- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01236209
Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback
The overall objective of this randomized controlled study (RCT) financed by the Norwegian Research Council (grant no. 182012/V50) is to establish the effectiveness of situational feedback to the self-management of fibromyalgia syndrome (FMS) using innovative means of patient-provider communication in a randomized controlled study (RCT). Thereby this project will contribute to the knowledge of treatment of patients with FMS. The effectiveness of the intervention will be expressed in terms of a) reduced pain, b) psychometric outcomes, c) quality of life, d) improved engagement in daily activities and e) prevented transition to chronic disability. We furthermore aim to 1) determine the effectiveness of providing regular situational feedback in enhancing self-management and, consequently 2) study the effectiveness of enhancing self-management in reducing pain and physical disability.
Self-management of chronic pain is increasingly seen as an important tool in providing adequate care to patients with FMS and other types of Chronic Non-malignant Pain. Enhancing the patient's self-management of her/his condition is thought to be effective in reducing pain and disability. However, sufficient empirical evidence to support this is yet unavailable. This may be due to the non-situational nature of many interventions studied so far: Patients are taught management skills in a clinical setting, and may not be able to successfully use these skills in daily care. Therefore, enhancing self-management of chronic pain, by providing immediate feedback that is directly related to patient's daily life ("situational" feedback) complementary to care-as usual, is thought to be more effective than conventional interventions in a clinical setting. This may even be even more effective when the patient receives quick response feedback using mobile communication technology, i.e. any place any time.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Moss, 노르웨이, 1517
- Jeloy kurbad rehabilitation centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female, having wide spread pain like FMS (IPCS codes CD-10, 79.0 - coded) for at least three months ,> 18 years, able to understand Norwegian; able to use the webenabled mobile phone.
Exclusion Criteria:
- substantial psychological problems in need of treatment with intensive psychotherapy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: web page
Control group: Information web page with some mindfulness exercises |
one arm having access to a webpage with information about coping with pain and relaxation exercises
다른 이름들:
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실험적: Webpage and situational feedback
Intervention group: have access to the same web-page with information about coping with pain and relaxation and are completing 3 diaries and receiving personalized feedback for 4 weeks at home through a smartphone. |
having access to the same web-page with information about coping with pain and relaxation relaxation and completing 3 diaries and receiving situational feedback for 4 weeks at home through a web enabled mobile phone.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in catastrophizing cognitions
기간: T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1
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PCS: Pain Catastrophizing Scale (Sullivan et al., 1995).
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T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in acceptance
기간: T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1
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CPAQ: Chronic Pain Acceptance questionnaire (McCracken)
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T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Hilde Eide, PhD, Buskerud University College
간행물 및 유용한 링크
일반 간행물
- Nes AA, van Dulmen S, Wicksell R, Fors EA, Eide H. Analyzing Change Processes Resulting from a Smartphone Maintenance Intervention Based on Acceptance and Commitment Therapy for Women with Chronic Widespread Pain. Int J Behav Med. 2017 Apr;24(2):215-229. doi: 10.1007/s12529-016-9590-7.
- Nes AA, Eide H, Kristjansdottir OB, van Dulmen S. Web-based, self-management enhancing interventions with e-diaries and personalized feedback for persons with chronic illness: a tale of three studies. Patient Educ Couns. 2013 Dec;93(3):451-8. doi: 10.1016/j.pec.2013.01.022. Epub 2013 Feb 21.
- Smedslund G, Eide H, Kristjansdottir OB, Nes AA, Sexton H, Fors EA. Do weather changes influence pain levels in women with fibromyalgia, and can psychosocial variables moderate these influences? Int J Biometeorol. 2014 Sep;58(7):1451-7. doi: 10.1007/s00484-013-0747-7. Epub 2013 Oct 17.
- Kristjansdottir OB, Fors EA, Eide E, Finset A, Stensrud TL, van Dulmen S, Wigers SH, Eide H. A smartphone-based intervention with diaries and therapist feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain. part 2: 11-month follow-up results of a randomized trial. J Med Internet Res. 2013 Mar 28;15(3):e72. doi: 10.2196/jmir.2442.
- Kristjansdottir OB, Fors EA, Eide E, Finset A, Stensrud TL, van Dulmen S, Wigers SH, Eide H. A smartphone-based intervention with diaries and therapist-feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain: randomized controlled trial. J Med Internet Res. 2013 Jan 7;15(1):e5. doi: 10.2196/jmir.2249.
- Kristjansdottir OB, Fors EA, Eide E, Finset A, van Dulmen S, Wigers SH, Eide H. Written online situational feedback via mobile phone to support self-management of chronic widespread pain: a usability study of a Web-based intervention. BMC Musculoskelet Disord. 2011 Feb 25;12:51. doi: 10.1186/1471-2474-12-51.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .