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Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT): Development and design of a randomized controlled trial.

ABSTRACT: Early adolescents have difficulties performing asthma self-management behaviors, placing them at-risk for poor asthma control and reduced quality of life. This paper describes the development and plans for testing an interactive mobile health (mHealth) tool for early adolescents, ages 12-15years, and their caregivers to help improve asthma management. Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT) is informed by the Pediatric Self-management model, which posits that helpful caregiver support is facilitated by elucidating disease management behaviors and allocating treatment responsibility in the family system, and subsequently engaging in collaborative caregiver-adolescent asthma management. The AIM2ACT intervention was developed through iterative feedback from an advisory board composed of adolescent-caregiver dyads. A pilot randomized controlled trial of AIM2ACT will be conducted with 50 early adolescents with poorly controlled asthma and a caregiver. Adolescent-caregiver dyads will be randomized to receive the AIM2ACT smartphone application (AIM2ACT app) or a self-guided asthma control condition for a 4-month period. Feasibility and acceptability data will be collected throughout the trial. Efficacy outcomes, including family asthma management, lung function, adolescent asthma control, asthma-related quality of life, and self-efficacy for asthma management, will be collected at baseline, post-treatment, and 4-month follow-up. Results from the current study will inform the utility of mHealth to foster the development of asthma self-management skills among early adolescents.

SUBMITTER: Fedele DA

PROVIDER: S-EPMC5742020 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT): Development and design of a randomized controlled trial.

Fedele David A DA McConville Andrew A Graham Thomas J J McQuaid Elizabeth L EL Janicke David M DM Turner Elise M EM Moon Jon J Abu-Hasan Mutasim M

Contemporary clinical trials 20171003

Early adolescents have difficulties performing asthma self-management behaviors, placing them at-risk for poor asthma control and reduced quality of life. This paper describes the development and plans for testing an interactive mobile health (mHealth) tool for early adolescents, ages 12-15years, and their caregivers to help improve asthma management. Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT) is informed by the Pediatric Self-management model, which posits that helpful ...[more]

PMID: 28986245

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Project description:IntroductionAsthma is a leading cause of youth morbidity in the USA, affecting >8% of youth. Adherence to inhaled corticosteroids (ICS) can prevent asthma-related morbidity; however, the typical adolescent with asthma takes fewer than 50% of their prescribed doses. Adolescents are uniquely vulnerable to suboptimal asthma self-management due to still-developing executive functioning capabilities that may impede consistent self-regulation and weaken attempts to use problem solving to overcome barriers to ICS adherence.Methods and analysisThe aims of this project are to improve adherence to ICS as an important step towards better self-management among adolescents aged 13-17 years diagnosed with asthma by merging the efficacious behaviour change strategies found in behavioural health interventions with scalable, adaptive mobile health (mHealth) technologies to create the Responsive Asthma Care for Teens programme (ReACT). ReACT intervention content will be developed through an iterative user-centred design process that includes conducting (1) one-on-one interviews with 20 teens with asthma; (2) crowdsourced feedback from a nationally representative panel of 100 adolescents with asthma and (3) an advisory board of youth with asthma, a paediatric pulmonologist and a behavioural health expert. In tandem, we will work with an existing technology vendor to programme ReACT algorithms to allow for tailored intervention delivery. We will conduct usability testing of an alpha version of ReACT with a sample of 20 target users to assess acceptability and usability of our mHealth intervention. Participants will complete a 4-week run-in period to monitor their adherence with all ReACT features turned off. Subsequently, participants will complete a 4-week intervention period with all ReACT features activated. The study started in October 2018 and is scheduled to conclude in late 2019.Ethics and disseminationInstitutional review board approval was obtained at the University of Kansas and the University of Florida. We will submit study findings for presentation at national research conferences that are well attended by a mix of psychologists, allied health professionals and physicians. We will publish study findings in peer-reviewed journals read by members of the psychology, nursing and pulmonary communities.

Project description:BackgroundIn order to achieve improved weight status, behavioral pediatric obesity treatment is resource intensive. Mobile Health (mHealth) is more accessible than standard care but effective approaches are scarce. Therefore, the aim of this feasibility trial was to study trial design, mHealth usage, compliance, and acceptability of a novel mHealth approach in pediatric obesity treatment.MethodsThis six-month parallel two-arm feasibility trial took place at three pediatric outpatient clinics in Stockholm, Sweden. Participants, 5-12 years, starting obesity treatment were randomized to using an mHealth support system as an addition to standard care (intervention) or to standard care alone (control). The intervention included daily self-monitoring of weight transferred to a mobile application (app) used by parents, a website in which clinicians could track treatment progress, prespecified treatment goals for change in degree of obesity shown in the app and on the website, and text message interactions between clinicians and parents. The main outcome was description of feasibility. Height and weight were measured at baseline, three, and 6 months to explore changes in body mass index standard deviation score (BMI SDS).ResultsOf 40 children eligible for inclusion, 28 agreed to participate (54% girls) and were randomized to intervention (n = 15) or control (n = 13). Weight was measured at home regularly throughout the entire trial period by 12/15 children in the intervention group. Attendance at appointments were better in the intervention group (p = 0.024). Both parents and clinicians had a positive experience and found the mHealth support system accessible. At 6 months the intervention group had a greater reduction of 0.24 units in BMI SDS than standard care (- 0.23 vs. 0.01, p = 0.002).ConclusionsThe mHealth support system was a feasible and innovative treatment approach which, in addition to standard care, generated better treatment results than standard care alone. Future research should evaluate the treatment effects over a longer follow-up time in a larger study sample.Trial registrationThis trial was retrospectively registered at ClinicalTrials.gov , ID: NCT03380598 , on November 8, 2017.

Project description:BackgroundThe use of technology has the potential to support the patient´s active participation regarding treatment of hypertension. This might lead to changes in the roles of the patient and health care professional and affect the partnership between them.ObjectiveThe aim of this qualitative study was to explore the partnership between patients and health care professionals and the roles of patients and professionals in hypertension management when using an interactive web-based system for self-management of hypertension via the patient's own mobile phone.MethodsFocus group interviews were conducted with 22 patients and 15 professionals participating in a randomized controlled trial in Sweden aimed at lowering blood pressure (BP) using an interactive web-based system via mobile phones. The interviews were audiorecorded and transcribed and analyzed using thematic analysis.ResultsThree themes were identified: the technology, the patient, and the professional. The technology enabled documentation of BP treatment, mainly for sharing knowledge between the patient and the professional. The patients gained increased knowledge of BP values and their relation to daily activities and treatment. They were able to narrate about their BP treatment and take a greater responsibility, inspired by new insights and motivation for lifestyle changes. Based on the patient's understanding of hypertension, professionals could use the system as an educational tool and some found new ways of communicating BP treatment with patients. Some reservations were raised about using the system, that it might be too time-consuming to function in clinical practice and that too much measuring could result in stress for the patient and an increased workload for the professionals. In addition, not all professionals and patients had adopted the instructions regarding the use of the system, resulting in less realization of its potential.ConclusionsThe use of the system led to the patients taking on a more active role in their BP treatment, becoming more of an expert of their BP. When using the system as intended, the professionals experienced it as a useful resource for communication regarding BP and lifestyle. Patients and professionals described a consultation on more equal grounds. The use of technology in hypertension management can promote a constructive and person-centered partnership between patient and professional. However, implementation of a new way of working should bring benefits and not be considered a burden for the professionals. To establish a successful partnership, both the patient and the professional need to be motivated toward a new way of working.Trial registrationClinicalTrials.gov NCT03554382; https://clinicaltrials.gov/ct2/show/NCT03554382.

Project description:Medication regimens for asthma are particularly vulnerable to adherence problems because of the requirement for long-term use and periods of symptom remission experienced by patients. Pharmacists are suited to impact medication adherence given their training, skills, and frequent contact with patients. The Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS) trial involves an intervention leveraging mobile health (mHealth) technology to support community pharmacy practice with the hypothesis of improved medication adherence in asthma.This study is a pragmatic pharmacy-based, cluster, randomized controlled trial with 12 months of intervention delivery and follow-up. Pharmacies (the clusters) will be randomized at a 1:1 ratio to provide intervention or usual care. The EmPhAsIS intervention consists of patient asthma education, short message service (SMS)-based monthly assessment of adherence, and follow-up of non-adherent individuals by community pharmacists. There are no inclusion or exclusion criteria for pharmacies. Patients are eligible if they: are 14 years of age or older, fill a prescription for inhaled corticosteroid (either monotherapy or in a combination inhaler with long-acting beta-agonists), have been diagnosed with asthma, possess a mobile phone with SMS capabilities, and have no communication difficulties such as inability to communicate in English, or significant impairment in vision, hearing, or speech. The primary outcome is adherence to inhaled corticosteroids ascertained by the medication possession ratio, the ratio of the days of medication supplied to days in a given time interval. This study will also evaluate secondary outcomes including: asthma control, asthma-related quality of life, asthma-related hospital admissions, and use of reliever medications during the follow-up period. A nested economic evaluation using a probabilistic decision-analytic model will be used to perform a cost-effectiveness analysis from the societal perspective of the intervention compared with usual care over a 10-year time horizon.Considering the prevalence of asthma, the extent of the non-adherence problem in this disease, and the availability of effective treatments, there is a tremendous potential to reduce the burden of asthma through improving adherence. This is the first study of an intervention based on mobile communication technology involving community pharmacists in asthma management.ClinicalTrials.gov identifier: NCT02170883; date of registration: 19 June 2014.

Project description:BACKGROUND:Uncontrolled asthma poses substantial negative personal and health system impacts. Web-based technologies, including smartphones, are novel means to enable evidence-based care and improve patient outcomes. OBJECTIVE:The aim of this study was to design, develop, and assess the utilization of an asthma collaborative self-management (CSM) platform (breathe) using content based on international evidence-based clinical guidelines. METHODS:We designed and developed breathe as a Web-based mobile health (mHealth) platform accessible on smartphones, tablets, or desktop with user-centered design methods and International Organization for Standardization-certified quality development processes. Moreover, breathe was envisioned as a multifunctional, CSM mHealth platform, with content based on international clinical practice guidelines and compliant with national privacy and security specifications. The system enabled CSM (patient, provider, and breathe) and self-monitoring of asthma patients through (1) assessment of asthma control, (2) real-time access to a dynamic asthma action plan, (3) access to real-time environmental conditions, and (4) risk-reduction messaging. The data collection protocol collected user data for 12 months, with clinic visits at baseline and 6 and 12 months. Utilization outcomes included user interactions with the platform, user impressions, self-reported medication use, asthma symptom profile, reported peak flow measurement, and the delivery and impact of email reminders. RESULTS:We enrolled 138 patients with a mean age of 45.3 years to receive the breathe intervention. Majority were female (100/138, 72.5%), had a smartphone (92/138, 66.7%), and had a mean Asthma Control Test score of 18.3 (SD 4.9). A majority reported that breathe helped in the management of their asthma. Moreover, breathe scored 71.1 (SD 18.9) on the System Usability Scale. Overall, 123 patients had complete usage analytics datasets. The platform sent 7.96 reminder emails per patient per week (pppw), patients accessed breathe 3.08 times, journaled symptoms 2.56 times, reported medication usage 0.30 times, and reported peak flow measurements 0.92 times pppw. Furthermore, breathe calculated patients' action plan zone of control 2.72 times pppw, with patients being in the green (well-controlled) zone in 47.71% (8300/17,396) of the total calculations. Usage analysis showed that 67.5% (83/123) of the participants used the app at week 4 and only 57.7% (71/123) by week 45. Physician visits, email reminders, and aged 50 years and above were associated with higher utilization. CONCLUSIONS:Individuals with asthma reported good usability and high satisfaction levels, reacted to breathe notifications, and had confidence in the platform's assessment of asthma control. Strong utilization was seen at the intervention's initiation, followed by a rapid reduction in use. Patient reminders, physician visits, and being aged 50 years and above were associated with higher utilization. TRIAL REGISTRATION:ClinicalTrials.gov NCT01964469; https://clinicaltrials.gov/ct2/show/NCT01964469.

Project description:BackgroundSkin cancer diagnostics is challenging, and mastery requires extended periods of dedicated practice.ObjectiveThe aim of the study was to determine if self-paced pattern recognition training in skin cancer diagnostics with clinical and dermoscopic images of skin lesions using a large-scale interactive image repository (LIIR) with patient cases improves primary care physicians' (PCPs') diagnostic skills and confidence.MethodsA total of 115 PCPs were randomized (allocation ratio 3:1) to receive or not receive self-paced pattern recognition training in skin cancer diagnostics using an LIIR with patient cases through a quiz-based smartphone app during an 8-day period. The participants' ability to diagnose skin cancer was evaluated using a 12-item multiple-choice questionnaire prior to and 8 days after the educational intervention period. Their thoughts on the use of dermoscopy were assessed using a study-specific questionnaire. A learning curve was calculated through the analysis of data from the mobile app.ResultsOn average, participants in the intervention group spent 2 hours 26 minutes quizzing digital patient cases and 41 minutes reading the educational material. They had an average preintervention multiple choice questionnaire score of 52.0% of correct answers, which increased to 66.4% on the postintervention test; a statistically significant improvement of 14.3 percentage points (P<.001; 95% CI 9.8-18.9) with intention-to-treat analysis. Analysis of participants who received the intervention as per protocol (500 patient cases in 8 days) showed an average increase of 16.7 percentage points (P<.001; 95% CI 11.3-22.0) from 53.9% to 70.5%. Their overall ability to correctly recognize malignant lesions in the LIIR patient cases improved over the intervention period by 6.6 percentage points from 67.1% (95% CI 65.2-69.3) to 73.7% (95% CI 72.5-75.0) and their ability to set the correct diagnosis improved by 10.5 percentage points from 42.5% (95% CI 40.2%-44.8%) to 53.0% (95% CI 51.3-54.9). The diagnostic confidence of participants in the intervention group increased on a scale from 1 to 4 by 32.9% from 1.6 to 2.1 (P<.001). Participants in the control group did not increase their postintervention score or their diagnostic confidence during the same period.ConclusionsSelf-paced pattern recognition training in skin cancer diagnostics through the use of a digital LIIR with patient cases delivered by a quiz-based mobile app improves the diagnostic accuracy of PCPs.Trial registrationClinicalTrials.gov NCT05661370; https://classic.clinicaltrials.gov/ct2/show/NCT05661370.

Project description:BackgroundDespite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education) randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions.MethodsA randomized controlled trial (RCT) with three arms; 1) PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention), 2) REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention), and 3) CONTROL (pedometer only, but no intervention will be conducted). A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary), immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity.DiscussionIf efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral sciences and mHealth.Trial registrationClinicalTrials.gov#:NCTO1280812.

Dataset Information

Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT): Development and design of a randomized controlled trial.

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Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT): Development and design of a randomized controlled trial.

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