Effect of a Home-Based Exercise Intervention of Wearable Technology and Telephone Coaching on Walking Performance in Peripheral Artery Disease: The HONOR Randomized Clinical Trial.
McDermott Mary M,Spring Bonnie,Berger Jeffrey S,Treat-Jacobson Diane,Conte Michael S,Creager Mark A,Criqui Michael H,Ferrucci Luigi,Gornik Heather L,Guralnik Jack M,Hahn Elizabeth A,Henke Peter,Kibbe Melina R,Kohlman-Trighoff Debra,Li Lingyu,Lloyd-Jones Donald,McCarthy Walter,Polonsky Tamar S,Skelly Christopher,Tian Lu,Zhao Lihui,Zhang Dongxue,Rejeski W Jack
Importance:Clinical practice guidelines support home-based exercise for patients with peripheral artery disease (PAD), but no randomized trials have tested whether an exercise intervention without periodic medical center visits improves walking performance. Objective:To determine whether a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching improves walking ability over 9 months in patients with PAD. Design, Setting, and Participants:Randomized clinical trial conducted at 3 US medical centers. Patients with PAD were randomized between June 18, 2015, and April 4, 2017, to home-based exercise vs usual care for 9 months. Final follow-up was on December 5, 2017. Interventions:The exercise intervention group (n = 99) received 4 weekly medical center visits during the first month followed by 8 months of a wearable activity monitor and telephone coaching. The usual care group (n = 101) received no onsite sessions, active exercise, or coaching intervention. Main Outcomes and Measures:The primary outcome was change in 6-minute walk distance at 9-month follow-up (minimal clinically important difference [MCID], 20 m). Secondary outcomes included 9-month change in subcomponents of the Walking Impairment Questionnaire (WIQ) (0-100 score; 100, best), SF-36 physical functioning score, Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire (higher = better; MCID, 2 points), PROMIS satisfaction with social roles questionnaire, PROMIS pain interference questionnaire (lower = better; MCID range, 3.5-4.5 points), and objectively measured physical activity. Results:Among 200 randomized participants (mean [SD] age, 70.2 [10.4] years; 105 [52.5%] women), 182 (91%) completed 9-month follow-up. The mean change from baseline to 9-month follow-up in the 6-minute walk distance was 5.5 m in the intervention group vs 14.4 m in the usual care group (difference, -8.9 m; 95% CI, -26.0 to 8.2 m; P = .31). The exercise intervention worsened the PROMIS pain interference score, mean change from baseline to 9 months was 0.7 in the intervention group vs -2.8 in the usual care group (difference, 3.5; 95% CI, 1.3 to 5.8; P = .002). There were no significant between-group differences in the WIQ score, the SF-36 physical functioning score, or the PROMIS mobility or satisfaction with social roles scores. Conclusions and Relevance:Among patients with PAD, a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching, compared with usual care, did not improve walking performance at 9-month follow-up. These results do not support home-based exercise interventions of wearable devices and telephone counseling without periodic onsite visits to improve walking performance in patients with PAD. Trial Registration:clinicaltrials.gov Identifier: NCT02462824.
Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial.
McManus Richard J,Mant Jonathan,Franssen Marloes,Nickless Alecia,Schwartz Claire,Hodgkinson James,Bradburn Peter,Farmer Andrew,Grant Sabrina,Greenfield Sheila M,Heneghan Carl,Jowett Susan,Martin Una,Milner Siobhan,Monahan Mark,Mort Sam,Ogburn Emma,Perera-Salazar Rafael,Shah Syed Ahmar,Yu Ly-Mee,Tarassenko Lionel,Hobbs F D Richard,
Lancet (London, England)
BACKGROUND:Studies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care. METHODS:This study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366. FINDINGS:1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, -3·5 mm Hg [95% CI -5·8 to -1·2]; telemonitoring, -4·7 mm Hg [-7·0 to -2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference -1·2 mm Hg [95% CI -3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups. INTERPRETATION:Self-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care. FUNDING:National Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK.
Taking connected mobile-health diagnostics of infectious diseases to the field.
Wood Christopher S,Thomas Michael R,Budd Jobie,Mashamba-Thompson Tivani P,Herbst Kobus,Pillay Deenan,Peeling Rosanna W,Johnson Anne M,McKendry Rachel A,Stevens Molly M
Mobile health, or 'mHealth', is the application of mobile devices, their components and related technologies to healthcare. It is already improving patients' access to treatment and advice. Now, in combination with internet-connected diagnostic devices, it offers novel ways to diagnose, track and control infectious diseases and to improve the efficiency of the health system. Here we examine the promise of these technologies and discuss the challenges in realizing their potential to increase patients' access to testing, aid in their treatment and improve the capability of public health authorities to monitor outbreaks, implement response strategies and assess the impact of interventions across the world.
Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial.
van der Meij Eva,Anema Johannes R,Leclercq Wouter K G,Bongers Marlies Y,Consten Esther C J,Schraffordt Koops Steven E,van de Ven Peter M,Terwee Caroline B,van Dongen Johanna M,Schaafsma Frederieke G,Meijerink Wilhelmus J H J,Bonjer Hendrik J,Huirne Judith A F
Lancet (London, England)
BACKGROUND:Instructing and guiding patients after surgery is essential for successful recovery. However, the time that health-care professionals can spend with their patients postoperatively has been reduced because of efficiency-driven, shortened hospital stays. We evaluated the effect of a personalised e-health-care programme on return to normal activities after surgery. METHODS:A multicentre, single-blind, randomised controlled trial was done at seven teaching hospitals in the Netherlands. Patients aged 18-75 years who were scheduled for laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication were recruited. An independent researcher randomly allocated participants to either the intervention or control group using computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised, e-health-care programme, which managed recovery expectations and provided postoperative guidance tailored to the patient. The control group received usual care and access to a placebo website containing standard general recovery advice. Participants were unaware of the study hypothesis and were asked to complete questionnaires at five timepoints during the 6-month period after surgery. The primary outcome was time between surgery and return to normal activities, measured using personalised patient-reported outcome measures. Intention-to-treat and per-protocol analyses were done. This trial is registered in the Netherlands National Trial Register, number NTR4699. FINDINGS:Between Aug 24, 2015, and Aug 12, 2016, 344 participants were enrolled and randomly allocated to either the intervention (n=173) or control (n=171) group. 14 participants (4%) were lost to follow-up, with 330 participants included in the primary outcome analysis. Median time until return to normal activities was 21 days (95% CI 17-25) in the intervention group and 26 days (20-32) in the control group (hazard ratio 1·38, 95% CI 1·09-1·73; p=0·007). Complications did not differ between groups. INTERPRETATION:A personalised e-health intervention after abdominal surgery speeds up the return to normal activities compared with usual care. Implementation of this e-health programme is recommended in patients undergoing intermediate-grade abdominal, gynaecological, or general surgical procedures. FUNDING:ZonMw.
The Effect of Nursing Quality Improvement and Mobile Health Interventions on Infant Sleep Practices: A Randomized Clinical Trial.
Moon Rachel Y,Hauck Fern R,Colson Eve R,Kellams Ann L,Geller Nicole L,Heeren Timothy,Kerr Stephen M,Drake Emily E,Tanabe Kawai,McClain Mary,Corwin Michael J
Importance:Inadequate adherence to recommendations known to reduce the risk of sudden unexpected infant death has contributed to a slowing in the decline of these deaths. Objective:To assess the effectiveness of 2 interventions separately and combined to promote infant safe sleep practices compared with control interventions. Design, Setting, and Participants:Four-group cluster randomized clinical trial of mothers of healthy term newborns who were recruited between March 2015 and May 2016 at 16 US hospitals with more than 100 births annually. Data collection ended in October 2016. Interventions:All participants were beneficiaries of a nursing quality improvement campaign in infant safe sleep practices (intervention) or breastfeeding (control), and then received a 60-day mobile health program, in which mothers received frequent emails or text messages containing short videos with educational content about infant safe sleep practices (intervention) or breastfeeding (control) and queries about infant care practices. Main Outcomes and Measures:The primary outcome was maternal self-reported adherence to 4 infant safe sleep practices of sleep position (supine), sleep location (room sharing without bed sharing), soft bedding use (none), and pacifier use (any); data were collected by maternal survey when the infant was aged 60 to 240 days. Results:Of the 1600 mothers who were randomized to 1 of 4 groups (400 per group), 1263 completed the survey (78.9%). The mean (SD) maternal age was 28.1 years (5.8 years) and 32.8% of respondents were non-Hispanic white, 32.3% Hispanic, 27.2% non-Hispanic black, and 7.7% other race/ethnicity. The mean (SD) infant age was 11.2 weeks (4.4 weeks) and 51.2% were female. In the adjusted analyses, mothers receiving the safe sleep mobile health intervention had higher prevalence of placing their infants supine compared with mothers receiving the control mobile health intervention (89.1% vs 80.2%, respectively; adjusted risk difference, 8.9% [95% CI, 5.3%-11.7%]), room sharing without bed sharing (82.8% vs 70.4%; adjusted risk difference, 12.4% [95% CI, 9.3%-15.1%]), no soft bedding use (79.4% vs 67.6%; adjusted risk difference, 11.8% [95% CI, 8.1%-15.2%]), and any pacifier use (68.5% vs 59.8%; adjusted risk difference, 8.7% [95% CI, 3.9%-13.1%]). The independent effect of the nursing quality improvement intervention was not significant for all outcomes. Interactions between the 2 interventions were only significant for the supine sleep position. Conclusions and Relevance:Among mothers of healthy term newborns, a mobile health intervention, but not a nursing quality improvement intervention, improved adherence to infant safe sleep practices compared with control interventions. Whether widespread implementation is feasible or if it reduces sudden and unexpected infant death rates remains to be studied. Trial Registration:clinicaltrials.gov Identifier: NCT01713868.
Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation.
The New England journal of medicine
BACKGROUND:Optical sensors on wearable devices can detect irregular pulses. The ability of a smartwatch application (app) to identify atrial fibrillation during typical use is unknown. METHODS:Participants without atrial fibrillation (as reported by the participants themselves) used a smartphone (Apple iPhone) app to consent to monitoring. If a smartwatch-based irregular pulse notification algorithm identified possible atrial fibrillation, a telemedicine visit was initiated and an electrocardiography (ECG) patch was mailed to the participant, to be worn for up to 7 days. Surveys were administered 90 days after notification of the irregular pulse and at the end of the study. The main objectives were to estimate the proportion of notified participants with atrial fibrillation shown on an ECG patch and the positive predictive value of irregular pulse intervals with a targeted confidence interval width of 0.10. RESULTS:We recruited 419,297 participants over 8 months. Over a median of 117 days of monitoring, 2161 participants (0.52%) received notifications of irregular pulse. Among the 450 participants who returned ECG patches containing data that could be analyzed - which had been applied, on average, 13 days after notification - atrial fibrillation was present in 34% (97.5% confidence interval [CI], 29 to 39) overall and in 35% (97.5% CI, 27 to 43) of participants 65 years of age or older. Among participants who were notified of an irregular pulse, the positive predictive value was 0.84 (95% CI, 0.76 to 0.92) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular pulse notification and 0.71 (97.5% CI, 0.69 to 0.74) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular tachogram. Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study. There were no reports of serious app-related adverse events. CONCLUSIONS:The probability of receiving an irregular pulse notification was low. Among participants who received notification of an irregular pulse, 34% had atrial fibrillation on subsequent ECG patch readings and 84% of notifications were concordant with atrial fibrillation. This siteless (no on-site visits were required for the participants), pragmatic study design provides a foundation for large-scale pragmatic studies in which outcomes or adherence can be reliably assessed with user-owned devices. (Funded by Apple; Apple Heart Study ClinicalTrials.gov number, NCT03335800.).
Web-Based Stress Management for Newly Diagnosed Patients With Cancer (STREAM): A Randomized, Wait-List Controlled Intervention Study.
Urech Corinne,Grossert Astrid,Alder Judith,Scherer Sandra,Handschin Barbara,Kasenda Benjamin,Borislavova Borislava,Degen Sven,Erb Jennifer,Faessler Alexandra,Gattlen Laura,Schibli Sarah,Werndli Celine,Gaab Jens,Berger Thomas,Zumbrunn Thomas,Hess Viviane
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Purpose Being diagnosed with cancer causes major psychological distress; however, a majority of patients lack psychological support during this critical period. Internet interventions help patients overcome many barriers to seeking face-to-face support and may thus close this gap. We assessed feasibility and efficacy of Web-based stress management (STREAM [Stress-Aktiv-Mindern]) for newly diagnosed patients with cancer. Patients and Methods In a randomized controlled trial, patients with cancer who had started first-line treatment within the previous 12 weeks were randomly assigned to a therapist-guided Web-based intervention or a wait-list (control), stratified according to distress level (≥ 5 v < 5 on scale of 0 to 10). Primary efficacy end point was quality of life after the intervention (Functional Assessment of Chronic Illness Therapy-Fatigue). Secondary end points included distress (Distress Thermometer) and anxiety or depression (Hospital Anxiety and Depression Scale). Treatment effect was assessed with analyses of covariance, adjusted for baseline distress. Results A total of 222 of 229 screened patients applied online for participation. Between September 2014 and November 2016, 129 newly diagnosed patients with cancer, including 92 women treated for breast cancer, were randomly assigned to the intervention (n = 65) or control (n = 64) group. Adherence was good, with 80.0% of patients using ≥ six of eight modules. Psychologists spent 13.3 minutes per week (interquartile range, 9.5-17.9 minutes per week) per patient for online guidance. After the intervention, quality of life was significantly higher (Functional Assessment of Chronic Illness Therapy-Fatigue: mean, 8.59 points; 95% CI, 2.45 to 14.73 points; P = .007) and distress significantly lower (Distress Thermometer: mean, -0.85; 95% CI, -1.60 to -0.10; P = .03) in the intervention group as compared with the control. Changes in anxiety or depression were not significant in the intention-to-treat population (Hospital Anxiety and Depression Scale: mean, -1.28; 95% CI, -3.02 to 0.45; P = .15). Quality of life increased in the control group with the delayed intervention. Conclusion The Web-based stress management program STREAM is feasible and effective in improving quality of life.
Face-to-Face and Internet-Based Mindfulness-Based Cognitive Therapy Compared With Treatment as Usual in Reducing Psychological Distress in Patients With Cancer: A Multicenter Randomized Controlled Trial.
Compen Félix,Bisseling Else,Schellekens Melanie,Donders Rogier,Carlson Linda,van der Lee Marije,Speckens Anne
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Purpose Mindfulness-based cognitive therapy (MBCT) has been shown to alleviate psychological distress in patients with cancer. However, patients experience barriers to participating in face-to-face MBCT. Individual Internet-based MBCT (eMBCT) could be an alternative. The study aim was to compare MBCT and eMBCT with treatment as usual (TAU) for psychological distress in patients with cancer. Patients and Methods We obtained ethical and safety approval to include 245 patients with cancer with psychological distress (≥ 11 on the Hospital Anxiety and Depression Scale) in the study. They were randomly allocated to MBCT (n = 77), eMBCT (n = 90), or TAU (n = 78). Patients completed baseline (T0) and postintervention (T1) assessments. The primary outcome was psychological distress on the Hospital Anxiety and Depression Scale. Secondary outcomes were psychiatric diagnosis, fear of cancer recurrence, rumination, health-related quality of life, mindfulness skills, and positive mental health. Continuous outcomes were analyzed using linear mixed modeling on the intention-to-treat sample. Because both interventions were compared with TAU, the type I error rate was set at P < .025. Results Compared with TAU, patients reported significantly less psychological distress after both MBCT (Cohen's d, .45; P < .001) and eMBCT (Cohen's d, .71; P < .001) . In addition, post-treatment prevalence of psychiatric diagnosis was lower with both MBCT (33% improvement; P = .030) and eMBCT (29% improvement; P = .076) in comparison with TAU (16%), but these changes were not statistically significant. Both interventions reduced fear of cancer recurrence and rumination, and increased mental health-related quality of life, mindfulness skills, and positive mental health compared with TAU (all Ps < .025). Physical health-related quality of life did not improve ( P = .343). Conclusion Compared with TAU, MBCT and eMBCT were similarly effective in reducing psychological distress in a sample of distressed heterogeneous patients with cancer.
Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.
Koehler Friedrich,Koehler Kerstin,Deckwart Oliver,Prescher Sandra,Wegscheider Karl,Kirwan Bridget-Anne,Winkler Sebastian,Vettorazzi Eik,Bruch Leonhard,Oeff Michael,Zugck Christian,Doerr Gesine,Naegele Herbert,Störk Stefan,Butter Christian,Sechtem Udo,Angermann Christiane,Gola Guntram,Prondzinsky Roland,Edelmann Frank,Spethmann Sebastian,Schellong Sebastian M,Schulze P Christian,Bauersachs Johann,Wellge Brunhilde,Schoebel Christoph,Tajsic Milos,Dreger Henryk,Anker Stefan D,Stangl Karl
Lancet (London, England)
BACKGROUND:Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population. METHODS:The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed. FINDINGS:Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55-5·23) in the remote patient management group and 6·64% (6·19-7·13) in the usual care group (ratio 0·80, 95% CI 0·65-1·00; p=0·0460). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6-19·1) per year compared with 24·2 days (22·6-26·0) per year for patients assigned to usual care. The all-cause death rate was 7·86 (95% CI 6·14-10·10) per 100 person-years of follow-up in the remote patient management group compared with 11·34 (9·21-13·95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR] 0·70, 95% CI 0·50-0·96; p=0·0280). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45-1·01; p=0·0560). INTERPRETATION:The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality. FUNDING:German Federal Ministry of Education and Research.
The Asthma Mobile Health Study, a large-scale clinical observational study using ResearchKit.
Chan Yu-Feng Yvonne,Wang Pei,Rogers Linda,Tignor Nicole,Zweig Micol,Hershman Steven G,Genes Nicholas,Scott Erick R,Krock Eric,Badgeley Marcus,Edgar Ron,Violante Samantha,Wright Rosalind,Powell Charles A,Dudley Joel T,Schadt Eric E
The feasibility of using mobile health applications to conduct observational clinical studies requires rigorous validation. Here, we report initial findings from the Asthma Mobile Health Study, a research study, including recruitment, consent, and enrollment, conducted entirely remotely by smartphone. We achieved secure bidirectional data flow between investigators and 7,593 participants from across the United States, including many with severe asthma. Our platform enabled prospective collection of longitudinal, multidimensional data (e.g., surveys, devices, geolocation, and air quality) in a subset of users over the 6-month study period. Consistent trending and correlation of interrelated variables support the quality of data obtained via this method. We detected increased reporting of asthma symptoms in regions affected by heat, pollen, and wildfires. Potential challenges with this technology include selection bias, low retention rates, reporting bias, and data security. These issues require attention to realize the full potential of mobile platforms in research and patient care.
Fluid status telemedicine alerts for heart failure: a randomized controlled trial.
Böhm Michael,Drexler Helmut,Oswald Hanno,Rybak Karin,Bosch Ralph,Butter Christian,Klein Gunnar,Gerritse Bart,Monteiro Joao,Israel Carsten,Bimmel Dieter,Käab Stefan,Huegl Burkhard,Brachmann Johannes,
European heart journal
AIMS:Hospital admissions are frequently preceded by increased pulmonary congestion in heart failure (HF) patients. This study evaluated whether early automated fluid status alert notification via telemedicine improves outcome in HF patients. METHODS AND RESULTS:Patients recently implanted with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy were eligible if one of three conditions was met: prior HF hospitalization, recent diuretic treatment, or recent brain natriuretic peptide increase. Eligible patients were randomized (1:1) to have fluid status alerts automatically transmitted as inaudible text message alerts to the responsible physician or to receive standard care (no alerts). In the intervention arm, following a telemedicine alert, a protocol-specified algorithm with remote review of device data and telephone contact was prescribed to assess symptoms and initiate treatment. The primary endpoint was a composite of all-cause death and cardiovascular hospitalization. We followed 1002 patients for an average of 1.9 years. The primary endpoint occurred in 227 patients (45.0%) in the intervention arm and 239 patients (48.1%) in the control arm [hazard ratio, HR, 0.87; 95% confidence interval (CI), 0.72-1.04; P = 0.13]. There were 59 (11.7%) deaths in the intervention arm and 63 (12.7%) in the control arm (HR, 0.89; 95% CI, 0.62-1.28; P = 0.52). Twenty-four per cent of alerts were not transmitted and 30% were followed by a medical intervention. CONCLUSION:Among ICD patients with advanced HF, fluid status telemedicine alerts did not significantly improve outcomes. Adherence to treatment protocols by physicians and patients might be challenge for further developments in the telemedicine field.
Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial.
de Jong Marin J,van der Meulen-de Jong Andrea E,Romberg-Camps Mariëlle J,Becx Marco C,Maljaars Jeroen P,Cilissen Mia,van Bodegraven Ad A,Mahmmod Nofel,Markus Tineke,Hameeteman Wim M,Dijkstra Gerard,Masclee Ad A,Boonen Annelies,Winkens Bjorn,van Tubergen Astrid,Jonkers Daisy M,Pierik Marie J
Lancet (London, England)
BACKGROUND:Tight and personalised control of inflammatory bowel disease in a traditional setting is challenging because of the disease complexity, high pressure on outpatient clinics, and rising incidence. We compared the effects of self-management with a telemedicine system, which was developed for all subtypes of inflammatory bowel disease, on health-care utilisation and patient-reported quality of care versus standard care. METHODS:We did this pragmatic, randomised trial in two academic and two non-academic hospitals in the Netherlands. Outpatients aged 18-75 years with inflammatory bowel disease and without an ileoanal or ileorectal pouch anastomosis, who had internet access and Dutch proficiency, were randomly assigned (1:1) to care via a telemedicine system (myIBDcoach) that monitors and registers disease activity or standard care and followed up for 12 months. Randomisation was done with a computer-generated sequence and used the minimisation method. Participants, health-care providers, and staff who assessed outcome measures were not masked to treatment allocation. Primary outcomes were the number of outpatient visits and patient-reported quality of care (assessed by visual analogue scale score 0-10). Safety endpoints were the numbers of flares, corticosteroid courses, hospital admissions, emergency visits, and surgeries. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02173002. FINDINGS:Between Sept 9, 2014, and May 18, 2015, 909 patients were randomly assigned to telemedicine (n=465) or standard care (n=444). At 12 months, the mean number of outpatient visits to the gastroenterologist or nurse was significantly lower in the telemedicine group (1·55 [SD 1·50]) than in the standard care group (2·34 [1·64]; difference -0·79 [95% CI -0·98 to -0·59]; p<0·0001), as was the mean number of hospital admissions (0·05 [0·28] vs 0·10 [0·43]; difference -0·05 [-0·10 to 0·00]; p=0·046). At 12 months, both groups reported high mean patient-reported quality of care scores (8·16 [1·37] in the telemedicine group vs 8·27 [1·28] in the standard care group; difference 0·10 [-0·13 to 0·32]; p=0·411). The mean numbers of flares, corticosteroid courses, emergency visits, and surgeries did not differ between groups. INTERPRETATION:Telemedicine was safe and reduced outpatient visits and hospital admissions compared with standard care. This self-management tool might be useful for reorganising care of inflammatory bowel disease towards personalised and value-based health care. FUNDING:Maastricht University Medical Centre and Ferring.