En omfattende selvbehandlingsintervensjon for personer med inflammatorisk tarmsykdom
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98195
- University of Washington
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Annen: Usual care group
The control group will receive standard care without the comprehensive self-management intervention. |
The control group will receive standard care. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment Feasibility
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Quality of Life
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-Efficacy for Managing Chronic Disease
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, 3 months
|
Number of Participants with Inactive Disease based on fecal calprotectin (<150 µg/g) assessed using ELISA. |
Baseline, 3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kendra Kamp, PHD, RN, University of Washington
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00015210
- 1K23NR020044-01A1 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .