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

17 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

204

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Noruega
    • Oslo
      • Oslo, Oslo, Noruega, 0317
        • Reclutamiento
        • Diakonhjemmet Hospital
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Comparador activo: Control group
Getting access to publicly available information in the waiting period from referral to consultation in specialist healthcare
Otro: Control
Information on where to access publically available information about knee osteoarthritis

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Knee Osteoathritis Knowlegde Scale (KOAKS)
Periodo de tiempo: 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)
Periodo de tiempo: 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))

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Concordance between preferences and treatment decision
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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))

Otras medidas de resultado

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Diakonhjemmet Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de octubre de 2025

Finalización primaria (Estimado)

1 de octubre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2035

Fechas de registro del estudio

Enviado por primera vez

11 de diciembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

17 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

IPD will not be shared due to GDPR regulations

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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