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Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial.

ABSTRACT: BACKGROUND:The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. OBJECTIVE:The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App - A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. METHODS:The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. RESULTS:This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication of results is planned at 24 months after trial initiation. CONCLUSIONS:This study will serve as a basis for future studies aiming to exploit the constant innovation in mobile medical appliances and integrate novel patient-centered concepts into patient care in the context of radiotherapy. TRIAL REGISTRATION:ClinicalTrials.gov NCT03168048; https://clinicaltrials.gov/ct2/show/NCT03168048 (Archived at WebCite http://www.webcitation.org/6wtWGgi0X).

SUBMITTER: El Shafie RA

PROVIDER: S-EPMC5861302 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Project description:BackgroundAdherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence.ObjectiveThe primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes.MethodsThis study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations.ResultsPhase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020.ConclusionsThis study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus.Trial registrationClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128.International registered report identifier (irrid)DERR1-10.2196/15356.

Project description:BACKGROUND:Despite the importance and popularity of mutual support groups, there have been no systematic attempts to implement and evaluate routine outcome monitoring (ROM) in these settings. Unlike other mutual support groups for addiction, trained facilitators lead all Self-Management and Recovery Training (SMART Recovery) groups, thereby providing an opportunity to implement ROM as a routine component of SMART Recovery groups. OBJECTIVE:This study protocol aims to describe a stage 1 pilot study designed to explore the feasibility and acceptability of a novel, purpose-built mobile health (mHealth) ROM and feedback app (Smart Track) in SMART Recovery groups coordinated by SMART Recovery Australia (SRAU) The secondary objectives are to describe Smart Track usage patterns, explore psychometric properties of the ROM items (ie, internal reliability and convergent and divergent validity), and provide preliminary evidence for participant reported outcomes (such as alcohol and other drug use, self-reported recovery, and mental health). METHODS:Participants (n=100) from the SMART Recovery groups across New South Wales, Australia, will be recruited to a nonrandomized, prospective, single-arm trial of the Smart Track app. There are 4 modes of data collection: (1) ROM data collected from group participants via the Smart Track app, (2) data analytics summarizing user interactions with Smart Track, (3) quantitative interview and survey data of group participants (baseline, 2-week follow-up, and 2-month follow-up), and (4) qualitative interviews with group participants (n=20) and facilitators (n=10). Feasibility and acceptability (primary objectives) will be analyzed using descriptive statistics, a cost analysis, and a qualitative evaluation. RESULTS:At the time of submission, 13 sites (25 groups per week) had agreed to be involved. Funding was awarded on August 14, 2017, and ethics approval was granted on April 26, 2018 (HREC/18/WGONG/34; 2018/099). Enrollment is due to commence in July 2019. Data collection is due to be finalized in October 2019. CONCLUSIONS:To the best of our knowledge, this study is the first to use ROM and tailored feedback within a mutual support group setting for addictive behaviors. Our study design will provide an opportunity to identify the acceptability of a novel mHealth ROM and feedback app within this setting and provide detailed information on what factors promote or hinder ROM usage within this context. This project aims to offer a new tool, should Smart Track prove feasible and acceptable, that service providers, policy makers, and researchers could use in the future to understand the impact of SMART Recovery groups. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000686101; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/15113.

Project description:BackgroundCare delivered by physiotherapists aims to facilitate engagement in positive health behaviors by patients (eg, adherence to exercise). However, research suggests that behavioral interventions are frequently omitted from care. Hence, better understanding of strategies that can be used by physiotherapists to support patients to engage in positive behaviors is important and likely to optimize outcomes. Digital health interventions delivered via mobile apps are garnering attention for their ability to support behavior change. They have potential to incorporate numerous behavior change techniques (BCTs) to support goals of physiotherapy care, including but not limited to self-monitoring, goal setting, and prompts/alerts. Despite their potential to support physiotherapy care, much is still unknown about what apps are available to consumers, the BCTs they use, their quality, and their potential to change behaviors.ObjectiveThe primary aim of this study is to systematically review the mobile apps available in app stores that are intended for use by patients to support physiotherapy care, including the BCTs within these apps. The secondary aims are to evaluate the quality and behavior change potential of these apps.MethodsA systematic review of mobile apps in app stores will be undertaken. This will be guided by recommendations for systematic reviews in line with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement but adapted to suit our app store search, consistent with similar systematic reviews of apps published in the Journal of Medical Internet Research. Apple Store and Google Play will be searched with a two-step search strategy, using terms relevant to physiotherapy, physiotherapists, and common physiotherapy care. Key eligibility criteria will include apps that are intended for use by patients and are self-contained or stand-alone without the need of additional wearable devices or other add-ons. Included apps will be coded for BCTs and rated for quality using the Mobile Application Rating Scale (MARS) and for potential to change behavior using the App Behavior Change Scale (ABACUS).ResultsApp store search and screening are expected to be completed in 2021. Data extraction and quality appraisal are expected to commence by November 2021. The study results are expected to be published in a subsequent paper in 2022.ConclusionsKnowledge gained from this review will support clinical practice and inform research by providing a greater understanding of the quality of currently available mobile apps and their potential to support patient behavior change goals of physiotherapy care.International registered report identifier (irrid)PRR1-10.2196/29047.

Project description:Introduction: Previous studies have shown an improvement in the access to treatment for patients with first-episode psychosis (FEP), specifically young patients, through mobile app-based interventions. The aim of this study is to test the effectiveness of a mobile app-based intervention to improve community functioning in adolescents with FEP. Mobile app-based interventions could increase quality of life and disease awareness, which improve adherence to treatment and reduce the frequency of relapses and rehospitalizations in adolescents with FEP. Methods: This article describes a mobile app treatment and the pilot trial protocol for patients with FEP. We will perform a single-blind randomized clinical trial (RCT) including patients with FEP aged 14-19 years recruited from Gregorio Marañón Hospital, Madrid, Spain. Patients will be randomly assigned to an intervention group, which will receive treatment as usual plus five modules of a psychological intervention through the mobile app (psychoeducation, recognition of symptoms and prevention of relapses, problem solving, mindfulness, and contact wall), or to a control group (standard care). The effectiveness of the intervention will be assessed by means of an extensive battery of clinical tests at baseline and at 3 months of follow-up. The primary outcome is reduction in psychotic and depressive symptoms; secondary outcomes comprise adherence, awareness, use of drugs, and quality of life. Data will be analyzed on an intention-to-treat (ITT) basis. Mixed model repeated-measures analysis will be used to explore the following effect: group × time interaction between the control group and the intervention group for clinical and functional variables during the follow-up period. Discussion: This is an innovative study for the assessment of a psychological intervention through a mobile app for patients with FEP during the critical period. This pilot RCT is intended to be a precursor to larger studies, which in turn could facilitate dissemination of mobile app therapy for patients with FEP. Ethics and Dissemination: The local ethics committee approved the study protocol. All participants must sign the informed consent, to participate. After finalizing the study, the results will be published. Trial registration: NCT03161249. NCT clinicaltrials.gov. Date of registration in primary registry 02 May 2017. clinicaltrials.gov.

Project description:BACKGROUND:Shared decision making (SDM) is recognized as a person-centered approach to improving health care quality and outcomes. Few digital interventions to improve SDM have been tested in child and adolescent mental health (CAMH) settings. One such intervention is Power Up, a mobile phone app for young people (YP), which has shown some evidence of promise that YP who received Power Up reported greater levels of SDM. However, even though parents play a critical role in CAMH care and treatment, they often feel excluded from services. OBJECTIVE:This protocol is for a pilot trial to determine the feasibility of a large-scale randomized trial to develop and evaluate a Web app called Power Up for Parents (PUfP) to support parents and promote involvement in CAMH decisions. METHODS:A 2-stage process, consisting of the development stage and pilot-testing stage of the initial PUfP prototype, will be conducted. At the development stage, a qualitative study with parents and clinicians will be conducted. The interviews will aim to capture the experience of making CAMH decisions, preferences for involvement in SDM, and determine situations within which PUfP can be useful. At the pilot-testing stage, up to 90 parents and their clinicians will be invited to participate in the testing of the prototype. Parents will be randomly allocated to receive the intervention or be part of the control group. This study design will allow us to assess the acceptability and usefulness of PUfP in addition to examining the feasibility of a prospective randomized trial. Clinicians' perceptions of the prototype and how it has influenced parents' involvement in SDM will also be examined. RESULTS:Recruitment began in January 2019 and is scheduled to last for 10 months. Interviews and baseline data collection are currently in progress. To date, 11 CAMH sites have been recruited to take part in the study. It is anticipated that data collection will be completed by October 2019. CONCLUSIONS:The lack of parents' involvement in CAMH care and treatment can lead to higher rates of dropout from care and lower adherence to therapeutic interventions. There are significant benefits to be gained globally if digital SDM interventions are adopted by parents and shown to be successful in CAMH settings. TRIAL REGISTRATION:ISRCTN Registry ISRCTN39238984; http://www.isrctn.com/ISRCTN39238984. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14571.

Project description:BackgroundChronic kidney disease (CKD) is a global health burden. Self-management plays a key role in improving modifiable risk factors.ObjectiveThe aim of this study was to evaluate the effectiveness of wearable devices, a health management platform, and social media at improving the self-management of CKD, with the goal of establishing a new self-management intervention model.MethodsIn a 90-day prospective experimental study, a total of 60 people with CKD at stages 1-4 were enrolled in the intervention group (n=30) and control group (n=30). All participants were provided with wearable devices that collected exercise-related data. All participants maintained dietary diaries using a smartphone app. All dietary and exercise information was then uploaded to a health management platform. Suggestions about diet and exercise were provided to the intervention group only, and a social media group was created to inspire the participants in the intervention group. Participants' self-efficacy and self-management questionnaire scores, Kidney Disease Quality of Life scores, body composition, and laboratory examinations before and after the intervention were compared between the intervention and control groups.ResultsA total of 49 participants completed the study (25 in the intervention group and 24 in the control group); 74% of the participants were men and the mean age was 51.22 years. There were no differences in measured baseline characteristics between the groups except for educational background. After the intervention, the intervention group showed significantly higher scores for self-efficacy (mean 171.28, SD 22.92 vs mean 142.21, SD 26.36; P<.001) and self-management (mean 54.16, SD 6.71 vs mean 47.58, SD 6.42; P=.001). Kidney Disease Quality of Life scores were also higher in the intervention group (mean 293.16, SD 34.21 vs mean 276.37, SD 32.21; P=.02). The number of steps per day increased in the intervention group (9768.56 in week 1 and 11,389.12 in week 12). The estimated glomerular filtration rate (eGFR) of the intervention group was higher than that of the control group (mean 72.47, SD 24.28 vs mean 59.69, SD 22.25 mL/min/1.73m2; P=.03) and the decline in eGFR was significantly slower in the intervention group (-0.56 vs -4.58 mL/min/1.73m2). There were no differences in body composition between groups postintervention.ConclusionsThe use of wearable devices, a health management platform, and social media support not only strengthened self-efficacy and self-management but also improved quality of life and a slower eGFR decline in people with CKD at stages 1-4. These results outline a new self-management model to promote healthy lifestyle behaviors for patients with CKD.Trial registrationClinicalTrials.gov NCT04617431; https://www.clinicaltrials.gov/ct2/show/NCT04617431.

Project description:BackgroundIt is estimated that the number of individuals living with dementia worldwide will increase from 50 million in 2017 to 152 million by 2050. Assistive technology has been recognized as a promising tool to improve the lives of persons living with memory loss and their caregivers. The use of assistive technology in dementia care is expanding, although it is most often intended to manage care and promote safety. There is a lack of assistive technology designed to aid persons with memory loss in participating in meaningful activities. The Social Support Aid (SSA) is a mobile phone-based app that employs facial recognition software. It was designed to assist persons with memory loss remember the names and relationships of the people they interact with to promote social engagement.ObjectiveThis study uses a pilot randomized controlled trial (RCT) design to evaluate the SSA. The objectives were to ascertain (1) the feasibility and utility of the SSA, (2) whether the outcomes of SSA use suggest potential benefits for persons living with memory loss and their care partners, and (3) how study design components could inform subsequent RCTs.MethodsPersons with memory loss were randomized to the SSA (n=20) or the usual care control group (n=28). Quantitative data were collected at three timepoints (baseline, 3 months, and 6 months). Participants in the intervention group participated in qualitative interviews following completion of their 6-month survey.ResultsParticipant eligibility, willingness to be randomized, and retention were not barriers to conducting a full-scale RCT; however, recruitment strategies should be addressed before doing so. Feasibility and utility scores indicated that participants felt neutral about the technology. Use of the SSA was not significantly associated with changes in quality of social interactions or quality of life measures over the 6 months of follow-up (P>.05). The qualitative analysis revealed three themes that described how and why the SSA worked or not: (1) outcomes, (2) reasons why it was or was not useful, and (3) recommendations.ConclusionsThere is a need to develop effective assistive technology that improves the quality of life of persons with memory loss. Assistive technology that allows persons living with memory loss to maintain some level of autonomy should be a priority for future research. This study suggests reasons why the SSA facial recognition software did not appear to improve the quality of social interaction and quality of life of people with memory loss. Results also provide recommendations for future assistive technology development and evaluation.Trial registrationClinicalTrials.gov NCT03645694; https://clinicaltrials.gov/ct2/show/NCT03645694 (Archived by WebCite at http://www.webcitation.org/78dcVZIqq).

Project description:BackgroundThe rapid advancement in media technology has radically changed the way we learn and interact with one another. Games, with their engaging and interactive approach, hold promise in the delivery of knowledge and building of skills. This has potential in child and adolescent mental health work, where the lack of insight and motivation for therapy are major barriers to treatment. However, research on the use of serious games in mental health interventions for children and adolescents is still in its infancy.ObjectiveThis study adds to the research on serious games in mental health interventions through the development and evaluation of RegnaTales, a series of 6 mobile apps designed to help children and adolescents manage anger. We examined the usability and playability of RegnaTales, as well as children's aggression levels before and after the game play.MethodsA total of 72 children aged between 6 and 12 years were recruited for the study. Thirty-five participants had a clinical diagnosis of disruptive behavior disorders (DBD), whereas 37 were typically developing (TD) children. Each child played 1 of the 6 RegnaTales apps for approximately 50 min before completing the Playability and Usability Questionnaire. The Reactive-Proactive Aggression Questionnaire was completed before and after the game play.ResultsThe overall results showed high levels of enjoyment and playability. TD children and children with DBD had similar experienced fun and perceived playability scores on all 6 mobile apps. All 6 mobile apps garnered comparable experienced fun and perceived playability scores. Furthermore, 42% (5/12) to 67% (8/12) of the children indicated that they would like to play the games again. Importantly, children felt that they acquired skills in anger management, were motivated to use them in their daily lives, and felt confident that the skills would help them better manage their anger. Children reported significantly lower reactive aggression after playing the mobile apps Rage Raver (P=.001), Abaddon (P=.008), and RegnaTools (P=.03). These apps focused on the psychoeducation of the link between thoughts and emotions, as well as equipping the participants with various emotion regulation strategies such as relaxation and cognitive restructuring.ConclusionsThis study presents evidence to support RegnaTales as a feasible serious game. The preliminary findings associated with reduction in reactive aggression, coupled with future research to further establish its efficacy, could warrant RegnaTales as a potential intervention for anger issues among clinical and community populations.

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Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial.

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