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| ID | Type | Description | Link |
|---|---|---|---|
| 938916 | Other Identifier | Regional committees for medical and health research ethics (REK) | |
| CIV-25-08-053975 | Other Identifier | Eudamed CIV ID |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Getting access to an information- and self-management app in the waiting period from referral to consultation in specialist healthcare |
|
| Control group | Active Comparator | Getting access to publicly available information in the waiting period from referral to consultation in specialist healthcare |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)) |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance between preferences and treatment decision | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation for exercise | 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 | Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Therese Tveter, PhD | Contact | +4791115550 | a.t.tveter@medisin.uio.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diakonhjemmet Hospital | Recruiting | Oslo | Oslo | 0317 | Norway |
IPD will not be shared due to GDPR regulations
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Control | Other | Information on where to access publically available information about knee osteoarthritis |
|
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 | 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 | 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)) |
| Baseline, 4 weeks (only intervention group), 8 weeks |
| Assessment of knee-related pain | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Measured with a numeric rating scale from 0 (no disease activity) to 10 (worst disease activity) | Baseline, 8 weeks, 1 and 2 years |
| Fatigue | 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 | 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 | Measured with a question about if they prefer surgery or non-surgical treatment | Baseline, 8 weeks |
| Health literacy | 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 | 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 | 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 | 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 | 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 | 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 | Measured with questions about gender, age, education level, working status, smoking, living arrangements, sosioeconomic status, and support | Baseline |
| Antropometrics | Measured as self-reported hight and weight | Baseline |
| Joint-spesific information | Measured with questions about most trouble some knee, duration of complaints, other joints with complaints | Baseline |
| Exercise level | 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 | Assessed with 15 questions about the presens of different diseases (yes/no) | Baseline |
| Usability of the app | 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 | 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 | 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 | 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 |
| D012216 |
| Rheumatic Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |