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Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial.

ABSTRACT: This randomized controlled trial aims to determine the feasibility and preliminary efficacy of a patient-centered, mobile health technology intervention (iCardia4HF) in patients with chronic Heart Failure (HF). Participants (n = 92) are recruited and randomized 1:1 to the intervention or control group. The intervention group receives a commercial HF self-care app (Heart Failure Storylines), three connected health devices that interface with the app (Withings weight scale and blood pressure monitor, and Fitbit activity tracker), and a program of individually tailored text-messages targeting health beliefs, self-care self-efficacy, HF-knowledge, and physical activity. The control group receives the same connected health devices, but without the HF self-care app and text messages. Follow-up assessments occur at 30 days and 12 weeks. The main outcome of interest is adherence to HF self-care assessed objectively through time-stamped data from the electronic devices and also via patient self-reports. Primary measures of HF self-care include medication adherence and adherence to daily weight monitoring. Secondary measures of HF self-care include adherence to daily self-monitoring of HF symptoms and blood pressure, adherence to low-sodium diet, and engagement in physical activity. Self-reported HF self-care and health-related quality of life are assessed with the Self-care Heart Failure Index and the Kansas City Cardiomyopathy Questionnaire, respectively. Hospitalizations and emergency room visits are tracked in both groups over 12 weeks as part of our safety protocol. This study represents an important step in testing a scalable mHealth solution that has the potential to bring about a new paradigm in self-management of HF.

SUBMITTER: Kitsiou S

PROVIDER: S-EPMC8222185 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program.MethodsThis feasibility trial was embedded in the SPIN Cohort and utilized the cohort multiple RCT design. In this design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about the trial. Participants in the intervention arm are informed and provide consent, but not the control group. Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program were randomized (3:2 ratio) to be offered the SPIN-SELF Program or usual care for 3 months. Program usage was examined via automated usage logs. User satisfaction was assessed with semi-structured interviews. Trial personnel time requirements and implementation challenges were logged.ResultsOf 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly, except that two participants with SEMCD scores > 7 (scores of 7.2 and 7.3, respectively) were included, which was caused by a system programming error that rounded SEMCD scores. Of 26 SPIN Cohort participants offered the SPIN-SELF Program, only 9 (35%) consented to use the program. Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program's modules (median = 2).ConclusionsThe results of this study will lead to substantial changes for the planned full-scale RCT of the SPIN-SELF Program that we will incorporate into a planned additional feasibility trial with progression to a full-scale trial. These changes include transitioning to a conventional RCT design with pre-randomization consent and supplementing the online self-help with peer-facilitated videoconference-based groups to enhance engagement.Trial registrationclinicaltrials.gov , NCT03914781 . Registered 16 April 2019.

Project description:BACKGROUND:Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. OBJECTIVE:The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. METHODS:The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ?7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. RESULTS:Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. CONCLUSIONS:The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16799.

Project description:BackgroundHeart failure (HF) causes significant economic and humanistic burden for patients and their families, especially those with a low income, partly due to high hospital readmission rates. Optimal self-care is considered an important nonpharmacological aspect of HF management that can improve health outcomes. Emerging evidence suggests that self-management assisted by smartphone apps may reduce rehospitalization rates and improve the quality of life of patients. We developed a virtual human-assisted, patient-centered mobile health app (iHeartU) for patients with HF to enhance their engagement in self-management and improve their communication with health care providers and family caregivers. iHeartU may help patients with HF in self-management to reduce the technical knowledge and usability barrier while maintaining a low cost and natural, effective social interaction with the user.ObjectiveWith a standardized systematic usability assessment, this study had two objectives: (1) to determine the obstacles to effective and efficient use of iHeartU in patients with HF and (2) to evaluate of HF patients' adoption, satisfaction, and engagement with regard to the of iHeartU app.MethodsThe basic methodology to develop iHeartU systems consists of a user-centric design, development, and mixed methods formative evaluation. The iterative design and evaluation are based on the guidelines of the American College of Cardiology Foundation and American Heart Association for the management of heart failure and the validated "Information, Motivation, and Behavioral skills" behavior change model. Our hypothesis is that this method of a user-centric design will generate a more usable, useful, and easy-to-use mobile health system for patients, caregivers, and practitioners.ResultsThe prototype of iHeartU has been developed. It is currently undergoing usability testing. As of September 2018, the first round of usability testing data have been collected. The final data collection and analysis are expected to be completed by the end of 2019.ConclusionsThe main contribution of this project is the development of a patient-centered self-management system, which may support HF patients' self-care at home and aid in the communication between patients and their health care providers in a more effective and efficient way. Widely available mobile phones serve as care coordination and "no-cost" continuum of care. For low-income patients with HF, a mobile self-management tool will expand their accessibility to care and reduce the cost incurred due to emergency visits or readmissions. The user-centered design will improve the level of engagement of patients and ultimately lead to better health outcomes. Developing and testing a novel mobile system for patients with HF that incorporates chronic disease management is critical for advancing research and clinical practice of care for them. This research fills in the gap in user-centric design and lays the groundwork for a large-scale population study in the next phase.International registered report identifier (irrid)DERR1-10.2196/13502.

Project description:BackgroundCoronary heart disease (CHD) is the leading cause of cardiovascular mortality worldwide, yet implementation of evidence-based strategies for secondary prevention remains suboptimal.ObjectiveThis study aimed to evaluate the feasibility, specifically the usability and acceptability, and estimate the preliminary effectiveness of a mobile health (mHealth) intervention targeting both physicians and patients to improve adherence to evidence-based medications and lifestyle modifications.MethodsWe conducted a 12-week pre-post interventional pilot study at two sites in Shanghai and Hainan, China. Physicians used the app designed in this study to prescribe evidence-based medicines and record patient information. Eligible and consenting patients received automatic text messages or voice calls 4 to 5 times per week for 12 weeks on medication adherence and healthy behaviors. Interviews were conducted among 10 physicians and 24 patients at the two sites for their thoughts on medication adherence and feedback on the usability and acceptability. Questions on usability and acceptability were also asked in a patient follow-up survey. With regard to estimating effectiveness, the primary outcome was medication adherence (as estimated by the Morisky Green Levine Scale) at 12 weeks. Secondary outcomes included physical activity, smoking status, fruits and vegetables consumption, and facility visit frequency.ResultsInterview findings and patient survey showed the good usability and acceptability of the intervention. Among 190 patients who completed the intervention, there was a significant increase in medication adherence (odds ratio [OR] 1.80, 95% CI 1.14-2.85). The study also showed decrease of smokers' percentage (-5%, P=.05), increase of daily vegetables consumption frequency (+0.3/day, P=.01), and community health care center visit frequency (+3 in 3 months, P=.04). The following site-specific differences were noted: medication adherence appeared to increase in Hainan (OR 14.68, 95% CI 5.20-41.45) but not in Shanghai (OR 0.61, 95% CI 0.33-1.12).ConclusionsOur study demonstrated that the intervention was feasible in both a tertiary care center and an urban community health center in China. Preliminary results from pre-post comparison suggest the possibility that provider and patient-linked mHealth interventions may improve medication adherence and lifestyle modifications among CHD patients, especially in resource-scarce settings. Randomized controlled trials are needed to verify the findings.

Project description:BACKGROUND:Human-centered design is a methodology that applies an iterative participatory process that engages the end-user for whom an innovation or intervention is designed for from start to end. There is general evidence to support the use of human-centered design for development of tools to affect health behavior, but specifically for family planning provision. This study is part two of a three-phase study that uses a user-centered design methodology which uses the findings from Phase I to design, develop, and test a digital health solution to support follow-up after an induced surgical abortion. OBJECTIVE:The objectives for this study were to: (1) develop a Web-based intervention based on preferences and experiences of women who underwent an abortion as measured in the formative phase of the Feasibility and Acceptability of a Mobile Technology Intervention to Support Postabortion Care Study; (2) conduct usability testing of the intervention to determine user-friendliness and appropriateness of the intervention; and (3) finalize a beta version of the Web-based intervention for pilot testing. METHODS:The study design was based on the "development-evaluation-implementation" process from the Medical Research Council Framework for Complex Medical Interventions. This study is in Phase II of III and is based on user-centered design methodology. Phase I findings demonstrated that women engage with technology to assist in clinical care and they preferred a comprehensive website with email or text notifications to support follow-up care. In Phase II we collaborated with family planning experts and key stakeholders to synthesize evidence from Phase I. With them and a development partner we built a prototype. Usability testing was completed with 9 participants using a validated System Usability Scale. This was then used to refine the intervention for Phase III pilot study. This study was approved by the local Ethics board. RESULTS:We developed a comprehensive Web-based tool called myPostCare.ca, which includes: Post-Procedure Care, Emotional Well-Being Tool, Contraception Explorer, Sexual Health, Book an Appointment, and Other Resources. Additionally, over the course of a month after the procedure, automatic email notifications were sent to women as a form of virtual follow-up support, directing them to myPostCare.ca resources. The Web-based tool was refined based on usability testing results. CONCLUSIONS:This study demonstrated that user-centered design is a useful methodology to build programs and interventions that are women-centered, specifically for abortion care.

Project description:Background: Telehealth affords rehabilitation professionals opportunities to expand access to intervention for people in rural areas. Complex interventions have not been adapted for remote delivery using mobile health technologies. Strategy training is a complex intervention that teaches clients skills for identifying barriers and solutions to engagement in meaningful activities. Our goal was to adapt the delivery of strategy training for remote delivery using mobile health technology.Methods: We conducted a sequential descriptive case series study (n = 5) in which community-dwelling participants with chronic stroke and prior exposure to strategy training used the iADAPTS mobile health application for 5 weeks. Expert practitioners advised revisions to the intervention process. Safety was assessed via monitoring occurrence of adverse events and risk for adverse events. Acceptability was assessed via the Client Satisfaction Questionnaire-8 (CSQ-8) and the Patient-Provider Connection Short Form of the Healing Encounters and Attitudes Lists (HEAL PPC).Results: Revisions to the intervention process supported the delivery of strategy training using mobile health technology after stroke. No adverse events occurred and risk for adverse events was managed through the intervention process. Acceptability was high (CSQ-8, 25 to 32; HEAL PPC, 59.9 to 72.5).Conclusions: Strategy training can be adapted for delivery using mobile health technology, with careful consideration to methods for training participants on new technology and the intervention delivery. Future research should establish the efficacy and effectiveness of integrating mobile health in delivery of interventions that promote engagement in client-selected activities and community participation.Implications for rehabilitationTranslating the strategy training intervention from face-to-face to remote delivery required thoughtful adaptation of the intervention protocol.Strategies for training clients to use mobile health technology during intervention may be important when designing remotely delivered mHealth intervention protocols.Client safety should be considered within the design of the intervention protocol for a complex intervention designed to be delivered remotely.Future studies should examine the efficacy of complex rehabilitation interventions such as strategy training on clinical outcomes (e.g., community participation).

Project description:BackgroundDigital adherence technologies hold promise to improve patient-centered tuberculosis (TB) monitoring, yet few studies have incorporated direct adherence monitoring or assessed patients' experiences with these technologies. We explored acceptability, feasibility, and refinement needs of the TB Treatment Support Tools (TB-TSTs) intervention linking a mobile app, a urine drug metabolite test, and interactive communication with a treatment supporter.MethodsThis pilot study was a parallel-designed single-center randomized controlled trial with exit interviews. Newly diagnosed TB patients were randomized 1:1 using a treatment allocation button in the REDCap software preloaded with a random allocation sequence to usual care or usual care plus the TB-TSTs intervention from a respiratory medicine hospital in the province of Buenos Aires, Argentina and followed for 6-months. Due to the nature of the intervention, blinding to the group allocation could not be achieved for the recruiter or patients. The treatment outcome data extractor was blinded to the group allocation of the participants. Intervention participants used the app to report self-administering medication, potential side effects, submit photos of the urine test, and interact with a treatment supporter. Outcomes were feasibility, acceptability, and treatment outcomes.FindingsForty-two patients were enrolled and evenly assigned to each group. Intervention participants submitted 147·2±58 (mean, SD) medication self-administration and 144·5±55 side effect reports out of 180 and 47.5±38·4 photos of the urine test out of 77. Treatment success for usual care was 81% [17/21] and 95% [20/21] for the TB-TSTs intervention. Thirty-three themes were identified within the main categories of motivation, what worked, issues experienced, and recommendations. Participants (n=12) rated it as 'easy to use' (4.57/5), 'would highly recommend to others' (4·43/5) and reported that access to the treatment support was a critical component. Recommendations included adding an alarm, appointment reminders, and off-line functionality.InterpretationFindings suggest that the TB-TSTs intervention was feasible and acceptable and further refinement and testing is warranted.FundingNational Institute of Health K23NR017210.

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Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial.

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