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      A Medication Adherence App for Children With Sickle Cell Disease: Qualitative Study

      research-article
      , BSc (Hons), MSc, PhD 1 , 2 , , , MSc 3 , , CPsychol, PhD 4 , 5 , , MD, MSc 6
      (Reviewer), (Reviewer), (Reviewer), (Reviewer)
      JMIR mHealth and uHealth
      JMIR Publications
      children, adolescents, sickle cell disease, medication adherence, models, theoretical, mHealth

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          Abstract

          Background

          Young people with sickle cell disease (SCD) often demonstrate low medication adherence and low motivation for effectively self-managing their condition. The growing sophistication of mobile phones and their popularity among young people render them a promising platform for increasing medication adherence. However, so far, few apps targeting SCD have been developed from research with the target population and underpinned with theory and evidence.

          Objective

          The aim of this study was to develop a theory-and-evidence-based medication adherence app to support children and adolescents with SCD.

          Methods

          The Behavior Change Wheel (BCW), a theoretically based intervention development framework, along with a review of the literature, 10 interviews with children and adolescents with SCD aged between 12 and 18 years, and consultation with experts informed app development. Thematic analysis of interviews provided relevant theoretical and evidence-based components to underpin the design and development of the app.

          Results

          Findings suggested that some patients had lapses in memory for taking their medication (capability); variation in beliefs toward the effectiveness of medication and confidence in self-managing their condition (motivation); a limited time to take medication; and barriers and enablers within the changing context of social support during the transition into adulthood (opportunity). Steps were taken to select the appropriate behavioral change components (involving behavior change techniques [BCTs] such as information on antecedents, prompts/cues; self-monitoring of the behavior; and social support) and translate them into app features designed to overcome these barriers to medication adherence.

          Conclusions

          Patients with SCD have complex barriers to medication adherence necessitating the need for comprehensive models of behavior change to analyze the problem. Children and adolescents require an app that goes beyond simple medication reminders and takes into account the patient’s beliefs, emotions, and environmental barriers to medication adherence.

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          Most cited references32

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          Rigour and qualitative research.

          N Mays, C Pope (1995)
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            Patient adherence and medical treatment outcomes: a meta-analysis.

            Adherence is a factor in the outcome of medical treatment, but the strength and moderators of the adherence-outcome association have not been systematically assessed. A quantitative review using meta-analysis of three decades of empirical research correlating adherence with objective measures of treatment outcomes. Sixty-three studies assessing patient adherence and outcomes of medical treatment were found involving medical regimens recommended by a nonpsychiatrist physician, and measuring patient adherence and health outcomes. Studies were analyzed according to disease (acute/chronic, severity), population (adult/child), type of regimen (preventive/treatment, use of medication), and type and sensitivity of adherence and outcomes measurements. Overall, the outcome difference between high and low adherence is 26%. According to a stringent random effects model, adherence is most strongly related to outcomes in studies of nonmedication regimens, where measures of adherence are continuous, and where the disease is chronic (particularly hypertension, hypercholesterolemia, intestinal disease, and sleep apnea). A less stringent fixed effects model shows a trend for higher adherence-outcome correlations in studies of less serious conditions, of pediatric patients, and in those studies using self-reports of adherence, multiple measures of adherence, and less specific measures of outcomes. Intercorrelations among moderator variables in multiple regression show that the best predictor of the adherence-outcome relationship is methodological-the sensitivity/quality of the adherence assessment.
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              Smartphone and tablet self management apps for asthma.

              Asthma is one of the most common long-term conditions worldwide, which places considerable pressure on patients, communities and health systems. The major international clinical guidelines now recommend the inclusion of self management programmes in the routine management of patients with asthma. These programmes have been associated with improved outcomes in patients with asthma. However, the implementation of self management programmes in clinical practice, and their uptake by patients, is still poor. Recent developments in mobile technology, such as smartphone and tablet computer apps, could help develop a platform for the delivery of self management interventions that are highly customisable, low-cost and easily accessible. To assess the effectiveness, cost-effectiveness and feasibility of using smartphone and tablet apps to facilitate the self management of individuals with asthma. We searched the Cochrane Airways Group Register (CAGR), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, Global Health Library, Compendex/Inspec/Referex, IEEEXplore, ACM Digital Library, CiteSeer(x) and CAB abstracts via Web of Knowledge. We also searched registers of current and ongoing trials and the grey literature. We checked the reference lists of all primary studies and review articles for additional references. We searched for studies published from 2000 onwards. The latest search was run in June 2013. We included parallel randomised controlled trials (RCTs) that compared self management interventions for patients with clinician-diagnosed asthma delivered via smartphone apps to self management interventions delivered via traditional methods (e.g. paper-based asthma diaries). We used standard methods expected by the Cochrane Collaboration. Our primary outcomes were symptom scores; frequency of healthcare visits due to asthma exacerbations or complications and health-related quality of life. We included two RCTs with a total of 408 participants. We found no cluster RCTs, controlled before and after studies or interrupted time series studies that met the inclusion criteria for this systematic review. Both RCTs evaluated the effect of a mobile phone-based asthma self management intervention on asthma control by comparing it to traditional, paper-based asthma self management. One study allowed participants to keep daily entries of their asthma symptoms, asthma medication usage, peak flow readings and peak flow variability on their mobile phone, from which their level of asthma control was calculated remotely and displayed together with the corresponding asthma self management recommendations. In the other study, participants recorded the same readings twice daily, and they received immediate self management feedback in the form of a three-colour traffic light display on their phones. Participants falling into the amber zone of their action plan twice, or into the red zone once, received a phone call from an asthma nurse who enquired about the reasons for their uncontrolled asthma.We did not conduct a meta-analysis of the data extracted due to the considerable degree of heterogeneity between these studies. Instead we adopted a narrative synthesis approach. Overall, the results were inconclusive and we judged the evidence to have a GRADE rating of low quality because further evidence is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. In addition, there was not enough information in one of the included studies to assess the risk of bias for the majority of the domains. Although the other included study was methodologically rigorous, it was not possible to blind participants or personnel in the study. Moreover, there are concerns in both studies in relation to attrition bias and other sources of bias.One study showed that the use of a smartphone app for the delivery of an asthma self management programme had no statistically significant effect on asthma symptom scores (mean difference (MD) 0.01, 95% confidence interval (CI) -0.23 to 0.25), asthma-related quality of life (MD of mean scores 0.02, 95% CI -0.35 to 0.39), unscheduled visits to the emergency department (OR 7.20, 95% CI 0.37 to 140.76) or frequency of hospital admissions (odds ratio (OR) 3.07, 95% CI 0.32 to 29.83). The other included study found that the use of a smartphone app resulted in higher asthma-related quality of life scores at six-month follow-up (MD 5.50, 95% CI 1.48 to 9.52 for the physical component score of the SF-12 questionnaire; MD 6.00, 95% CI 2.51 to 9.49 for the mental component score of the SF-12 questionnaire), improved lung function (PEFR) at four (MD 27.80, 95% CI 4.51 to 51.09), five (MD 31.40, 95% CI 8.51 to 54.29) and six months (MD 39.20, 95% CI 16.58 to 61.82), and reduced visits to the emergency department due to asthma-related complications (OR 0.20, 95% CI 0.04 to 0.99). Both studies failed to find any statistical differences in terms of adherence to the intervention and occurrence of other asthma-related complications. The current evidence base is not sufficient to advise clinical practitioners, policy-makers and the general public with regards to the use of smartphone and tablet computer apps for the delivery of asthma self management programmes. In order to understand the efficacy of apps as standalone interventions, future research should attempt to minimise the differential clinical management of patients between control and intervention groups. Those studies evaluating apps as part of complex, multicomponent interventions, should attempt to tease out the relative contribution of each intervention component. Consideration of the theoretical constructs used to inform the development of the intervention would help to achieve this goal. Finally, researchers should also take into account: the role of ancillary components in moderating the observed effects, the seasonal nature of asthma and long-term adherence to self management practices.
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                Author and article information

                Contributors
                Journal
                JMIR Mhealth Uhealth
                JMIR Mhealth Uhealth
                JMU
                JMIR mHealth and uHealth
                JMIR Publications (Toronto, Canada )
                2291-5222
                June 2019
                18 June 2019
                : 7
                : 6
                : e8130
                Affiliations
                [1 ] Health Behaviour and Interventions Research Faculty of Health and Life Sciences Coventry University Coventry United Kingdom
                [2 ] Public Health Warwickshire Warwickshire County Council Warwick United Kingdom
                [3 ] Klinik für Pädiatrie mS, Onkologie/Hämatologie Charité-Universitätsmedizin Berlin Berlin Germany
                [4 ] Division of Psychiatry University College London London United Kingdom
                [5 ] Research and Development Department North East London Foundation Trust Goodmayes Hospital Essex United Kingdom
                [6 ] Amsterdam Street Children's Hospital Cologne Germany
                Author notes
                Corresponding Author: Kristina Curtis kristina.curtis@ 123456coventry.ac.uk
                Author information
                http://orcid.org/0000-0001-6845-1236
                http://orcid.org/0000-0002-7540-6617
                http://orcid.org/0000-0003-4096-5109
                http://orcid.org/0000-0001-5398-0610
                Article
                v7i6e8130
                10.2196/mhealth.8130
                6604509
                31215518
                63cbe247-fdb5-4e32-b164-a30107daf324
                ©Kristina Curtis, Anastasiya Lebedev, Elisa Aguirre, Stephan Lobitz. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 18.06.2019.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mhealth and uhealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/.as well as this copyright and license information must be included.

                History
                : 21 June 2017
                : 22 November 2017
                : 19 February 2019
                : 18 April 2019
                Categories
                Original Paper
                Original Paper

                children,adolescents,sickle cell disease,medication adherence,models, theoretical,mhealth

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