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

scholarly journals A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Javier Del Hoyo ◽  
Pilar Nos ◽  
Raquel Faubel ◽  
Diana Muñoz ◽  
David Domínguez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Outcomes ◽  
Disease Activity ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Web Based ◽  
Randomized Controlled ◽  
Inflammatory Bowel ◽  
Telephone Calls

BACKGROUND The reported efficacy of telemedicine in patients with inflammatory bowel disease (IBD) is inconsistent among studies, and data for complex IBD are lacking. OBJECTIVE We aimed to evaluate the impact of remote monitoring using a Web system—Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis (TECCU)—as compared to standard care and telephone care on health outcomes and health care in patients with complex IBD. METHODS We performed a 3-arm randomized controlled trial. Adult patients with IBD who received immunosuppressants and biological agents were recruited from the IBD Unit of a tertiary university hospital. The patients were randomized into groups to receive remote monitoring (G_TECCU), nurse-assisted telephone care (G_NT), or standard care with in-person visits (G_control). All patients completed the study visits at baseline and at 12 and 24 weeks in addition to each type of intervention. The primary outcome was the percentage of patients in remission at 24 weeks. Secondary health outcomes were quality of life, medication adherence, adverse effects, satisfaction, and social activities. Data on the number of outpatient visits and telephone calls, emergency visits, hospitalizations, IBD-related surgeries, and corticosteroid courses were also collected. RESULTS A total of 63 patients were selected (21 patients in each group). During the study, 90.5% (19/21) of patients in G_control, 95.2% (20/21) in G_NT, and 85.7% (18/21) in G_TECCU were compliant to the intervention. After 24 weeks, the percentage of patients in remission was higher in G_TECCU (17/21, 81%) than in G_NT (14/21, 66.7%) and G_control (15/21, 71.4%). A higher improvement in disease activity was observed in G_TECCU than in G_control in terms of the Harvey-Bradshaw/Mayo (odds ratio=0.12, 95% CI=0.003-2.162, P=.19) and Harvey-Bradshaw/Walmsley (odds ratio=0.11, 95% CI=0.004-1.55, P=.13) indexes. Improvement in disease activity was associated with a larger reduction in fecal calprotectin values in G_TECCU compared to G_control (estimated intervention effect: odds ratio=–0.90; 95% CI=–1.96 to 0.16, P=.11). All completers adhered to treatment in G_TECCU. In addition, the quality of life, social activities, and satisfaction improved in all 3 groups. Although the number of outpatient visits and telephone calls was lower in G_TECCU than in G_NT and G_control, the safety profile was similar in all 3 groups. CONCLUSIONS This pilot clinical trial suggests that the TECCU Web-based system is a safe strategy for improving health outcomes in patients with complex IBD and reducing the use of health care resources. CLINICALTRIAL ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/746CRRtDN).

scholarly journals Efficacy and safety of two Ayurvedic dosage forms for Allergic rhinitis: Study protocol for an open-label randomized controlled trial

2019 ◽  
Author(s):  
JM Dahanayake ◽  
Pathirage Kamal Perera ◽  
P Galappaththy ◽  
D Samaranayake
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Allergic Rhinitis ◽  
Dosage Forms ◽  
Open Label ◽  
Randomized Controlled ◽  
Nasal Symptoms ◽  
Freeze Dried

Abstract Background Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system in Sri Lanka. The aim of this study is to find out whether the use of two preparations (decoction and its freeze dried powder) over a period of 4 weeks is able to cure the symptoms of allergic rhinitis. Study design This is a three arm open label non-inferiority randomized controlled clinical trial in patients with AR. The study duration is 28 days oral administration of the two Ayurvedic dosage forms (Decoction and freeze dried) and the antihistamine loratidine into the 3 arms allocated randomly. After a 1 week run-in period, eligible subjects are randomly assigned to the TMD12 decoction group, TMD12 freeze dried group and the antihistamine group. Total Nasal symptom Score (TNSS) of the patients are used as the primary efficacy outcome. TNSS is recorded and compared in all 3 arms prior to visit 1, at the end of 28 days, end of the first month of follow up and second month of follow up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and Health Related Quality of Life questionnaire are used as secondary end points. Discussion This clinical trial will be able to provide supportive evidence based scientific data on classical Ayurvedic dosage forms and the new dosage forms developed as freeze dried powder in the treatment of allergic rhinitis. Also by this trial, it is expected to develop capacity to scientifically evaluate Ayurvedic treatments that may help patients having conditions such as allergic rhinitis.

scholarly journals The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors

10.2196/31976 ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. e31976
Author(s):  
Nicholas J Hulbert-Williams ◽  
Monica Leslie ◽  
Lee Hulbert-Williams ◽  
Bogda Koczwara ◽  
Eila K Watson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Research Network ◽  
Web Based ◽  
Randomized Controlled ◽  
The Impact

Background Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. Finding My Way (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that FMW is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. Objective This study aims to adapt the Australian FMW website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of FMW UK against a treatment-as-usual waitlist control. Methods To an extent, our trial design replicates the existing Australian randomized controlled trial of FMW. Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, FMW UK and suggestions for future improvements. Results The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of FMW UK. Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. Conclusions Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the FMW trial in the UK setting, content updating was required. If FMW UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248 International Registered Report Identifier (IRRID) DERR1-10.2196/31976

scholarly journals The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors (Preprint)

2021 ◽  
Author(s):  
Nicholas J Hulbert-Williams ◽  
Monica Leslie ◽  
Lee Hulbert-Williams ◽  
Bogda Koczwara ◽  
Eila K Watson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Research Network ◽  
Web Based ◽  
Randomized Controlled ◽  
The Impact

BACKGROUND Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. <i>Finding My Way</i> (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that <i>FMW</i> is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. OBJECTIVE This study aims to adapt the Australian <i>FMW</i> website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of <i>FMW UK</i> against a treatment-as-usual waitlist control. METHODS To an extent, our trial design replicates the existing Australian randomized controlled trial of <i>FMW.</i> Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, <i>FMW UK</i> and suggestions for future improvements<i>.</i> RESULTS The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of <i>FMW UK.</i> Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the <i>Improving Communication</i> and <i>Sexuality and Intimacy</i> content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. CONCLUSIONS Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the <i>FMW</i> trial in the UK setting, content updating was required. If <i>FMW UK</i> now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/31976

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 P181 Long-term improvement in axial spondyloarthritis clinical outcomes following 2-weeks of intensive education and rehabilitation: results from the Bath residential rehabilitation programme

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Rosie Barnett ◽  
Anita McGrogan ◽  
Matthew Young ◽  
Charlotte Cavill ◽  
Mandy Freeth ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Rehabilitation Programme ◽  
Spinal Mobility ◽  
The Impact

Abstract Background/Aims  Axial spondyloarthritis (axSpA) is a chronic rheumatic condition, characterised by inflammatory back pain - often associated with impaired function and mobility, sleep disturbance, fatigue, and reduced quality of life. Despite the vast advances in pharmacological treatments for axSpA over the last few decades, physical activity and rehabilitation remain vital for effective disease management. At the Royal National Hospital for Rheumatic Diseases in Bath (RNHRD), the 2-week inpatient axSpA rehabilitation programme has been integral to axSpA care since the 1970’s. Prior research has demonstrated significant short-term improvements in spinal mobility (BASMI), function (BASFI) and disease activity (BASDAI) following course attendance. However, the long-term outcomes are yet to be evaluated in this unique cohort. Methods  Since the early 1990’s, clinical measures of spinal mobility, function and disease activity have been routinely collected at the RNHRD at all clinical appointments through administration of the BASMI, BASFI and BASDAI, respectively. Dates of attending the axSpA course and standard clinical and treatment follow-up data were also collected. Multiple linear regression models were used to investigate the impact of course attendance on final reported BASMI, BASDAI and BASFI scores (final score=most recent). Length of follow-up was defined as time between first and last recorded BASMI. Results  Of the 203 patients within the Bath SPARC200 cohort, 77.8% (158/203) had attended at least one rehabilitation course throughout follow-up. 70.0% (140/203) of patients were male. The mean duration of follow-up was 13.5 years (range 0-35 years); 28.1% (57/203) of individuals with 20+ years of follow-up. Course attendance (yes versus no) significantly reduced final BASMI score by 0.84 (p = 0.001, 95%CI -1.31 to -0.37) and final BASDAI score by 0.74 (p = 0.018, 95%CI -1.34 to -0.13). Although course attendance reduced final BASFI by 0.45 (95%CI -1.17 to 0.28), this relationship did not reach significance (p = 0.225). Whilst minimally clinically important difference (MCID) is, to our knowledge, yet to be defined for BASMI, MCIDs were achieved long-term for both BASDAI and BASFI - defined by van der Heijde and colleagues in 2016 as 0.7 and 0.4 for BASDAI and BASFI, respectively. Conclusion  These results provide novel evidence to support the integral role of education, physical activity and rehabilitation in the management of axSpA. Future work should investigate additional outcomes of critical importance to patients and clinicians, such as fatigue, quality of life and work productivity. Furthermore, a greater understanding of the factors that confound these outcomes may provide insights into those patients who may most benefit from attending a 2-week rehabilitation course. In addition to facilitating identification of those patients who may require additional clinical support. Disclosure  R. Barnett: None. A. McGrogan: None. M. Young: None. C. Cavill: None. M. Freeth: None. R. Sengupta: Honoraria; Biogen, Celgene, AbbVie, Novartis, MSD. Grants/research support; Novartis, UCB.

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