Knee OsteoarthritisOA-AIDNCT07603973
Effect of an Information- and Self-management App for People With Knee Osteoarthritis
A study testing Information- and self-management app in people with Knee Osteoarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Information- and self-management app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteNorway
- Study dates
- 30 Oct 2025to 31 Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Diakonhjemmet Hospital
Oslo, Oslo, 0317
Anne Therese Tveter, PhD, +4791115550, a.t.tveter@medisin.uio.no
Tuva Moseng, PhD, +4747306697, tuva.moseng@diakonsyk.no
About this study
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.
Read more
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
- Being tested
- Information- and self-management app, Control
- Keywords
- knee osteoarthritis, digital support tool, app, evidence-based treatment, information, self-management
- Medical subject headings
- Osteoarthritis, Knee, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information- and self-management appDevice
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
ControlOther
Information on where to access publically available information about knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Getting access to an information- and self-management app in the waiting period from referral to consultation in specialist healthcare Receives: 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 Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Secondary outcomes (4)
Concordance between preferences and treatment decision
Measured with one qustion form the Decision Conflict Scale (DSC), 5 response options.
Measured: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Decisional quality
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.
Measured: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Level of shared decision-making
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
Measured: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Satisfaction with treatment choice
Measured on a numeric rating scale (0-10, with higher score indicating more satisfaction)
Measured: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start30 Oct 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Therese Tveter, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603973
- Sponsor's protocol ID
- DS-00926
- Other IDs
- 938916, CIV-25-08-053975
- Acronym
- OA-AID
- Status last verified
- May 2026
- First submitted
- 11 Dec 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to GDPR regulations
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Information- and Self-management App for People With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07603973
- Acronym / sponsor ID
- OA-AID / DS-00926
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, digital support tool, app, evidence-based treatment, information, self-management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 22 May 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Information- and self-management appGetting access to an information- and self-management app in the waiting period from referral to consultation in specialist healthcare |
| Control group | Active comparator | Other: ControlGetting access to publicly available information in the waiting period from referral to consultation in specialist healthcare |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women > 50 years referred to specialist healthcare for knee OA management
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Information- and self-management appAn 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 | Device | Intervention group |
| ControlInformation on where to access publically available information about knee osteoarthritis | Other | Control group |
Primary outcome
Knee Osteoathritis Knowlegde Scale (KOAKS)
Time frame: 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
Decision Conflict Scale (DCS)
Time frame: 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.
4 secondary outcomes
Concordance between preferences and treatment decision
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Decisional quality
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Level of shared decision-making
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Satisfaction with treatment choice
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to GDPR regulations
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information- and self-management app in people with Knee Osteoarthritis, 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Therese Tveter, PhD (+4791115550, a.t.tveter@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Osteoathritis Knowlegde Scale (KOAKS) (time frame: Baseline, 8 weeks, approx. 2-4 months after baseline (1 day after consultation (post consultation))). The study lists 2 primary outcomes in all. 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 22 May 2026.