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

17 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

204

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Intervention group
Getting access to an information- and self-management app in the waiting period from referral to consultation in specialist healthcare
Urządzenie: 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
Aktywny komparator: Control group
Getting access to publicly available information in the waiting period from referral to consultation in specialist healthcare
Inny: Control
Information on where to access publically available information about knee osteoarthritis

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Knee Osteoathritis Knowlegde Scale (KOAKS)
Ramy czasowe: 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)
Ramy czasowe: 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))

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Concordance between preferences and treatment decision
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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))

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Motivation for exercise
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline, 8 weeks
Measured with a question about if they prefer surgery or non-surgical treatment
Baseline, 8 weeks
Health literacy
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline
Measured with questions about gender, age, education level, working status, smoking, living arrangements, sosioeconomic status, and support
Baseline
Antropometrics
Ramy czasowe: Baseline
Measured as self-reported hight and weight
Baseline
Joint-spesific information
Ramy czasowe: Baseline
Measured with questions about most trouble some knee, duration of complaints, other joints with complaints
Baseline
Exercise level
Ramy czasowe: 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
Ramy czasowe: Baseline
Assessed with 15 questions about the presens of different diseases (yes/no)
Baseline
Usability of the app
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Diakonhjemmet Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 października 2025

Zakończenie podstawowe (Szacowany)

1 października 2028

Ukończenie studiów (Szacowany)

31 grudnia 2035

Daty rejestracji na studia

Pierwszy przesłany

11 grudnia 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 maja 2026

Pierwszy wysłany (Rzeczywisty)

22 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

IPD will not be shared due to GDPR regulations

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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