NCT06656845

Brief Summary

In this feasibility trial, an 8-week digital intervention including remote monitoring in patients with knee osteoarthritis (OA) will be tested. The app will provide information on osteoarthritis and recommended treatment for people with knee OA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2025

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

October 8, 2024

Last Update Submit

August 8, 2025

Conditions

Knee Osteoarthristis

Keywords

OsteoarthritisE-healthRemote careFeasibility

Outcome Measures

Primary Outcomes (1)

  • Desirable feasibility level

    Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility

    Through the 8 weeks intervention period

Secondary Outcomes (15)

  • Patient-reported software usability

    At 8 weeks

  • Patient-reported experiences and perceived benefits

    At 8 weeks

  • Patient-reported satisfaction with the app

    At 8 weeks

  • Integration of workflow for health professionals

    At baseline

  • Time use in the intervention period

    Through the 8 weeks intervention period

  • +10 more secondary outcomes

Study Arms (1)

To determine the feasibility of a patient self-management app in patients with knee osteoarthritis

EXPERIMENTAL

The intended purpose of the app (Genus) is to provide information on osteoarthritis and recommended treatment for people with knee OA.

Device: Genus, a self-management app for patients with knee osteoarthritis

Interventions

Genus, a self-management app for patients with knee osteoarthritisDEVICE

The self-management app (Genus) will include weekly reminders with information videos on knee osteoarthritis and treatment options, exercise videos, quizzes, questionnaires, and a platform for remote monitoring by health professionals.

To determine the feasibility of a patient self-management app in patients with knee osteoarthritis

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women =\>50 years of age
  • 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 uncontrolled serious comorbidities
  • Have cognitive dysfunction
  • Are seeking care for trauma conditions or psoriatic/rheumatoid arthritis
  • Unable to understand Norwegian
  • Do not have a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diakonhjemmet hospital

Oslo, Oslo County, 0319, Norway

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Anne Therese Tveter, PhD

    Diakonhjemmet Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 24, 2024

Study Start

January 5, 2025

Primary Completion

May 7, 2025

Study Completion

May 31, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)