Digital Osteoarthritis Care (DigiOA)

December 4, 2023 updated by: Anne Therese Tveter, Diakonhjemmet Hospital

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.

Study Overview

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:

  1. 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?
  2. 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?
  3. 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 Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bergen, Norway
        • Not yet recruiting
        • Laguneparken fysioterapi/Arna fysikalske
        • Contact:
          • Randi Instefjord
      • Bergen, Norway
        • Recruiting
        • Sandviken fysioterapi og trening
        • Contact:
          • Elin Solheimsnes
      • Drammen, Norway
        • Recruiting
        • Trimmen
        • Contact:
          • Marius Hoel
      • Gjøvik, Norway
        • Recruiting
        • Sentrum Fysioterapi
        • Contact:
          • Torhild Nordengen
      • Harestua, Norway
        • Withdrawn
        • Harestua Medisinske Senter
      • Indre Østfold, Norway
        • Recruiting
        • Ace Treningssenter
        • Contact:
          • Terese Brustad
      • Indre Østfold, Norway
        • Recruiting
        • Trøgstad fysioterapi
        • Contact:
          • Hege Novak
      • Nittedal, Norway
        • Recruiting
        • Nittedal fysikalske institutt
        • Contact:
          • Julie Folden
      • Notodden, Norway
        • Recruiting
        • Physiotherapist Stein Listaul
        • Contact:
          • Stein Listaul
      • Oslo, Norway
        • Not yet recruiting
        • Aktifys Institutt
        • Contact:
          • Ole Martin Langvoll
      • Oslo, Norway
        • Recruiting
        • Furuset Fysioterapi
        • Contact:
          • Maria Krog
      • Oslo, Norway
        • Recruiting
        • Røa Centrum Fysioterapi og Akupunktur
        • Contact:
          • Patrick Jensen
      • Ski, Norway
        • Recruiting
        • Ski Fysioterapisenter
        • Contact:
          • Iselin Horn
      • Skiptvet, Norway
        • Completed
        • Skiptvet Fysikalske

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OA school + Virtual Training mobile health application

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.

Patient education according to guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
Individually tailored home exercise programs delivered through a mobile health application
Active Comparator: OA school + usual care

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

Patient education according to guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
Individually tailored exercise programs conducted in weekly supervised individual or group sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks (end of intervention period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of responders according to OMERACT-OARSI responder criteria
Time Frame: 18 weeks post randomization

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
18 weeks post randomization
Physical performance test, 30 seconds sit to stand test (30 sec STS)
Time Frame: Baseline
Number of repetitions in the 30 seconds sit to stand-test
Baseline
Physical performance test, 30 seconds sit to stand test (30 sec STS)
Time Frame: 6 weeks (end of intervention period)
Number of repetitions in the 30 seconds sit to stand-test
6 weeks (end of intervention period)
Self reported goal achievement, Patient-specific functional scale (PSFS)
Time Frame: Baseline
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)
Baseline
Self reported goal achievement, Patient-specific functional scale (PSFS)
Time Frame: 6 weeks (end of intervention period)
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)
6 weeks (end of intervention period)
Self reported goal achievement, Patient-specific functional scale (PSFS)
Time Frame: 18 weeks post randomization
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)
18 weeks post randomization
Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: Baseline
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)
Baseline
Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: 6 weeks (end of intervention period)
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)
6 weeks (end of intervention period)
Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: 18 weeks post randomization
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)
18 weeks post randomization
Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline
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)
Baseline
Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 weeks (end of intervention period)
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)
6 weeks (end of intervention period)
Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
Time Frame: 18 weeks post randomization
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)
18 weeks post randomization
Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
Time Frame: Baseline
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.
Baseline
Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
Time Frame: 6 weeks (end of intervention)
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.
6 weeks (end of intervention)
Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
Time Frame: 18 weeks post randomization
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.
18 weeks post randomization
Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
Time Frame: Baseline
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.
Baseline
Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
Time Frame: 6 weeks (end of intervention)
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.
6 weeks (end of intervention)
Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
Time Frame: 18 weeks post randomization
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.
18 weeks post randomization
Exercise self-efficacy
Time Frame: Baseline
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.
Baseline
Exercise self-efficacy
Time Frame: 6 weeks (end of intervention)
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.
6 weeks (end of intervention)
Exercise self-efficacy
Time Frame: 18 weeks post randomization
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.
18 weeks post randomization
Health-related quality of life, EuroQoL (EQ5D-5L)
Time Frame: Baseline
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.
Baseline
Health-related quality of life, EuroQoL (EQ5D-5L)
Time Frame: 6 weeks (end of intervention)
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.
6 weeks (end of intervention)
Health-related quality of life, EuroQoL (EQ5D-5L)
Time Frame: 18 weeks post randomization
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.
18 weeks post randomization
Anxiety and depression, Hopkins symptom checklist (HSCL-5)
Time Frame: Baseline
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.
Baseline
Anxiety and depression, Hopkins symptom checklist (HSCL-5)
Time Frame: 6 weeks (end of intervention)
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.
6 weeks (end of intervention)
Anxiety and depression, Hopkins symptom checklist (HSCL-5)
Time Frame: 18 weeks post randomization
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.
18 weeks post randomization
Social participation
Time Frame: Baseline
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.
Baseline
Social participation
Time Frame: 6 weeks (end of intervention)
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.
6 weeks (end of intervention)
Social participation
Time Frame: 18 weeks post randomization
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.
18 weeks post randomization
Usability of mobile health application, System Usability Scale (SUS)
Time Frame: 6 weeks (end of intervention)
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
6 weeks (end of intervention)
Usage of medication
Time Frame: Baseline
Usage of medications last three months. Measured in dosage and frequency.
Baseline
Usage of medication
Time Frame: 18 weeks post randomization
Usage of medications last three months. Measured in dosage and frequency.
18 weeks post randomization
Change in disease activity
Time Frame: Baseline and 6 weeks (end of intervention)
Change in disease activity from baseline is reported on a 7 point Likert scale rating from Very much worse to Very much better.
Baseline and 6 weeks (end of intervention)
Change in disease activity
Time Frame: Baseline and 18 weeks post randomization
Change in disease activity from baseline is reported on a 7 point Likert scale rating from Very much worse to Very much better.
Baseline and 18 weeks post randomization
Disease activity
Time Frame: Baseline
Last week's experience of disease activity is measured on a Numeric rating scale ranging from 0 (Good, no symptoms) to 10 (Very bad).
Baseline
Disease activity
Time Frame: 6 weeks (end of intervention)
Last week's experience of disease activity is measured on a Numeric rating scale ranging from 0 (Good, no symptoms) to 10 (Very bad).
6 weeks (end of intervention)
Disease activity
Time Frame: 18 weeks post randomization
Last week's experience of disease activity is measured on a Numeric rating scale ranging from 0 (Good, no symptoms) to 10 (Very bad).
18 weeks post randomization
Diagnose specific pain experience
Time Frame: Baseline
Last week's experience of pain is measured on a Numeric rating scale ranging from 0 (No pain) to 10 (Worst imaginable pain).
Baseline
Diagnose specific pain experience
Time Frame: 6 weeks (end of intervention)
Last week's experience of pain is measured on a Numeric rating scale ranging from 0 (No pain) to 10 (Worst imaginable pain).
6 weeks (end of intervention)
Diagnose specific pain experience
Time Frame: 18 weeks post randomization
Last week's experience of pain is measured on a Numeric rating scale ranging from 0 (No pain) to 10 (Worst imaginable pain).
18 weeks post randomization
Fatigue
Time Frame: Baseline
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Baseline
Fatigue
Time Frame: 6 weeks (end of intervention)
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
6 weeks (end of intervention)
Fatigue
Time Frame: 18 weeks post randomization
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
18 weeks post randomization
Use of health care services
Time Frame: 6 weeks (end of intervention)
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.
6 weeks (end of intervention)
Use of health care services
Time Frame: 18 weeks post randomization
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.
18 weeks post randomization
General digital competence
Time Frame: Baseline
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.
Baseline
Satisfaction with use of app in exercise therapy
Time Frame: 6 weeks (end of intervention)
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.
6 weeks (end of intervention)
Suitability of using an app in exercise therapy
Time Frame: 6 weeks (end of intervention)
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.
6 weeks (end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anne Therese Tveter, PhD, Diakonhjemmet Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2021/FO347383

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data may be made available on reasonably request to 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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