Dataset Information

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 | 2020

REPOSITORIES: biostudies-literature

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

Redfern Julie J Coorey Genevieve G Mulley John J Scaria Anish A Neubeck Lis L Hafiz Nashid N Pitt Chris C Weir Kristie K Forbes Joanna J Parker Sharon S Bampi Fiona F Coenen Alison A Enright Gemma G Wong Annette A Nguyen Theresa T Harris Mark M Zwar Nick N Chow Clara K CK Rodgers Anthony A Heeley Emma E Panaretto Katie K Lau Annie A Hayman Noel N Usherwood Tim T Peiris David D

NPJ digital medicine 20200910

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 ...[more]

PMID: 32964140

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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:ImportanceDespite evidence of the short-term benefits of multicomponent primary care-based interventions, their long-term effects are unproven.ObjectiveTo evaluate the long-term outcomes of a system-integrated technology-enabled model of care (SINEMA intervention) for stroke management for systolic blood pressure (BP) and other outcomes among patients with stroke in China.Design, setting, and participantsThis long-term follow-up included community-dwelling clinically stable surviving participants with stroke in an open-label cluster randomized clinical trial. Of 218 villages from Nanhe County in Hebei, China, an area with suboptimal health care resources and stroke prevalence doubling the national average, 50 villages (clusters) were recruited between June 23 and July 29, 2017, and randomized in a 1:1 ratio to an intervention or a control arm (usual care). The intervention lasted 1 year (to July 31, 2018), with a posttrial observational follow-up conducted from October 1, 2022, to August 27, 2023.InterventionsVillage doctors were provided with training, performance-based incentives, technical support, and customized mobile health tools to deliver monthly follow-up to patients. Patients also received daily voice messages emphasizing medication adherence and physical activity. No intervention was requested or supported during the posttrial period.Main outcomes and measuresBetween-arm differences in intention-to-treat analyses of individual-level changes from baseline to long-term posttrial in systolic BP (primary outcome) and stroke recurrence, diastolic BP, BP control, antihypertensive medication use and regimen adherence, and disability (secondary outcomes).ResultsAmong a total of 1042 stroke survivors, 44 (4.2%) were lost to follow-up and 998 (mean [SD] age at baseline: 65.0 [8.2] years; 544 [54.4%] men) completed posttrial assessment at a mean (SD) period of 66.6 (3.7) months (5.5 years) after baseline. The multicomponent intervention was associated with an estimated between-arm net reduction in systolic BP of -2.8 (95% CI, -5.3 to -0.3) mm Hg (P = .03). Most secondary outcomes showed a tendency toward lasting effects, with a notable absolute net reduction of 6.0 (95% CI, -11.3 to -0.7) percentage points and risk ratio of 0.77 (95% CI, 0.61-0.99) for stroke recurrence. In subgroup analyses, significant between-arm differences were observed among women and people with lower educational attainment, lower income, and higher use of and adherence to medications.Conclusions and relevanceIn this long-term follow-up of a cluster randomized clinical trial, the 1-year intervention was associated with significantly reduced systolic BP and stroke recurrence at 5.5 years, providing evidence of long-term health and inequity-reducing benefits and holding promise for scaling up of the intervention in resource-limited settings.Trial registrationClinicalTrials.gov Identifier: NCT05792618.

Project description:IntroductionFewer 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.Methods and analysisRandomised 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.Ethics and disseminationPrimary 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 conferencesClinical trials registration numberACTRN12613000715774.

Project description:BackgroundImplementing evidence-based recommendations for treating pediatric overweight and obesity is challenging in low-resource settings. We conducted a randomized controlled trial to evaluate the effects of implementing the American Academy of Pediatrics overweight/obesity recommendations using a Standard Care approach alone or with the addition of an enhanced program in a safety-net pediatric primary care setting (located in Bronx, New York, United States).MethodsIn a 12-month trial, families of children (age 7-12 years; body mass index ≥85th American percentile for age and sex; 74% self-identified as Hispanic/Latino; n = 360) were randomly assigned to receive Standard Care Alone or Standard Care + Enhanced Program. An English/Spanish bilingual staff provided the Standard Care Alone consisting of quarterly semi-structured pediatrician visits targeting family-based behavioral changes. The Standard Care + Enhanced Program was enriched with eight Skill-Building Core and monthly Post-Core Support sessions.ResultsThe mean body mass index Z-score declined in both arms (P < 0.01) with no significant difference between the Standard Care Alone (0.12 kg [SE: 0.03]) and Standard Care + Enhanced Program (0.15 kg [SE: 0.03]) arm (P = 0.15). Compared to the Standard Care Alone, the Standard Care + Enhanced Program resulted in significantly greater improvements in total cholesterol (P = 0.05), low-density lipoprotein cholesterol (P = 0.04), aspartate aminotransferase (P = 0.02), and alanine transaminase (P = 0.03) concentrations.ConclusionsSafety-net primary care settings can provide efficacious pediatric weight management services. Targeted family-based behavioral counseling helps overweight/obese children achieve a modest body mass index Z-score improvement. A more intensive lifestyle intervention program may improve some metabolic parameters.Trial registrationClinicalTrials.gov Identifier: NCT00851201 . Registered 23 February 2009.

Dataset Information

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

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

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