SC-IBD自己管理評価尺度の開発 (SC-IBD)
炎症性腸疾患（IBD）患者のためのセルフケア測定尺度の開発とその外来診療における応用
This study aims to develop and validate a disease-specific self-care measurement scale for patients with Inflammatory Bowel Disease (IBD). The research follows a sequential mixed-methods design: a qualitative phase to identify key self-care concepts, followed by a quantitative phase to test the psychometric properties of the newly developed SC-IBD scale in an outpatient population.
調査の概要
詳細な説明
This study is designed to develop and validate the SC-IBD scale, a disease-specific instrument for measuring self-care in patients with Inflammatory Bowel Disease (IBD). The project uses a sequential exploratory mixed-methods design.
In the qualitative phase, semi-structured interviews will be conducted with outpatients diagnosed with IBD to explore their experiences of self-care across the three theoretical dimensions described in the Middle-Range Theory of Self-Care of Chronic Illness: maintenance, monitoring, and management. The qualitative findings will inform item generation and content validity assessment through a multidisciplinary expert panel.
The quantitative phase will include the administration of the preliminary SC-IBD scale to an outpatient cohort in order to evaluate its psychometric properties, including construct validity, internal consistency, and test-retest reliability. Additional validated instruments (DASS-21, SF-12, BIPQ, IBD-Control, and the Short Food Literacy Questionnaire) will be used to assess convergent and divergent validity and to describe relevant psychological, clinical and behavioral correlates of self-care in IBD.
The ultimate goal of the study is to produce a reliable, valid, and clinically useful tool for assessing self-care behaviors in individuals living with IBD, supporting both research and clinical practice.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Daniele Napolitano, RN
- 電話番号：+393382650440
- メール：daniele.napolitano@policlinicogemelli.it
研究場所
-
-
RM
-
Roma、RM、イタリア、00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
-
コンタクト：
- Daniele Napolitano, RN
- 電話番号：+393382650440
- メール：daniele.napolitano@policlinicogemelli.it
-
主任研究者：
- Daniele Napolitano, RN
-
-
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
サンプリング方法
調査対象母集団
The study population consists of adult outpatients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) followed at the IBD outpatient clinic of the Fondazione Policlinico Universitario A. Gemelli IRCCS and affiliated satellite centers. Participants must have received an IBD diagnosis for at least 12 months, be able to read and speak Italian, and be willing to participate in either the qualitative or quantitative phase of the study. A total of 275 patients will be enrolled.
説明
Inclusion Criteria:
- Voluntary willingness to participate in the study.
- Diagnosis of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) for at least 12 months.
- Follow-up in outpatient setting.
- Age 18 years or older.
- Ability to read and speak Italian.
- Ability to understand the study procedures.
- Signed informed consent.
Exclusion Criteria:
- Age younger than 18 years.
- Significant cognitive impairment (e.g., dementia) that may limit participation.
- Insufficient comprehension of the Italian language.
- Severe psychiatric disorders that may compromise participation.
- Severe clinical conditions preventing participation in interviews or questionnaire completion.
- Refusal to sign the informed consent form.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
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 |
|---|---|---|
|
Psychometric Validation of the SC-IBD Scale
時間枠：Baseline to 3 months
|
Assessment of the psychometric properties of the SC-IBD scale, including internal consistency (e.g., McDonald's Omega), construct validity (exploratory and confirmatory factor analyses), content validity, convergent and divergent validity, and test-retest reliability. Analyses will determine whether the scale reliably and validly measures self-care behaviors in patients with Inflammatory Bowel Disease. |
Baseline to 3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Qualitative Themes of Self-Care in Patients with IBD
時間枠：Baseline
|
Qualitative analysis of semi-structured interviews to identify recurring themes and patterns of self-care behaviors across the dimensions of self-care maintenance, monitoring, and management, based on the Middle-Range Theory of Self-Care of Chronic Illness. Findings inform the generation and refinement of SC-IBD scale items. |
Baseline
|
|
Psychological Distress Measured by DASS-21
時間枠：Baseline
|
Assessment of depression, anxiety, and stress using the DASS-21 validated Italian version. Scores will be used to evaluate convergent and divergent validity of the SC-IBD scale and explore associations between self-care and psychological distress. |
Baseline
|
|
Health-Related Quality of Life Assessed by SF-12
時間枠：Baseline
|
Measurement of physical and mental health components through the SF-12 questionnaire to evaluate relationships between self-care behaviors and quality of life, supporting the SC-IBD validity analysis. |
Baseline
|
|
Illness Perception Measured by BIPQ
時間枠：Baseline
|
Evaluation of cognitive and emotional representations of illness using the Brief Illness Perception Questionnaire. Correlations with the SC-IBD scale will be used to assess construct validity. |
Baseline
|
|
Perceived Disease Control Measured by IBD-Control
時間枠：Baseline
|
Assessment of patient-reported control of IBD using the validated Italian version of the IBD-Control questionnaire (extended form with VAS). Used to explore relationships between perceived disease control and self-care behaviors. |
Baseline
|
|
Food Literacy Assessed by the Short Food Literacy Questionnaire
時間枠：Baseline
|
Measurement of food literacy using the SFLQ (Italian version). Results will help determine whether food literacy acts as a determinant or moderator of self-care in patients with IBD and evaluate convergent validity of the SC-IBD scale. |
Baseline
|
協力者と研究者
捜査官
- 主任研究者：Daniele Napolitano, RN、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
No, there is no plan to share individual participant data (IPD). Data will remain stored in pseudonymized form within the institution according to GDPR and local ethical requirements.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。