Dataset Information

Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study.

ABSTRACT: To fully capitalize on the promise of mobile technology to enable scalable, participant-centered research, we must develop companion self-administered electronic informed consent (eConsent) processes. As we do so, we have an ethical obligation to ensure that core tenants of informed consent-informedness, comprehension, and voluntariness-are upheld. Furthermore, we should be wary of recapitulating the pitfalls of "traditional" informed consent processes.Our objective was to describe the essential qualities of participant experience, including delineation of common and novel themes relating to informed consent, with a self-administered, smartphone-based eConsent process. We sought to identify participant responses related to informedness, comprehension, and voluntariness as well as to capture any emergent themes relating to the informed consent process in an app-mediated research study.We performed qualitative thematic analysis of participant responses to a daily general prompt collected over a 6-month period within the Parkinson mPower app. We employed a combination of a priori and emergent codes for our analysis. A priori codes focused on the core concepts of informed consent; emergent codes were derived to capture additional themes relating to self-administered consent processes. We used self-reported demographic information from the study's baseline survey to characterize study participants and respondents.During the study period, 9846 people completed the eConsent process and enrolled in the Parkinson mPower study. In total, 2758 participants submitted 7483 comments; initial categorization identified a subset of 3875 germane responses submitted by 1678 distinct participants. Respondents were more likely to self-report a Parkinson disease diagnosis (30.21% vs 11.10%), be female (28.26% vs 20.18%), be older (42.89 years vs 34.47 years), and have completed more formal education (66.23% with a 4-year college degree or more education vs 55.77%) than all the mPower participants (P<.001 for all values). Within our qualitative analysis, 3 conceptual domains emerged. First, consistent with fully facilitated in-person informed consent settings, we observed a broad spectrum of comprehension of core research concepts following eConsent. Second, we identified new consent themes born out of the remote mobile research setting, for example the impact of the study design on the engagement of controls and the misconstruction of the open response field as a method for responsive communication with researchers, that bear consideration for inclusion within self-administered eConsent. Finally, our findings highlighted participants' desire to be empowered as partners.Our study serves as a formative evaluation of participant experience with a self-administered informed consent process via a mobile app. Areas for future investigation include direct comparison of the efficacy of self-administered eConsent with facilitated informed consent processes, exploring the potential benefits and pitfalls of smartphone user behavioral habits on participant engagement in research, and developing best practices to increase informedness, comprehension, and voluntariness via participant coengagement in the research endeavor.

SUBMITTER: Doerr M

PROVIDER: S-EPMC5334514 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study.

Doerr Megan M Maguire Truong Amy A Bot Brian M BM Wilbanks John J Suver Christine C Mangravite Lara M LM

JMIR mHealth and uHealth 20170216 2

<h4>Background</h4>To fully capitalize on the promise of mobile technology to enable scalable, participant-centered research, we must develop companion self-administered electronic informed consent (eConsent) processes. As we do so, we have an ethical obligation to ensure that core tenants of informed consent-informedness, comprehension, and voluntariness-are upheld. Furthermore, we should be wary of recapitulating the pitfalls of "traditional" informed consent processes.<h4>Objective</h4>Our ob ...[more]

PMID: 28209557

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Project description:BACKGROUND:Early nutrition interventions to improve food knowledge and skills are critical in enhancing the diet quality of children and reducing the lifelong risk of chronic disease. Despite the rise of mobile health (mHealth) apps and their known effectiveness for improving health behaviors, few evidence-based apps exist to help engage children in learning about nutrition and healthy eating. OBJECTIVE:This study aimed to describe the iterative development and user testing of Foodbot Factory, a novel nutrition education gamified app for children to use at home or in the classroom and to present data from user testing experiments conducted to evaluate the app. METHODS:An interdisciplinary team of experts in nutrition, education (pedagogy), and game design led to the creation of Foodbot Factory. First, a literature review and an environmental scan of the app marketplace were conducted, and stakeholders were consulted to define the key objectives and content of Foodbot Factory. Dietitian and teacher stakeholders identified priority age groups and learning objectives. Using a quasi-experimental mixed method design guided by the Iterative Convergent Design for Mobile Health Usability Testing approach, five app user testing sessions were conducted among students (ages 9-12 years). During gameplay, engagement and usability were assessed via direct observations with a semistructured form. After gameplay, qualitative interviews and questionnaires were used to assess user satisfaction, engagement, usability, and knowledge gained. RESULTS:The environmental scan data revealed that few evidence-based nutrition education apps existed for children. A literature search identified key nutrients of concern for Canadian children and techniques that could be incorporated into the app to engage users in learning. Foodbot Factory included characters (2 scientists and Foodbots) who initiate fun and engaging dialogue and challenges (minigames), with storylines incorporating healthy eating messages that align with the established learning objectives. A total of five modules were developed: drinks, vegetables and fruit, grain foods, animal protein foods, and plant protein foods. Seven behavior change techniques and three unique gamified components were integrated into the app. Data from each user testing session were used to inform and optimize the next app iteration. The final user testing session demonstrated that participants agreed that they wanted to play Foodbot Factory again (12/17, 71%), that the app is easy to use (12/17, 71%) and fun (14/17, 88%), and that the app goals were clearly presented (15/17, 94%). CONCLUSIONS:Foodbot Factory is an engaging and educational mHealth intervention for the Canadian public that is grounded in evidence and developed by an interdisciplinary team of experts. The use of an iterative development approach is a demonstrated method to improve engagement, satisfaction, and usability with each iteration. Children find Foodbot Factory to be fun and easy to use, and can engage children in learning about nutrition.

Project description:BackgroundA major cause of lapse and relapse to smoking during a quit attempt is craving triggered by cues from a smoker's immediate environment. To help smokers address these cue-induced cravings when attempting to quit, we have developed a context-aware smoking cessation app, Q Sense, which uses a smoking episode-reporting system combined with location sensing and geofencing to tailor support content and trigger support delivery in real time.ObjectiveWe sought to (1) assess smokers' compliance with reporting their smoking in real time and identify reasons for noncompliance, (2) assess the app's accuracy in identifying user-specific high-risk locations for smoking, (3) explore the feasibility and user perspective of geofence-triggered support, and (4) identify any technological issues or privacy concerns.MethodsAn explanatory sequential mixed-methods design was used, where data collected by the app informed semistructured interviews. Participants were smokers who owned an Android mobile phone and were willing to set a quit date within one month (N=15). App data included smoking reports with context information and geolocation, end-of-day (EoD) surveys of smoking beliefs and behavior, support message ratings, and app interaction data. Interviews were undertaken and analyzed thematically (N=13). Quantitative and qualitative data were analyzed separately and findings presented sequentially.ResultsOut of 15 participants, 3 (20%) discontinued use of the app prematurely. Pre-quit date, the mean number of smoking reports received was 37.8 (SD 21.2) per participant, or 2.0 (SD 2.2) per day per participant. EoD surveys indicated that participants underreported smoking on at least 56.2% of days. Geolocation was collected in 97.0% of smoking reports with a mean accuracy of 31.6 (SD 16.8) meters. A total of 5 out of 9 (56%) eligible participants received geofence-triggered support. Interaction data indicated that 50.0% (137/274) of geofence-triggered message notifications were tapped within 30 minutes of being generated, resulting in delivery of a support message, and 78.2% (158/202) of delivered messages were rated by participants. Qualitative findings identified multiple reasons for noncompliance in reporting smoking, most notably due to environmental constraints and forgetting. Participants verified the app's identification of their smoking locations, were largely positive about the value of geofence-triggered support, and had no privacy concerns about the data collected by the app.ConclusionsUser-initiated self-report is feasible for training a cessation app about an individual's smoking behavior, although underreporting is likely. Geofencing was a reliable and accurate method of identifying smoking locations, and geofence-triggered support was regarded positively by participants.

Project description:BackgroundPersonal health records (PHRs) can be useful in the emergency department, as they provide patient information in an accurate and timely manner and enable it to be used actively. This has an effect on patients' health outcomes and patient experience. Despite the importance of PHRs in emergencies, there are only a few studies related to PHRs in emergencies that evaluate patient experience.ObjectiveThis study aims to introduce the novel mobile PHR (mPHR) platform to emergency environments and assess user experience.MethodsThe study was conducted from October 2019 to November 2019. In total, 1000 patients or carers in the emergency departments of 3 hospitals were provided an application-based service called FirstER, which was developed to collect and utilize medical information for patients in the emergency department. This study was performed as a mixed methods study. After using FirstER, we investigated its usability and conducted a survey on the experience of obtaining medical information with a legacy system and with FirstER. Additionally, we interviewed 24 patients to gain insight into their experiences regarding medical information using FirstER. For the quantitative analysis, the survey results were analyzed using descriptive statistics (mean and standard deviation). For the qualitative analysis, we determined the keywords and their frequencies from each survey question and interview question.ResultsIn total, 1000 participants, consisting of both patients and carers, were recruited in this study. Their mean age was 41.4 (SD 13.3) years. We ascertained participants' satisfaction with FirstER and their mPHR needs through a survey and an in-depth interview. With the current system, participants were not well aware of their health conditions and medical information, and they were passive in the use of their medical information and treatment. However, they wanted their medical information for several reasons, such as information sharing and managing their health conditions. FirstER provided participants with their needed information and an easy way to access it. The mean System Usability Scale (SUS) value was 67.1 (SD 13.8), which was considered very near to acceptable.ConclusionsThis study is the first to implement mPHRs in the emergency department of large tertiary hospitals in the Republic of Korea. FirstER was found to enhance user experience in emergencies, as it provided necessary medical information and proper user experience. Moreover, the average SUS was 67.1, which means that participants found FirstER to be very near to acceptable. This is very encouraging in that FirstER was developed within a very short time, and it was a pilot study.Trial registrationClinicaltrials.gov NCT04180618; https://clinicaltrials.gov/ct2/show/NCT04180618.

Project description:BACKGROUND:Family-based drug prevention programs that use group-based formats with trained facilitators, such as the Strengthening Families Program (SFP), are effective in preventing underage drinking and youth drug use. However, these programs are resource-intensive and have high costs and logistical demands. Tailoring them for Web-based delivery is more cost-effective and makes it easier to scale these programs for widespread dissemination. This requires the active involvement of all key stakeholders to determine content and delivery format. OBJECTIVE:The aim was to obtain consumer, agency stakeholder, and expert input into the design of a Web-based parenting skills training and youth drug prevention program. METHODS:We conducted 10 focus groups with 85 adults (range 4-10, average 8 per group), 20 stakeholder interviews with family services agency staff, and discussed critical design considerations with 10 prevention scientists and e-learning experts to determine the optimal program content and technology features for SFP Online. Focus group participants also answered survey questions on perceived barriers to use, desired navigational features, preferred course format, desired content, preferred reward structures, course length, interactive components, computer efficacy, and technology use. Descriptive statistics were used to examine consumer characteristics; linear regression was used to examine relations between SFP exposure and four continuous outcome measures, including desired program content, interactive technology, and concerns that may inhibit future use of SFP Online. Logistic regression was used as a binary measure of whether consumers desired fun games in the SFP Online program. RESULTS:Three broad thematic categories emerged from the qualitative interviews enumerating the importance of (1) lesson content, (2) logistics for program delivery, and (3) multimedia interactivity. Among the many significant relations, parents who viewed more SFP lessons reported more reasons to use an online program (beta=1.48, P=.03) and also wanted more interactivity (6 lessons: beta=3.72, P=.01; >6 lessons: beta=2.39, P=.01), parents with less interest in a mixed delivery format (class and online) reported fewer reasons to use the online program (beta=-3.93, P=.01), comfort using computers was negatively associated with concerns about the program (beta=-1.83, P=.01), having mobile phone access was related to fewer concerns about online programs (beta=-1.63, P=.02), willingness to view an online program using a mobile phone was positively associated with wanting more online components (beta=1.95, P=.02), and parents who wanted fun games wanted more interactivity (beta=2.28, P=.01). CONCLUSIONS:Formative evaluation based on user-centered approaches can provide rich information that fuels development of an online program. The user-centered strategies in this study lay the foundation for improving SFP Online and provide a means to accommodate user interests and ensure the product serves as an effective prevention tool that is attractive to consumers, engaging, and can overcome some of the barriers to recruitment and retention that have previously affected program outcomes in family-based prevention.

Project description:BackgroundFunctional abdominal pain disorders are chronic abdominal pain conditions, which affect up to 20% of children worldwide. Of the various functional abdominal pain disorder treatment modalities, psychological therapies such as guided imagery therapy appear most effective. However, there are significant barriers to receiving psychological therapies, including access to trained therapists. Alternatively, remotely delivered psychological therapies for functional abdominal pain disorders have been efficacious.ObjectiveThe objective of our study was to assess acceptability of a proposed guided imagery therapy app designed to treat functional abdominal pain disorders through remote delivery of prerecorded audio sessions and to evaluate user preferences for using such an app.MethodsUsing a mixed-methods approach, we conducted a predevelopment formative study among children aged 7 to 12 years with a functional abdominal pain disorder and their parents. The parents completed our modified Technology Acceptance Model (TAM) questionnaire, which quantified behavioral intention and related factors for using a guided imagery therapy app. Dyads participated in separate in-person semistructured interviews to assess their attitudes toward and preferences for a guided imagery therapy app. Questionnaire and interview findings were collected concurrently, analyzed separately, and then integrated through methods triangulation.ResultsAmong the 15 participating parent-child dyads, 5 (33%) children were Hispanic and 11 (73%) had irritable bowel syndrome. They had diverse socioeconomic status. All parent participants were mothers. The TAM questionnaire indicated that mothers scored favorably on behavioral intention to use a guided imagery therapy app (mean score 12.0, SD 2.6, possible range 3-15). Scores for the TAM factors perceived usefulness, perceived ease of use, hedonic motivation, compatibility, and habit also were favorable. Maternal interviews confirmed positive attitudes toward the proposed app. They advocated a visual component to hold their child's attention during the guided imagery therapy sessions; recommended incorporating background sounds into the sessions; favored session reminder notifications from the app; and thought the best time for their child to listen to the sessions would be in the evening or before bed. The child interviews also confirmed positive attitudes toward the proposed app. They suggested guided imagery therapy session topics such as sports and adventures; listening to sessions in their bedroom; and the need for parental supervision to install the app on their mobile device. Integration of the quantitative and qualitative methods findings complimented one another on acceptability. The favorable behavioral intention TAM score aligned well with expressed positive maternal and child attitudes toward the app and can be explained by the desire to avoid medications. The questionnaire and interviews also confirmed therapeutic benefit as an intrinsic motivator to promote routine use.ConclusionsA guided imagery therapy app designed to treat pediatric patients with functional abdominal pain disorders appears to be acceptable to both mothers and children. Incorporating parent and child preferences into a guided imagery therapy app could promote therapeutic compliance and increase access to optimal care.

Project description:With the popularity of mobile phones, mobile apps have great potential for the management of diabetes, but the effectiveness of current diabetes apps for type 1 diabetes mellitus (T1DM) is poor. No study has explored the reasons for this deficiency from the users' perspective.The aims of this study were to explore the perspectives and needs of T1DM patients and diabetes experts concerning a diabetes app and to design a new T1DM management mobile app.A mixed-methods design combining quantitative surveys and qualitative interviews was used to explore users' needs and perspectives. Experts were surveyed at 2 diabetes conferences using paper questionnaires. T1DM patients were surveyed using Sojump (Changsha ran Xing InfoTech Ltd) on a network. We conducted semistructured, in-depth interviews with adult T1DM patients or parents of child patients who had ever used diabetes apps. The interviews were audio-recorded, transcribed, and coded for theme identification.The expert response rate was 63.5% (127/200). The respondents thought that the reasons for app invalidity were that patients did not continue using the app (76.4%, 97/127), little guidance was received from health care professionals (HCPs; 73.2%, 93/127), diabetes education knowledge was unsystematic (52.8%, 67/127), and the app functions were incomplete (44.1%, 56/127). A total of 245 T1DM patient questionnaires were collected, of which 21.2% (52/245) of the respondents had used diabetes apps. The reasons for their reluctance to use an app were limited time (39%, 20/52), complicated operations (25%, 13/52), uselessness (25%, 13/52), and cost (25%, 13/52). Both the experts and patients thought that the most important functions of the app were patient-doctor communication and the availability of a diabetes diary. Two themes that were useful for app design were identified from the interviews: (1) problems with patients' diabetes self-management and (2) problems with current apps. In addition, needs and suggestions for a diabetes app were obtained. Patient-doctor communication, diabetes diary, diabetes education, and peer support were all considered important by the patients, which informed the development of a prototype multifunctional app.Patient-doctor communication is the most important function of a diabetes app. Apps should be integrated with HCPs rather than stand-alone. We advocate that doctors follow up with their patients using a diabetes app. Our user-centered method explored comprehensively and deeply why the effectiveness of current diabetes apps for T1DM was poor and what T1DM patients needed for a diabetes app and provided meaningful guidance for app design.

Project description:BACKGROUND:Supporting patient engagement and empowerment is increasingly seen as essential in providing person-centered health care to people with chronic illness. Mobile apps helping patients reflect on their concerns as preparation for consultations with their health care providers can have beneficial effects on the consultation quality. However, apps focusing on empowerment and personal strengths are still scarce. OBJECTIVE:This study aimed to (1) develop a mobile app to support patients with rheumatic diseases in reflecting on their strengths in preparation for consultations with health care providers and (2) explore patients' perceived usability of the app in a nonclinical test setting. METHODS:A prototype app was developed based on input from patients and health care providers, as reported in previous studies. The app was designed for use in self-management support settings aiming to promote awareness of strengths and to focus attention on strengths in the patient-health care provider dialogue. The features included in the prototype were as follows: (1) introduction to the topic of strengths, (2) list of examples of strengths to promote reflection and registration of own strengths, (3) summary of registered strengths, (4) value-based goal setting, (5) linking of strengths to goals, (6) summary of all registrations, and (7) options to share summary digitally or as a print version. In this study, the app was refined through a formative evaluation with patients and health care providers recruited from a specialized rheumatology hospital unit. Patients' perceptions of the app's usability were explored in a test setting with self-report measurements and semistructured interviews. The interviews were audiotaped, transcribed, and analyzed with directed content analysis. Data from questionnaires were analyzed with descriptive statistics. RESULTS:Developmental and formative evaluation included 18 patients and 7 health care providers. The evaluation resulted in minor adjustments to the prototype but no major changes in features. The usability testing included 12 patients. All participants found the usability acceptable; the median score on the System Usability Scale was 86.3 (range 70-100). All reported that it was meaningful and relevant to use the app. Out of 12 participants, 9 (75%) reported becoming more aware of their own strengths by using the app; 1 (8%) disagreed and 2 (17%) provided a neutral response. The results on the goal-related feature were mixed, with half of the patients finding it useful to link strengths to concrete goals. A statistically significant positive change from pre- to postintervention was identified on measures of self-efficacy and negative emotions. CONCLUSIONS:In this formative evaluation of a mobile app to promote patients' reflections on their strengths, patients perceived the app as meaningful and supporting awareness. The results suggest the usefulness of building in functionality to support use of strengths and goal attainment. Further studies on efficacy and usability in a clinical setting, including health care providers, are needed.

Dataset Information

Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study.

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Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study.

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