염증성 장질환 환자를 위한 포괄적인 자가 관리 개입
This study aims to test the feasibility, acceptability, and preliminary efficacy of a comprehensive self-management (CSM) intervention for people with inflammatory bowel disease (IBD). The CSM-IBD intervention is an adaption of the CSM intervention initially developed for individuals with irritable bowel syndrome. The intervention has eight sessions which cover an introduction to IBD, symptom tracking, cognitive behavioral strategies, relaxation, sleep, diet, and pain management.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthcare provider diagnosis of inflammatory bowel disease
- Report current symptoms
- Able to read and write in English
Exclusion Criteria:
- Live outside of Washington state
- Bowel-related surgery within the past month
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Comprehensive Self-Management
The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse. |
In addition to standard care, participants receive content on self-management which includes cognitive behavioral therapy, relaxation, and diet. Weekly phone calls provide support for achieving the sessions goals. |
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다른: Usual care group
The control group will receive standard care without the comprehensive self-management intervention. |
The control group will receive standard care. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment Feasibility
기간: From screening to enrollment, an average of one month
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Percentage comprised of number of participants enrolled divided by the number of participants approached. |
From screening to enrollment, an average of one month
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Intervention Feasibility
기간: 3 months
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Measured with the Feasibility of Intervention Measure (FIM) in which participants respond to four questions on a 5-point Likert scale from completely disagree (1) to completely agree (5). Range: 1 to 5. A higher score indicates greater feasibility. |
3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Quality of Life
기간: Baseline, 3 months, 6 months
|
Short Inflammatory Bowel Disease Questionnaire is a 10-item questionnaire which evaluates quality of life. Participants respond on a 7-item Likert scale from all the time to none of the time. Total score range: 10 to 70. A higher score indicates greater quality of life. |
Baseline, 3 months, 6 months
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Change in Abdominal Pain Symptoms
기간: Baseline, 3 months, 6 months
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Abdominal pain was measured using a numeric rating scale where participants report the severity of the symptom from not present (0) to worst possible (10). |
Baseline, 3 months, 6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Self-Efficacy for Managing Chronic Disease
기간: Baseline, 3 months, 6 months
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A 6-item self-report scale. Participants report ranging from not at all confident to totally confident. Range: 1-10. A higher score indicates greater self-efficacy |
Baseline, 3 months, 6 months
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Index of Self-Regulation
기간: Baseline, 3 months, 6 months
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A 9-item scale to measure individual's level of self-regulation. Range: 0-36. A higher score indicates greater self-regulation. |
Baseline, 3 months, 6 months
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Patient Activation Measure
기간: Baseline, 3 months, 6 months
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A 13-item scale which assess patient's beliefs, knowledge and confidence in managing their health. Range: 0-100. A higher score indicates greater activation. |
Baseline, 3 months, 6 months
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Fecal Calprotectin
기간: Baseline, 3 months
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Number of Participants with Inactive Disease based on fecal calprotectin (<150 µg/g) assessed using ELISA. |
Baseline, 3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kendra Kamp, PHD, RN, University of Washington
간행물 및 유용한 링크
일반 간행물
- Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Kamp K, Clark-Snustad K, Yoo L, Winders S, Cain K, Levy RL, Dey N, Lee S, Keefer L, Heitkemper M. A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 7;12:e46307. doi: 10.2196/46307.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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. .