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Effect of an Information- and Self-management App for People With Knee Osteoarthritis (OA-AID)

17 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

204

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention group
Getting access to an information- and self-management app in the waiting period from referral to consultation in specialist healthcare
Dispositivo: Information- and self-management app
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
Comparatore attivo: Control group
Getting access to publicly available information in the waiting period from referral to consultation in specialist healthcare
Altro: Control
Information on where to access publically available information about knee osteoarthritis

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Knee Osteoathritis Knowlegde Scale (KOAKS)
Lasso di tempo: Baseline, 8 weeks, approx. 2-4 months after baseline (1 day after consultation (post consultation))
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
Baseline, 8 weeks, approx. 2-4 months after baseline (1 day after consultation (post consultation))
Decision Conflict Scale (DCS)
Lasso di tempo: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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.
approx. 2-4 months after baseline (1 day after consultation (post consultation))

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Concordance between preferences and treatment decision
Lasso di tempo: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Measured with one qustion form the Decision Conflict Scale (DSC), 5 response options.
approx. 2-4 months after baseline (1 day after consultation (post consultation))
Decisional quality
Lasso di tempo: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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.
approx. 2-4 months after baseline (1 day after consultation (post consultation))
Level of shared decision-making
Lasso di tempo: approx. 2-4 months after baseline (1 day after consultation (post consultation))
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
approx. 2-4 months after baseline (1 day after consultation (post consultation))
Satisfaction with treatment choice
Lasso di tempo: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Measured on a numeric rating scale (0-10, with higher score indicating more satisfaction)
approx. 2-4 months after baseline (1 day after consultation (post consultation))

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Motivation for exercise
Lasso di tempo: Baseline, 4 weeks (only intervention group), 8 weeks
Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation
Baseline, 4 weeks (only intervention group), 8 weeks
Motivation for surgery
Lasso di tempo: Baseline, 4 weeks (only intervention group), 8 weeks
Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation
Baseline, 4 weeks (only intervention group), 8 weeks
Assessment of knee-related pain
Lasso di tempo: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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
Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
Assessment of knee-related function
Lasso di tempo: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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
Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
Assessment of knee-related quality of life
Lasso di tempo: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
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
Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
Health-related quality of life
Lasso di tempo: Baseline, 1 and 2 years
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.
Baseline, 1 and 2 years
Level of shared decision-making therapist
Lasso di tempo: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Measured with 7 statements from the MAPPIN'SDM Therapist, measured on a 5-point scale
approx. 2-4 months after baseline (1 day after consultation (post consultation))
Preferred decision-making role
Lasso di tempo: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Measured with the Control Preference Scale, comprising a question with 5 statements about roles, corresponding to active role, collaborative role and passive role
approx. 2-4 months after baseline (1 day after consultation (post consultation))
Illness perception
Lasso di tempo: Baseline, 8 weeks
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
Baseline, 8 weeks
Pain self-efficacy
Lasso di tempo: Baseline, 8 weeks
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.
Baseline, 8 weeks
Pain catastrophizing
Lasso di tempo: Baseline, 8 weeks
Measured with one question about consern about pain, measured on a 0 (not at all) to 4 (all the time) scale.
Baseline, 8 weeks
Pain intensity
Lasso di tempo: Baseline, 8 weeks
Measured with four questions from the Brief Pain Inventory, assessed on numeric rating scales from 0 (no pain) to 10 (worst possible pain).
Baseline, 8 weeks
Pain intensity now
Lasso di tempo: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
Measured with one question about pain intensity now on a numeric rating scale from 0 (no pain) to 10 (worst possible pain).
Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
Disease activity
Lasso di tempo: Baseline, 8 weeks, 1 and 2 years
Measured with a numeric rating scale from 0 (no disease activity) to 10 (worst disease activity)
Baseline, 8 weeks, 1 and 2 years
Fatigue
Lasso di tempo: Baseline, 8 weeks, 1 and 2 years
Measured on a numeric rating scale from 0 (no fatigue) to 10 (worst possible fatigue)
Baseline, 8 weeks, 1 and 2 years
Importance of treatment options
Lasso di tempo: Baseline, 8 weeks
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)
Baseline, 8 weeks
Preferred treatment
Lasso di tempo: Baseline, 8 weeks
Measured with a question about if they prefer surgery or non-surgical treatment
Baseline, 8 weeks
Health literacy
Lasso di tempo: Baseline
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
Baseline
Self-efficacy of digital solutions
Lasso di tempo: Baseline
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
Baseline
Previous treatment
Lasso di tempo: Baseline
Assessment of previous treatment, answered with yes/no on questions related to previous physiotherapy treatment, previous osteoarthritis school,
Baseline
Health problems impact on daily living
Lasso di tempo: Baseline, 8 weeks, 1 and 2 years
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)
Baseline, 8 weeks, 1 and 2 years
Decision regret
Lasso di tempo: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Measured with item 2 from the Decision regret scale, answered on a 5-point scale from totally agree to totally disagree
approx. 2-4 months after baseline (1 day after consultation (post consultation))
Use of pain medication
Lasso di tempo: Baseline, 8 weeks, 1 and 2 years
Assessed with an open-ended question about the use of pain medication last three months (type and dosage)
Baseline, 8 weeks, 1 and 2 years
Demographics
Lasso di tempo: Baseline
Measured with questions about gender, age, education level, working status, smoking, living arrangements, sosioeconomic status, and support
Baseline
Antropometrics
Lasso di tempo: Baseline
Measured as self-reported hight and weight
Baseline
Joint-spesific information
Lasso di tempo: Baseline
Measured with questions about most trouble some knee, duration of complaints, other joints with complaints
Baseline
Exercise level
Lasso di tempo: Baseline, 8 weeks, 1 and 2 years
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
Baseline, 8 weeks, 1 and 2 years
Comorbidities
Lasso di tempo: Baseline
Assessed with 15 questions about the presens of different diseases (yes/no)
Baseline
Usability of the app
Lasso di tempo: 8 weeks (only intervention group)
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
8 weeks (only intervention group)
Satisfaction with the app
Lasso di tempo: 8 weeks (only the intervention group)
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)
8 weeks (only the intervention group)
Suitability of the app
Lasso di tempo: 8 weeks (only the intervention group)
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)
8 weeks (only the intervention group)
Surgical treatment
Lasso di tempo: 1 and 2 years
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
1 and 2 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Diakonhjemmet Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 ottobre 2025

Completamento primario (Stimato)

1 ottobre 2028

Completamento dello studio (Stimato)

31 dicembre 2035

Date di iscrizione allo studio

Primo inviato

11 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

17 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DS-00926
  • 938916 (Altro identificatore: Regional committees for medical and health research ethics (REK))
  • CIV-25-08-053975 (Altro identificatore: Eudamed CIV ID)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

IPD will not be shared due to GDPR regulations

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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