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TitleThe effect of a clinical decision-making mHealth support system on maternal and neonatal mortality and morbidity in Ghana: study protocol for a cluster randomized controlled trial.
AuthorsAmoakoh, HB; Klipstein-Grobusch, K; Amoakoh-Coleman, M; Agyepong, IA; Kayode, GA; Sarpong, C; Grobbee, DE; Ansah, EK
JournalTrials
Publication Date4 Apr 2017
Date Added to PubMed5 Apr 2017
AbstractMobile health (mHealth) presents one of the potential solutions to maximize health worker impact and efficiency in an effort to reach the Sustainable Development Goals 3.1 and 3.2, particularly in sub-Saharan African countries. Poor-quality clinical decision-making is known to be associated with poor pregnancy and birth outcomes. This study aims to assess the effect of a clinical decision-making support system (CDMSS) directed at frontline health care providers on neonatal and maternal health outcomes. A cluster randomized controlled trial will be conducted in 16 eligible districts (clusters) in the Eastern Region of Ghana to assess the effect of an mHealth CDMSS for maternal and neonatal health care services on maternal and neonatal outcomes. The CDMSS intervention consists of an Unstructured Supplementary Service Data (USSD)-based text messaging of standard emergency obstetric and neonatal protocols to providers on their request. The primary outcome of the intervention is the incidence of institutional neonatal mortality. Outcomes will be assessed through an analysis of data on maternal and neonatal morbidity and mortality extracted from the District Health Information Management System-2 (DHIMS-2) and health facility-based records. The quality of maternal and neonatal health care will be assessed in two purposively selected clusters from each study arm. In this trial the effect of a mobile CDMSS on institutional maternal and neonatal health outcomes will be evaluated to generate evidence-based recommendations for the use of mobile CDMSS in Ghana and other West African countries. ClinicalTrials.gov, identifier: NCT02468310 . Registered on 7 September 2015; Pan African Clinical Trials Registry, identifier: PACTR20151200109073 . Registered on 9 December 2015 retrospectively from trial start date.
Linkhttp://doi.org/10.1186/s13063-017-1897-4
TitleProtocols of a diagnostic study and a randomized controlled non-inferiority trial comparing televisits vs standard in-person outpatient visits for narcolepsy diagnosis and care: TElemedicine for NARcolepsy (TENAR).
AuthorsIngravallo, F; Vignatelli, L; Pagotto, U; Vandi, S; Moresco, M; Mangiaruga, A; Oriolo, C; Zenesini, C; Pizza, F; Plazzi, G
JournalBMC neurology
Publication Date11 May 2020
Date Added to PubMed13 May 2020
AbstractNarcolepsy is a rare chronic sleep disorder that typically begins in youth. Excessive daytime sleepiness is the main disabling symptom, but the disease is often associated with severe endocrine-metabolic and psychosocial issues, worsened by a long diagnostic delay, requiring a multidisciplinary approach. The scarcity of reference Sleep Centres forces the patient and family to travel for seeking medical consultations, increasing the economic and psychosocial burden of the disease. Growing evidence suggests that Telemedicine may facilitate patient access to sleep consultations and its non-inferiority in terms of patient satisfaction, adherence to treatment, and symptom improvement for sleep disorders. However, Telemedicine clinical and economic benefits for patients with narcolepsy are still unknown. TENAR is a two-part project, including: 1. a cross-sectional study (involving 250 children and adults with suspected narcolepsy) evaluating the accuracy of Teletriage (i.e., a synchronous live interactive sleep assessment through a Televisit) for narcolepsy diagnosis compared to the reference standard; and 2. a two-arm, parallel, open randomized controlled trial (RCT) to demonstrate the non-inferiority of the multidisciplinary care of narcolepsy through Televisits versus standard care. In this RCT, 202 adolescents (> 14 y.o.) and adults with narcolepsy will be randomly allocated (1:1 ratio) either to Televisits via videoconference or to standard in-person outpatient follow-up visits (control arm). The primary outcome is sleepiness control (according to the Epworth Sleepiness Scale). Secondary outcomes are other symptoms control, compliance with treatment, metabolic control, quality of life, feasibility, patient and family satisfaction with care, safety, and disease-related costs. At baseline and at 12 months, patients will undergo neurologic, metabolic, and psychosocial assessments and we will measure primary and secondary outcomes. Primary outcomes will be also measured at 6 months (remotely or in person, according to the arm). TENAR project will assess, for the first time, the feasibility, accuracy, efficacy and safety of Telemedicine procedures applied to the diagnosis and the multidisciplinary care of children and adults with narcolepsy. The study may be a model for the remote management of other rare disorders, offering care access for patients living in areas lacking medical centres with specific expertise. Number of the Tele-multidisciplinary care study NCT04316286. Registered 20 March 2020.
Linkhttp://doi.org/10.1186/s12883-020-01762-9
TitleSystematic Review about QoS and QoE in Telemedicine and eHealth Services and Applications.
Authorsde la Torre Díez, I; Alonso, SG; Hamrioui, S; López-Coronado, M; Cruz, EM
JournalJournal of medical systems
Publication Date29 Aug 2018
Date Added to PubMed30 Aug 2018
AbstractThe provision of Quality of Service (QoS) and Quality of Experience (QoE) is a mandatory requirement when transmitting telemedicine traffic, due to information relevance to maintain the patient's health. The main objective of this paper is to present a review of existing research works in the literature, referring to QoS and QoE in telemedicine and eHealth applications. The academic databases that were used to perform the searches are Google Scholar, IEEE Xplore, PubMed, Science Direct and Web of Science, taking into account the date of publication from 2008 to the present. These databases cover the most information of scientific texts in multidisciplinary fields, engineering and medicine. Several search criteria were established such as 'QoS' AND 'eHealth' OR 'Telemedicine', 'QoE' AND 'eHealth' AND 'Telemedicine' etc. selecting the items of greatest interest. A total of 248 papers related to QoS and QoE in telemedicine and eHealth have been found, of which 39 papers have been identified as relevant works. The results show that the percentage of studies related to QoS in literature is higher with 74.36% to QoE with 25.64%. From the review of the research articles analyzed, it can be said that QoS and QoE in telemedicine and eHealth are important and necessary factors to guarantee the privacy, reliability, quality and security of data in health care systems.
Linkhttp://doi.org/10.1007/s10916-018-1040-4
TitleEfficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials.
AuthorsCharrier, N; Zarca, K; Durand-Zaleski, I; Calinaud, C
JournalBMC health services research
Publication Date8 Feb 2016
Date Added to PubMed10 Feb 2016
AbstractWith the development of information and communication technologies, telemedicine has been proposed as a way to improve patient management by facilitating access to appropriate diagnosis and treatment. The Paris Ile de France Regional Health Agency is currently funding a comprehensive program of telemedicine experiments. This article describes the protocols for the evaluation of the implementation of telemedicine in the Paris region. Over 2,500 patients have been included in eight studies addressing the use of telemedicine in the context of specific diseases or settings. Two projects are randomized controlled trials, while the six other projects are based on before-after designs (differences in differences studies). Based on the MAST model and the French national framework, we identified endpoints to assess the impact of telemedicine on five dimensions: clinical effectiveness, cost-effectiveness, security of the application, patient satisfaction and quality of life and perception of professionals. Telemedicine encompasses a wide range of services and stakeholders, and thus study protocols must be tailored to the specific constraints and interests of the users. NCT02110433 (03/07/2014), NCT02157740 (05/27/2014), NCT02374697 (02/05/2015), NCT02157727 (05/27/2014), NCT02229279 (08/28/2014), NCT02368769 (02/05/2015), NCT02164747 (NCT02164747), NCT02309905 (11/27/2014).
Linkhttp://doi.org/10.1186/s12913-016-1281-1
TitleNonpublication Rates and Characteristics of Registered Randomized Clinical Trials in Digital Health: Cross-Sectional Analysis.
AuthorsAl-Durra, M; Nolan, RP; Seto, E; Cafazzo, JA; Eysenbach, G
JournalJournal of medical Internet research
Publication Date18 Dec 2018
Date Added to PubMed30 Nov 2018
AbstractClinical trials are key to advancing evidence-based medical research. The medical research literature has identified the impact of publication bias in clinical trials. Selective publication for positive outcomes or nonpublication of negative results could misdirect subsequent research and result in literature reviews leaning toward positive outcomes. Digital health trials face specific challenges, including a high attrition rate, usability issues, and insufficient formative research. These challenges may contribute to nonpublication of the trial results. To our knowledge, no study has thus far reported the nonpublication rates of digital health trials. The primary research objective was to evaluate the nonpublication rate of digital health randomized clinical trials registered in ClinicalTrials.gov. Our secondary research objective was to determine whether industry funding contributes to nonpublication of digital health trials. To identify digital health trials, a list of 47 search terms was developed through an iterative process and applied to the "Title," "Interventions," and "Outcome Measures" fields of registered trials with completion dates between April 1, 2010, and April 1, 2013. The search was based on the full dataset exported from the ClinlicalTrials.gov database, with 265,657 trials entries downloaded on February 10, 2018, to allow publication of studies within 5 years of trial completion. We identified publications related to the results of the trials through a comprehensive approach that included an automated and manual publication-identification process. In total, 6717 articles matched the a priori search terms, of which 803 trials matched our latest completion date criteria. After screening, 556 trials were included in this study. We found that 150 (27%) of all included trials remained unpublished 5 years after their completion date. In bivariate analyses, we observed statistically significant differences in trial characteristics between published and unpublished trials in terms of the intervention target condition, country, trial size, trial phases, recruitment, and prospective trial registration. In multivariate analyses, differences in trial characteristics between published and unpublished trials remained statistically significant for the intervention target condition, country, trial size, trial phases, and recruitment; the odds of publication for non-US-based trials were significant, and these trials were 3.3 (95% CI 1.845-5.964) times more likely to be published than US-based trials. We observed a trend of 1.5 times higher nonpublication rates for industry-funded trials. However, the trend was not statistically significant. In the domain of digital health, 27% of registered clinical trials results are unpublished, which is lower than nonpublication rates in other fields. There are substantial differences in nonpublication rates between trials funded by industry and nonindustry sponsors. Further research is required to define the determinants and reasons for nonpublication and, more importantly, to articulate the impact and risk of publication bias in the field of digital health trials.
Linkhttp://doi.org/10.2196/11924
TitleA coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's community hypertension care: study protocol for a randomized controlled trial.
AuthorsXu, L; Fang, WY; Zhu, F; Zhang, HG; Liu, K
JournalTrials
Publication Date25 May 2017
Date Added to PubMed27 May 2017
AbstractHypertension is a major risk factor for cardiovascular disease, and its control rate has remained low worldwide. Studies have found that telemonitoring blood pressure (BP) helped control hypertension in randomized controlled trials. However, little is known about its effect in a structured primary care model in which primary care physicians (PCPs) are partnering with cardiology specialists in electronic healthcare data sharing and medical interventions. This study aims to identify the effects of a coordinated PCP-cardiologist model that applies telemedicine tools to facilitate community hypertension control in China. Patients with hypertension receiving care at four community healthcare centers that are academically affiliated to Shanghai Chest Hospital, Shanghai JiaoTong University are eligible if they have had uncontrolled BP in the previous 3 months and access to mobile Internet. Study subjects are randomly assigned to three interventional groups: (1) usual care; (2) home-based BP telemonitor with embedded Global System for Mobile Communications (GSM) module and unlimited data plan, an app to access personal healthcare record and receive personalized lifestyle coaching contents, and proficiency training of their use; or (3) this plus coordinated PCP-cardiologist care in which PCPs and cardiologists share data via a secure CareLinker website to determine interventional approaches. The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes are changes of diastolic blood pressure, HbA1C, blood lipids, and medication adherence measured by the eight-item Morisky Medication Adherence Scale. This study will determine whether a coordinated PCP-Cardiologist Telemedicine Model that incorporates the latest telemedicine technologies will improve hypertension care. Success of the model would help streamline the present community healthcare processes and impact a greater number of patients with uncontrolled hypertension. ClinicalTrials.gov, NCT02919033 . Registered on 23 September 2016.
Linkhttp://doi.org/10.1186/s13063-017-1970-z
TitleBarriers and enablers to implementing a virtual tertiary-regional Telemedicine Rounding and Consultation (TRAC) model of inpatient pediatric care using the Theoretical Domains Framework (TDF) approach: a study protocol.
AuthorsBele, S; Cassidy, C; Curran, J; Johnson, DW; Saunders, C; Bailey, JAM
JournalBMC health services research
Publication Date11 Jan 2019
Date Added to PubMed13 Jan 2019
AbstractOver-occupancy at the two tertiary pediatric care hospitals in Alberta, Canada is steadily increasing with simultaneous decline in occupancy of pediatric beds at regional hospitals. Over-occupancy negatively impacts timeliness and potentially, the safety of patient care provided at these two tertiary hospitals. In contrast, underutilization of pediatric beds at regional hospitals poses the risk of losing beds provincially, dilution of regional pediatric expertise and potential erosion of confidence by regional providers. One approach to the current situation in provincial pediatric care capacity is development of telemedicine based innovative models of care that increase the population of patients cared for in regional pediatric beds. A Telemedicine Rounding and Consultation (TRAC) model involves discussing patient care or aspects of their care using telemedicine by employing visual displays, audio and information sharing between tertiary and regional hospitals. To facilitate implementation of a TRAC model, it is essential to understand the perceived barriers among its potential users in local context. The current study utilizes qualitative methodologies to assess these perceived clinician barriers to inform a future pilot and evaluation of this innovative virtual pediatric tertiary-regional collaborative care model in Alberta. We will use a qualitative descriptive design guided by the Theoretical Domain Framework (TDF) to systematically identify the tertiary and regional clinical stakeholder's perceived barriers and enablers to the implementation of proposed TRAC model of inpatient pediatric care. Semi-structured interviews and focus groups with pediatricians, nurses and allied health professionals, administrators, and family members will be conducted to identify key barriers and enablers to implementation of the TRAC model using TDF. Appropriate behaviour change techniques will be identified to develop potential intervention strategies to overcome identified barriers. These intervention strategies will facilitate implementation of the TRAC model during the pilot phase. The proposed TRAC model has the potential to address the imbalance between utilization of regional and tertiary inpatient pediatric facilities in Alberta. Knowledge generated regarding barriers and enablers to the TRAC model and the process outlined in this study could be used by health services researchers to develop similar telemedicine-based interventions in Canada and other parts of the world.
Linkhttp://doi.org/10.1186/s12913-018-3859-2
TitleImplementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial.
AuthorsLazo-Porras, M; Bernabe-Ortiz, A; Sacksteder, KA; Gilman, RH; Malaga, G; Armstrong, DG; Miranda, JJ
JournalTrials
Publication Date19 Apr 2016
Date Added to PubMed21 Apr 2016
AbstractDiabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period. This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru. participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care. the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study. This study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability. This study is registered in ClinicalTrials.gov: Identifier NCT02373592 .
Linkhttp://doi.org/10.1186/s13063-016-1333-1
TitleUse of Flowchart for Automation of Clinical Protocols in mHealth.
AuthorsDias, KN; Welfer, D; Cordeiro d'Ornellas, M; Pereira Haygert, CJ; Dotto, GN
JournalStudies in health technology and informatics
Publication Date1 Dec 2017
Date Added to PubMed4 Jan 2018
AbstractFor healthcare professionals to use mobile applications we need someone who knows software development, provide them. In healthcare institutions, health professionals use clinical protocols to govern care, and sometimes these documents are computerized through mobile applications to assist them. This work aims to present a proposal of an application of flow as a way of describing clinical protocols for automatic generation of mobile applications to assist health professionals. The purpose of this research is to enable health professionals to develop applications from the description of their own clinical protocols. As a result, we developed a web system that automates clinical protocols for an Android platform, and we validated with two clinical protocols used in a Brazilian hospital. Preliminary results of the developed architecture demonstrate the feasibility of this study.
Link
Title'Re-engage' pilot study protocol: a nurse-led eHealth intervention to re-engage, educate and empower childhood cancer survivors.
AuthorsSignorelli, C; Wakefield, CE; Johnston, KA; Fardell, JE; Brierley, ME; Thornton-Benko, E; Foreman, T; Webber, K; Wallace, WH; Cohn, RJ
JournalBMJ open
Publication Date12 Apr 2018
Date Added to PubMed15 Apr 2018
AbstractMany childhood cancer survivors are disengaged from cancer-related follow-up care despite being at high risk of treatment-related late effects. Innovative models of long-term follow-up (LTFU) care to manage ongoing treatment-related complications are needed. 'Re-engage' is a nurse-led eHealth intervention designed to improve survivors' health-related self-efficacy, targeted at survivors disengaged from follow-up. Re-engage aims to overcome survivor- and parent-reported barriers to care and ensure survivors receive the care most appropriate to their risk level. This study will recruit 30 Australian childhood cancer survivors who are not receiving any cancer-related care. Participation involves two online/telephone consultations with a survivorship nurse for medical assessment, a case review, risk stratification and creation of a care plan by a multidisciplinary team of specialists. We will assess the feasibility of implementing 'Re-engage' and its acceptability to participants and health professionals involved. The primary outcome will be survivors' health-related self-efficacy, measured at baseline and 1 and 6 months postintervention. Secondary outcomes will include the effect of 'Re-engage' on survivors' health behaviours and beliefs, engagement in healthcare, information needs and emotional well-being. We will also document the cost per patient to deliver 'Re-engage'. If Re-engage is acceptable, feasible and demonstrates early efficacy, it may have the potential to empower survivors in coordinating their complex care, improving survivors' long-term engagement and satisfaction with care. Ideally, it will be implemented into clinical practice to recall survivors lost to follow-up and reduce the ongoing burden of treatment for childhood cancer. The study protocol has been approved by the South Eastern Sydney Local Health District Human Research Ethics Committee (reference number: 16/366). The results will be disseminated in peer-reviewed journals and at scientific conferences. A lay summary will be published on the Behavioural Sciences Unit website. ACTRN12618000194268.
Linkhttp://doi.org/10.1136/bmjopen-2018-022269
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