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Effect of an Information- and Self-management App for People With Knee Osteoarthritis (OA-AID)

2026년 5월 17일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

204

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention group
Getting access to an information- and self-management app in the waiting period from referral to consultation in specialist healthcare
장치: Information- and self-management app
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
활성 비교기: Control group
Getting access to publicly available information in the waiting period from referral to consultation in specialist healthcare
다른: Control
Information on where to access publically available information about knee osteoarthritis

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Knee Osteoathritis Knowlegde Scale (KOAKS)
기간: 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)
기간: 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))

2차 결과 측정

결과 측정
측정값 설명
기간
Concordance between preferences and treatment decision
기간: 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
기간: 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
기간: 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
기간: 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))

기타 결과 측정

결과 측정
측정값 설명
기간
Motivation for exercise
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline, 8 weeks
Measured with a question about if they prefer surgery or non-surgical treatment
Baseline, 8 weeks
Health literacy
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline
Measured with questions about gender, age, education level, working status, smoking, living arrangements, sosioeconomic status, and support
Baseline
Antropometrics
기간: Baseline
Measured as self-reported hight and weight
Baseline
Joint-spesific information
기간: Baseline
Measured with questions about most trouble some knee, duration of complaints, other joints with complaints
Baseline
Exercise level
기간: 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
기간: Baseline
Assessed with 15 questions about the presens of different diseases (yes/no)
Baseline
Usability of the app
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Diakonhjemmet Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 10월 30일

기본 완료 (추정된)

2028년 10월 1일

연구 완료 (추정된)

2035년 12월 31일

연구 등록 날짜

최초 제출

2025년 12월 11일

QC 기준을 충족하는 최초 제출

2026년 5월 17일

처음 게시됨 (실제)

2026년 5월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 17일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DS-00926
  • 938916 (기타 식별자: Regional committees for medical and health research ethics (REK))
  • CIV-25-08-053975 (기타 식별자: Eudamed CIV ID)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

IPD will not be shared due to GDPR regulations

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Information- and self-management app에 대한 임상 시험

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약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다