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 Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

2016 ◽  
Vol 3 (3) ◽  
pp. e37 ◽  
Author(s):  
Helané Wahbeh ◽  
Barry S Oken
Keyword(s):  
Quality Of Life ◽  
Health Outcomes ◽  
Mindfulness Meditation ◽  
Controlled Trial ◽  
Meditation Practice ◽  
Home Practice ◽  
Web Based ◽  
Randomized Controlled ◽  
Practice Behavior

Background Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. Objectives The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI’s ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. Methods Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants’ own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance, perceived stress, and mindfulness were completed before and after the intervention period via Web-based surveys. Results We enrolled 44 adults were enrolled and 31 adults completed all study activities. There were no group differences on demographics or important variables at baseline. Participants rated the IMMI arm higher than the Access to Guided Meditation arm on Client Satisfaction Questionnaire. IMMI was able to increase home practice behavior significantly compared to the Access to Guided Meditation arm: days practiced (P=.05), total minutes (P=.01), and average minutes (P=.05). As expected, there were no significant differences on health outcomes. Conclusions In conclusion, IMMI was found to be feasible and acceptable. The IMMI arm had increased daily meditation practice compared with the Access to Guided Meditation control group. More interaction through staff and/or through built-in email or text reminders may increase daily practice even more. Future studies will examine IMMI’s efficacy at improving health outcomes in the general population and also compare it directly to the well-studied mindfulness-based group interventions to evaluate relative efficacy. Trial Registration Clinicaltrials.gov NCT02655835; http://clinicaltrials.gov/ct2/show/NCT02655835 (Archived by WebCite at http://www.webcitation/ 6jUDuQsG2)

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

Web-Based Intervention to Improve Implantable Cardioverter Defibrillator Patients’ Shock-Related Anxiety and Quality of Life: A Randomized Controlled Trial

2017 ◽  
Vol 28 (2) ◽  
pp. 150-164 ◽  
Author(s):  
Tuğba Yardımcı ◽  
Hatice Mert
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Implantable Cardioverter Defibrillator ◽  
Controlled Trial ◽  
Web Based ◽  
Cardioverter Defibrillator ◽  
Randomized Controlled ◽  
Sf 36 ◽  
Shock Anxiety

In spite of its effectiveness, implantable cardioverter defibrillator (ICD) patients face psychological problems such as shock-related anxiety due to device shocks. The aim of this study was to evaluate whether a web-based intervention program for ICD patients would reduce shock-related anxiety and improve quality of life compared with usual care. This was a randomized controlled trial study including a total of 76 patients. Data were collected using Turkish versions of the Florida Shock Anxiety Scale and Short Form Health Survey (SF-36) at 0 (baseline), 3, and 6 months. Following intervention, there was a significant decrease in shock anxiety levels of patients and a statistically significant increase in social functioning, role-physical, mental health, vitality, and bodily pain subdimensions of SF-36. While no statistically significant difference was found between groups in terms of summary scores of SF-36, our results suggest that web-based interventions can be useful for ICD patients.

Short-term effectiveness of a web-based tailored intervention for cancer survivors on quality of life, anxiety, depression, and fatigue: randomized controlled trial

2016 ◽  
Vol 26 (2) ◽  
pp. 222-230 ◽  
Author(s):  
Roy A. Willems ◽  
Catherine A. W. Bolman ◽  
Ilse Mesters ◽  
Iris M. Kanera ◽  
Audrey A. J. M. Beaulen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Tailored Intervention ◽  
Short Term ◽  
Web Based ◽  
Randomized Controlled ◽  
Anxiety Depression
Sign in / Sign up

Export Citation Format

Share Document