Effect of an Information- and Self-management App for People With Knee Osteoarthritis (OA-AID)
sunnuntai 17. toukokuuta 2026 päivittänyt: Anne Therese Tveter, Diakonhjemmet Hospital
The primary aim of the trial is to assess if an information- and self-management app provided in the period between referral and consultation in specialist healthcare can improve knowledge about osteoarthritis and decision quality during consultation in patients with knee osteoarthritis.
204 patients will be randomized to either being on the waiting list for consultation, accessing publically available information about osteoarthritis (control group) or getting access to an 8-week information- and self-management intervention delivered through the Genus app prior to consultation.
Pasients with answer questionnaires at baseline, 4 weeks (intervention group only), 8 weeks, post consultation and 1 and 2 years after consultation.
The Genus app contains information videos, exercise videos, quizzes, feedback and questionnaires provided in a progressive order over an 8 week period.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
204
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Anne Therese Tveter, PhD
- Puhelinnumero: +4791115550
- Sähköposti: a.t.tveter@medisin.uio.no
Opiskelupaikat
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Oslo
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Oslo, Oslo, Norja, 0317
- Rekrytointi
- Diakonhjemmet Hospital
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Ottaa yhteyttä:
- Anne Therese Tveter, PhD
- Puhelinnumero: +4791115550
- Sähköposti: a.t.tveter@medisin.uio.no
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Ottaa yhteyttä:
- Tuva Moseng, PhD
- Puhelinnumero: +4747306697
- Sähköposti: tuva.moseng@diakonsyk.no
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Inclusion Criteria:
- Men and women > 50 years referred to specialist healthcare for knee OA management
Exclusion Criteria:
- Received joint replacement or are under consideration for revision in the referred joint
- Have undergone joint replacement surgery in opposite knee
- Have uncontrolled serious comorbidities
- Have cognitive deficits
- Are seeking care for recent knee trauma conditions (less than 6 months after trauma) or mainly psoriatic/rheumatoid arthritis
- Unable to understand Norwegian
- Do not possess a smartphone
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Intervention group
Getting access to an information- and self-management app in the waiting period from referral to consultation in specialist healthcare
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An information- and self-management intervention delivered through the Genus app, including information videos, exercise videos, questionnaires, quizzes and feedback provided over an 8 week period prior to consultation in specialist healthcare
|
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Active Comparator: Control group
Getting access to publicly available information in the waiting period from referral to consultation in specialist healthcare
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Information on where to access publically available information about knee osteoarthritis
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Knee Osteoathritis Knowlegde Scale (KOAKS)
Aikaikkuna: Baseline, 8 weeks, approx. 2-4 months after baseline (1 day after consultation (post consultation))
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11 statements about osteoarthritis and treatment options, answered on a 5-point scale from 1 (=true) to 5 (=not true), summed up to a scale from 11 to 55
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Baseline, 8 weeks, approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Decision Conflict Scale (DCS)
Aikaikkuna: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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16 statements with 5 response categories about the patients uncertainty with treatment options.
The total score range from 0 (no decisional conflict) to 100 (extreme decisional conflict).
The DCS also has five subscales (all 0-100): 1) uncertainty, 2) informed, 3) values clarity, 4) support, and 5) effective decision.
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approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Concordance between preferences and treatment decision
Aikaikkuna: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Measured with one qustion form the Decision Conflict Scale (DSC), 5 response options.
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approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Decisional quality
Aikaikkuna: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Measured with section 3 (decision process scale) in the Decision Quality Index for Knee Osteoarthritis (K-DQI) which consists of 5 questions.
Four of these questions are summed to a 0-4 score with higher score indicating more shared decision-making.
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approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Level of shared decision-making
Aikaikkuna: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Mesured with the CollaboRATE questionnaire, comprising 3 questions measured on a 0-9 scale, with a higher score indicating better experience.
Scores are calculated using the top score method indicating the percentage of patients scoring top score for all three questions, or
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approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Satisfaction with treatment choice
Aikaikkuna: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Measured on a numeric rating scale (0-10, with higher score indicating more satisfaction)
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approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Motivation for exercise
Aikaikkuna: Baseline, 4 weeks (only intervention group), 8 weeks
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Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation
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Baseline, 4 weeks (only intervention group), 8 weeks
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Motivation for surgery
Aikaikkuna: Baseline, 4 weeks (only intervention group), 8 weeks
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Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation
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Baseline, 4 weeks (only intervention group), 8 weeks
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Assessment of knee-related pain
Aikaikkuna: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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Measured with the Knee Injury and Osteoarthritis Outcome Score (pain section), comprising 9 questions scored on a 5-point scale and calculated to a 0-100 score with higher score indicating less pain
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Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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Assessment of knee-related function
Aikaikkuna: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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Measured with the Knee Injury and Osteoarthritis Outcome Score (function section), comprising 17 questions scored on a 5-point scale and calculated to a 0-100 score with higher score indicating less pain
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Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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Assessment of knee-related quality of life
Aikaikkuna: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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Measured with the Knee Injury and Osteoarthritis Outcome Score (quality of life section), comprising 4 questions scored on a 5-point scale and calculated to a 0-100 score with higher score indicating less pain
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Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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Health-related quality of life
Aikaikkuna: Baseline, 1 and 2 years
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Mesured with EQ-5D-5L, comprising 5 questions with 5 response options.
Summed to an utility index from 1 to 0, with 1 being best health-related quality of life.
Additionally a visual analog scale from 0 to 100 with 100 indicating best health.
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Baseline, 1 and 2 years
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Level of shared decision-making therapist
Aikaikkuna: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Measured with 7 statements from the MAPPIN'SDM Therapist, measured on a 5-point scale
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approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Preferred decision-making role
Aikaikkuna: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Measured with the Control Preference Scale, comprising a question with 5 statements about roles, corresponding to active role, collaborative role and passive role
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approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Illness perception
Aikaikkuna: Baseline, 8 weeks
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Measured with the Brief Illness Perception Questionnaire (B-IPQ) comprising 8 questions scored on a 0-10 scale, summed to a 0 to 80 score with higher score indicating poorer illness perception
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Baseline, 8 weeks
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Pain self-efficacy
Aikaikkuna: Baseline, 8 weeks
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Measured with the Pain Self-Efficacy Questionnaire (PSEQ-2) comprising 2 questions about pain self-efficacy, answered on a 0 (not at all confident) to 6 (completely confident) scale.
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Baseline, 8 weeks
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Pain catastrophizing
Aikaikkuna: Baseline, 8 weeks
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Measured with one question about consern about pain, measured on a 0 (not at all) to 4 (all the time) scale.
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Baseline, 8 weeks
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Pain intensity
Aikaikkuna: Baseline, 8 weeks
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Measured with four questions from the Brief Pain Inventory, assessed on numeric rating scales from 0 (no pain) to 10 (worst possible pain).
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Baseline, 8 weeks
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Pain intensity now
Aikaikkuna: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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Measured with one question about pain intensity now on a numeric rating scale from 0 (no pain) to 10 (worst possible pain).
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Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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Disease activity
Aikaikkuna: Baseline, 8 weeks, 1 and 2 years
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Measured with a numeric rating scale from 0 (no disease activity) to 10 (worst disease activity)
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Baseline, 8 weeks, 1 and 2 years
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Fatigue
Aikaikkuna: Baseline, 8 weeks, 1 and 2 years
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Measured on a numeric rating scale from 0 (no fatigue) to 10 (worst possible fatigue)
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Baseline, 8 weeks, 1 and 2 years
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Importance of treatment options
Aikaikkuna: Baseline, 8 weeks
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Measured with five questions from Dicision Quality Index for Knee Osteoarthritis (section 1).
Assessed on numeric rating scales from 0 (not at all important) to 10 (extremely important)
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Baseline, 8 weeks
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Preferred treatment
Aikaikkuna: Baseline, 8 weeks
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Measured with a question about if they prefer surgery or non-surgical treatment
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Baseline, 8 weeks
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Health literacy
Aikaikkuna: Baseline
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Measured with the HLS19-Q12 comprising 12 questions about health literacy answered on a 4-point likert scale from 1 (very difficult) to 4 (very easy).
Calculated as percentage (0-100) of items with valid responses that were answered with very easy or easy
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Baseline
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Self-efficacy of digital solutions
Aikaikkuna: Baseline
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Measured with six questions about the self-efficacy of using different digital solutions (mobile phone, tablet, computer, apps, identification portal, helsenorge.no),
assessed on a 6-point scale from never tried to manage very well
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Baseline
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Previous treatment
Aikaikkuna: Baseline
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Assessment of previous treatment, answered with yes/no on questions related to previous physiotherapy treatment, previous osteoarthritis school,
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Baseline
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Health problems impact on daily living
Aikaikkuna: Baseline, 8 weeks, 1 and 2 years
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Measured with one question from the Work Productivity and Activity Impairment questionnaire (WPAI) (question 6), anwered on a numeric rating scale from 0 (no effect on daily activities) to 10 (completely prevent from doing daily activities)
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Baseline, 8 weeks, 1 and 2 years
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Decision regret
Aikaikkuna: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Measured with item 2 from the Decision regret scale, answered on a 5-point scale from totally agree to totally disagree
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approx. 2-4 months after baseline (1 day after consultation (post consultation))
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Use of pain medication
Aikaikkuna: Baseline, 8 weeks, 1 and 2 years
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Assessed with an open-ended question about the use of pain medication last three months (type and dosage)
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Baseline, 8 weeks, 1 and 2 years
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Demographics
Aikaikkuna: Baseline
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Measured with questions about gender, age, education level, working status, smoking, living arrangements, sosioeconomic status, and support
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Baseline
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Antropometrics
Aikaikkuna: Baseline
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Measured as self-reported hight and weight
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Baseline
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Joint-spesific information
Aikaikkuna: Baseline
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Measured with questions about most trouble some knee, duration of complaints, other joints with complaints
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Baseline
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Exercise level
Aikaikkuna: Baseline, 8 weeks, 1 and 2 years
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Measured with one question about exercise level answered on a 5-point scale from do not exercise to exercise 3 or more times per week
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Baseline, 8 weeks, 1 and 2 years
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Comorbidities
Aikaikkuna: Baseline
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Assessed with 15 questions about the presens of different diseases (yes/no)
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Baseline
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Usability of the app
Aikaikkuna: 8 weeks (only intervention group)
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Measured with System Usability Scale (SUS) comprising 10 statements answered on a 5-point scale from strongly disagree to strongly agree, converted to a 0 to 100 score with higher score indicating better usability
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8 weeks (only intervention group)
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Satisfaction with the app
Aikaikkuna: 8 weeks (only the intervention group)
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Measured with two questions about the satisfaction with the information videos and exercise videos in the app, answered on numeric rating scales from 0 (not statisfied) to 10 (very satisfied)
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8 weeks (only the intervention group)
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Suitability of the app
Aikaikkuna: 8 weeks (only the intervention group)
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Measured with two questions about the suitability of providing information and exercises through an app, answered on numeric rating scales from 0 (not suitable) to 10 (very suitable)
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8 weeks (only the intervention group)
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Surgical treatment
Aikaikkuna: 1 and 2 years
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Measured with a question about whether the patient has undergone surgical treatment (yes/no) and for those answering yes; five questions about the improvement/satisfaction with the surgical treatment, measured on a 5-point scale from very satisfied to very dissatisfied
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1 and 2 years
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Torstai 11. joulukuuta 2025
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Ensimmäinen Lähetetty (Todellinen)
Perjantai 22. toukokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 22. toukokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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Viimeksi vahvistettu
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- DS-00926
- 938916 (Muu tunniste: Regional committees for medical and health research ethics (REK))
- CIV-25-08-053975 (Muu tunniste: Eudamed CIV ID)
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IPD-suunnitelman kuvaus
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