Inflammatory Bowel DiseasesNCT07456566
Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease
A study testing Digital self-management program in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Michigan at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Digital self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60
Who cannot join
- 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
- Have short bowel syndrome
- Uncontrolled medical or psychiatric disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Micigan
Ann Arbor, Michigan, 48109
Shirley Cohen-Mekelburg, MD, MS, 734-845-5735, shcohen@med.umich.edu
Shirley Cohen-Mekelburg, MD, MS
About this study
Official title: Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial
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
- Being tested
- Digital self-management program, Standard Care
- Keywords
- Digital self-management program, Standard of care, Randomization, Questionnaires
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital self-management programBehavioural
Participants 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 CareBehavioural
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Care as usual Receives: Behavioral: Standard Care |
| Standard Care plus digital self-management program | Experimental | 24-week digital self-management program Receives: Behavioral: Digital self-management program; Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years (during the recruitment period)
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,
Measured: 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.
Measured: 24 weeks
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.
Measured: 24 weeks
Secondary outcomes (3)
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start20 Jul 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Cohen-Mekelburg, University of Michigan
- Investigators
- Shirley Cohen-Mekelburg, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456566
- Sponsor's protocol ID
- HUM00246865
- Other IDs
- 1K23DK136928-01A1
- Status last verified
- Jul 2026
- First submitted
- 2 Mar 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial
- ClinicalTrials.gov ID
- NCT07456566
- Acronym / sponsor ID
- HUM00246865
- Keywords
- Digital self-management program, Standard of care, Randomization, Questionnaires
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Behavioral: Standard CareCare as usual |
| Standard Care plus digital self-management program | Experimental | Behavioral: Digital self-management program, Behavioral: Standard Care24-week digital self-management program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
- Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60
Key exclusion criteria (6 listed)
- 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
- Have short bowel syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital self-management programParticipants 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. | Behavioural | Standard Care plus digital self-management program |
| Standard CareParticipants 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. | Behavioural | Standard Care plus digital self-management program, Standard care |
Primary outcome
Participant recruitment rate
Time frame: 2 years (during the recruitment period)
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
Time frame: 24 weeks
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
Time frame: 24 weeks
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
Time frame: 24 weeks
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.
3 secondary outcomes
Theoretical Framework of Acceptability (TFA)
Time frame: 24 weeks
Treatment Acceptability Adherence Scale (TAAS)
Time frame: 24 weeks
Qualitative interviews - self-management program group
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shirley Cohen-Mekelburg, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital self-management program in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shirley Cohen-Mekelburg, MD, MS (734-845-5735, shcohen@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment rate (time frame: 2 years (during the recruitment period)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.