- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02333656
Management of Hip and Knee Osteoarthritis in Primary Health Care
2018년 1월 30일 업데이트: Nina Osteras, Diakonhjemmet Hospital
Improved Management of Patients With Hip and Knee Osteoarthritis in Primary Health Care
Previous research has shown that the osteoarthritis care for persons with hip or knee osteoarthritis in Norway has a potential for improvement as the provided care may not necessarily reflect evidence-based guideline recommendations.
This study will determine if a new model for integrated osteoarthritis (OA) care in primary health care will result in improved quality of osteoarthritis care and health benefits for the patients (reduced pain and body weight, increased function and activity level) among patients with hip and/or knee osteoarthritis.
Further, this study will examine if the new model reduce the number of unnecessary referrals to Magnetic Resonance Imaging (MRI) and to orthopaedic surgeons in secondary care, and if it increases the number of referrals to physiotherapy treatment and the number of discharge reports from the physiotherapists to the referring general practitioner.
연구 개요
상세 설명
A new model for integrated care for patients with hip and/or knee osteoarthritis (OA) in primary care will be developed and implemented.
The purpose of the model is to improve quality of OA care in primary health care services by increasing the collaboration between health care professionals and across health care levels, providing an integrated care and a patient pathway, and facilitating an active and healthy lifestyle among individuals with OA.
This implementation study represents a collaborative study between six municipalities and a hospital department aiming to fulfill the intentions of the Norwegian Health Care Coordination Reform.
The main aim of the present study is to implement and perform process and effect evaluations of this new model for integrated OA care.
The study design will be a cluster randomized controlled trial with a stepped wedge design.
Six neighboring municipalities will constitute the six clusters, which will switch from control (current OA care) to intervention phase (new OA model) in a randomized order.
All municipalities start the trial simultaneously and act as controls until the point in time they are randomized to crossover from control to intervention, and all municipalities have implemented the intervention by the end of inclusion.
The method consists of two parts; 1) Identification of barriers/facilitators + development of the model and interventions, 2) Implementation of the new model (interactive workshops) with process and effect evaluations.
Participants will be general practitioners and physiotherapists in primary care as well as people with hip or knee OA.
연구 유형
중재적
등록 (실제)
393
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Oslo, 노르웨이, 0319
- Diakonhjemmet Hospital
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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
45년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Activity-related hip and/or knee pain/complaints AND
- Clinical signs and symptoms corresponding to hip and/or knee OA OR radiologically diagnosed OA OR Registered in the medical journal with the ICPC codes L89 (osteoarthritis of the hip), L90 (osteoarthritis of knee), L91 (osteoarthritis not classified elsewhere), L13 (hip symptoms/complaints), L15 (knee symptoms/complaints) and/or L20 (joint symptoms/complaints not classified elsewhere).
Exclusion Criteria:
- Total hip or knee replacement in the actual joint(s) and no pain/complaints in the other hip or knee joint(s)
- Inflammatory rheumatic diseases (e.g. rheumatoid arthritis, spondyloarthritis)
- Malignant illness or other major conditions (i.e unstable cardiovascular disorders or lung disease, dementia) that restrict the ability to adhere to the recommended OA treatment
- Do not understand the Norwegian language
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Control group
Usual care.
The participants enrolled in the control period will receive OA treatment as it is currently offered in primary health care services.
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실험적: Intervention group
New OA model.
Health professionals attend an interactive workshop, implementation of international recommendations for OA care, multidiciplinary collaboration
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The general practitioners and the physiotherapists will attend an inter-active workshop and deliver osteoarthritis care in line with international recommendations for osteoarthritis treatment.
The general practitioner will refer eligible patients to treatment by physiotherapists at "Healthy Living Center" or by physiotherapists in private practice.
This treatment will include a standardized patient education program followed by structured exercise program with individual adjustments.
The general practitioner will schedule a follow-up after the 12-week treatment and will receive a treatment report from the physiotherapist.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Osteoarthritis Quality Indicator questionnaire
기간: 6 months
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Patient reported achievement of quality indicators for osteoarthritis care
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain
기간: 6 months
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Pain level in hip/knee past week
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6 months
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Joint stiffness
기간: 6 months
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Stiffness in the hip/knee past week
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6 months
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Global function
기간: 6 months
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Hip/knee function in the past week
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6 months
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Patient global assessment of the OA disease
기간: 6 months
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6 months
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Patient Acceptable Symptom State (PASS)
기간: 6 months
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6 months
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Hip/knee function, quality of living subscale
기간: 6 months
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Function (Knee injury and Osteoarthritis Outcome Score ADL subscale/ Hip disability and Osteoarthritis Outcome Score OoL subscale (K/HOOS)
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6 months
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Physical activity level
기간: 6 months
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An index based on self-reported frequency, intensity, duration of physical activity
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6 months
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Daily sitting
기간: 6 months
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Daily hours in sitting position
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6 months
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Satisfaction with the care provided
기간: 6 months
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6 months
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Health related quality of life (EQ-5D)
기간: 6 months
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6 months
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Self-reported body weight
기간: 6 months
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6 months
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Health care use, medication use and sick leave
기간: 6 months
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6 months
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Adverse events
기간: Up to 1 year
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Up to 1 year
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Health professionals' knowledge, attitude and behavior in OA care
기간: Pre- and post-workshop + 6 months post-workshop
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Pre- and post-workshop + 6 months post-workshop
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Referrals to orthopaedic surgeons
기간: Up to 1 year
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Number of referrals to secondary care that does not lead to scheduled joint surgery
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Up to 1 year
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Referrals to MRI
기간: Up to 1 year
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Number of referrals to MRI for OA assessment
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Up to 1 year
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Number of referrals to physiotherapy treatment
기간: Up to 1 year
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Up to 1 year
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Discharge reports from physiotherapists
기간: Up to 1 year
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Number of discharge reports from PTs at FLSs/ private practice to the referring GP
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Up to 1 year
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Arthritis Self-efficacy Scale
기간: 6 months
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6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Kåre Hagen, Prof., Project administrator/Research director
- 수석 연구원: Nina Østerås, PhD, Researcher
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Moseng T, Dagfinrud H, van Bodegom-Vos L, Dziedzic K, Hagen KB, Natvig B, Rotterud JH, Vlieland TV, Osteras N. Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated osteoarthritis care model: secondary analyses from a cluster-randomised stepped-wedge trial. BMC Musculoskelet Disord. 2020 Apr 13;21(1):236. doi: 10.1186/s12891-020-03235-z.
- Osteras N, Moseng T, van Bodegom-Vos L, Dziedzic K, Mdala I, Natvig B, Rotterud JH, Schjervheim UB, Vlieland TV, Andreassen O, Hansen JN, Hagen KB. Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial. PLoS Med. 2019 Oct 15;16(10):e1002949. doi: 10.1371/journal.pmed.1002949. eCollection 2019 Oct. Erratum In: PLoS Med. 2019 Dec 19;16(12):e1002993.
- Moseng T, Dagfinrud H, Osteras N. Implementing international osteoarthritis guidelines in primary care: uptake and fidelity among health professionals and patients. Osteoarthritis Cartilage. 2019 Aug;27(8):1138-1147. doi: 10.1016/j.joca.2019.03.010. Epub 2019 May 8.
- Osteras N, van Bodegom-Vos L, Dziedzic K, Moseng T, Aas E, Andreassen O, Mdala I, Natvig B, Rotterud JH, Schjervheim UB, Vlieland TV, Hagen KB. Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial. Implement Sci. 2015 Dec 2;10:165. doi: 10.1186/s13012-015-0353-7.
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
2015년 1월 1일
기본 완료 (실제)
2017년 10월 1일
연구 완료 (실제)
2017년 10월 1일
연구 등록 날짜
최초 제출
2015년 1월 4일
QC 기준을 충족하는 최초 제출
2015년 1월 5일
처음 게시됨 (추정)
2015년 1월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 2월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 1월 30일
마지막으로 확인됨
2018년 1월 1일
추가 정보
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. .
New OA model에 대한 임상 시험
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Oasis Pharmaceuticals, LLCMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)모병
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StemMedical A/S아직 모집하지 않음
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Afeka, The Tel-Aviv Academic College of EngineeringHebrew University of Jerusalem완전한