Effect of an Information- and Self-management App for People With Knee Osteoarthritis (OA-AID)
2026年5月17日 更新者：Anne Therese Tveter、Diakonhjemmet Hospital
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.
研究概览
研究类型
介入性
注册 (估计的)
204
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Anne Therese Tveter, PhD
- 电话号码：+4791115550
- 邮箱：a.t.tveter@medisin.uio.no
学习地点
-
-
Oslo
-
Oslo、Oslo、挪威、0317
- 招聘中
- Diakonhjemmet Hospital
-
接触：
- Anne Therese Tveter, PhD
- 电话号码：+4791115550
- 邮箱：a.t.tveter@medisin.uio.no
-
接触：
- Tuva Moseng, PhD
- 电话号码：+4747306697
- 邮箱：tuva.moseng@diakonsyk.no
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Men and women > 50 years referred to specialist healthcare for knee OA management
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention group
Getting access to an information- and self-management app in the waiting period from referral to consultation in specialist healthcare
|
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
|
|
有源比较器：Control group
Getting access to publicly available information in the waiting period from referral to consultation in specialist healthcare
|
Information on where to access publically available information about knee osteoarthritis
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Knee Osteoathritis Knowlegde Scale (KOAKS)
大体时间：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
|
Baseline, 8 weeks, approx. 2-4 months after baseline (1 day after consultation (post consultation))
|
|
Decision Conflict Scale (DCS)
大体时间：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.
|
approx. 2-4 months after baseline (1 day after consultation (post consultation))
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Concordance between preferences and treatment decision
大体时间：approx. 2-4 months after baseline (1 day after consultation (post consultation))
|
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
大体时间：approx. 2-4 months after baseline (1 day after consultation (post consultation))
|
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
大体时间：approx. 2-4 months after baseline (1 day after consultation (post consultation))
|
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
大体时间：approx. 2-4 months after baseline (1 day after consultation (post consultation))
|
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))
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Motivation for exercise
大体时间：Baseline, 4 weeks (only intervention group), 8 weeks
|
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
大体时间：Baseline, 4 weeks (only intervention group), 8 weeks
|
Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation
|
Baseline, 4 weeks (only intervention group), 8 weeks
|
|
Assessment of knee-related pain
大体时间：Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
|
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
大体时间：Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
|
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
大体时间：Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
|
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
大体时间：Baseline, 1 and 2 years
|
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
大体时间：approx. 2-4 months after baseline (1 day after consultation (post consultation))
|
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
大体时间：approx. 2-4 months after baseline (1 day after consultation (post consultation))
|
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
大体时间：Baseline, 8 weeks
|
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
大体时间：Baseline, 8 weeks
|
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
大体时间：Baseline, 8 weeks
|
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
大体时间：Baseline, 8 weeks
|
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
大体时间：Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
|
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
大体时间：Baseline, 8 weeks, 1 and 2 years
|
Measured with a numeric rating scale from 0 (no disease activity) to 10 (worst disease activity)
|
Baseline, 8 weeks, 1 and 2 years
|
|
Fatigue
大体时间：Baseline, 8 weeks, 1 and 2 years
|
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
大体时间：Baseline, 8 weeks
|
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
大体时间：Baseline, 8 weeks
|
Measured with a question about if they prefer surgery or non-surgical treatment
|
Baseline, 8 weeks
|
|
Health literacy
大体时间：Baseline
|
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
大体时间：Baseline
|
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
大体时间：Baseline
|
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
大体时间：Baseline, 8 weeks, 1 and 2 years
|
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
大体时间：approx. 2-4 months after baseline (1 day after consultation (post consultation))
|
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
大体时间：Baseline, 8 weeks, 1 and 2 years
|
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
大体时间：Baseline
|
Measured with questions about gender, age, education level, working status, smoking, living arrangements, sosioeconomic status, and support
|
Baseline
|
|
Antropometrics
大体时间：Baseline
|
Measured as self-reported hight and weight
|
Baseline
|
|
Joint-spesific information
大体时间：Baseline
|
Measured with questions about most trouble some knee, duration of complaints, other joints with complaints
|
Baseline
|
|
Exercise level
大体时间：Baseline, 8 weeks, 1 and 2 years
|
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
大体时间：Baseline
|
Assessed with 15 questions about the presens of different diseases (yes/no)
|
Baseline
|
|
Usability of the app
大体时间：8 weeks (only intervention group)
|
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
大体时间：8 weeks (only the intervention group)
|
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
大体时间：8 weeks (only the intervention group)
|
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
大体时间：1 and 2 years
|
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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年10月30日
初级完成 (估计的)
2028年10月1日
研究完成 (估计的)
2035年12月31日
研究注册日期
首次提交
2025年12月11日
首先提交符合 QC 标准的
2026年5月17日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月17日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- DS-00926
- 938916 (其他标识符：Regional committees for medical and health research ethics (REK))
- CIV-25-08-053975 (其他标识符：Eudamed CIV ID)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
IPD will not be shared due to GDPR regulations
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.