A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD.
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ABSTRACT:
SUBMITTER: Cronin RM
PROVIDER: S-EPMC10582837 | biostudies-literature | 2023 Oct
REPOSITORIES: biostudies-literature
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A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD.
Cronin Robert M RM Quaye Nives N Liu Xin X Landes Kristina K Crosby Lori E LE Kassim Adetola A AA Volanakis Emmanuel J EJ Schnell Patrick M PM DeBaun Michael R MR
Blood advances 20231001 20
Despite the increased number of evidence-based guidelines for sickle cell disease (SCD), dissemination of evidence-based guidelines in lay language for individuals or families with SCD has not been evaluated. We conducted a feasibility randomized controlled trial to determine the acceptability of a mobile health (mHealth) app with patient-facing guidelines to improve the knowledge of individuals with SCD about SCD-specific knowledge and reduce hospitalizations. Primary outcome measures include r ...[more]
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Project description:BACKGROUND:Translating research into practice, especially the implementation of digital health technologies in routine care, is increasingly important. Yet, there are few studies examining the challenges of implementing patient-facing digital technologies in health care settings. OBJECTIVE:The aim of this study was to report challenges experienced when implementing mobile apps for patients to support their postsurgical rehabilitation in an orthopedic setting. METHODS:A mobile app was tailored to the needs of patients undergoing rotator cuff repair. A 30-min usability session and a 12-week feasibility study were conducted with patients to evaluate the app in routine care. Implementation records (observation reports, issues log, and email correspondence) explored factors that hindered or facilitated patient acceptance. Interviews with clinicians explored factors that influenced app integration in routine care. RESULTS:Participant completion was low (47%, 9/19). Factors that affected patient acceptance included digital literacy, health status, information technology (IT) infrastructure at home, privacy concerns, time limitations, the role of a caregiver, inconsistencies in instruction received from clinicians and the app, and app advice not reflective of patient progress over time. Factors that negatively influenced app integration in routine care included competing demands among clinicians, IT infrastructure in health care settings, identifying the right time to introduce the app to patients, user interface complexity for older patients, lack of coordination among multidisciplinary clinicians, and technical issues with app installation. CONCLUSIONS:Three insights were identified for mobile app implementation in routine care: (1) apps for patients need to reflect their journey over time and in particular, postoperative apps ought to be introduced as part of preoperative care with opportunities for patients to learn and adopt the app during their postoperative journey; (2) strategies to address digital literacy issues among patients and clinicians are essential; and (3) impact of the app on patient outcomes and clinician workflow needs to be communicated, monitored, and reviewed. Lastly, digital health interventions should supplement but not replace patient interaction with clinicians.
| S-EPMC5740262 | biostudies-literature
Project description:BackgroundSwallowing difficulties (ie, dysphagia) are common among older adults, with a 13% to 54% prevalence. Adequate interventions to improve the swallowing function of older adults would reduce morbidity and enhance health-related quality of life outcomes. Mobile health (mHealth) apps may help alleviate dysphagia symptoms by providing programs that maximize the intensity and frequency of training without requiring high costs or regular clinic visits.ObjectiveThe aim of this pilot study was to assess the usability of swallowing training apps by quantitatively and qualitatively evaluating older adults' self-reported data, taking into consideration their educational levels and exposure to mobile technology. We conducted surveys and brief interviews while the participants used a swallowing intervention app we developed. We subsequently identified and resolved individual-specific usability issues to improve future implementation of the app protocol for older persons with swallowing difficulties.MethodsA total of 11 participants (10 women, 91%; mean age 75.7 years, SD 3.93) from two district-run senior welfare centers took part in this study. The participants were divided into a high-potential group and a low-potential group based on their total number of years of education and smart device usage. To investigate the usability of the app twice (ie, in the second week of the intervention and the postintervention stage), we used mixed methods consisting of both quantitative approaches, namely the System Usability Scale (SUS) and modified Computer Self-Efficacy Scale (mCSES) surveys, and qualitative approaches (ie, interviews).ResultsThe quantitative results of the SUS and mCSES surveys revealed that the high-potential group was more inclined to adopt and learn new technology than the low-potential group. Specifically, within the high-potential group, a Wilcoxon signed-rank test indicated that the postintervention mCSES scores (median 65.50) were significantly higher than those in the second week of intervention (median 54.00; z=-2.023, P=.04). Additionally, the usability scores in the low-potential group were within the "marginal acceptability" range even after completion of an 8-week intervention program. Qualitative analyses via semi-structured interviews yielded promising outcomes regarding app acceptability, training program utilization, emotional responses, and learning experience.ConclusionsTo the best of the authors' knowledge, this usability and feasibility study is the first report of a swallowing training app designed to improve the swallowing function of older adults. Future research should consider several issues, such as user characteristics, pretraining education, and the intensity and innate characteristics of the intervention program.
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Project description:Pre-eclampsia is one of the leading causes of maternal death and morbidity in low-resource countries due to delays in case identification and a shortage of health workers trained to manage the disorder. Pre-eclampsia Integrated Estimate of RiSk (PIERS) on the Move (PotM) is a low cost, easy-to-use, mobile health (mHealth) platform that has been created to aid health workers in making decisions around the management of hypertensive pregnant women. PotM combines two previously successful innovations into a mHealth app: the miniPIERS risk assessment model and the Phone Oximeter.The aim of this study was to assess the usability of PotM (with mid-level health workers) for iteratively refining the system.Development of the PotM user interface involved usability testing with target end-users in South Africa. Users were asked to complete clinical scenario tasks, speaking aloud to give feedback on the interface and then complete a questionnaire. The tool was then evaluated in a pilot clinical evaluation in Tygerberg Hospital, Cape Town.After ethical approval and informed consent, 37 nurses and midwives evaluated the tool. During Study 1, major issues in the functionality of the touch-screen keyboard and date scroll wheels were identified (total errors n=212); during Study 2 major improvements in navigation of the app were suggested (total errors n=144). Overall, users felt the app was usable using the Computer Systems Usability Questionnaire; median (range) values for Study 1 = 2 (1-6) and Study 2 = 1 (1-7). To demonstrate feasibility, PotM was used by one research nurse for the pilot clinical study. In total, more than 500 evaluations were performed on more than 200 patients. The median (interquartile range) time to complete an evaluation was 4 min 55 sec (3 min 25 sec to 6 min 56 sec).By including target end-users in the design and evaluation of PotM, we have developed an app that can be easily integrated into health care settings in low- and middle-income countries. Usability problems were often related to mobile phone features (eg, scroll wheels, touch screen use). Larger scale evaluation of the clinical impact of this tool is underway.
| S-EPMC4417132 | biostudies-other
Project description:ObjectiveMobile health (mHealth) apps may prove to be useful tools for supporting chronic disease management. We assessed the feasibility of implementing a clinically integrated mHealth app and practice model to facilitate between-visit asthma symptom monitoring as per guidelines and with the help of patient-reported outcomes (PRO).MethodsWe implemented the intervention at two pulmonary clinics and conducted a mixed-methods analysis of app usage data and semi-structured interview of patients and clinician participants over a 25-week study period.ResultsFive physicians, 1 physician's assistant, 1 nurse, and 26 patients participated. Twenty-four patients (92%) were still participating in the intervention at the end of the 25-week study period. On average, each patient participant completed 21 of 25 questionnaires (84% completion rate). Weekly completion rates were higher for participants who were female (88 vs. 73%, p = 0.02) and obtained a bachelor's degree level or higher (94 vs. 74%, p = 0.04). On average, of all questionnaires, including both completed and not completed (25 weekly questionnaires times 26 patient participants), 25% had results severe enough to qualify for a callback from a nurse; however, patients declined this option in roughly half of the cases in which they were offered the option. We identified 6 key themes from an analysis of 21 patients and 5 clinician interviews. From the patient's perspective, these include more awareness of asthma, more connected with provider, and app simplicity. From the clinician's perspective, these include minimal additional work required, facilitating triage, and informing conversations during visits.ConclusionImplementation of a clinically integrated mHealth app and practice model can achieve high patient retention and adherence to guideline-recommended asthma symptom monitoring, while minimally burdening clinicians. The intervention has the potential for scaling to primary care and reducing utilization of urgent and emergency care.
| S-EPMC6795530 | biostudies-literature
Project description:Hematopoietic stem cell transplantation (HCT) is a curative treatment option for patients with hematologic conditions but presents many complications that must be managed as a complex, chronic condition. Mobile health applications (mHealth apps) may permit tracking of symptoms in HCT. In seeking strategies to manage the complexities of HCT, our team collaborated with Sicklesoft, Inc., to develop an mHealth app specifically for HCT patients to allow for daily evaluation of patient health, Technology Recordings to better Understand Bone Marrow Transplantation (TRU-BMT). The primary value of this application is that of potentially enhancing the monitoring of symptoms and general health of patients undergoing HCT, with the ultimate goal of allowing earlier detection of adverse events, earlier intervention, and improving outcomes. To first evaluate patient interest in mHealth apps, we designed and administered an interest survey to patients at the 2017 BMT-InfoNet reunion. As a follow-up to the positive feedback received, we began testing the TRU-BMT app in a Phase 1 pilot study. Thirty patients were enrolled in this single-arm study and were given the TRU-BMT mHealth app on a smartphone device in addition to a wearable activity tracker. Patients were followed for up to 180 days, all the while receiving daily app monitoring. Adherence to TRU-BMT was approximately 30% daily and 44% weekly, and greater adherence was associated with increased meal completion, decreased heart rate, and shorter hospital stay. TRU-BMT assessments of symptom severity were significantly associated with duration of hospital stay and development of chronic graft-versus-host disease. Our findings suggest that using TRU-BMT throughout HCT is feasible for patients and established a proof-of-concept for a future randomized control trial of the TRU-BMT application in HCT. © 2021 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
| S-EPMC10522407 | biostudies-literature
Project description:BackgroundFalls are the leading cause of injury-related death in older adults. Due to various constraints, objective fall risk screening is seldom performed in clinical settings. Smartphones offer a high potential to provide fall risk screening for older adults in home settings. However, there is limited understanding of whether smartphone technology for falls screening is usable by older adults who present age-related changes in perceptual, cognitive, and motor capabilities.ObjectiveThe aims of this study were to develop a fall risk mobile health (mHealth) app and to determine the usability of the fall risk app in healthy, older adults.MethodsA fall risk app was developed that consists of a health history questionnaire and 5 progressively challenging mobility tasks to measure individual fall risk. An iterative design-evaluation process of semistructured interviews was performed to determine the usability of the app on a smartphone and tablet. Participants also completed a Systematic Usability Scale (SUS). In the first round of interviews, 6 older adults participated, and in the second round, 5 older adults participated. Interviews were videotaped and transcribed, and the data were coded to create themes. Average SUS scores were calculated for the smartphone and tablet.ResultsThere were 2 themes identified from the first round of interviews, related to perceived ease of use and perceived usefulness. While instructions for the balance tasks were difficult to understand, participants found it beneficial to learn about their risk for falls, found the app easy to follow, and reported confidence in using the app on their own. Modifications were made to the app, and following the second round of interviews, participants reported high ease of use and usefulness in learning about their risk of falling. Few differences were reported between using a smartphone or tablet. Average SUS scores ranged from 79 to 84.ConclusionsOur fall risk app was found to be highly usable by older adults as reported from interviews and high scores on the SUS. When designing a mHealth app for older adults, developers should include clear and simple instructions and preventative strategies to improve health. Furthermore, if the design accommodates for age-related sensory changes, smartphones can be as effective as tablets. A mobile app to assess fall risk has the potential to be used in home settings by older adults.
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Project description:BackgroundThe See Me Smoke-Free (SMSF) mobile health (mHealth) app was developed to help women quit smoking by targeting concerns about body weight, body image, and self-efficacy through cognitive behavioral techniques and guided imagery audio files addressing smoking, diet, and physical activity. A feasibility trial found associations between SMSF usage and positive treatment outcomes. This paper reports a detailed exploration of program use among eligible individuals consenting to study participation and completing the baseline survey (participants) and ineligible or nonconsenting app installers (nonparticipants), as well as the relationship between program use and treatment outcomes.ObjectiveThe aim of this study was to determine whether (1) participants were more likely to set quit dates, be current smokers, and report higher levels of smoking at baseline than nonparticipants; (2) participants opened the app and listened to audio files more frequently than nonparticipants; and (3) participants with more app usage had a higher likelihood of self-reported smoking abstinence at follow up.MethodsThe SMSF feasibility trial was a single arm, within-subjects, prospective cohort study with assessments at baseline and 30 and 90 days post enrollment. The SMSF app was deployed on the Google Play Store for download, and basic profile characteristics were obtained for all app installers. Additional variables were assessed for study participants. Participants were prompted to use the app daily during study participation. Crude differences in baseline characteristics between trial participants and nonparticipants were evaluated using t tests (continuous variables) and Fisher exact tests (categorical variables). Exact Poisson tests were used to assess group-level differences in mean usage rates over the full study period using aggregate Google Analytics data on participation and usage. Negative binomial regression models were used to estimate associations of app usage with participant baseline characteristics after adjustment for putative confounders. Associations between app usage and self-reported smoking abstinence were assessed using separate logistic regression models for each outcome measure.ResultsParticipants (n=151) were more likely than nonparticipants (n=96) to report female gender (P<.02) and smoking in the 30 days before enrollment (P<.001). Participants and nonparticipants opened the app and updated quit dates at the same average rate (rate ratio [RR] 0.98; 95% CI 0.92-1.04; P=.43), but participants started audio files (RR 1.07; 95% CI 1.00-1.13; P<.04) and completed audio files (RR 1.11; 95% CI 1.03-1.18; P<.003) at significantly higher rates than nonparticipants. Higher app usage among participants was positively associated with some smoking cessation outcomes.ConclusionsThis study suggests potential efficacy of the SMSF app, as increased usage was generally associated with higher self-reported smoking abstinence. A planned randomized controlled trial will assess the SMSF app's efficacy as an intervention tool to help women quit smoking.
| S-EPMC5653904 | biostudies-literature
Project description:BackgroundThe number of pregnancies affected by gestational diabetes mellitus (GDM) is growing. With the increased use of smartphones and predictive modeling, a mobile health (mHealth) solution could be developed to improve care and management of GDM while streamlining care through risk stratification.MethodsA user-centered mHealth tool was designed from ethnographic observations and 11 semi-structured interviews (six health care professionals [HCPs] and five women with GDM), followed by iterative changes and evaluation from three feedback groups with 31 participants (17 HCPs, 14 researchers) and 13 questionnaires with women with GDM.Results"MyGDM" includes a clinical dashboard that centralizes the clinic's patients, highlighting off-target blood glucose and predicting the need for pharmacological intervention. It is linked with a patient-facing app that includes structured education, culturally inclusive language options, and meal ideas. Through the feedback sessions, iterative changes were made around visualization and patient safety, and participants were positive toward the potential user experience. In the 13 questionnaires with women with GDM, 100% said it would fit into their lifestyle and help them manage GDM. Educational resources and the "request a call" functions were well received with 61.5% (8/13) and 69.2% (9/13) saying they were very likely or likely to use these, respectively.ConclusionA user-centered mHealth tool consisting of a clinical dashboard linked with a patient-facing app for GDM care and management has been designed. Evaluation of the interactive design by end users was positive and showed that it met their needs.
| S-EPMC11607713 | biostudies-literature
Project description:Despite the well-known benefits of breastfeeding, breastfeeding rates remain suboptimal, particularly for women with lower socioeconomic position. Although popular, breastfeeding apps are often poor quality; their impact on breastfeeding knowledge, attitudes, confidence and intentions is unknown. A mixed method pre-post feasibility study was conducted to: 1) explore the feasibility of the My Baby Now app in providing perinatal breastfeeding support; 2) examine the impact on breastfeeding knowledge, attitudes, confidence and intentions; 3) to examine any differences in acceptability and impact of the app according to maternal education. The My Baby Now app was offered to pregnant women 20-30 weeks gestation. Breastfeeding knowledge and intentions were collected at baseline (T1) and 36-38 weeks gestation (T2); attitudes and confidence were collected at baseline, T2 and T3 (8-12 weeks post-partum). App engagement was measured via app analytics. Qualitative interviews were conducted with a purposeful sample following T3. Of 266 participants recruited, 169 (64%) completed T2 and 157 (59%) completed T3. Mothers without university education rated the app to be higher quality, more useful and impactful than mothers with university education. From T1-T2, breastfeeding knowledge (59.6% vs. 66.5%, p < 0.001) and exclusive breastfeeding intentions (76.6% vs. 80.9%, p < 0.001) increased. Breastfeeding attitudes and confidence scores also increased significantly across T1-T2 and T1-T3. App engagement during pregnancy predicted changes in breastfeeding attitudes from T1-T2 among participants without university education. App engagement did not predict changes in breastfeeding knowledge, confidence or intentions. Future randomised controlled studies should examine the effectiveness of mHealth interventions on breastfeeding outcomes.
| S-EPMC10019053 | biostudies-literature
Project description:BackgroundMobile health (mHealth) interventions can improve health by improving cardiovascular risk factors, but their adoption in care by physicians and patients is untapped. Few mHealth apps have been evaluated in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available. Given the rapid pace of change in this field, it is not feasible to rigorously evaluate mHealth apps with current methodologies.ObjectiveThe overall aim of this pilot study was to test the feasibility of using a web research platform called Trial My App to conduct efficient and rigorous web-based randomized controlled trials (RCTs) of mHealth apps relevant to patients with cardiovascular risk factors by evaluating an app that targets hypertension.MethodsFor this study, 200 participants with suboptimally controlled hypertension will be recruited through advertisements in newsletters, media, and the internet, as well as through referrals from their health care providers. Screening, consent, randomization, and collection of patient-important health confidence and self-management ability outcomes will be conducted online through the Trial My App research platform. Participants will be randomized into 2 groups: 100 that will use an mHealth app for tracking hypertension and 100 that will be considered as an educational control. All participants will complete questionnaires at 0, 1, 3 and 6 months after enrolment. A substudy to validate the method of blood pressure readings and the consistency of data entered through Trial My App will be conducted with 40 participants.ResultsThe development of the Trial My App web platform has been completed. The creation of survey instruments has been completed in collaboration with our patient partners and advisory board. Recruitment is expected to begin in the first quarter of 2021; data collection and analysis are expected to be completed approximately 1 year after study commencement. Results will be disseminated through conferences and publications. The primary outcomes of this study include the feasibility of conducting an RCT using the Trial My App platform by reporting recruitment, retention, and completion statistics. We will validate app-entered data with a standard 7-day home blood pressure measurement method. Lastly, the pilot, nonblinded RCT will assess the effectiveness of the mHealth app in improving the control of hypertension compared with the control of hypertension in the educational control group.ConclusionsThis study will determine if it is feasible to use the Trial My App web-based platform to evaluate the effectiveness of mHealth apps for patients with cardiovascular risk factors. As more mHealth apps are evaluated in RCTs, patients will be able to select apps that meet their needs and physicians will be able to make evidence-based recommendations to their patients for apps aimed at improving cardiovascular health.Trial registrationClinicalTrials.gov NCT04528654; https://clinicaltrials.gov/ct2/show/NCT04528654.International registered report identifier (irrid)PRR1-10.2196/26155.
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