Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial.
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ABSTRACT:
SUBMITTER: Gomis-Pastor M
PROVIDER: S-EPMC8070926 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSolid organ transplantation could be the only life-saving treatment for end-stage heart failure. Nevertheless, multimorbidity and polypharmacy remain major problems after heart transplant. A technology-based behavioral intervention model was established to improve clinical practice in a heart transplant outpatient setting. To support the new strategy, the mHeart app, a mobile health (mHealth) tool, was developed for use by patients and providers.ObjectiveThe primary objective of this study was to describe the implementation of the mHeart model and to outline the main facilitators identified when conceiving an mHealth approach. The secondary objectives were to evaluate the barriers, benefits, and willingness to use mHealth services reported by heart transplant recipients and cardiology providers.MethodsThis was an implementation strategy study directed by a multidisciplinary cardiology team conducted in four stages: design of the model and the software, development of the mHeart tool, interoperability among systems, and quality and security requirements. A mixed methods study design was applied combining a literature review, several surveys, interviews, and focus groups. The approach involved merging engineering and behavioral theory science. Participants were chronic-stage heart transplant recipients, patient associations, health providers, stakeholders, and diverse experts from the legal, data protection, and interoperability fields.ResultsAn interdisciplinary and patient-centered process was applied to obtain a comprehensive care model. The heart transplant recipients (N=135) included in the study confirmed they had access to smartphones (132/135, 97.7%) and were willing to use the mHeart system (132/135, 97.7%). Based on stakeholder agreement (>75%, N=26), the major priorities identified of the mHealth approach were to improve therapy management, patient empowerment, and patient-provider interactions. Stakeholder agreement on the barriers to implementing the system was weak (<75%). Establishing the new model posed several challenges to the multidisciplinary team in charge. The main factors that needed to be overcome were ensuring data confidentiality, reducing workload, minimizing the digital divide, and increasing interoperability. Experts from various fields, scientific societies, and patient associations were essential to meet the quality requirements and the model scalability.ConclusionsThe mHeart model will be applicable in distinct clinical and research contexts, and may inspire other cardiology health providers to create innovative ways to deal with therapeutic complexity and multimorbidity through health care systems. Professionals and patients are willing to use such innovative mHealth programs. The facilitators and key strategies described were needed for success in the implementation of the new holistic theory-based mHealth strategy.
| S-EPMC7723747 | biostudies-literature
Project description:BACKGROUND:Nonadherence to immunosuppressive therapy after renal transplantation is associated with poor graft outcomes. We aimed to evaluate whether the use of the Adhere4U mobile medication manager application could improve adherence among renal transplant recipients ?1 year posttransplantation. Adhere4U can provide medication reminders, monitor medication use, and provide information on immunosuppressants. METHODS:We conducted a prospective randomized controlled study to compare the rate of nonadherence to index immunosuppressant (tacrolimus or cyclosporine) in a group using the Adhere4U app (mobile group) and in another group receiving conventional care (control group). The primary outcome was the nonadherence rate, which was evaluated using an electronic medication event monitoring system during the 6-month intervention period. Our secondary outcome included self-reported adherence using the Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS) and the visual analog scale (VAS) based on a 4-week recall on days 28, 90, and 180. Longitudinal data of repeated measures of self-rated adherence were analyzed using generalized estimating equations (GEE) to compare the between-group difference in adherence change over time. RESULTS:Between November 2013 and May 2015, 138 renal transplant recipients were randomly allocated to the control (n = 67) or the mobile group (n = 71). The overall nonadherence rate over the 6-month study period by electronic monitoring was 63.6%, with no between-group difference [mobile group, 65.0% (n = 39/60); control group, 62.1% (n = 36/58); odds ratio 1.14; 95% confidence interval 0.53-2.40; p = 0.89]. Self-rated nonadherence assessed using the BAASIS and VAS at baseline was 53.7% and 51.5%, respectively. Although the self-rated nonadherence by BAASIS of the mobile group was lower than the control group throughout the study period, there was no between-group difference in the change of nonadherence over time (?2 = 2.82, df = 3, p = 0.42 by logistic GEE). There also was no significant between-group difference in the nonadherence by VAS (?2 = 1.71, df = 3, p = 0.63 by logistic GEE) over time. The main limitation of this study was the low rate of patient engagement with the app among the mobile group. The rate of app use was 47.6% (31/65) at 28 days, 33.9% (19/56) at 90 days, and 11.5% (6/52) at 180 days. CONCLUSIONS:The Adhere4U application did not improve adherence to immunosuppressive therapy. Our evidence is limited by the high rate of attrition. Further studies on strategies to facilitate patient engagement with mobile interventions are warranted.
| S-EPMC6830819 | biostudies-literature
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.
| S-EPMC6881780 | biostudies-literature
Project description:BackgroundMobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities (eg, hypertension, diabetes). These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients' physiological data. This technology is also relatively inexpensive, has an intuitive interface, and provides the capability for real-time personalized feedback to help motivate patient self-efficacy. Automated summary reports of patients' adherence and blood pressure can easily be uploaded to providers' networks helping reduce clinical inertia by reducing regimen alteration time.ObjectiveThe aim of this study was to assess the feasibility, acceptability, and preliminary outcomes of a prototype mobile health (mHealth) medication and blood pressure (BP) self-management system for kidney transplant patients with uncontrolled hypertension.MethodsA smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design. The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback. A 3-month proof-of-concept randomized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray. Participants randomized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging. Controls received standard of care and their adherence continued to be monitored with the medication tray reminders turned off. Providers received weekly summary reports of patient medication adherence and BP readings.ResultsParticipation and retention rates were 41/55 (75%) and 31/34 (91%), respectively. The prototype system appears to be safe, highly acceptable, and useful to patients and providers. Compared to the standard care control group (SC), the mHealth intervention group exhibited significant improvements in medication adherence and significant reductions in clinic-measured systolic blood pressures across the monthly evaluations. Physicians made more anti-hypertensive medication adjustments in the mHealth group versus the standard care group (7 adjustments in 5 patients versus 3 adjustments in 3 patients) during the 3-month trial based on the information provided in the weekly reports.ConclusionsThese data support the acceptability and feasibility of the prototype mHealth system. Further trials with larger sample sizes and additional biomarkers (eg, whole blood medication levels) are needed to examine efficacy and effectiveness of the system for improving medication adherence and blood pressure control after kidney transplantation over longer time periods.Trial registrationClinicaltrials.gov NCT01859273; http://clinicaltrials.gov/ct2/show/NCT01859273 (Archived by WebCite at http://www.webcitation.org/6IqfCa3A3).
| S-EPMC3786124 | biostudies-literature
Project description:Poor adherence to hypertension treatment increases complications of the disease and is characterized by a lack of awareness and acceptance of ongoing treatment. Mobile health (mHealth) apps can optimize processes and facilitate access to health information by combining treatment methods with attractive solutions. In this study, we aimed at verifying the influence of using an mHealth app on patients' adherence to hypertension treatment, also examining how user experience toward the app influenced the outcomes. A total of 49 participants completed the study, men and women, diagnosed with hypertension and ongoing medical treatment. For 12 weeks, the control group continued with conventional monitoring, while the experimental group used an mHealth app. From the experimental group, at baseline, 8% were non-adherent, 64% were partial adherents and 28% were adherent to the treatment. Baseline in the control group indicated 4.2% non-adherents, 58.3% partial adherents, and 37.5% adherents. After follow-up, the experimental group had an increase to 92% adherent, 8% partially adherent, and 0% non-adherent (P < 0.001). In the control group, adherence after follow-up remained virtually the same (P ≥ 0.999). Results of user experience were substantially positive and indicate that the participants in the experimental group had a satisfactory perception of the app. In conclusion, this study suggests that using an mHealth app can empower patients to manage their own health and increase adherence to hypertension treatment, especially when the app provides a positive user experience.
| S-EPMC8166239 | biostudies-literature
Project description: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.
| S-EPMC8222185 | biostudies-literature
Project description:OBJECTIVE:To design and investigate a pharmacist-run intervention using low health literacy flashcards and a smartphone-activated quick response (QR) barcoded educational flashcard video to increase medication adherence and disease state understanding. DESIGN:Prospective, matched, quasi-experimental design. SETTING:County health system in Dallas, Texas. PARTICIPANTS:Sixty-eight primary care patients prescribed targeted heart failure, hypertension, and diabetes medications INTERVENTION: Low health literacy medication and disease specific flashcards, which were also available as QR-coded online videos, were designed for the intervention patients. The following validated health literacy tools were conducted: Newest Vital Sign (NVS), Rapid Estimate of Adult Literacy Medicine-Short Form, and Short Assessment of Health Literacy-50. MAIN OUTCOME MEASURES:The primary outcome was the difference in medication adherence at 180 days after pharmacist intervention compared with the control group, who were matched on the basis of comorbid conditions, targeted medications, and medication class. Medication adherence was measured using a modified Pharmacy Quality Alliance proportion of days covered (PDC) calculation. Secondary outcomes included 90-day PDC, improvement of greater than 25% in baseline PDC, and final PDC greater than 80%. Linear regression was performed to evaluate the effect of potential confounders on the primary outcome. RESULTS:Of the 34 patients receiving the intervention, a majority of patients scored a high possibility of limited health literacy on the NVS tool (91.2%). The medication with the least adherence at baseline was metformin, followed by angiotensin-converting enzyme inhibitors and beta blockers. At 180 days after intervention, patients in the intervention group had higher PDCs compared with their matched controls (71% vs. 44%; P = 0.0069). CONCLUSION:The use of flashcards and QR-coded prescription bottles for medication and disease state education is an innovative way of improving adherence to diabetes, hypertension, and heart failure medications in a low-health literacy patient population.
| S-EPMC5507206 | biostudies-literature
Project description:BACKGROUND:Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. OBJECTIVE:The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT). METHODS:We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports. RESULTS:Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. CONCLUSIONS:Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence. TRIAL REGISTRATION:ClinicalTrials.gov NCT03022669.
| S-EPMC5539386 | biostudies-literature
Project description:OBJECTIVE:To check if mobile health (m-Health) short message service (SMS) can improve the knowledge and practice of the American Diabetic Association preventive care guidelines (ADA guidelines) recommendations among physicians. METHODOLOGY:Quasi-experimental pre-post study design with a control group. PARTICIPANTS:The participants of the study were 62 medical officers/medical postgraduate trainees from two hospitals in Lahore, Pakistan. Pretested questionnaire was used to collect baseline information about physicians' knowledge and adherence according to the ADA guidelines. All the respondents attended 1-day workshop about the guidelines. The intervention group received regular reminders by SMS about the ADA guidelines for the next 5 months. Postintervention knowledge and practice scores of 13 variables were checked again using the same questionnaire. Statistical analysis included χ2 and McNemar's tests for categorical variables and t-test for continuous variables. Pearson's correlation analysis was done to check correlation between knowledge and practice scores in the intervention group. P values of <0.05 were considered statistically significant. RESULTS:The total number of participating physicians was 62. Fifty-three (85.5%) respondents completed the study. Composite scores within the intervention group showed statistically significant improvement in knowledge (p<0.001) and practice (p<0.001) postintervention. The overall composite scores preintervention and postintervention also showed statistically significant difference of improvement in knowledge (p=0.002) and practice (p=0.001) between non-intervention and intervention groups. Adherence to individual 13 ADA preventive care guidelines level was noted to be suboptimal at baseline. Statistically significant improvement in the intervention group was seen in the following individual variables: review of symptoms of hypoglycaemia and hyperglycaemia, eye examination, neurological examination, lipid examination, referral to ophthalmologist, and counselling about non-smoking. CONCLUSION:m-Health technology can be a useful educational tool to help with improving knowledge and practice of diabetic guidelines. Future multicentre trials will help to scale this intervention for wider use in resource-limited countries.
| S-EPMC5988082 | biostudies-literature
Project description:BACKGROUND:In order to play an active role in their health care, patients need information and motivation. Current delivery systems limit patients' involvement because they do not routinely provide them with enough details of their own clinical results, conditions and other important clinical data. The purpose of this study was to identify, from the perspective of patients, which topics matter the most, who should be communicating them, and when and how should they be provided. METHODS:We conducted a qualitative, phenomenological study analysing the content of subjective experiences, feelings and behaviours. We organized two focus groups with 13 participants and 15 in-depth interviews. Transcripts of the focus groups and interviews were checked for accuracy and then entered into Atlas ti™ v7.5.13 qualitative software. Two independent researchers performed a qualitative inductive content analysis to classify the data in two levels: themes and categories. RESULTS:The qualitative analysis provided 377?units of meaning synthesized into 22 categories and six themes: hospitalization procedure, Health Literacy relating to the patient's condition, information content, satisfaction, professional-patient relationship, and patient proactivity. Patients described which information they wished for, when they needed it, and who would provide it, usually related to actions such as admission, discharge or diagnostic tests. Oral information was more difficult to comprehend than the written kind, as patients can check written information several times if needed. Nurses were the most available professionals, and patients found easier to relate to them and ask them questions. Moreover, patients identified physicians as those professionals responsible for providing clinical information. CONCLUSIONS:Our results showed that patients suffered from poor Health Literacy regarding their personal condition, as they were unable to describe the symptoms, the type of tests being performed or their results, and some of them also had difficulties in naming the specific disease or comorbidities they had. During the hospitalization process, patients were in good shape to come with doubts and actively asked for more information. Healthcare organizations and professionals were offered the chance to ensure the correct communication and comprehension to their patients.
| S-EPMC7035644 | biostudies-literature