Dataset Information

American Heart Association's Cholesterol CarePlan as a Smartphone-Delivered Web App for Patients Prescribed Cholesterol-Lowering Medication: Protocol for an Observational Feasibility Study.

ABSTRACT: BACKGROUND:Adoption of healthy lifestyle and compliance with cholesterol-lowering medication reduces the risk of cardiovascular disease (CVD). The use of digital tools and mobile technology may be important for sustaining positive behavioral change. OBJECTIVE:The primary objective of this study is to evaluate the feasibility and acceptability of administering the Cholesterol CarePlan Web app developed by the American Heart Association aimed at improving lifestyle and medication adherence among patients prescribed cholesterol-lowering medication. The secondary objective is to assess the Web app's efficacy. METHODS:A prospective, observational feasibility study will be conducted to demonstrate whether the Web app may be successfully taken up by patients and will be associated with improved clinical and behavioral outcomes. The study will aim to recruit 180 study participants being prescribed cholesterol-lowering medication for at least 30 days across 14 general practices in London, England. Potentially eligible patients will be invited to use the Web app on a smartphone and visit general practice for three 20-minute clinical assessments of blood pressure, height, weight, smoking, and nonfasting cholesterol over 24 weeks. The feasibility of administering the Web app will be judged by recruitment and dropout statistics and the sociodemographic and comorbidity profile of consenting study participants, consenting nonparticipants, and all potentially eligible patients. Acceptability will be assessed using patients' readiness to embrace new technologies, the usability of the Web app, and patient satisfaction. The efficacy of the Web app will be assessed by changes in medication adherence and clinical risk factors by levels of the Web app compliance. RESULTS:This study is currently funded by the American Heart Association. Initial study recruitment will take place between February and July 2018 followed by patient follow-up. Patient level data will be obtained in January 2019. Data analysis will be completed by February 2019. Results will be submitted for publication in March 2019. CONCLUSIONS:The potential of an app to improve patients' lifestyle and management of cholesterol may inform the design of a randomized controlled trial and the delivery of more effective CVD prevention programs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/9017.

SUBMITTER: Woringer M

PROVIDER: S-EPMC6365873 | biostudies-other | 2019 Jan

REPOSITORIES: biostudies-other

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American Heart Association's Cholesterol CarePlan as a Smartphone-Delivered Web App for Patients Prescribed Cholesterol-Lowering Medication: Protocol for an Observational Feasibility Study.

Woringer Maria M Dharmayat Kanika I KI Greenfield Geva G Bottle Alex A Ray Kausik K KK Ray Kausik K KK

JMIR research protocols 20190124 1

<h4>Background</h4>Adoption of healthy lifestyle and compliance with cholesterol-lowering medication reduces the risk of cardiovascular disease (CVD). The use of digital tools and mobile technology may be important for sustaining positive behavioral change.<h4>Objective</h4>The primary objective of this study is to evaluate the feasibility and acceptability of administering the Cholesterol CarePlan Web app developed by the American Heart Association aimed at improving lifestyle and medication ad ...[more]

PMID: 30679150

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Project description:BackgroundRegular aerobic physical activity (PA) is an important component of healthy aging. However, only 27%-40% of African American women achieve national PA guidelines. Available data also show a clear decline in PA as African American women transition from young adulthood (ie, 25-44 years) into midlife. This decline in PA during midlife coincides with an increased risk for African American women developing cardiometabolic disease conditions, including obesity, type 2 diabetes, and cardiovascular disease. Thus, effective efforts are needed to promote PA among sedentary African American women during midlife.ObjectiveThis study aims to examine the acceptability and feasibility of a culturally tailored, smartphone-delivered PA intervention, originally developed to increase PA among African American women aged 24-49 years, among a slightly older sample of midlife African American women aged 50-65 years.MethodsA single-arm pretest-posttest study design was implemented. In total, 20 insufficiently active African American (ie, ≤60 min per week of PA) women between the ages of 50-65 years participated in the 4-month feasibility trial. The Smart Walk intervention was delivered through the study Smart Walk smartphone app and text messages. Features available on the Smart Walk app include personal profile pages, multimedia PA promotion modules, discussion board forums, and an activity tracking feature that integrates with Fitbit activity monitors. Self-reported PA and social cognitive theory mediators targeted by the intervention (ie, self-regulation, behavioral capability, outcome expectations, self-efficacy, and social support) were assessed at baseline and at 4 months. Feasibility and acceptability were assessed using a postintervention satisfaction survey that included multiple-choice and open-ended questions evaluating participant perceptions of the intervention and suggestions for intervention improvement. Wilcoxon signed-rank tests were used to examine pre- and postintervention changes in the PA and social cognitive theory variables. The effect size estimates were calculated using the Pearson r test statistic.ResultsParticipants increased moderate-to-vigorous PA (median 30 minutes per week increase; r=0.503; P=.002) and reported improvements in 2 theoretical mediators (self-regulation: r=0.397; P=.01; behavioral capability: r=0.440; P=.006). Nearly all participants (14/15, 93% completing the satisfaction survey) indicated that they would recommend the intervention to a friend. Participants' suggestions for improving the intervention included enhancing the intervention's provisions of social support for PA.ConclusionsThe results provide preliminary support for the feasibility of the smartphone-based approach to increase PA among midlife African American women. However, before larger-scale implementation among midlife African American women, enhancements to the social support components of the intervention are warranted.Trial registrationClinicalTrials.gov NCT04073355; https://clinicaltrials.gov/ct2/show/NCT04073355.

Project description:BACKGROUND:The efficacy of smartphone apps for improving medication adherence in type 2 diabetes is not well studied in Asian populations. OBJECTIVE:This study aimed to determine the feasibility, acceptability, and clinical outcomes of using a smartphone app to improve medication adherence in a multiethnic Asian population with type 2 diabetes. METHODS:We block randomized 51 nonadherent and digitally literate patients with type 2 diabetes between the ages of 21 and 75 years into two treatment arms (control: usual care; intervention: usual care+Medisafe app) and followed them up for 12 weeks. Recruitment occurred at a public tertiary diabetes specialist outpatient center in Singapore. The intervention group received email reminders to complete online surveys monthly, while the control group only received an email reminder(s) at the end of the study. Barriers to medication adherence and self-appraisal of diabetes were assessed using the Adherence Starts with Knowledge-12 (ASK-12) and Appraisal of Diabetes Scale (ADS) questionnaires at baseline and poststudy in both groups. Perception toward medication adherence and app usage, attitude, and satisfaction were assessed in the intervention group during and after the follow-up period. Sociodemographic data were collected at baseline. Clinical data (ie, hemoglobin A1c, body mass index, low-density lipoprotein, high-density lipoprotein, and total cholesterol levels) were extracted from patients' electronic medical records. RESULTS:A total of 51 (intervention group: 25 [49%]; control group: 26 [51%]) participants were randomized, of which 41 (intervention group: 22 [88.0%]; control group: 19 [73.1%]) completed the poststudy survey. The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01). No changes were observed in the clinical outcomes. The average 12-week medication adherence rate of participants tracked by the app was between 38.3% and 100% in the intervention group. The majority (>80%) of the participants agreed that the app was easy to use and made them more adherent to their medication. CONCLUSIONS:Our feasibility study showed that among medication-nonadherent patients with type 2 diabetes, a smartphone app intervention was acceptable, improved awareness of medication adherence, and reduced self-reported barriers to medication adherence, but did not improve clinical outcomes in a developed Asian setting.

Project description:BackgroundAscites is a common, painful, and serious complication of cirrhosis. Body weight is a reliable proxy for ascites volume; therefore, daily weight monitoring is recommended to optimize ascites management.ObjectiveThis study aims to evaluate the feasibility of a smartphone app in facilitating outpatient ascites management.MethodsIn this feasibility study, patients with cirrhotic ascites requiring active management were identified in both inpatient and outpatient settings. Patients were provided with a Bluetooth-connected scale, which transmitted weight data to a smartphone app and then via the internet to an electronic medical record (EMR). Weights were monitored every weekday. In the event of a weight change of ≥5 lbs in 1 week, patients were called and administered a short symptom questionnaire, and providers received an email alert. The primary outcomes of this study were the percentage of enrolled days during which weight data were successfully transmitted to an EMR and the percentage of weight alerts that prompted responses by the provider.ResultsIn this study, 25 patients were enrolled: 12 (48%) were male, and the mean age was 58 (SD 13; range 35-81) years. A total of 18 (72%) inpatients were enrolled. Weight data were successfully transmitted to an EMR during 71.2% (697/979) of the study enrollment days, with technology issues reported on 16.5% (162/979) of the days. Of a total of 79 weight change alerts fired, 41 (52%) were triggered by weight loss and 38 (48%) were by weight gain. Providers responded in some fashion to 66 (84%) of the weight alerts and intervened in response to 45 (57%) of the alerts, for example, by contacting the patient, scheduling clinic or paracentesis appointments, modifying the diuretic dose, or requesting a laboratory workup. Providers responded equally to weight increase and decrease alerts (P=.87). The staff called patients a mean of 3.7 (SD 3.5) times per patient, and the number of phone calls correlated with technology issues (r=0.60; P=.002). A total of 60% (15/25) of the patients chose to extend their participation beyond 30 days. A total of 17 patient readmissions occurred during the study period, with only 4 (24%) related to ascites.ConclusionsWe demonstrated the feasibility of a smartphone app to facilitate the management of ascites and reported excellent rates of patient and provider engagement. This innovation could enable early therapeutic intervention, thereby decreasing the burden of morbidity and mortality among patients with cirrhosis.

Project description:Optimal bowel preparation is one of the major cornerstones for quality of colonoscopy. But poor bowel preparation still occurs in 10% to 25% of all patients. To optimize patient guidance, we developed a new smartphone app (ColoprAPP) for Android smartphones which guides and accompanies the patient starting 4 days before colonoscopy throughout the whole colonoscopy preparation procedure.The objective of this study was to assess the function of a newly developed smartphone app for supporting colonoscopy preparation.We carried out a prospective feasibility study including 25 patients undergoing outpatient colonoscopy at our hospital. As a control, we retrieved the data of 25 patients undergoing outpatient colonoscopy matching in age, sex, and indication for colonoscopy from our colonoscopy database. Patients were asked to download the smartphone app, ColoprAPP, in addition to being given the regular colonoscopy preparation leaflet. All colonoscopies were performed in the morning after using a split-dose preparation containing a polyethlene glycol-based purgative. The study was designed to test feasibility of the prototype, evaluate grade of bowel cleanliness (Boston bowel preparation scale [BBPS]), and assess patient satisfaction with the app.The smartphone app use was feasible in all patients. BBPS count as a marker for grade of bowel preparation was significantly higher in the smartphone app-supported group (mean 8.1 [SD 0.3] vs 7.1 [SD 0.4], P=.02). Left (mean 2.8 [SD 0.1] vs 2.4 [SD 0.11], P=.02) and transverse colon (mean 2.8 [SD 0.07] vs 2.4 [SD 0.11], P<.001) revealed significantly higher BBPS counts in the smartphone app-supported group than in controls. Patient satisfaction with a smartphone app-supported colonoscopy preparation was high with an average numeric rating scale score for usefulness of 8.2 (visual analog scale 1-10).A novel developed smartphone app for reinforced education of bowel cleansing was feasible and led to high BBPS scores and patient satisfaction.ClinicalTrials.gov NCT02512328; https://clinicaltrials.gov/ct2/show/NCT02512328 (Archived by WebCite at http://www.webcitation.org/6sz3Kk26z).

Project description:ObjectivesTo test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.DesignA two-arm unblinded feasibility RCT.SettingSix NHS EIP services in England.ParticipantsAdults using EIP services who own an Android Smartphone. Participants were recruited until the recruitment target was met (n=40).InterventionsParticipants were randomised with a 1:1 allocation to one of two conditions: (1) treatment as usual from EIP services (TAU) or (2) TAU plus access to My Journey 3 on their own Smartphone. My Journey 3 features a range of self-management components including access to digital recovery and relapse prevention plans, medication tracking and symptom monitoring. My Journey 3 use was at the users' discretion and was supported by EIP service clinicians. Participants had access for a median of 38.1 weeks.Primary and secondary outcome measuresFeasibility outcomes included recruitment, follow-up rates and intervention engagement. Participant data on mental health outcomes were collected from clinical records and from research assessments at baseline, 4 months and 12 months.Results83% and 75% of participants were retained in the trial at the 4-month and 12-month assessments. All treatment group participants had access to My Journey 3 during the trial, but technical difficulties caused delays in ensuring timely access to the intervention. The median number of My Journey 3 uses was 16.5 (IQR 8.5 to 23) and median total minutes spent using My Journey 3 was 26.8 (IQR 18.3 to 57.3). No serious adverse events were reported.ConclusionsRecruitment and retention were feasible. Within a trial context, My Journey 3 could be successfully delivered to adults using EIP services, but with relatively low usage rates. Further evaluation of the intervention in a larger trial may be warranted, but should include attention to implementation.Trial registrationISRCTN10004994.

Project description:Smartphone apps can be a tool to facilitate independent medication management among persons with developmental disabilities. At present, multiple medication management apps exist in the market, but only 1 has been specifically designed for persons with developmental disabilities. Before initiating further app development targeting this population, input from stakeholders including persons with developmental disabilities, caregivers, and professionals regarding the most preferred features should be obtained.The aim of this study was to identify medication management app features that are suitable to promote independence in the medication management process by young adults with developmental disabilities using a Delphi consensus method.A compilation of medication management app features was performed by searching the iTunes App Store, United States, in February 2016, using the following terms: adherence, medication, medication management, medication list, and medication reminder. After identifying features within the retrieved apps, a final list of 42 features grouped into 4 modules (medication list, medication reminder, medication administration record, and additional features) was included in a questionnaire for expert consensus rating. A total of 52 experts in developmental disabilities, including persons with developmental disabilities, caregivers, and professionals, were invited to participate in a 3-round Delphi technique. The purpose was to obtain consensus on features that are preferred and suitable to promote independence in the medication management process among persons with developmental disabilities. Consensus for the first, second, and third rounds was defined as ≥90%, ≥80%, and ≥75% agreement, respectively.A total of 75 responses were received over the 3 Delphi rounds-30 in the first round, 24 in the second round, and 21 in the third round. At the end of the third round, cumulative consensus was achieved for 60% (12/20) items in the medication list module, 100% (3/3) in the medication reminder module, 67% (2/3) in the medication administration record module, and 63% (10/16) in the additional features module. In addition to the medication list, medication reminder, and medication administration record features, experts selected the following top 3 most important additional features: automatic refills through pharmacies; ability to share medication information from the app with providers; and ability to share medication information from the app with family, friends, and caregivers. The top 3 least important features included a link to an official drug information source, privacy settings and password protection, and prescription refill reminders.Although several mobile apps for medication management exist, few are specifically designed to support persons with developmental disabilities in the complex medication management process. Of the 42 different features assessed, 64% (27/42) achieved consensus for inclusion in a future medication management app. This study provides information on the features of a medication management app that are most important to persons with developmental disabilities, caregivers, and professionals.

Dataset Information

American Heart Association's Cholesterol CarePlan as a Smartphone-Delivered Web App for Patients Prescribed Cholesterol-Lowering Medication: Protocol for an Observational Feasibility Study.

Publications

American Heart Association's Cholesterol CarePlan as a Smartphone-Delivered Web App for Patients Prescribed Cholesterol-Lowering Medication: Protocol for an Observational Feasibility Study.

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