This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease.
The study team hypothesizes:
* the study will achieve a recruitment rate of 10 participants every 3 months * 70% participant retention at 24 weeks * 70% outcome data collection * 70% intervention completion * high acceptability
Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBD
Impaired health-related quality of life
Clinically active IBD will be indicated by both a modified Harvey Bradshaw Index (HBI) ≥5 for Crohn's disease (CD) or a Simple Clinical Colitis Activity Index (SCCAI) ≥3 for ulcerative colitis (UC)
Fecal calprotectin > 250 microgram (ug/g)
Unable to speak and read English
Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention components
Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses
Are planned for imminent surgery
Parallel
Digital self-management program
BehavioralParticipants will receive this 24-week digital self-management program that was developed for patients with inflammatory bowel disease in addition to standard care. The program will be accessed through the web or a mobile device and will include different modules that will help support in managing participant's symptoms and disease both in the short-term as well as helping to build habits and skills to support participants in managing disease long-term. Participants are not required to use the self-management program and may stop using it at any time without any penalty to standard inpatient treatment. Additionally, participants will be asked to complete a follow-up self-report questionnaire at week 8 and week 12, and a clinician assessment at week 12. After 24 weeks a final remote visit or video meeting will be completed.
Standard Care
BehavioralParticipants will have baseline assessment of symptoms both based on self-report and a clinician's assessment, and review the electronic health record for standard of care inflammatory biomarker measurements. In addition, questionnaires will be collected and visit completed at 8,12, and 24-week follow-ups.
Participant recruitment rate
Feasibility will be defined by participant recruitment rate (the proportion of the proposed sample size who enroll to participate in the study over time). The study team hypothesize that the team will achieve a recruitment rate of 10 participants every 3 months.
The proportion of enrolled participants that complete the study without dropout
Feasibility will be defined by retention (the proportion enrolled participants who complete the study without dropout). The study team hypothesize that 70% participant retention at 24 weeks,
The proportion of study assessments completed by the participant
Feasibility willed be defined by the outcome assessment completion (the proportion of study assessments completed by participant). The study team hypothesize that 70% outcome data collection.
Qualitative interviews - self-management program group
Protocol acceptability will be determined based on post-intervention qualitative data. Discussion with participants will be facilitated by questions focusing on feedback about intervention characteristics, including content and functionality (e.g., usability, timing, frequency) and evaluate helpfulness, likes and dislikes, barriers and facilitators to use, and suggestions for improvement.
Theoretical Framework of Acceptability (TFA)
Intervention acceptability will be measured using a 19-item Likert scale questionnaire developed from Sekhon's Theoretical Framework of Acceptability (TFA).TFA is organized into seven domains that are important to assess the acceptability of healthcare interventions from the perspective of those receiving the intervention (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy). The 19-item questionnaire uses a 5-point Likert scale, where responses ranged from 5 (strongly agree) to 1 (strongly disagree). Scores range from 19-95 with higher scores representing higher acceptability.
Treatment Acceptability Adherence Scale (TAAS)
The 10-item TAAS was developed to assess both the acceptability of psychological interventions and anticipated adherence. The TAAS uses a 7-point Likert scale (1 = disagree strongly to 7 = agree strongly) for each item. Total scores range from 10 to 70, with higher scores indicating greater acceptability and anticipated adherence.
Qualitative interviews - self-management program group
Intervention acceptability will be determined based on post-intervention qualitative data. Discussion with participants will be facilitated by questions focusing on feedback about intervention characteristics, including content and functionality (e.g., usability, timing, frequency) and evaluate helpfulness, likes and dislikes, barriers and facilitators to use, and suggestions for improvement.
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University of Michigan
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
