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TitleUsing digital health to facilitate compliance with standardized pediatric cancer treatment guidelines in Tanzania: protocol for an early-stage effectiveness-implementation hybrid study.
AuthorsVasudevan, L; Schroeder, K; Raveendran, Y; Goel, K; Makarushka, C; Masalu, N; Zullig, LL
JournalBMC cancer
Publication Date29 Mar 2020
Date Added to PubMed1 Apr 2020
AbstractIn high-income countries (HICs), increased rates of survival among pediatric cancer patients are achieved through the use of protocol-driven treatment. Compared to HICs, differences in infrastructure, supportive care, and human resources, make compliance with protocol-driven treatment challenging in low- and middle-income countries (LMICs). For successful implementation of protocol-driven treatment, treatment protocols must be resource-adapted for the LMIC context, and additional supportive tools must be developed to promote protocol compliance. In Tanzania, an LMIC where resource-adapted treatment protocols are available, digital health applications could promote protocol compliance through incorporation of systematic decision support algorithms, reminders and alerts related to patient visits, and up-to-date data for care coordination. However, evidence on the use of digital health applications in improving compliance with protocol-driven treatment for pediatric cancer is limited. This study protocol describes the development and evaluation of a digital health application, called mNavigator, to facilitate compliance with protocol-driven treatment for pediatric cancer in Tanzania. mNavigator is a digital case management system that incorporates nationally-approved and resource-adapted treatment protocols for two pediatric cancers in Tanzania, Burkitt lymphoma and retinoblastoma. mNavigator is developed from an open-source digital health platform, called CommCare, and guided by the Consolidated Framework for Implementation Research. From July 2019-July 2020 at Bugando Medical Centre in Mwanza, Tanzania, all new pediatric cancer patients will be registered and managed using mNavigator as the new standard of care for patient intake and outcome assessment. Pediatric cancer patients with a clinical diagnosis of Burkitt lymphoma or retinoblastoma will be approached for participation in the study evaluating mNavigator. mNavigator users will document pre-treatment and treatment details for study participants using digital forms and checklists that facilitate compliance with protocol-driven treatment. Compliance with treatment protocols using mNavigator will be compared to historical compliance rates as the primary outcome. Throughout the implementation period, we will document factors that facilitate or inhibit mNavigator implementation. Study findings will inform implementation and scale up of mNavigator in tertiary pediatric cancer facilities in Tanzania, with the goal of facilitating protocol-driven treatment. The study protocol was registered in (NCT03677128) on September 19, 2018.
TitleA single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol.
AuthorsHickey, KT; Hauser, NR; Valente, LE; Riga, TC; Frulla, AP; Masterson Creber, R; Whang, W; Garan, H; Jia, H; Sciacca, RR; Wang, DY
JournalBMC cardiovascular disorders
Publication Date16 Jul 2016
Date Added to PubMed17 Jul 2016
AbstractAtrial fibrillation is a major public health problem and is the most common cardiac arrhythmia, affecting an estimated 2.7 million Americans. The true prevalence of atrial fibrillation is likely underestimated because episodes are often sporadic; therefore, it is challenging to detect and record an occurrence in a "real world" setting. To date, mobile health tools that promote earlier detection and treatment of atrial fibrillation and improvement in self-management behaviors and knowledge have not been evaluated. This study will be the first to address the epidemic problem of atrial fibrillation with a novel approach utilizing advancements in mobile health electrocardiogram technology to empower patients to actively engage in their healthcare and to evaluate impact on quality of life and quality-adjusted life years. Furthermore, sending a daily electrocardiogram transmission, coupled with receiving educational and motivational text messages aimed at promoting self-management and a healthy lifestyle may improve the management of chronic cardiovascular conditions (e.g., hypertension, diabetes, heart failure, etc.). Therefore, we are currently conducting a randomized controlled trial to assess the efficacy of a mobile health intervention, iPhone® Helping Evaluate Atrial fibrillation Rhythm through Technology (iHEART) versus usual cardiac care. The iHEART study is a single center, prospective, randomized controlled trial. A total of 300 participants with a recent history of atrial fibrillation will be enrolled. Participants will be randomized 1:1 to receive the iHEART intervention, receiving an iPhone® equipped with an AliveCor® Mobile ECG and accompanying Kardia application and behavioral altering motivational text messages or usual cardiac care for 6 months. This will be the first study to investigate the utility of a mobile health intervention in a "real world" setting. We will evaluate the ability of the iHEART intervention to improve the detection and treatment of recurrent atrial fibrillation and assess the intervention's impact on improving clinical outcomes, quality of life, quality-adjusted life-years and disease-specific knowledge. NCT02731326 ; Verified April 2016.
TitleNurses' Role in Implementing and Sustaining Acute Telemedicine: A Mixed-Methods, Pre-Post Design Using an Extended Technology Acceptance Model.
AuthorsBagot, K; Moloczij, N; Arthurson, L; Hair, C; Hancock, S; Bladin, CF; Cadilhac, DA
JournalJournal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing
Publication Date1 Jan 2020
Date Added to PubMed12 Sep 2019
AbstractTechnology-based systems like telemedicine are frequently being implemented into healthcare settings, impacting clinician practices. Little is known about factors influencing acute telemedicine uptake, if factors differ across time, or between nurses and non-nurses. A mixed-methods, pre-post design with implementation of a new acute stroke telemedicine service. A survey based on an extended Technology Acceptance Model (TAM) was administered to clinicians involved in acute stroke care at 16 regional hospitals (2014-2017). Open-ended questions postimplementation (at 6 months) included strengths of the program and areas to improve. Subsequently, a secondary analysis of nurses' semistructured interviews at the first telemedicine site (2010-2011) was completed to provide greater explanatory detail. Surveys were completed by nurses (preimplementation n = 77, postimplementation n = 92) and non-nurses (pre n = 90, post n = 44). Preimplementation, perceived usefulness was the only significant predictor of intending to use telemedicine for nurses, while perceived ease of use and social influence were significant for non-nurses. Postimplementation, perceived usefulness was significant for both groups, as was facilitating conditions for nurses. Specific examples aligned to TAM categories from our detailed interviews (n = 11 nurses) included perceived usefulness (improved clinical support and patient care), perceived ease of use (technical, clinical aspects), facilitating conditions (setting, education, confidence), and social influence (working relationships). Important factors for acute stroke telemedicine varied between nurses and non-nurses, and changed after implementation. The benefits of telemedicine should be emphasized to nurses. Preimplementation, more non-nurses wanted systems to be easy. Support in clinical, technical, and relationship aspects of telemedicine consultations is required. Nurses are influential in implementing acute telemedicine, which is complex, with clinical and technical aspects entwined. Evidence-based implementation strategies must be tailored over time, and between nurses and non-nurses, to ensure initial uptake and ongoing use.
TitleTelemedicine infectious diseases consultations and clinical outcomes: a systematic review and meta-analysis protocol.
AuthorsBurnham, JP; Fritz, SA; Yaeger, LH; Colditz, GA
JournalSystematic reviews
Publication Date7 Jun 2019
Date Added to PubMed9 Jun 2019
AbstractTelemedicine use is increasing in many specialties, but its impact on clinical outcomes in infectious diseases has not been systematically studied and reviewed. The proposed systematic review will evaluate the current evidence regarding the effect of telemedicine infectious diseases consultation on a range of clinical outcomes, including mortality, hospital readmission, antimicrobial use, and cost. Standard systematic review methodology will be used, with searches of Ovid MEDLINE 1946-, 1947-, Scopus 1823-, Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), and 1997-. There will be no restriction on language or year of publication. The primary outcome will be 30-day all-cause mortality and secondary outcomes will include readmission within 30 days after discharge from an initial hospitalization with an infection, patient compliance/adherence, patient satisfaction, cost or cost effectiveness, length of hospital stay, antimicrobial use, and antimicrobial stewardship. Bias will be assessed using standard Cochrane methodologies. Data will be grouped by outcome and narratively synthesized. Meta-analysis will be performed for outcomes with clinical or methodological homogeneity. The systematic review and meta-analysis will be registered through PROSPERO. Pre-planned subgroup analyses will be detailed. A number of studies have documented the feasibility of telemedicine for infectious diseases, but a synthesis of clinical outcomes data with telemedicine infectious diseases consultation has not been performed. This systematic review will analyze many clinical outcomes of telemedicine infectious diseases consultation. The findings of this study will add to established literature about feasibility of telemedicine consultation by synthesizing the evidence for clinical effectiveness. PROSPERO CRD42018105225.
TitleAcute neurological care in north-east Germany with telemedicine support (ANNOTeM): protocol of a multi-center, controlled, open-label, two-arm intervention study.
AuthorsWeber, JE; Angermaier, A; Bollweg, K; Erdur, H; Ernst, S; Flöel, A; Gorski, C; Kandil, FI; Kinze, S; Kleinsteuber, K; Kurth, T; Schmehl, I; Theen, S; Endres, M; Audebert, HJ
JournalBMC health services research
Publication Date17 Aug 2020
Date Added to PubMed19 Aug 2020
AbstractBoth diagnosis and treatment of neurological emergencies require neurological expertise and are time-sensitive. The lack of fast neurological expertise in regions with underserved infrastructure poses a major barrier for state-of-the-art care of patients with acute neurological diseases and leads to disparity in provision of health care. The main purpose of ANNOTeM (acute neurological care in North East Germany with telemedicine support) is to establish effective and sustainable support structures for evidence based treatments for stroke and other neurological emergencies and to improve outcome for acute neurological diseases in these rural regions. A "hub-and-spoke" network structure was implemented connecting three academic neurological centres ("hubs") and rural hospitals ("spokes") caring for neurological emergencies. The network structure includes (1) the establishment of a 24/7 telemedicine consultation service, (2) the implementation of standardized operating procedures (SOPs) in the network hospitals, (3) a multiprofessional training scheme, and (4) a quality management program. Data from three major health insurance companies as well as data from the quality management program are being collected and evaluated. Primary outcome is the composite of first time of receiving paid outpatient nursing care, first time of receiving care in a nursing home, or death within 90 days after hospital admission. Beyond stroke only few studies have assessed the effects of telemedically supported networks on diagnosis and outcome of neurological emergencies. ANNOTeM will provide information whether this approach leads to improved outcome. In addition, a health economic analysis will be performed. German Clinical Trials Register DRKS00013067, date of registration: November 16 th, 2017, URL:
TitleAn evidence-based gamified mHealth intervention for overweight young adults with maladaptive eating habits: study protocol for a randomized controlled trial.
AuthorsPodina, IR; Fodor, LA; Cosmoiu, A; Boian, R
Publication Date12 Dec 2017
Date Added to PubMed14 Dec 2017
AbstractCognitive behavior therapy (CBT) is the first-line of treatment for overweight and obesity patients whose problems originate in maladaptive eating habits (e.g., emotional eating). However, in-person CBT is currently difficult to access by large segments of the population. The proposed SIGMA intervention (i.e., the Self-help, Integrated, and Gamified Mobile-phone Application) is a mHealth intervention based on CBT principles. It specifically targets overweight young adults with underlying maladaptive behaviors and cognitions regarding food. The SIGMA app was designed as a serious game and intended to work as a standalone app for weight maintenance or alongside a calorie-restrictive diet for weight loss. It uses a complex and novel scoring system that allows points earned within the game to be supplemented by points earned during outdoor activities with the help of an embedded pedometer. The efficacy of the SIGMA mHealth intervention will be investigated within a randomized, placebo-controlled trial. The intervention will be set to last 2 months with a 3-month follow-up. Selected participants will be young overweight adults with non-clinical maladaptive eating habits embodied by food cravings, binge eating, and emotional eating. The primary outcomes will be represented by changes in (1) self-reported maladaptive thoughts related to eating and body weight, (2) self-reported maladaptive eating behaviors in the range of urgent food cravings, emotional eating or binge eating, (3) as well as biased attentional processing of food items as indexed by reaction times. Secondary outcomes will be represented by changes in weight, Body Mass Index, general mood, and physical activity as indexed by the number of steps per day. Through an evidence-based cognitive behavioral approach and a user-friendly game interface, the SIGMA intervention offers a significant contribution to the development of a cost-effective and preventive self-help tool for young overweight adults with maladaptive eating habits. ISRCTN, ID: 70907354 . Registered on 6 February 2017. The ISRCTN registration is in line with the World Health Organization Trial Registration Data Set. The present paper represents the original version of the protocol. Any changes to the protocol will be communicated to ISRCTN.
TitleA smartphone application for treating depressive symptoms: study protocol for a randomised controlled trial.
AuthorsDeady, M; Johnston, DA; Glozier, N; Milne, D; Choi, I; Mackinnon, A; Mykletun, A; Calvo, RA; Gayed, A; Bryant, R; Christensen, H; Harvey, SB
JournalBMC psychiatry
Publication Date1 Jun 2018
Date Added to PubMed3 Jun 2018
AbstractDepression is a commonly occurring disorder linked to diminished role functioning and quality of life. The development of treatments that overcome barriers to accessing treatment remains an important area of clinical research as most people delay or do not receive treatment at an appropriate time. The workplace is an ideal setting to roll-out an intervention, particularly given the substantial psychological benefits associated with remaining in the workforce. Mobile health (mhealth) interventions utilising smartphone applications (apps) offer novel solutions to disseminating evidence based programs, however few apps have undergone rigorous testing. The present study aims to evaluate the effectiveness of a smartphone app designed to treat depressive symptoms in workers. The present study is a multicentre randomised controlled trial (RCT), comparing the effectiveness of the intervention to that of an attention control. The primary outcome measured will be reduced depressive symptoms at 3 months. Secondary outcomes such as wellbeing and work performance will also be measured. Employees from a range of industries will be recruited via a mixture of targeted social media advertising and Industry partners. Participants will be included if they present with likely current depression at baseline. Following baseline assessment (administered within the app), participants will be randomised to receive one of two versions of the Headgear application: 1) Intervention (a 30-day mental health intervention focusing on behavioural activation and mindfulness), or 2) attention control app (mood monitoring for 30 days). Participants will be blinded to their allocation. Analyses will be conducted within an intention to treat framework using mixed modelling. The results of this trial will provide valuable information about the effectiveness of mhealth interventions in the treatment of depressive symptoms in a workplace context. The current trial is registered with the Australian and New Zealand Clinical Trials Registry ( ACTRN12617000547347 , Registration date: 19/04/2017).
TitleImproving chronic pain management with eHealth and mHealth: study protocol for a randomised controlled trial.
AuthorsJaén, I; Suso-Ribera, C; Castilla, D; Zaragoza, I; García-Palacios, A; Gómez Palones, JL
JournalBMJ open
Publication Date29 Dec 2019
Date Added to PubMed1 Jan 2020
AbstractChronic pain has become a matter of public health concern due to its high prevalence and because public costs associated with treatment and disability increase each year. Research suggests that limitations in the traditional assessment of chronic pain patients limit the effectiveness of current medical treatments. The use of technology might serve change patient traditional monitoring into ecological momentary assessments, which might be visualised by physicians live. This study describes a randomised control trial designed to test the utility of a technology-based solution for pain telemonitoring consisting of a smartphone app for patients and a web application for physicians. The goal of this study will be to explore whether this combination of eHealth and mHealth improves the effectiveness of existing pain treatments. Participants will be 250 patients randomly assigned to one of these two conditions: treatment-as-usual (TAU) and TAU +app+ web. All participants will receive the usual treatment for their pain. Only the TAU +app+ web group use Pain Monitor app, which generates alarms that are sent to the physicians in the face of previously established undesired events. Physicians will be able to monitor app reports using a web application, which might result in an adjustment of treatment. We anticipate that the use of Pain Monitor plus the therapist web will result in a reduction of pain intensity and side effects of the medication. Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected. Mixed repeated-measure multivariate analyses of variances will be conducted to investigate whether there are differences between preassessment and postassessment scores as a function of the experimental condition. Ethical approval from the Hospital General Universitari de Castellon was obtained. The findings will be published in peer-reviewed journals. NCT03606265.
TitleThe effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial.
AuthorsGustafson, DH; Landucci, G; McTavish, F; Kornfield, R; Johnson, RA; Mares, ML; Westergaard, RP; Quanbeck, A; Alagoz, E; Pe-Romashko, K; Thomas, C; Shah, D
Publication Date12 Dec 2016
Date Added to PubMed14 Dec 2016
AbstractOpioid dependence has devastating and increasingly widespread consequences and costs, and the most common outcome of treatment is early relapse. People who inject opioids are also at disproportionate risk for contracting the human immunodeficiency virus (HIV) and hepatitis C virus (HCV). This study tests an approach that has been shown to improve recovery rates: medication along with other supportive services (medication-assisted treatment, or MAT) against MAT combined with a smartphone innovation called A-CHESS (MAT + A-CHESS). This unblinded study will randomly assign 440 patients to receive MAT + A-CHESS or MAT alone. Eligible patients will meet criteria for having an opioid use disorder of at least moderate severity and will be taking methadone, injectable naltrexone, or buprenorphine. Patients with A-CHESS will have smartphones for 16 months; all patients will be followed for 24 months. The primary outcome is the difference between patients in the two arms in percentage of days using illicit opioids during the 24-month intervention. Secondary outcomes are differences between patients receiving MAT +���A-CHESS versus MAT in other substance use, quality of life, retention in treatment, health service use, and, related to HIV and HCV, screening and testing rates, medication adherence, risk behaviors, and links to care. We will also examine mediators and moderators of the effects of MAT + A-CHESS. We will measure variables at baseline and months 4, 8, 12, 16, 20, and 24. At each point, patients will respond to a 20- to 30-min phone survey; urine screens will be collected at baseline and up to twice a month thereafter. We will use mixed-effects to evaluate the primary and secondary outcomes, with baseline scores functioning as covariates, treatment condition as a between-subject factor, and the outcomes reflecting scores for a given assessment at the six time points. Separate analyses will be conducted for each outcome. A-CHESS has been shown to improve recovery for people with alcohol dependence. It offers an adaptive and extensive menu of services and can attend to patients nearly as constantly as addiction does. This suggests the possibility of increasing both the effectiveness of, and access to, treatment for opioid dependence., NCT02712034 . Registered on 14 March 2016.
TitleImpact of Chest Pain Protocol with Access to Telemedicine on Implementation of Pharmacoinvasive Strategy in a Private Hospital Network.
AuthorsMacedo, TA; de Barros E Silva, PG; Simões, SA; Okada, MY; Garcia, JC; Sampaio, MC; Dantas, RN; Oliveira, RP; Rocha, LG; da Cunha Lopes, BB; Frigini, T; Furlan, V
JournalTelemedicine journal and e-health : the official journal of the American Telemedicine Association
Publication Date1 Jul 2016
Date Added to PubMed24 Dec 2015
AbstractBrazilian registries have shown a gap between evidence-based therapies and real treatments. We aim to compare the use of the pharmacoinvasive strategy and mortality in patients with ST elevation myocardial infarction (STEMI) transferred pre- and post-chest pain protocol with access to telemedicine (CPPT) in a private hospital network. A CPPT was implemented in 22 private emergency departments in 2012. Emergency physicians and nurses of all facilities were trained to disseminate the information to comply with a chest pain protocol focusing on reperfusion therapy (pharmacoinvasive strategy) for STEMI. To conduct clinical discussions using telemedicine, a cardiologist from a reference hospital in cardiology (RHC) was available 24 h/day, 7 days/week. Using the database of all consecutive admissions, we compared the data of patients with STEMI transferred to the RHC in 2011 (pre-CPPT) and 2013-2014 (post-CPPT). We included 376 patients (113 pre-CPPT and 263 post-CPPT) with STEMI. All patients admitted in the RHC were transferred from the 22 emergency departments. Comparing pre-CPPT and post-CPPT, we did not find differences regarding age, gender, hypertension, dyslipidemia, diabetes, smoking, previous myocardial infarction, or Killip classification. However, the use of CPPT was associated with a greater use of pharmacoinvasive strategy (55.8% versus 38%; p = 0.002) and a trend toward lower in-hospital mortality (3% versus 8%; p = 0.06). The implementation of a CPPT was associated with a significant increase in the use of pharmacoinvasive strategy in patients with STEMI and a trend toward reduced in-hospital mortality in a private hospital network.
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