Effect of an Information- and Self-management App for People With Knee Osteoarthritis

NCT07603973 | Recruiting

• 3 other identifiers: DS-00926938916CIV-25-08-053975
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; digital support tool; app; evidence-based treatment; information; self-management

Outcome Measures

Primary Outcomes (2)

• Knee Osteoathritis Knowlegde Scale (KOAKS)

  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)

  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))

Secondary Outcomes (4)

• Concordance between preferences and treatment decision

  approx. 2-4 months after baseline (1 day after consultation (post consultation))

• Decisional quality

  approx. 2-4 months after baseline (1 day after consultation (post consultation))

• Level of shared decision-making

  approx. 2-4 months after baseline (1 day after consultation (post consultation))

• Satisfaction with treatment choice

  approx. 2-4 months after baseline (1 day after consultation (post consultation))

Other Outcomes (32)

• Motivation for exercise

  Baseline, 4 weeks (only intervention group), 8 weeks

• Motivation for surgery

  Baseline, 4 weeks (only intervention group), 8 weeks

• Assessment of knee-related pain

  Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years

Study Arms (2)

Intervention group

EXPERIMENTAL

Getting access to an information- and self-management app in the waiting period from referral to consultation in specialist healthcare

Device: Information- and self-management app

Control group

ACTIVE COMPARATOR

Getting access to publicly available information in the waiting period from referral to consultation in specialist healthcare

Other: Control

Interventions

Information- and self-management app DEVICE

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

Intervention group

Control OTHER

Information on where to access publically available information about knee osteoarthritis

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women \> 50 years referred to specialist healthcare for knee OA management

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Diakonhjemmet Hospital

Oslo, Oslo, 0317, Norway

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Alzheimer Disease

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Anne Therese Tveter, PhD

CONTACT

+4791115550; a.t.tveter@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: May 22, 2026
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2035
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)