Telemedicine for Patients with Inflammatory Bowel Disease (TELE-IBD) Clinical Trial: Qualitative Assessment of Participants’ Perceptions of the TELE-IBD Intervention (Preprint)

2019 ◽  
Author(s):  
Charlene C Quinn ◽  
Sarah Chard ◽  
Erin G Roth ◽  
J. Kevin Eckert ◽  
Katharine M Russman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Disease Activity ◽  
Remote Monitoring ◽  
Standard Care ◽  
Disease Process ◽  
The United States ◽  
Qualitative Assessment ◽  
Structured Interviews ◽  
Treatment Groups ◽  
Inflammatory Bowel

BACKGROUND Inflammatory bowel diseases (IBD), comprising Crohn’s disease and ulcerative colitis, affects 1 to 3 million people in the United States. Telemedicine has shown promise in IBD. The objective of the parent study, TELE-IBD, was to compare disease activity and quality of life (QoL) in a one-year randomized clinical trial of IBD patients receiving telemedicine versus standard care. Treatment groups experienced improvements in disease activity and QoL but there was not significant differences between groups. Study adherence to the text-based intervention was less than the 80% of the targeted goal. OBJECTIVE To understand adherence to remote monitoring, the goal of this qualitative assessment was to obtain TELE-IBD trial participants’ perceptions of the TELE-IBD system, including their recommendations for future TELE-IBD monitoring. METHODS In the parent study, patients attending three tertiary referral centers with worsening IBD symptoms in the previous two years were eligible for randomization to remote monitoring via texts every other week (EOW), weekly (W) or standard care. Participants (n=348) were evenly enrolled in the treatment groups and 259 (74.4%) completed the study. For this study, a purposive sample of adherent (N=15) and non-adherent (N=14) patients was drawn from the TELE-IBD trial population. Adherence was defined as the completion of 80% or more of the W or EOW self-assessments. Semi-structured interviews conducted by phone surveyed 1) the strengths and benefits of TELE-IBD; 2) challenges associated with using TELE-IBD; and 3) how to improve the TELE-IBD intervention. Interviews were recorded, professionally transcribed, and coded based on a priori concepts and emergent themes with the aid of ATLAS.ti qualitative data analysis software. RESULTS Participants' discussions centered on three elements of the intervention: 1) self-assessment questions, 2) action plans, and 3) educational messages. Participants also commented on: text-based platform, depression and adherence, TELE-IBD system in place of office visit, and their recommendations for future TELE-IBD systems. Adherent and non-adherent participants prefer a flexible system that is personalized, including targeted education messages, and they perceive TELE-IBD as effective in facilitating IBD self-management. CONCLUSIONS Participants identified clear benefits to the TELE-IBD system, including obtaining a better understanding of the disease process, monitoring their symptoms, and feeling connected to their health care provider. Participants' perceptions obtained in this qualitative study will assist in improving the TELE-IBD system to be more responsive to patients with IBD. CLINICALTRIAL NCT01692743

scholarly journals A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial (Preprint)

2017 ◽  
Author(s):  
Mariam Aguas ◽  
Javier del Hoyo ◽  
Raquel Faubel ◽  
Diana Mu�oz ◽  
David Dom�nguez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Disease Activity ◽  
Remote Monitoring ◽  
Web Based ◽  
Randomized Controlled ◽  
Inflammatory Bowel ◽  
Web Platform

BACKGROUND Telemedicine has been successfully used to provide inflammatory bowel disease (IBD) patients with health care services remotely via the implementation of information and communications technology, which uses safe and feasible apps that have been well accepted by patients in remission. However, the design of telemedicine apps in this setting involves difficulties that hinder the adherence of patients to the follow-up plans and the efficacy of these systems to improve disease activity and quality of life. OBJECTIVE This study aimed to evaluate the development of a Web platform, Telemonitoring of Crohn Disease and Ulcerative Colitis (TECCU), for remote monitoring of patients with complex IBD and the design of a clinical trial involving IBD patients who received standard care (G_Control), nurse-assisted telephone care (G_NT), or care based on distance monitoring (G_TECCU). METHODS We describe the development of a remote monitoring system and the difficulties encountered in designing the platform. A 3-arm randomized controlled trial was designed to evaluate the effectiveness of this Web platform in disease management compared with G_NT and G_Control. RESULTS According to the schedules established for the medical treatment initiated (corticosteroids, immunosuppressants, or biological agents), a total of 63 patients (21 patients from each group) answered periodic questionnaires regarding disease activity, quality of life, therapeutic adherence, adverse effects, satisfaction, work productivity, and social activities. Blood and stool analyses (fecal calprotectin) were performed periodically. On the basis of the results of these tests in G_TECCU, alerts were generated in a Web platform with adapted action plans, including changes in medication and frequency of follow-up. The main issues found were the development of an easy-to-use Web platform, the selection of validated clinical scores and objective biomarkers for remote monitoring, and the design of a clinical trial to compare the 3 main follow-up methods evaluated to date in IBD. CONCLUSIONS The development of a Web-based remote management program for safe and adequate control of IBD proved challenging. The results of this clinical trial will advance knowledge regarding the effectiveness of TECCU Web platform for improvement of disease activity, quality of life, and use of health care resources in complex IBD patients. CLINICALTRIAL ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/6y4DQdmt8) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/9639

P003 INFLAMMATORY BOWEL DISEASE PATIENTS’ PERSPECTIVES OF CLINICAL TRIALS

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S53-S53
Author(s):  
David Rubin ◽  
Laurent Peyrin-Biroulet ◽  
Walter Reinisch ◽  
Swati Tole ◽  
Laura Sullivan ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Health Care Providers ◽  
Online Survey ◽  
The United States ◽  
Trial Participation ◽  
Pharmaceutical Manufacturer ◽  
Care Providers ◽  
Inflammatory Bowel

Abstract Background Despite recent progress in treatment for inflammatory bowel diseases (IBD), there is a need for therapies with long-term efficacy and improved safety. Clinical trials in IBD face challenges with patient recruitment because of study designs, competitive or overlapping trials, and a limited number of eligible patients. We sought to better understand patients’ motivations, awareness of, and experience with IBD clinical trials. Methods We conducted an international survey of adult patients with IBD consisting of 2 components. The quantitative component, a 15-minute online survey, was completed by all patients. A qualitative component, a 30-minute telephone interview, was completed by a subset of patients from the United States (US). All percentages indicate results from the online survey. Results 226 patients (mean age, 41.9 y) completed the online survey. Survey respondents included patients with ulcerative colitis (52%) and Crohn’s disease (48%) from the US (n=100, 21 of whom underwent a phone interview), Brazil (n=26), Canada (n=25), France (n=25), Germany (n=25), and Spain (n=25). Ninety-six percent of respondents reported at least a basic understanding of clinical trials, and 34 (15%) were current or past clinical trial participants. Patients reported learning about trials through 1 or more sources (could select as many as applied): health care providers (42%), pharmaceutical manufacturer websites (31%), social media (30%), online support groups (28%), and foundations (18%-23%). In the survey, patients rated conversations with health care providers most helpful, but patients who were interviewed revealed that most physicians often do not initiate conversations about clinical trials, and patients typically do not ask. Primary motivators for trial participation (rated from “does not encourage me at all” to “encourages me very much”) included altruistic goals of advancing medicine (67%), potentially mitigating risks of uncontrolled IBD such as colon cancer (59%), and access to treatment options that could improve quality of life (59%) or would otherwise be unaffordable (52%). Major barriers to participation (rated from “does not discourage me at all” to “discourages me very much”) included invasive screening and monitoring (35%), concern over receiving placebo (35%), or suboptimal treatment (33%), and concerns about posttrial access to study medication (27%). The majority (68%) reported that being in a clinical trial means being a “guinea pig” for an experimental treatment. Conclusion Opportunities to improve patients’ clinical trial experience in IBD include better communication with health care providers and improved patient education about clinical trial design and ethics. Ultimately, a better understanding of the patient perspective will be important for more informed patients and potentially higher recruitment and enrollment.

scholarly journals Reinventing Inflammatory Bowel Disease (IBD) Clinical Trial Recruitment Using Novel Digital Medicine Tools (Preprint)

2018 ◽  
Author(s):  
Emamuzo Otobo ◽  
Christopher Park ◽  
Jason Rogers ◽  
Farah Fasihuddin ◽  
Shashank Garg ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Rapid Development ◽  
The United States ◽  
Population Characteristics ◽  
Patient Recruitment ◽  
Digital Medicine ◽  
Inflammatory Bowel

BACKGROUND Issues with patient recruitment and enrollment are the primary barriers for missed clinical trial timelines; 8 out of 10 clinical trials are delayed or unable to be completed because of lack of timely patient recruitment. Current patient recruitment efforts are inefficient and time-consuming, since they are typically dependent on manually screening patients during face-to-face visits to the clinic or hospital. With the rapid development of digital communication platforms within health care and the broad consumer adoption of smartphones, there are increasing opportunities to overcome some of these barriers. These platforms have particularly great potential for research and clinical care of chronic conditions, such as inflammatory bowel disease (IBD), an often debilitating disease which currently affects over three million adults in the United States. OBJECTIVE To integrate and utilize a digital medicine platform to improve patient recruitment and enrollment processes in clinical trials. METHODS Patients enrolled in the Mount Sinai Crohn’s and Colitis Registry (MSCCR) were remotely approached about enrolling in a mindfulness study for IBD patients. A text-based clinical rules engine was used to inform registry patients about the trial and to allow patients to indicate interest in participating via text message. Eligible IBD patients were bulk “prescribed” a notification through RxHealth’s digital medicine platform, RxUniverse. Characteristics of the enrolled population, characteristics of patients who responded, and timeliness of responses were analyzed. RESULTS Of the 1364 patients in the MSCCR with available phone numbers, 270 patients affirmatively replied they wanted to participate in to the study. Patients who opted into receiving more information about the study were more likely to have inadequate control of their IBD (25.64% vs 18.97%; P<.05) and more likely to have a recent history of depression based on a validated patient health questionnaire (15.38% vs 8.4%; P<.05) than those who opted out. Furthermore, patients who opted in tended to be younger, were more likely to be female, and less likely to have ulcerative colitis, though these trends did not reach statistical significance. Patient race did not significantly differ between those who opted in and opted out. In terms of timeliness of response among those enrolled, the majority of patients responded within 2 hours of notification. CONCLUSIONS Digital medicine software platforms can facilitate large-scale, lower-effort recruitment of eligible patients for clinical trials. Future research should be done to explore their expanded use for recruitment, patient education, and study data collection. Additional technologies such as patient-powered networks, social media, e-recruiting bots, and other remote engagement platforms can aid clinical trials by saving time and reducing costs of patient recruitment.

scholarly journals The Telemedicine for Patients With Inflammatory Bowel Disease (TELE-IBD) Clinical Trial: Qualitative Assessment of Participants’ Perceptions

10.2196/14165 ◽  
2019 ◽  
Vol 21 (6) ◽  
pp. e14165 ◽  
Author(s):  
Charlene Connolly Quinn ◽  
Sarah Chard ◽  
Erin G Roth ◽  
J Kevin Eckert ◽  
Katharine M Russman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Qualitative Assessment ◽  
Inflammatory Bowel

scholarly journals REINVENTING INFLAMMATORY BOWEL DISEASE (IBD) CLINICAL TRIAL RECRUITMENT USING NOVEL DIGITAL MEDICINE TOOLS

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S7-S7
Author(s):  
Farah Fasihuddin ◽  
Nicole Wedel ◽  
Ashish Atreja ◽  
Divya Madisetty ◽  
Charu Madhwani Jain ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Rapid Development ◽  
The United States ◽  
Population Characteristics ◽  
Patient Recruitment ◽  
Digital Medicine ◽  
Inflammatory Bowel

Abstract Background Issues with patient recruitment and enrolment are the primary barriers for missed clinical trial timelines; 8 out of 10 clinical trials are delayed or unable to be completed because of the lack of timely patient recruitment. Current patient recruitment efforts are inefficient as they are typically dependent on the manual screening of patients during face-to-face visits. With the rapid development of digital communication platforms within healthcare and the broad consumer adoption of smartphones, there are increasing opportunities to overcome some of these barriers. Digital platforms have great potential for research and clinical care of chronic conditions, such as inflammatory bowel disease (IBD), an often debilitating disease that currently affects over three million adults in the United States. In this paper, we utilized a digital medicine platform (Trialengage, Rx.Health, New York, NY) to improve patient recruitment for an ongoing mindfulness trial which had limited success in face-face enrolment (16 patients over 6 months). Methods Patients enrolled in the Mount Sinai Crohn’s and Colitis Registry (MSCCR) were remotely outreached about enrolling in a mindfulness study for IBD patients. A text-based clinical rules engine was used to inform registry patients about the trial and to allow patients to indicate interest in participating via text message. Eligible IBD patients were bulk “prescribed” a notification through RxHealth’s digital medicine platform, RxUniverse. Characteristics of the enrolled population, characteristics of patients who responded, and timeliness of responses were analyzed. Results Of the 1364 patients in the MSCCR with available phone numbers, 270 patients affirmatively replied they wanted to participate in the study. Patients who opted-in to receiving more information about the study were more likely to have inadequate control of their IBD (25.64% vs 18.97%; P&lt;.05) and more likely to have a recent history of depression based on a validated patient health questionnaire (15.38% vs 8.4%; P&lt;.05) than those who opted-out. There were no significant differences in terms of race, gender, and age between the two groups. In terms of timeliness of response among those enrolled, the majority of patients responded within 2 hours of notification. Conclusion Digital medicine software platforms can facilitate large-scale, lower-effort recruitment of eligible patients for clinical trials. Future research should be done to explore their expanded use for recruitment, patient education, and study data collection. Additional technologies such as patient-powered networks, social media, e-recruiting bots, and other remote engagement platforms can aid clinical trials by saving time and reducing costs of patient recruitment.

scholarly journals The impact of COVID-19 on the clinical trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0251410
Author(s):  
Zhimin Chen ◽  
Liran Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Remote Monitoring ◽  
Structured Interviews ◽  
Trial Staff ◽  
The Impact ◽  
Express Delivery

The objective of this study was to explore the impact of the coronavirus disease 2019 epidemic on ongoing and upcoming drug clinical trials. Qualitative semi-structured interviews were conducted with clinical trial staff and clinical trial subjects were surveyed by questionnaire in this study. The results of interviews and questionnaire showed that coronavirus disease 2019 pandemic has led to many changes in the implementation of drug clinical trials, including: a variety of meetings being held online webinars using various platforms, telemedicine and follow-up by video, A large number of deviations from protocol and losses of follow-up, delivery of clinical trial drugs by express, additional workload caused by screening for coronavirus, and anxiety of subjects. These results suggest that the coronavirus disease 2019 outbreak has hindered the progress and damaged the quality of clinical trials. The online meeting, remote follow-up, express delivery of drugs and remote monitoring in the epidemic environment can ensure the progress of clinical trials to a certain extent, but they cannot fully guarantee the quality as before.

scholarly journals A Qualitative Assessment of an Innovative Suicide Prevention and Treatment Approach: Contextual-Conceptual Therapy

2020 ◽  
Vol 2 (2) ◽  
pp. 28-41
Author(s):  
Amita Vyas ◽  
Breahnna Saunders ◽  
Nitasha Nagaraj
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Suicide Prevention ◽  
Suicide Ideation ◽  
The United States ◽  
Health Condition ◽  
Qualitative Assessment ◽  
Structured Interviews ◽  
Health And Illness ◽  
The Impact

Mental health and mental illness is a critical to a person’s overall health. In the United States alone, mental illness effects one in six adults. Furthermore, 40% of those individuals who die of suicide have been diagnosed with a mental health condition or illness. Yet, there is a paucity of research on innovative methods that help prevent suicide. The Contextual-Conceptual Therapy (CCT) approach introduces an innovative way to treat suicide by working to uncover the strengths of the suicidal person and addressing a person’s true self. The CCT approach was developed over the course of 25 years working with more than 16,000 suicidal patients in Seattle, Washington, and is tailored specifically for primary and secondary prevention of suicide. While there has been anecdotal evidence of the effectiveness of the CCT program, the program has yet to be formally evaluated. This qualitative research study aims to understand the impact the CCT approach has had on its clients. Eleven former CCT clients were recruited to participate in semi-structured interviews. Outcomes described by participants included an increase in curiosity and self-efficacy as a means through which to decrease suicide ideation and behavior, and proved to be incredibly powerful in changing long-term outcomes. This qualitative study is a first-step in providing critical insight on suicide prevention for wider dissemination. At a time when adverse mental health and illness is impacting the lives of millions of people, the CCT approach has the potential to address suicide, mental illness and mental health across diverse populations.

scholarly journals P142 Role of e-health in the management of Inflammatory Bowel Disease: A systematic review and meta-analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S227-S228
Author(s):  
A J Kuriakose Kuzhiyanjal ◽  
G B Nigam ◽  
G A Antoniou ◽  
R K Cross ◽  
F A Farraye ◽  
...  
Keyword(s):  
Disease Activity ◽  
Statistical Method ◽  
Standard Care ◽  
Health Interventions ◽  
Inverse Variance ◽  
Health Group ◽  
Significant Difference ◽  
Related Hospitalisation ◽  
Inflammatory Bowel

Abstract Background The increasing incidence and prevalence of inflammatory bowel disease (IBD), has fuelled the need for innovative models of care. We aimed to compare effectiveness of e-health interventions (virtual clinics, telephone consultation, remote monitoring or any web-based health platform) with standard care in management of IBD. Our primary outcomes were to assess the difference in disease activity and percentage of patients in clinical remission at the end of follow up. Our secondary outcomes were to investigate differences in quality of life (QoL), IBD-knowledge & rate ratios (RR) for endoscopic procedures, total healthcare encounters, corticosteroid use, and IBD related hospitalisation or surgery. Methods We searched Medline, Embase, PubMed, CINAHL, PsychInfo, Clinical trials registry and Cochrane databases for randomised controlled trials (RCT) published in the English language until November 2020, comparing e-health interventions to standard care for patients with IBD. Pooled estimates of dichotomous outcomes were calculated using the odds ratio (OR) and 95% confidence interval (CI) using the Mantel-Haenszel statistical method. For continuous data, the standardised mean difference (SMD) and 95% CI were calculated using the inverse variance statistical method. Event data were analysed and expressed as RR with 95% CI using the inverse variance statistical method. Random effects model was used. Results Nine studies involving 1841 participants (991 e-health group and 850 controls) were identified. There was no statistically significant difference between the mean disease activity scores for UC (SMD 0.22, 95% CI: -0.04–0.48) and CD (SMD 0.02, 95% CI: -0.18–0.22) in the e-health and standard care groups and no statistically significant difference in the percentage of patients in clinical remission at the end of follow up between both groups (OR -1.05, 95% CI: 0.76–1.45). Higher QoL (SMD 0.19, 95% CI: 0.05–0.34) and IBD knowledge (SMD 0.25, 95% CI: 0.12–0.37) scores were noted in the e-health group compared to standard care. There were no statistically significant differences noted in the RR for endoscopic procedures (RR 1.01, 95% CI: 0.81–1.26), total healthcare encounters (RR 1.03, 95% CI: 0.93–1.15;), IBD related, corticosteroid use (RR 0.99, 95% CI: 0.51–1.92), and IBD related hospitalisation (RR 0.81, 95% CI: 0.53–1.25) or surgery (RR 0.87, 95% CI: 0.49–1.55) between both groups. Conclusion E-health interventions are comparable with standard care for impact on disease activity, remission, endoscopy utilisation, total healthcare encounters, corticosteroid use, and IBD related hospitalisation or surgery. QoL and IBD related knowledge were higher in the e-health compared to the standard care group.

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