Knee OsteoarthristisNCT06656845
Feasibility of a Self-management App for People With Knee Osteoarthritis (OA-AID Feasibility Study)
A study testing Genus, a self-management app for patients with knee osteoarthritis in people with Knee Osteoarthristis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Genus, a self-management app for patients with knee osteoarthritis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 5 Jan 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women =>50 years of age
- Referred to specialist healthcare for knee OA management
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
In this feasibility study various outcome measures will be assessed to determine whether the app (Genus) is viable, practical, and useful.
The study will test the feasibility of an 8-week digital intervention including remote monitoring prior to consultation in specialist healthcare. The app consist of information on osteoarthritis and recommended treatment for people with knee OA. A total of 20 patients referred to Diakonhjemmet Hospital due to knee OA will be recruited to the study. The study will include assessments of technical, operational, clinical, and trial aspects of feasibility. Data will be collected through digital questionnaires (through the app or Nettskjema), through interviews and from medical records. Primary outcome is the feasibility of the app after 8 weeks. Additionally, the feasibility of the study process until consultation in specialist healthcare will be assessed.
The aim of the app is to improve patients' health literacy and enhance the shared decision-making process between patient and healthcare provider at the consultation in specialist healthcare.
- Conditions
- Knee Osteoarthristis
- Being tested
- Genus, a self-management app for patients with knee osteoarthritis
- Keywords
- Osteoarthritis, E-health, Remote care, Feasibility
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Genus, a self-management app for patients with knee osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desirable feasibility level
Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility
Measured: Through the 8 weeks intervention period
Secondary outcomes (15)
Patient-reported software usability
Considered feasible if the System Usability Scale score ≥68 on a 0-100 scale, 100= best score).
Measured: At 8 weeks
Patient-reported experiences and perceived benefits
Experiences and perceived benefits collected in semi-structured interview
Measured: At 8 weeks
Patient-reported satisfaction with the app
Measured by a numeric rating scale (NRS) 0-10, higher scores indicate better outcome. Acceptable feasibility 70% with score ≥5
Measured: At 8 weeks
Integration of workflow for health professionals
Measured by registering time of time use: acceptable feasibility if <30 minutes is spent on screening and enrolling (consent, baseline questionnaire, and downloading).
Measured: At baseline
Time use in the intervention period
Acceptable feasibility if <10 minutes are spent in max 1/3 of the patients
Measured: Through the 8 weeks intervention period
Primary clinical outcome
Available data on total score in the Knee Osteoarthritis Knowledge Scale (KOAKS, scored on a scale from 11-55) at baseline and after intervention for ≥80% of patients.
Measured: At baseline and at study completion (approx. 3 months after inclusion)
Patient satisfaction with the intervention at 8 weeks
Considered feasible if 70% with score ≥5 on a numeric rating scale (NRS) 0-10 on patient satisfaction with intervention.
Measured: At 8 weeks
Other patient reported outcomes
Available data at 8 weeks for ≥80% of the patients
Measured: At 8 weeks
Recruitment rate
Acceptable recruitment rate is ≥50% of eligible patients
Measured: At baseline
Patient dropout
Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients.
Measured: At 8 weeks
Trial logistics as assessed through interviews
Acceptable overall trial logistics as evaluated by the study group.
Measured: At study completion (approx. 3 months after inclusion)
Patients' app use
Acceptable app use includes that ≥50% of the patients watch ≥80% of the videos (16 videos), ≥50% of the patients has exercised1 or more days, ≥50% have completed at least 1 quiz.
Measured: Through study completion (approx. 3 months after inclusion)
Potential risk and challenges as assessed through interviews
Identify potential risk and challenges that could hinder a successful clinical evaluation of the app in a large randomised, controlled trial: Acceptable overall potential risk and challenges as evaluated by the study group at end of study.
Measured: At study completion (approx. 3 months after inclusion)
Software performance and functionality
Acceptable number of errors (≤3 errors per patient) in the performance and functionality experienced by the patients and project group members
Measured: Through study completion (approx. 3 months after inclusion)
Other patient reported outcomes
Available data on other patient reported outcomes at pre- and post-consultation questionnaires for ≥80% of the patients
Measured: Through study completion (approx. 3 months after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start5 Jan 2025
- Primary completion7 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Therese Tveter, Diakonhjemmet Hospital
- Investigators
- Anne Therese Tveter, PhD, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656845
- Sponsor's protocol ID
- 786516
- Status last verified
- Aug 2025
- First submitted
- 8 Oct 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Self-management App for People With Knee Osteoarthritis (OA-AID Feasibility Study)
- ClinicalTrials.gov ID
- NCT06656845
- Acronym / sponsor ID
- 786516
- Conditions
- Knee Osteoarthristis
- Keywords
- Osteoarthritis, E-health, Remote care, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this feasibility study various outcome measures will be assessed to determine whether the app (Genus) is viable, practical, and useful.
The study will test the feasibility of an 8-week digital intervention including remote monitoring prior to consultation in specialist healthcare. The app consist of information on osteoarthritis and recommended treatment for people with knee OA. A total of 20 patients referred to Diakonhjemmet Hospital due to knee OA will be recruited to the study. The study will include assessments of technical, operational, clinical, and trial aspects of feasibility. Data will be collected through digital questionnaires (through the app or Nettskjema), through interviews and from medical records. Primary outcome is the feasibility of the app after 8 weeks. Additionally, the feasibility of the study process until consultation in specialist healthcare will be assessed.
The aim of the app is to improve patients' health literacy and enhance the shared decision-making process between patient and healthcare provider at the consultation in specialist healthcare.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To determine the feasibility of a patient self-management app in patients with knee osteoarthritis | Experimental | Device: Genus, a self-management app for patients with knee osteoarthritisThe intended purpose of the app (Genus) is to provide information on osteoarthritis and recommended treatment for people with knee OA. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women =>50 years of age
- Referred to specialist healthcare for knee OA management
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genus, a self-management app for patients with knee osteoarthritisThe 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. | Device | To determine the feasibility of a patient self-management app in patients with knee osteoarthritis |
Primary outcome
Desirable feasibility level
Time frame: Through the 8 weeks intervention period
Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility
15 secondary outcomes
Patient-reported software usability
Time frame: At 8 weeks
Patient-reported experiences and perceived benefits
Time frame: At 8 weeks
Patient-reported satisfaction with the app
Time frame: At 8 weeks
Integration of workflow for health professionals
Time frame: At baseline
Time use in the intervention period
Time frame: Through the 8 weeks intervention period
Primary clinical outcome
Time frame: At baseline and at study completion (approx. 3 months after inclusion)
Patient satisfaction with the intervention at 8 weeks
Time frame: At 8 weeks
Other patient reported outcomes
Time frame: At 8 weeks
Recruitment rate
Time frame: At baseline
Patient dropout
Time frame: At 8 weeks
Trial logistics as assessed through interviews
Time frame: At study completion (approx. 3 months after inclusion)
Patients' app use
Time frame: Through study completion (approx. 3 months after inclusion)
Potential risk and challenges as assessed through interviews
Time frame: At study completion (approx. 3 months after inclusion)
Software performance and functionality
Time frame: Through study completion (approx. 3 months after inclusion)
Other patient reported outcomes
Time frame: Through study completion (approx. 3 months after inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Therese Tveter, PhD principal investigator
Diakonhjemmet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genus, a self-management app for patients with knee osteoarthritis in people with Knee Osteoarthristis, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desirable feasibility level (time frame: Through the 8 weeks intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.