Digital Care for Inflammatory Bowel Disease
(PROMOTE IBD Trial)
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of North Carolina, Chapel Hill
Disqualifiers: Current pouch, Ostomy, others
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to learn whether IBD patients have better disease outcomes and feel more empowered to manage their condition if they have access to text messaging with their clinical team and if their symptoms are more regularly monitored through text-based surveys.
Researchers will compare participants who have access to text-based monitoring, communication and education to participants who have access to text-based education alone. Researchers will also examine if different social and other non-medical factors impact IBD symptoms and quality of life.
All participants will:
* complete 5 brief on-line surveys over 12 months about their IBD and social risk factors,
* receive IBD education content by text message up to 2 times a week.
Some participants will also:
* receive additional surveys by text to monitor their IBD progression,
* have the opportunity to directly text message their IBD medical team.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems to focus on text-based communication and monitoring rather than medication changes.
What data supports the effectiveness of the treatment Enhanced Digital Care, Text-Based Monitoring, Digital Health Intervention, Enhanced Electronic Healthcare for Inflammatory Bowel Disease?
Research shows that digital health technologies can help manage inflammatory bowel disease by improving disease monitoring, treatment adherence, and quality of life. Studies have found that using smartphone apps and digital platforms can reduce emergency room visits and hospitalizations, indicating better management of the condition.
12345Is digital care for inflammatory bowel disease safe for humans?
The studies reviewed did not report any safety concerns related to the use of digital health monitoring platforms for inflammatory bowel disease, suggesting that these digital tools are generally safe for human use.
12346How is the Enhanced Digital Care treatment for inflammatory bowel disease different from other treatments?
Enhanced Digital Care for inflammatory bowel disease is unique because it uses digital health technologies to monitor disease activity and medication adherence in real-time, improving patient self-management and reducing hospital visits. This approach leverages mobile apps and smart technologies to provide personalized care and support between clinical visits, unlike traditional treatments that may not offer such continuous monitoring and interaction.
14578Eligibility Criteria
This trial is for individuals with Crohn's Disease, Ulcerative Colitis, or other forms of Inflammatory Bowel Disease. Participants should be willing to complete online surveys and receive educational content via text messages. The eligibility criteria are not fully listed here.Inclusion Criteria
I can use a mobile phone and respond to texts.
I am 13 or older and have IBD (Crohn's, ulcerative colitis, or indeterminant colitis).
Followed at a participating site with an office visit (in-person or virtual) within the preceding 12 months
+2 more
Exclusion Criteria
Unable to provide informed consent and child assent for minors
I have IBD and have had surgery resulting in a pouch or ostomy.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants complete baseline surveys including demographic information, social risk assessment, and patient-reported outcomes
1 week
1 visit (virtual)
Intervention
Participants receive text-based education and monitoring. Enhanced care arm participants receive additional surveys and text communication with their clinical team.
12 months
Monthly virtual check-ins, weekly if severe symptoms reported
Follow-up
Participants are monitored for safety and effectiveness after the intervention period
4 weeks
Participant Groups
The study tests if regular text-based symptom monitoring and communication with the clinical team can improve disease management in IBD patients compared to those only receiving educational texts. It also explores how social factors affect IBD symptoms and life quality.
2Treatment groups
Active Control
Placebo Group
Group I: Enhanced Digital Care ArmActive Control2 Interventions
Participants will receive brief check-in surveys about their IBD symptoms minimally once a month, via text messaging. Participants will also receive IBD educational text messages twice each week.
Group II: Specialized Education ArmPlacebo Group1 Intervention
Participants in this arm will receive IBD educational text messages twice each week.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UNC-Chapel Hill School of MedicineChapel Hill, NC
NYU Langone Health Lake SuccessLake Success, NY
University of PennsylvaniaPhiladelphia, PA
University of California San DiegoSan Diego, CA
More Trial Locations
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
Centers for Disease Control and PreventionCollaborator
University of PennsylvaniaCollaborator
References
Digital Health Technologies for Remote Monitoring and Management of Inflammatory Bowel Disease: A Systematic Review. [2023]Digital health technologies may be useful tools in the management of chronic diseases. We performed a systematic review of digital health interventions in the management of patients with inflammatory bowel diseases (IBD) and evaluated its impact on (i) disease activity monitoring, (ii) treatment adherence, (iii) quality of life (QoL) measures, and/or (iv) health care utilization.
Readiness, acceptance and use of digital patient reported outcome in an outpatient clinic. [2022]Use of digital patient-reported outcomes is being introduced in care of chronic conditions, including Inflammatory Bowel Disease. The aim is to supplement face-to-face follow-up sessions through symptom screening, and to inform follow-up through questions about mental health and quality of life. However, little is known about who is using this as intended. This study aimed to map differences between users and non-users among people with IBD and explore the mechanisms behind. We administered a questionnaire including the Readiness and Enablement Index for Health Technology (ReadHy) and the Service User Technology Acceptability Questionnaire (SUTAQ) to all people with IBD registered at Silkeborg Regional Hospital. Comparison between users and non-users and cluster analysis was conducted. Effect size (Cohen's d) was used to estimate magnitude of difference between groups. The user and non-user groups differed most strongly by level of emotional distress (d = 0.45). Cluster analysis of the ReadHy scales showed profiles have different sets of difficulties and reservations towards digital solutions. These difficulties correlated moderately with SUTAQ dissatisfaction and low acceptability. The dimensions of ReadHy may help to better understand particular needs of people with IBD when accessing digital PROs, which may lead to higher acceptability and improved quality of care.
A Noninferiority Randomized Clinical Trial of the Use of the Smartphone-Based Health Applications IBDsmart and IBDoc in the Care of Inflammatory Bowel Disease Patients. [2021]Providing timely follow-up care for patients with inflammatory bowel disease in remission is important but often difficult because of resource limitations. Using smartphones to communicate symptoms and biomarkers is a potential alternative. We aimed to compare outpatient management using 2 smartphone apps (IBDsmart for symptoms and IBDoc for fecal calprotectin monitoring) vs standard face-to-face care. We hypothesized noninferiority of quality of life and symptoms at 12 months plus a reduction in face-to-face appointments in the smartphone app group.
Impact of Digital Health Monitoring in the Management of Inflammatory Bowel Disease. [2022]Technological advances now permit self-management strategies using mobile applications which could greatly benefit patient care. The purpose of this study was to investigate whether the use of the inflammatory bowel disease (IBD) digital health monitoring platform, HealthPROMISE, leads to better quality of care and improved health outcomes in IBD patients. IBD patients were recruited in gastroenterology clinics and asked to install the HealthPROMISE application onto their smartphones. Patient satisfaction, quality of care, quality of life, patient symptoms, and resource utilization metrics were collected throughout the study and sent directly to their healthcare teams. Patients with abnormal symptom/SIBDQ scores were flagged for their physicians to follow up. After one-year, patient outcome metrics were compared to baseline values. Overall, out of 59 patients enrolled in the study, 32 patients (54%) logged into the application at least once during the study period. The number of IBD-related ER visits/hospitalizations in the year of use compared to the prior year demonstrated a significant decrease from 25% of patients (8/32) to 3% (1/32) (p = 0.03). Patients also reported an increase in their understanding of the nature/causes of their condition after using the application (p = 0.026). No significant changes were observed in the number of quality indicators met (p = 0.67) or in SIBDQ scores (p = 0.48). Given the significant burden of IBD, there is a need to develop effective management strategies. This study demonstrated that digital health monitoring platforms may aid in reducing the number of ER visits and hospitalizations in IBD patients.
Using e-health tools and PROMs to support self-management in patients with inflammatory bowel disease. [2022]The use of digital health or e-health is growing. The potential positive impact on IBD care from supported self-management using these tools emerged from a literature review carried out in preparation for a service improvement project. A patient-reported outcomes measure (PROM) with validation across IBD sub-types was already available for use. This internationally recognised tool has potential for use with existing or new e-health systems.
The accuracy of self-reported medical history: a preliminary analysis of the promise of internet-based research in Inflammatory Bowel Diseases. [2022]Internet-based surveys provide a potentially important tool for Inflammatory Bowel Disease (IBD) research. The advantages include low cost, large numbers of participants, rapid study completion and less extensive infrastructure than traditional methods. The aim was to determine the accuracy of patient self-reporting in internet-based IBD research and identify predictors of greater reliability.
Digital Health Apps in the Clinical Care of Inflammatory Bowel Disease: Scoping Review. [2023]Digital health is poised to transform health care and redefine personalized health. As Internet and mobile phone usage increases, as technology develops new ways to collect data, and as clinical guidelines change, all areas of medicine face new challenges and opportunities. Inflammatory bowel disease (IBD) is one of many chronic diseases that may benefit from these advances in digital health. This review intends to lay a foundation for clinicians and technologists to understand future directions and opportunities together.
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and Persistence With Inflammatory Bowel Disease Therapy (ASSIST Study): Protocol for a Randomized Controlled Trial. [2023]Inflammatory bowel diseases (IBDs) are chronic inflammatory conditions of the gastrointestinal tract. Although adherence to IBD therapies is associated with improved clinical outcomes, overall adherence is poor. Consequently, there is a critical need to develop interventions that monitor adherence in real time and identify reasons for nonadherence to support clinical teams in initiating effective interventions. Recently, electronic- and web-based platforms have been developed to monitor adherence and guide interventions. A novel remote therapy monitoring (RTM) technology, the Tappt digital health system, has been developed to monitor real-time medication adherence patterns through smart label technologies, capture patient-reported outcomes and barriers to care, and process patient data through algorithms that trigger personalized digital and human touch points between clinical visits. Such a digital health solution enables care teams to proactively identify and mitigate nonadherence and worsening clinical outcomes.