炎症性腸疾患患者に対する包括的な自己管理介入
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Washington
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Seattle、Washington、アメリカ、98195
- University of Washington
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
他の：Usual care group
The control group will receive standard care without the comprehensive self-management intervention. |
The control group will receive standard care. |
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 |
|---|---|---|
|
Recruitment Feasibility
時間枠：From screening to enrollment, an average of one month
|
Percentage comprised of number of participants enrolled divided by the number of participants approached. |
From screening to enrollment, an average of one month
|
|
Intervention Feasibility
時間枠：3 months
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Quality of Life
時間枠：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
|
|
Change in Abdominal Pain Symptoms
時間枠：Baseline, 3 months, 6 months
|
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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-Efficacy for Managing Chronic Disease
時間枠：Baseline, 3 months, 6 months
|
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
|
|
Index of Self-Regulation
時間枠：Baseline, 3 months, 6 months
|
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
|
|
Patient Activation Measure
時間枠：Baseline, 3 months, 6 months
|
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
|
|
Fecal Calprotectin
時間枠：Baseline, 3 months
|
Number of Participants with Inactive Disease based on fecal calprotectin (<150 µg/g) assessed using ELISA. |
Baseline, 3 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Kendra Kamp, PHD, RN、University of Washington
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。