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A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial.

ABSTRACT: Digital health applications (apps) have the potential to improve health behaviors and outcomes. We aimed to examine the effectiveness of a consumer web-based app linked to primary care electronic health records (EHRs). CONNECT was a multicenter randomized controlled trial involving patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774). Intervention participants received an interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications. Interactive risk calculators, motivational messages and lifestyle goal tracking were also included. Control group received usual health care. Primary outcome was adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications). Secondary outcomes included attainment of risk factor targets and eHealth literacy. In total, 934 patients were recruited; mean age 67.6 (±8.1) years. At 12 months, the proportion with >80% days covered with recommended medicines was low overall and there was no difference between the groups (32.8% vs. 29.9%; relative risk [RR] 1.07 [95% CI, 0.88-1.20] p = 0.49). There was borderline improvement in the proportion meeting BP and LDL targets in intervention vs. control (17.1% vs. 12.1% RR 1.40 [95% CI, 0.97-2.03] p = 0.07). The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control, p = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control, p = 0.02). In conclusion, a consumer app integrated with primary health care EHRs was not effective in increasing medication adherence. Borderline improvements in risk factors and modest behavior changes were observed.

SUBMITTER: Redfern J

PROVIDER: S-EPMC7484809 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk. In this project, we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice. Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Islander and non-indigenous adults, recruited through primary care, at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care.Randomised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk. The trial will be augmented by formal economic and process evaluations to assess acceptability, equity and cost-effectiveness of the intervention. The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management. The programme is electronically integrated with the primary care provider's software and will include interactive smart phone and Internet platforms. The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline-recommended blood pressure (BP) and cholesterol targets. Secondary outcomes include change in mean BP and fasting cholesterol levels, proportion meeting BP and cholesterol targets separately, self-efficacy, health literacy, self-reported point prevalence abstinence in smoking, body mass index and waist circumference, self-reported physical activity and self-reported medication adherence.Primary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferencesACTRN12613000715774.

Project description:BackgroundDigital health interventions have been shown to improve data quality and health services in low- and middle-income countries (LMICs). Nonetheless, in LMICs, systematic assessments of time saved with the use of digital tools are rare. We ran a set of cluster-randomized controlled trials as part of the implementation of a digital maternal and child health registry (eRegistry) in the West Bank, Palestine.ObjectiveIn the eRegTime study, we compared time spent on health information management in clinics that use the eRegistry versus the existing paper-based documentation system.MethodsIntervention (eRegistry) and control (paper documentation) arms were defined by a stratified random subsample of primary health care clinics from the concurrent eRegQual trial. We used time-motion methodology to collect data on antenatal care service provision. Four observers used handheld tablets to record time-use data during one working day per clinic. We estimated relative time spent on health information management for booking and follow-up visits and on client care using mixed-effects linear regression.ResultsIn total, 22 of the 24 included clinics (12 intervention, 10 control) contributed data; no antenatal care visits occurred in the other two clinics during the study period. A total of 123 and 118 consultations of new pregnancy registrations and follow-up antenatal care visits were observed in the intervention and control groups, respectively. Average time spent on health information management for follow-up antenatal care visits in eRegistry clinics was 5.72 minutes versus 8.10 minutes in control clinics (adjusted relative time 0.69, 95% CI 0.60-0.79; P<.001), and 15.26 minutes versus 18.91 minutes (adjusted relative time 0.96, 95% CI 0.61-1.50; P=.85) for booking visits. The average time spent on documentation, a subcategory of health information management, was 5.50 minutes in eRegistry clinics versus 8.48 minutes in control clinics (adjusted relative time 0.68, 95% CI 0.56-0.83; P<.001). While the average time spent on client care was 5.01 minutes in eRegistry clinics versus 4.91 minutes in control clinics, some uncertainty remains, and the CI was consistent with eRegistry clinics using less, the same, or more time on client care compared to those that use paper (adjusted relative time 0.85, 95% CI 0.64-1.13; P=.27).ConclusionsThe eRegistry captures digital data at point of care during client consultations and generates automated routine reports based on the clinical data entered. Markedly less time (plausibly a saving of at least 18%) was spent on health information management in eRegistry clinics compared to those that use paper-based documentation. This is likely explained by the fact that the eRegistry requires lesser repetitive documentation work than paper-based systems. Adoption of eRegistry-like systems in comparable settings may save valuable and scarce health care resources.Trial registrationISRCTN registry ISRCTN18008445; https://doi.org/10.1186/ISRCTN18008445.International registered report identifier (irrid)RR2-10.2196/13653.

Project description:BackgroundObesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss weight management with patients or support behavior change. Evidence shows that commercial weight management services, that most primary care trusts have 'on prescription', are more effective than primary care treatment.Methods/designWe propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress, or advice to lose weight on medical grounds. The primary outcome will be weight change at 12-months. Other questions are: what actions do people take to manage their weight in response to the two GP intervention types? How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type? How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention? What is the cost per kg/m2 lost for each intervention? Research assistants visiting GP practices in England (n?=?60) would objectively measure weight and height prior to GP consultations and randomize willing patients (body mass index 30+, excess body fat, 18+ years) using sealed envelopes. Full recruitment (n?=?1824) is feasible in 46 weeks, requiring six sessions of advice-giving per GP. Participants will be contacted at 3 months (postintervention) via telephone to identify actions they have taken to manage their weight. We will book appointments for participants to be seen at their GP practice for a 12-month follow-up.DiscussionTrial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop Smoking Service. Likewise, the intervention could be introduced in the Quality and Outcomes Framework and influence practice worldwide.Trial registrationCurrent Controlled Trials ISRCTN26563137.

Project description:Background:Most health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of "Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management" (Health TAPESTRY-HC-DM) as an approach supporting diabetes self-management was explored to inform development of a future large-scale trial. Methods:Four-month pilot randomized controlled trial (RCT), sequential explanatory qualitative component. Participants-patients of an interprofessional primary care team-were over age 18?years, diagnosed with diabetes and hypertension, and had Internet access and one of the following: uncontrolled HbA1c, recent diabetes diagnosis, end-stage/secondary organ damage, or provider referral. The Health TAPESTRY-HC-DM intervention focused on patient health goals/needs, integrating community volunteers, eHealth technologies, interprofessional primary care teams, and system navigation. Pilot outcomes included process measures (recruitment, retention, program participation), perceived program feasibility, benefits and areas for improvement, and risks or safety issues. The primary trial outcome was self-efficacy for managing diabetes. There were a number of secondary trial outcomes. Results:Of 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers (n?=?20) met 28 clients in 234 client encounters (home visits, phone calls, electronic messages); 27 reports were sent to the interprofessional team. At 4 months, controlling for baseline, most outcomes were better in the intervention compared to control group; physical activity notably better. The most common goal domains set were physical activity, diet/nutrition, and social connection. Clients felt the biggest impact was motivation toward goal achievement. They struggled with some of the technologies. Several participants perceived that the program was not a good fit, mostly those that felt they were already well-managing their diabetes. Conclusions:Health TAPESTRY-HC-DM was feasible; a large-scale randomized controlled trial seems possible. However, further attention needs to be paid to improving recruitment and retention. The intervention was well received, though was a better fit for some participants than others. Trial registration:ClinicalTrials.gov, NCT02715791. Registered 22 March 2016-retrospectively registered.

Project description:BackgroundStress and anxiety are psychophysiological responses commonly experienced by patients during the perioperative process that can increase presurgical and postsurgical complications to a comprehensive and positive recovery. Preventing and intervening in stress and anxiety can help patients achieve positive health and well-being outcomes. Similarly, the provision of education about surgery can be a crucial component and is inversely correlated with preoperative anxiety levels. However, few patients receive stress and anxiety relief support before surgery, and resource constraints make face-to-face education sessions untenable. Digital health interventions can be helpful in empowering patients and enhancing a more positive experience. Digital health interventions have been shown to help patients feel informed about the possible benefits and risks of available treatment options. However, they currently focus only on providing informative content, neglecting the importance of personalization and patient empowerment.ObjectiveThis study aimed to explore the feasibility of a digital health intervention called the Adhera CARINAE Digital Health Program, designed to provide evidence-based, personalized stress- and anxiety-management methods enabled by a comprehensive digital ecosystem that incorporates wearable, mobile, and virtual reality technologies. The intervention program includes the use of advanced data-driven techniques for tailored patient education and lifestyle support.MethodsThe trial will include 5 hospitals across 3 European countries and will use a randomized controlled design including 30 intervention participants and 30 control group participants. The involved surgeries are cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacement, prostate or bladder cancer surgeries, hip and knee replacement, maxillofacial surgery, or scoliosis. The control group will receive standard care, and the intervention group will additionally be exposed to the digital health intervention program.ResultsThe recruitment process started in January 2022 and has been completed. The primary impact analysis is currently ongoing. The expected results will be published in early 2023.ConclusionsThis manuscript details a comprehensive protocol for a study that will provide valuable information about the intervention program, such as the measurement of comparative intervention effects on stress; anxiety and pain management; and usability by patients, caregivers, and health care professionals. This will contribute to the evidence planning process for the future adoption of diverse digital health solutions in the field of surgery.Trial registrationClinicalTrials.gov NCT05184725; https://www.clinicaltrials.gov/ct2/show/NCT05184725.International registered report identifier (irrid)DERR1-10.2196/38536.

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A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial.

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