absolute change of ≥2 in function
- Improvement in at least two of the three following from baseline to follow-up:
- ≥20% improvement + absolute change ≥1 in pain
- ≥20% improvement + absolute change ≥1 in function
- ≥20% improvement + absolute change ≥1 in the patient´s global assessment of disease activity
Measured: 18 weeks post randomization
Physical performance test, 30 seconds sit to stand test (30 sec STS)
Number of repetitions in the 30 seconds sit to stand-test
Measured: Baseline
Physical performance test, 30 seconds sit to stand test (30 sec STS)
Number of repetitions in the 30 seconds sit to stand-test
Measured: 6 weeks (end of intervention period)
Self reported goal achievement, Patient-specific functional scale (PSFS)
Patients will address one to three activities they have problems performing due to osteoarthritis. The degree of difficulty with performing these activities is rated from 0 (cannot perform the activity) to 10 (no problems)
Measured: Baseline
Self reported goal achievement, Patient-specific functional scale (PSFS)
Patients will address one to three activities they have problems performing due to osteoarthritis. The degree of difficulty with performing these activities is rated from 0 (cannot perform the activity) to 10 (no problems)
Measured: 6 weeks (end of intervention period)
Self reported goal achievement, Patient-specific functional scale (PSFS)
Patients will address one to three activities they have problems performing due to osteoarthritis. The degree of difficulty with performing these activities is rated from 0 (cannot perform the activity) to 10 (no problems)
Measured: 18 weeks post randomization
Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
Result in the last week disability on five subscales; pain (10 items, scale 0-40), symptoms (5 items, scale 0-20), function in daily living (17 items, scale 0-68), function in sport and recreation (4 items, scale 0-16) and quality of life (4 items, scale 0-16). Items are scored by a five-point Likert scale ranging from 0 (least severe) to 4 (most severe). Total sum-score and subscale sum-scores will be converted to normalized scores ranging from 0 (extreme disability) to 100 (no disability)
Measured: Baseline
Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
Result in the last week disability on five subscales; pain (10 items, scale 0-40), symptoms (5 items, scale 0-20), function in daily living (17 items, scale 0-68), function in sport and recreation (4 items, scale 0-16) and quality of life (4 items, scale 0-16). Items are scored by a five-point Likert scale ranging from 0 (least severe) to 4 (most severe). Total sum-score and subscale sum-scores will be converted to normalized scores ranging from 0 (extreme disability) to 100 (no disability)
Measured: 6 weeks (end of intervention period)
Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
Result in the last week disability on five subscales; pain (10 items, scale 0-40), symptoms (5 items, scale 0-20), function in daily living (17 items, scale 0-68), function in sport and recreation (4 items, scale 0-16) and quality of life (4 items, scale 0-16). Items are scored by a five-point Likert scale ranging from 0 (least severe) to 4 (most severe). Total sum-score and subscale sum-scores will be converted to normalized scores ranging from 0 (extreme disability) to 100 (no disability)
Measured: 18 weeks post randomization
Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
Result in the last week disability on five subscales; pain (9 items, scale 0-36), symptoms (7 items, scale 0-28), function in daily living (17 items, scale 0-68), function in sport and recreation (5 items, scale 0-20) and quality of life (4 items, scale 0-16). Items are scored by a five-point Likert scale ranging from 0 (least severe) to 4 (most severe). Total sum-score and subscale sum-scores will be converted to normalized scores ranging from 0 (extreme disability) to 100 (no disability)
Measured: Baseline
Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
Result in the last week disability on five subscales; pain (9 items, scale 0-36), symptoms (7 items, scale 0-28), function in daily living (17 items, scale 0-68), function in sport and recreation (5 items, scale 0-20) and quality of life (4 items, scale 0-16). Items are scored by a five-point Likert scale ranging from 0 (least severe) to 4 (most severe). Total sum-score and subscale sum-scores will be converted to normalized scores ranging from 0 (extreme disability) to 100 (no disability)
Measured: 6 weeks (end of intervention period)
Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
Result in the last week disability on five subscales; pain (9 items, scale 0-36), symptoms (7 items, scale 0-28), function in daily living (17 items, scale 0-68), function in sport and recreation (5 items, scale 0-20) and quality of life (4 items, scale 0-16). Items are scored by a five-point Likert scale ranging from 0 (least severe) to 4 (most severe). Total sum-score and subscale sum-scores will be converted to normalized scores ranging from 0 (extreme disability) to 100 (no disability)
Measured: 18 weeks post randomization
Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
Measured by The International Physical Activity Questionnaire-Short Form: Amount of time (minutes per week/day) spent on sitting, walking, and moderate- and vigorous intensity physical activity the last week (0-7 days). Results are reported as MET-scores and are categorized into categorical score of low, moderate or high level of physical activity.
Measured: Baseline
Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
Measured by The International Physical Activity Questionnaire-Short Form: Amount of time (minutes per week/day) spent on sitting, walking, and moderate- and vigorous intensity physical activity the last week (0-7 days). Results are reported as MET-scores and are categorized into categorical score of low, moderate or high level of physical activity.
Measured: 6 weeks (end of intervention)
Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
Measured by The International Physical Activity Questionnaire-Short Form: Amount of time (minutes per week/day) spent on sitting, walking, and moderate- and vigorous intensity physical activity the last week (0-7 days). Results are reported as MET-scores and are categorized into categorical score of low, moderate or high level of physical activity.
Measured: 18 weeks post randomization
Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
Measured by Arthritis Self-Efficacy Scale: average score in the subelements pain (5 questions) and symptoms (6 questions) on a 5 point Likert scale (very uncertain to very sure). Higher average score indicate higher degree of self-efficacy.
Measured: Baseline
Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
Measured by Arthritis Self-Efficacy Scale: average score in the subelements pain (5 questions) and symptoms (6 questions) on a 5 point Likert scale (very uncertain to very sure). Higher average score indicate higher degree of self-efficacy.
Measured: 6 weeks (end of intervention)
Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
Measured by Arthritis Self-Efficacy Scale: average score in the subelements pain (5 questions) and symptoms (6 questions) on a 5 point Likert scale (very uncertain to very sure). Higher average score indicate higher degree of self-efficacy.
Measured: 18 weeks post randomization
Exercise self-efficacy
Measured by the Exercise self-efficacy scale containing the subscales self-efficacy for exercise, barriers to exercise, benefits of exercise and the impact of exercise on OA. Each subscale contains 3-8 questions relevant to the topic, with a 5-point Likert scale ranging from strongly disagree to strongly agree. A sum score of the subscales is calculated, ranging from 20 to 100, with higher scores indicating less barriers and greater self-efficacy with physical activity.
Measured: Baseline
Exercise self-efficacy
Measured by the Exercise self-efficacy scale containing the subscales self-efficacy for exercise, barriers to exercise, benefits of exercise and the impact of exercise on OA. Each subscale contains 3-8 questions relevant to the topic, with a 5-point Likert scale ranging from strongly disagree to strongly agree. A sum score of the subscales is calculated, ranging from 20 to 100, with higher scores indicating less barriers and greater self-efficacy with physical activity.
Measured: 6 weeks (end of intervention)
Exercise self-efficacy
Measured by the Exercise self-efficacy scale containing the subscales self-efficacy for exercise, barriers to exercise, benefits of exercise and the impact of exercise on OA. Each subscale contains 3-8 questions relevant to the topic, with a 5-point Likert scale ranging from strongly disagree to strongly agree. A sum score of the subscales is calculated, ranging from 20 to 100, with higher scores indicating less barriers and greater self-efficacy with physical activity.
Measured: 18 weeks post randomization
Health-related quality of life, EuroQoL (EQ5D-5L)
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Measured: Baseline
Health-related quality of life, EuroQoL (EQ5D-5L)
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Measured: 6 weeks (end of intervention)
Health-related quality of life, EuroQoL (EQ5D-5L)
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Measured: 18 weeks post randomization
Anxiety and depression, Hopkins symptom checklist (HSCL-5)
Symptoms of anxiety and depression is measured by the short form of the Hopkins symptom checklist. Patients answers on five statements is used to measure general symptoms of anxiety and depression from the last 14 days, answers ranging from Not at all to Very much. Total sum score is (0-20) is calculated, higher score indicating greater symptoms of anxiety and depression.
Measured: Baseline
Anxiety and depression, Hopkins symptom checklist (HSCL-5)
Symptoms of anxiety and depression is measured by the short form of the Hopkins symptom checklist. Patients answers on five statements is used to measure general symptoms of anxiety and depression from the last 14 days, answers ranging from Not at all to Very much. Total sum score is (0-20) is calculated, higher score indicating greater symptoms of anxiety and depression.
Measured: 6 weeks (end of intervention)
Anxiety and depression, Hopkins symptom checklist (HSCL-5)
Symptoms of anxiety and depression is measured by the short form of the Hopkins symptom checklist. Patients answers on five statements is used to measure general symptoms of anxiety and depression from the last 14 days, answers ranging from Not at all to Very much. Total sum score is (0-20) is calculated, higher score indicating greater symptoms of anxiety and depression.
Measured: 18 weeks post randomization
Social participation
Limitations in social activities or contact with family, friends, neighbours or others last 14 days is reported on the social participation-subscale of the COOP/WONCA Functional Assessments Charts. Reported on a 5 point Likert scale ranging from Not at all to Very much, with Very much indicating greater limitations in social contact.
Measured: Baseline
Social participation
Limitations in social activities or contact with family, friends, neighbours or others last 14 days is reported on the social participation-subscale of the COOP/WONCA Functional Assessments Charts. Reported on a 5 point Likert scale ranging from Not at all to Very much, with Very much indicating greater limitations in social contact.
Measured: 6 weeks (end of intervention)
Social participation
Limitations in social activities or contact with family, friends, neighbours or others last 14 days is reported on the social participation-subscale of the COOP/WONCA Functional Assessments Charts. Reported on a 5 point Likert scale ranging from Not at all to Very much, with Very much indicating greater limitations in social contact.
Measured: 18 weeks post randomization
Usability of mobile health application, System Usability Scale (SUS)
Usability of the Virtual Training health application for patients, measured by the System Usability Scale. 10 item questionnaire with five response options for respondents; from strongly agree to strongly disagree
Measured: 6 weeks (end of intervention)
Usage of medication
Usage of medications last three months. Measured in dosage and frequency.
Measured: Baseline
Usage of medication
Usage of medications last three months. Measured in dosage and frequency.
Measured: 18 weeks post randomization
Change in disease activity
Change in disease activity from baseline is reported on a 7 point Likert scale rating from Very much worse to Very much better.
Measured: Baseline and 6 weeks (end of intervention)
Change in disease activity
Change in disease activity from baseline is reported on a 7 point Likert scale rating from Very much worse to Very much better.
Measured: Baseline and 18 weeks post randomization
Disease activity
Last week's experience of disease activity is measured on a Numeric rating scale ranging from 0 (Good, no symptoms) to 10 (Very bad).
Measured: Baseline
Disease activity
Last week's experience of disease activity is measured on a Numeric rating scale ranging from 0 (Good, no symptoms) to 10 (Very bad).
Measured: 6 weeks (end of intervention)
Disease activity
Last week's experience of disease activity is measured on a Numeric rating scale ranging from 0 (Good, no symptoms) to 10 (Very bad).
Measured: 18 weeks post randomization
Diagnose specific pain experience
Last week's experience of pain is measured on a Numeric rating scale ranging from 0 (No pain) to 10 (Worst imaginable pain).
Measured: Baseline
Diagnose specific pain experience
Last week's experience of pain is measured on a Numeric rating scale ranging from 0 (No pain) to 10 (Worst imaginable pain).
Measured: 6 weeks (end of intervention)
Diagnose specific pain experience
Last week's experience of pain is measured on a Numeric rating scale ranging from 0 (No pain) to 10 (Worst imaginable pain).
Measured: 18 weeks post randomization
Fatigue
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Measured: Baseline
Fatigue
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Measured: 6 weeks (end of intervention)
Fatigue
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Measured: 18 weeks post randomization
Use of health care services
Usage of health care services is measured by number of consultations to general practioner, medical specialist, physical therapist, occupational therapist and Healthy Life Centres, and number of x-rays and MRI's undertaken, last six weeks.
Measured: 6 weeks (end of intervention)
Use of health care services
Usage of health care services is measured by number of consultations to general practioner, medical specialist, physical therapist, occupational therapist and Healthy Life Centres, and number of x-rays and MRI's undertaken, last three months.
Measured: 18 weeks post randomization
General digital competence
19 questions concerning general digital competence, evaluated on a 4 point Likert-scale ranging from very difficult to very easy. Included also an option of answering Don't know.
Measured: Baseline
Satisfaction with use of app in exercise therapy
Satisfaction with use of app in exercise therapy evaluated on a visual analog scale ranging from very little satisfied to very satisfied (0-10). Question only concerns patients in intervention arm.
Measured: 6 weeks (end of intervention)
Suitability of using an app in exercise therapy
Suitability of using an app in exercise therapy evaluated on a visual analog scale ranging from very unsuitable to very suitable (0-10). Question only concerns patients in intervention arm.
Measured: 6 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation, The Norwegian Council for Musculoskeletal Health
- Responsible party
- Principal investigator, Anne Therese Tveter, Diakonhjemmet Hospital
- Investigators
- Anne Therese Tveter, PhD, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767854
- Sponsor's protocol ID
- 2021/FO347383
- Acronym
- DigiOA
- Status last verified
- Dec 2024
- First submitted
- 15 Feb 2021
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be made available on reasonably request to principal investigator
Publications
Martinsen L, Osteras N, Moseng T, Tveter AT. Adherence to in-person and app-based exercise for patients with hip or knee osteoarthritis; secondary analyses from a randomized controlled trial. Rheumatol Int. 2025 Aug 26;45(9):208. doi: 10.1007/s00296-025-05967-4.
PubMed 40856813Martinsen L, Osteras N, Moseng T, Tveter AT. Effect of a mHealth exercise intervention compared with supervised exercise therapy in osteoarthritis management: protocol of the DigiOA trial. BMJ Open. 2022 Sep 23;12(9):e066248. doi: 10.1136/bmjopen-2022-066248.
PubMed 36153027
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Osteoarthritis Care- DigiOA
- ClinicalTrials.gov ID
- NCT04767854
- Acronym / sponsor ID
- DigiOA / 2021/FO347383
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Telerehabilitation, Digital care, mHealth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- The Dam Foundation, The Norwegian Council for Musculoskeletal Health
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is among the most prevalent and costly diseases, with an estimate of $460 billion in all-cause medical costs. It causes pain and reduced physical function, and with no existing cure, the recommended first-line treatment is information, exercise and weight management if indicated. As the prevalence of OA is expected to increase in the coming years, exploring innovative solutions to maintain economical sustainable treatment in the future becomes a necessity. Telerehabilitation, technology which involves providing treatment through information and communication technology, regardless of the patient's geographical location, has shown its potential within cardiac, pulmonary, neurological and musculoskeletal conditions.
Virtual Training (VT) is a generic mobile health application used to deliver digital home exercise programs with text, audio and video support. Through a novel feedback system the therapist is able monitor the patients progress and pain level during exercise. This project aims to investigate, through a randomized controlled trial (RCT), whether the use of the VT-app is as effective as supervised exercise therapy in improving pain, physical function and disease activity in patients with hip and/or knee osteoarthritis. In addition, the investigators want to investigate if the use of the app is more cost effective than supervised exercise therapy, whether the use increases adherence with first line treatment, and whether there are certain characteristics of the patients responding to the intervention.
Detailed description
The study is a two-armed non-inferiority randomized controlled trial (RCT) situated in the primary care setting in Norway. Participants diagnosed with hip and/or knee OA will be randomized to either exercise therapy via app or usual care. Patients aged 18 years and older presenting with activity-related hip and/or knee pain/complaints and clinical signs and symptoms corresponding to hip and/or knee OA seeking treatment at physiotherapist working in private practice, will be included if eligible for the study.
The research questions are:
- Is exercise therapy, delivered through a mobile health application (Virtual Training), as effective as supervised exercise therapy in patients with hip and/or knee OA, measured by number of patients classified as responders according to the OMERACT-OARSI responder criteria?
- Is exercise therapy delivered through Virtual Training more cost-effective regarding health care and medication use than supervised exercise therapy for patients with hip and/or knee OA?
- Will patients with hip and/or knee OA, using Virtual Training, be more adherent to exercise during the intervention period compared to patients undergoing supervised exercise therapy, and are there any demographic or clinical factors characterizing the OMERACT-OARSI responding patients using Virtual Training?
The primary analysis will be conducted on an intention-to-treat basis by comparing the proportion of responders at 6 weeks and 3 months post-intervention according to the OMERACT-OARSI responder criteria in the intervention and the control group using logistic regression analysis. Per-protocol analyses will also be conducted. Difference in secondary outcomes will be assessed using analysis of covariance (ANCOVA) on the post-intervention values, with baseline values as covariates.
Cost-effectiveness will be evaluated assessing the difference in health care and medication use and quality of life during 3-month follow-up, reporting the incremental cost-effectiveness ratio (ICER) reflecting the between-group difference in incremental cost per adjusted life years (QALYs). Between-group difference in adherence to exercise will be assessed using linear regression, while patient characteristics in the intervention group will be assessed using logistic regression. Additional analyses assessing associations between physical activity, efficacy, barriers for exercise and OA-related questions will also be assessed in secondary analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OA school + Virtual Training mobile health application | Experimental | Behavioral: OA school, Other: Virtual Training mobile health applicationAfter a clinical examination by the physiotherapist, all patients will receive a 1-2-hour group session of patient education according to guidelines. The intervention group will receive an individually tailored exercise program through the Virtual Training mobile health application. After each exercise the patient score his/her execution of the exercise on a Likert-scale of 1 to 5, judging their effort from very poor to very good. After the session, patients rate their pain on a Numeric Rating Scale from 0 to 10. The patients in the intervention group will be instructed to exercise 3 times per week for 6 weeks. If the patients want to exercise more than 3 times per week, the exercise program will be available in the app once every day. |
| OA school + usual care | Active comparator | Behavioral: OA school, Other: Usual careAfter a clinical examination by the physiotherapist, all patients will receive a 1-2-hour group session of patient education according to guidelines. The control group will receive individually tailored supervised exercise therapy by a physiotherapist individually or in a group setting, twice a week for 6 weeks. Additionally, the patients will be motivated to perform one session of home exercise a week, a total of 3 sessions per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Activity-related hip and/or knee pain/complaints and clinical signs and symptoms corresponding to hip and/or knee OA
- Access to smartphone or tablet
Key exclusion criteria (6 listed)
- Neurological disorders
- Contraindication to physical activity
- Total hip or knee replacement in the actual joint(s) with no pain/ complaints in the other hip or knee joint(s)
- Inflammatory rheumatic diseases (e.g. rheumatoid arthritis, spondyloarthritis)
- Malignant illness or other major conditions (e.g. unstable cardiovascular disorders or lung disease, dementia) that restrict the ability to adhere to the recommended treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OA schoolPatient education according to guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information | Behavioural | OA school + Virtual Training mobile health application, OA school + usual care |
| Virtual Training mobile health applicationIndividually tailored home exercise programs delivered through a mobile health application | Other | OA school + Virtual Training mobile health application |
| Usual careIndividually tailored exercise programs conducted in weekly supervised individual or group sessions | Other | OA school + usual care |
Primary outcome
Number of responders according to OMERACT-OARSI responder criteria
Time frame: 6 weeks (end of intervention period)
A patient is classified as a responder if one of the following criteria is fulfilled: 1. High improvement in pain or function from baseline to follow-up * ≥50% improvement + absolute change of ≥2 in pain, OR * ≥50% improvement + absolute change of ≥2 in function 2. Improvement in at least two of the three following from baseline to follow-up: * ≥20% improvement + absolute change ≥1 in pain * ≥20% improvement + absolute change ≥1 in function * ≥20% improvement + absolute change ≥1 in the patient´s global assessment of disease activity
49 secondary outcomes
Number of responders according to OMERACT-OARSI responder criteria
Time frame: 18 weeks post randomization
Physical performance test, 30 seconds sit to stand test (30 sec STS)
Time frame: Baseline
Physical performance test, 30 seconds sit to stand test (30 sec STS)
Time frame: 6 weeks (end of intervention period)
Self reported goal achievement, Patient-specific functional scale (PSFS)
Time frame: Baseline
Self reported goal achievement, Patient-specific functional scale (PSFS)
Time frame: 6 weeks (end of intervention period)
Self reported goal achievement, Patient-specific functional scale (PSFS)
Time frame: 18 weeks post randomization
Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: Baseline
Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 6 weeks (end of intervention period)
Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 18 weeks post randomization
Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline
Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
Time frame: 6 weeks (end of intervention period)
Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
Time frame: 18 weeks post randomization
Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
Time frame: Baseline
Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
Time frame: 6 weeks (end of intervention)
Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
Time frame: 18 weeks post randomization
Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
Time frame: Baseline
Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
Time frame: 6 weeks (end of intervention)
Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
Time frame: 18 weeks post randomization
Exercise self-efficacy
Time frame: Baseline
Exercise self-efficacy
Time frame: 6 weeks (end of intervention)
Exercise self-efficacy
Time frame: 18 weeks post randomization
Health-related quality of life, EuroQoL (EQ5D-5L)
Time frame: Baseline
Health-related quality of life, EuroQoL (EQ5D-5L)
Time frame: 6 weeks (end of intervention)
Health-related quality of life, EuroQoL (EQ5D-5L)
Time frame: 18 weeks post randomization
Anxiety and depression, Hopkins symptom checklist (HSCL-5)
Time frame: Baseline
Anxiety and depression, Hopkins symptom checklist (HSCL-5)
Time frame: 6 weeks (end of intervention)
Anxiety and depression, Hopkins symptom checklist (HSCL-5)
Time frame: 18 weeks post randomization
Social participation
Time frame: Baseline
Social participation
Time frame: 6 weeks (end of intervention)
Social participation
Time frame: 18 weeks post randomization
Usability of mobile health application, System Usability Scale (SUS)
Time frame: 6 weeks (end of intervention)
Usage of medication
Time frame: Baseline
Usage of medication
Time frame: 18 weeks post randomization
Change in disease activity
Time frame: Baseline and 6 weeks (end of intervention)
Change in disease activity
Time frame: Baseline and 18 weeks post randomization
Disease activity
Time frame: Baseline
Disease activity
Time frame: 6 weeks (end of intervention)
Disease activity
Time frame: 18 weeks post randomization
Diagnose specific pain experience
Time frame: Baseline
Diagnose specific pain experience
Time frame: 6 weeks (end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 40856813Martinsen L, Osteras N, Moseng T, Tveter AT. Adherence to in-person and app-based exercise for patients with hip or knee osteoarthritis; secondary analyses from a randomized controlled trial. Rheumatol Int. 2025 Aug 26;45(9):208. doi: 10.1007/s00296-025-05967-4.
- Derived from this study: PubMed 36153027Martinsen L, Osteras N, Moseng T, Tveter AT. Effect of a mHealth exercise intervention compared with supervised exercise therapy in osteoarthritis management: protocol of the DigiOA trial. BMJ Open. 2022 Sep 23;12(9):e066248. doi: 10.1136/bmjopen-2022-066248.
- Individual participant dataSharing planned: No. Data may be made available on reasonably request to principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Therese Tveter, PhD principal investigator
Diakonhjemmet Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OA school and Virtual Training mobile health application in people with Osteoarthritis, run by Diakonhjemmet Hospital at 13 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of responders according to OMERACT-OARSI responder criteria (time frame: 6 weeks (end of intervention period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767854, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.