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Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among patients with asthma and chronic obstructive pulmonary disease (COPD) is high and patients are frequently hospitalized due to exacerbations. Reasons for uncontrolled diseases are manifold, but are often associated with poor inhalation technique and non-adherence to the prescribed treatment plan. This causes substantial mortality, morbidity, and costs to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase and maintain treatment adherence in chronic diseases is of major clinical importance. OBJECTIVE:The primary objective of this study is to investigate the impact of using specific, validated electronic devices on adherence to inhaled medication in patients with chronic obstructive lung diseases such as asthma and COPD. Furthermore, it aims to assess the impact of a reminder and close supervision of the course of disease and quality of life. METHODS:In this ongoing prospective, single-blind, randomized controlled study, adherence to inhaled medication is analyzed over a 6-month period in at least 154 in- and outpatients with asthma or COPD who have experienced at least 1 exacerbation during the last year. Adherence is measured using electronic data capture devices, which save the date and time of each inhalative device actuation and transfer these data daily via a wireless connection to a Web-based database. Patients are randomly assigned to either the intervention or the control group. The clinical intervention consists of an automated and personal reminder. The intervention group receives an audio reminder and support calls in case medication has not been taken as prescribed or if rescue medication is used more frequently than pre-specified in the study protocol. During the study, participants are assessed every 2 months in the form of clinical visits. RESULTS:Recruitment started in January 2014. To date, a total of 169 patients have been recruited. Follow-up assessments are still ongoing. The study will be concluded in the first quarter of 2017. Data analysis will take place during 2017. CONCLUSIONS:Few studies have investigated medication adherence in patients with chronic obstructive lung diseases. With this prospective study design and the use of state-of-the-art devices for measuring adherence, we expect scientifically relevant and clinically meaningful results that will have a substantial and positive impact on the provision of healthcare in chronically ill patients suffering from asthma or COPD. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02386722; https://clinicaltrials.gov/ct2/show/NCT02386722 (Archived by WebCite at http://www.webcitation.org/6oJq1fel0).

SUBMITTER: Gregoriano C

PROVIDER: S-EPMC5673887 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial.

Gregoriano Claudia C Dieterle Thomas T Dürr Selina S Arnet Isabelle I Hersberger Kurt E KE Leuppi Jörg D JD

JMIR research protocols 20171023 10

<h4>Background</h4>Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among patients with asthma and chronic obstructive pulmonary disease (COPD) is high and patients are frequently hospitalized due to exacerbations. Reasons for uncontrolled diseases are manifold, but are often associated with poor inhalation technique and non-adherence to the prescribed treatment plan. This causes substantial mortality, morbidity, and costs to the health ...[more]

PMID: 29061556

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Project description:BackgroundPoor treatment adherence in patients with chronic obstructive pulmonary disease (COPD) or asthma is a global public health concern with severe consequences in terms of patient health and societal costs. A potentially promising tool for addressing poor compliance is eHealth.ObjectiveThis review investigates the effects of eHealth interventions on medication adherence in patients with COPD or asthma.MethodsA systematic literature search was conducted in the databases of Cochrane Library, PsycINFO, PubMed, and Embase for studies with publication dates between January 1, 2000, and October 29, 2020. We selected randomized controlled trials targeting adult patients with COPD or asthma, which evaluated the effectiveness of an eHealth intervention on medication adherence. The risk of bias in the included studies was examined using the Cochrane Collaboration's risk of bias tool. The results were narratively reviewed.ResultsIn total, six studies focusing on COPD and seven focusing on asthma were analyzed. Interventions were mostly internet-based or telephone-based, and could entail telemonitoring of symptoms and medication adherence, education, counseling, consultations, and self-support modules. Control groups mostly comprised usual care conditions, whereas a small number of studies used a face-to-face intervention or waiting list as the control condition. For COPD, the majority of eHealth interventions were investigated as an add-on to usual care (5/6 studies), whereas for asthma the majority of interventions were investigated as a standalone intervention (5/7 studies). Regarding eHealth interventions targeting medication adherence for COPD, two studies reported nonsignificant effects, one study found a significant effect in comparison to usual care, and three reported mixed results. Of the seven studies that investigated eHealth interventions targeting medication adherence in asthma, three studies found significant effects, two reported nonsignificant effects, and two reported mixed effects.ConclusionsThe mixed results on the effectiveness of eHealth interventions in improving treatment adherence for asthma and COPD are presumably related to the type, context, and intensity of the interventions, as well as to differences in the operationalization and measurement of adherence outcomes. Much remains to be learned about the potential of eHealth to optimize treatment adherence in COPD and asthma.

Project description:ObjectiveTo test the feasibility and acceptability of a short-term reminder and incentives intervention in adolescents with low adherence to asthma medications.MethodsMixed-methods feasibility study in a tertiary care clinic. Adolescents recruited to a 24-week programme with three 8-weekly visits, receiving electronic reminders to prompt inhaled corticosteroid (ICS) inhalation through a mobile app coupled with electronic monitoring devices (EMD). From the second visit, monetary incentives based on adherence of ICS inhalation: £1 per dose, maximum £2 /day, up to £112/study, collected as gift cards at the third visit. End of study interviews and questionnaires assessing perceptions of asthma and ICS, analysed using the Perceptions and Practicalities Framework.ParticipantsAdolescents (11-18 years) with documented low ICS adherence (<80% by EMD), and poor asthma control at the first clinic visit.Results10 out of 12 adolescents approached were recruited (7 males, 3 females, 12-16 years). Eight participants provided adherence measures up to the fourth visits and received rewards. Mean study duration was 281 days, with 7/10 participants unable to attend their fourth visit due to COVID-19 lockdown. Only 3/10 participants managed to pair the app/EMD up to the fourth visit, which was associated with improved ICS adherence (from 0.51, SD 0.07 to 0.86, SD 0.05). Adherence did not change in adolescents unable to pair the app/EMD. The intervention was acceptable to participants and parents/guardians. Exit interviews showed that participants welcomed reminders and incentives, though expressed frustration with app/EMD technological difficulties. Participants stated the intervention helped through reminding ICS doses, promoting self-monitoring and increasing motivation to take inhalers.ConclusionsAn intervention using electronic reminders and incentives through an app coupled with an EMD was feasible and acceptable to adolescents with asthma. A pilot randomised controlled trial is warranted to better estimate the effect size on adherence, with improved technical support for the EMD.

Project description:BackgroundElectronic medication monitoring (EMM) is a digital tool that can be used for tracking daily medication use. Previous studies of EMM in asthma management have been conducted in adults or have examined pediatric interventions that use EMM for less than 1 year. To understand how to improve EMM-enhanced interventions, it is necessary to explore the experiences of parents of children with asthma, recruited from outpatient practices, who completed a 12-month intervention trial.ObjectiveThe objective of our study was to use qualitative inquiry to answer the following questions: (1) how did using an EMM-enhanced intervention change parents'/caregivers' experiences of managing their child's asthma, and (2) what do parents recommend for improving the intervention in the future?MethodsParents were recruited from the intervention arm of a multicomponent health intervention enhanced by Bluetooth-enabled sensors placed on inhaler medications. Semistructured interviews were conducted with 20 parents of children aged 4-12 years with asthma. Interviews were audio-recorded, transcribed, and inductively analyzed using a constant comparative approach.ResultsInterview participants reflected an even mix of publicly and privately insured children and a diverse racial-ethnic demographic. Parents discussed 6 key themes related to their experience with the EMM-enhanced intervention for the management of their child's asthma: (1) compatibility with the family's lifestyle, (2) impact on asthma management, (3) impact on the child's health, (4) emotional impact of the intervention, (5) child's engagement in asthma management with the intervention, and (6) recommendations for future intervention design. Overall, parents reported that the 12-month EMM intervention was compatible with their daily lives, positively influenced their preventive and acute asthma management, and promoted their child's engagement in their own asthma management. While parents found the intervention acceptable and generally favorable, some parents identified compatibility issues for families with multiple caregivers and frustration when the technology malfunctioned.ConclusionsParents generally viewed the intervention as a positive influence on the management of their child's asthma. However, our study also highlighted technology challenges related to having multiple caregivers, which will need to be addressed in future iterations for families. Attention must be paid to the needs of parents from low socioeconomic households, who may have more limited access to reliable internet or depend on other relatives for childcare. Understanding these family factors will help refine how a digital tool can be adopted into daily disease management of pediatric asthma.

Project description:High levels of adherence to medications for HIV infection are essential for optimal clinical outcomes and to reduce viral transmission, but many patients do not achieve required levels. Clinician-delivered interventions can improve patients' adherence, but usually require substantial effort by trained individuals and may not be widely available. Computer-delivered interventions can address this problem by reducing required staff time for delivery and by making the interventions widely available via the Internet. We previously developed a computer-delivered intervention designed to improve patients' level of health literacy as a strategy to improve their HIV medication adherence. The intervention was shown to increase patients' adherence, but it was not clear that the benefits resulting from the increase in adherence could justify the costs of developing and deploying the intervention. The purpose of this study was to evaluate the relation of development and deployment costs to the effectiveness of the intervention.Costs of intervention development were drawn from accounting reports for the grant under which its development was supported, adjusted for costs primarily resulting from the project's research purpose. Effectiveness of the intervention was drawn from results of the parent study. The relation of the intervention's effects to changes in health status, expressed as utilities, was also evaluated in order to assess the net cost of the intervention in terms of quality adjusted life years (QALYs). Sensitivity analyses evaluated ranges of possible intervention effectiveness and durations of its effects, and costs were evaluated over several deployment scenarios.The intervention's cost effectiveness depends largely on the number of persons using it and the duration of its effectiveness. Even with modest effects for a small number of patients the intervention was associated with net cost savings in some scenarios and for durations greater than three months and longer it was usually associated with a favorable cost per QALY. For intermediate and larger assumed effects and longer durations of intervention effectiveness, the intervention was associated with net cost savings.Computer-delivered adherence interventions may be a cost-effective strategy to improve adherence in persons treated for HIV.Clinicaltrials.gov identifier NCT01304186.

Dataset Information

Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial.

Publications

Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial.

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