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.
調査の概要
研究の種類
介入
入学 (推定)
204
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Anne Therese Tveter, PhD
- 電話番号：+4791115550
- メール：a.t.tveter@medisin.uio.no
研究場所
-
-
Oslo
-
Oslo、Oslo、ノルウェー、0317
- 募集
- Diakonhjemmet Hospital
-
コンタクト：
- Anne Therese Tveter, PhD
- 電話番号：+4791115550
- メール：a.t.tveter@medisin.uio.no
-
コンタクト：
- Tuva Moseng, PhD
- 電話番号：+4747306697
- メール：tuva.moseng@diakonsyk.no
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
アクティブコンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Knee Osteoathritis Knowlegde Scale (KOAKS)
時間枠：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)
時間枠：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))
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Concordance between preferences and treatment decision
時間枠：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
時間枠：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
時間枠：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
時間枠：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))
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Motivation for exercise
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, 8 weeks
|
Measured with a question about if they prefer surgery or non-surgical treatment
|
Baseline, 8 weeks
|
|
Health literacy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline
|
Measured with questions about gender, age, education level, working status, smoking, living arrangements, sosioeconomic status, and support
|
Baseline
|
|
Antropometrics
時間枠：Baseline
|
Measured as self-reported hight and weight
|
Baseline
|
|
Joint-spesific information
時間枠：Baseline
|
Measured with questions about most trouble some knee, duration of complaints, other joints with complaints
|
Baseline
|
|
Exercise level
時間枠：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
時間枠：Baseline
|
Assessed with 15 questions about the presens of different diseases (yes/no)
|
Baseline
|
|
Usability of the app
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年10月30日
一次修了 (推定)
2028年10月1日
研究の完了 (推定)
2035年12月31日
試験登録日
最初に提出
2025年12月11日
QC基準を満たした最初の提出物
2026年5月17日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22日
QC基準を満たした最後の更新が送信されました
2026年5月17日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- DS-00926
- 938916 (その他の識別子：Regional committees for medical and health research ethics (REK))
- CIV-25-08-053975 (その他の識別子：Eudamed CIV ID)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
IPD will not be shared due to GDPR regulations
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。