A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial.
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ABSTRACT:
SUBMITTER: Redfern J
PROVIDER: S-EPMC7484809 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings.Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months.Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression.Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment.
| S-EPMC4885789 | biostudies-literature
Project description:PurposePositive psychology shows promise in improving positive affect and happiness. We tested a digital version of a positive psychology intervention called Three Good Things (3GT) among health care workers to assess whether gratitude practice improved well-being.MethodsAll members of a large academic medicine department were invited. Participants were randomized to an immediate intervention group or control group (delayed intervention). Participants completed outcome measures surveys (demographics, depression, positive affect, gratitude, and life satisfaction) at baseline, and at 1 month and 3 months post-intervention. Controls completed additional surveys at 4 and 6 months (completion of the delayed intervention). During the intervention, we sent 3 text messages per week asking for 3GT that occurred that day. We used linear mixed models to compare the groups and to look at the effects of department role, sex, age, and time on outcomes.ResultsOf 468 eligible individuals, 223 (48%) enrolled and were randomized with high retention through the end of the study. Most (87%) identified as female. For the intervention group, positive affect improved slightly at 1 month, then declined slightly but remained significantly improved at 3 months. Depression, gratitude, and life satisfaction scores showed a similar trend but were not statistically different between groups.ConclusionsOur research showed adherence to a positive psychology intervention for health care workers created small positive improvements immediately post-intervention but were not sustained. Further work should evaluate whether utilizing different duration or intensity of the intervention improves benefits.
| S-EPMC10202508 | biostudies-literature
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.
| S-EPMC3918991 | biostudies-literature
Project description:Despite the availability of hepatitis B virus (HBV) and hepatitis C virus (HCV) testing in primary care, testing rates in China remain low. Social media is an inexpensive means of disseminating information and could facilitate hepatitis testing promotion. We evaluated the capacity of digitally crowdsourced materials to promote HBV/HCV testing uptake via a randomized controlled trial (identifier: ChiCTR1900025771), which enrolled 750 Chinese primary care patients. We randomized patients (1:1) to receive crowdsourced HBV/HCV promotion materials through social media or facility-based care without promotional materials for four weeks. Exposure to all intervention materials was associated with increased odds of HBV (aOR = 1.79, 95% CI: 1.09-3.00) and HCV (aOR = 1.95, 95% CI: 1.29-2.99) testing compared to facility-based care. There was a significant reduction in hepatitis stigma among intervention group participants (HBV slope: -0.15, p < 0.05; and HCV slope: -0.13, p < 0.05). Digitally crowdsourced promotion messages could enhance hepatitis testing uptake and should be considered in hepatitis reduction strategies.Trial registration: Chinese Clinical Trial Registry (ChiCTR1900025771) on September 9, 2019. Available from: http://www.chictr.org.cn/showproj.aspx?proj=42788.
| S-EPMC9296450 | biostudies-literature
Project description:Community health worker (CHW) interventions can help improve diabetes self-management and health outcomes. There is limited evidence on how to effectively integrate CHW programs with primary care efforts. Mobile health technology (mHealth) can connect CHWs to members of the health care team and enhance care. We tested a model for the integration of a CHW-delivered mHealth intervention to improve diabetes self-management. Seventy-two African American patients with diabetes were followed using the mHealth tool. This project partnered an academic institution, a safety-net clinic, and African American churches. The integration of mHealth technology into CHW programs was successfully achieved and readily accepted.
| S-EPMC5126964 | biostudies-literature
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.
| S-EPMC9143771 | biostudies-literature
Project description:BackgroundThere is limited evidence, mainly from high-income countries, that digital health interventions improve type 2 diabetes (T2DM) care. Large-scale implementation studies are lacking.MethodsA multifaceted digital health intervention comprising: (1) a self-management application ('app') for patients and lay 'family health promotors' (FHPs); and (2) clinical decision support for primary care doctors was evaluated in an open-label, parallel, cluster randomized controlled trial in 80 communities (serviced by a primary care facility for >1000 residents) in Hebei Province, China. People >40 years with T2DM and a glycated haemoglobin (HbA1c) ≥7% were recruited (∼25/community). After baseline assessment, community clusters were randomly assigned to intervention or control groups (1:1) via a web-based system, stratified by locality (rural/urban). Control arm clusters received usual care without access to the digital health application or family health promoters. The primary outcome was at the participant level defined as the proportion with ≥2 "ABC" risk factor targets achieved (HbA1c < 7.0%, blood pressure < 140/80 mmHg and LDL-cholesterol < 2.6 mmol/L) at 24 months.FindingsA total of 2072 people were recruited from the 80 community clusters (40 urban and 40 rural), with 1872 (90.3%) assessed at 24 months. In the intervention arm, patients used FHPs for support more in rural than urban communities (252 (48.6%) rural vs 92 (21.5%) urban, p < 0.0001). The mean monthly proportion of active app users was 46.4% (SD 7.8%) with no significant difference between urban and rural usage rates. The intervention was associated with improved ABC control rates (339 [35.9%] intervention vs 276 [29.9%] usual care; RR 1.20, 95% CI 1.02-1.40; p = 0.025), with significant heterogeneity by geography (rural 220 [42.6%] vs 158 [31.0%]; urban 119 [27.9%] vs 118 [28.6%]; p = 0.022 for interaction). Risk factor reductions were mainly driven by improved glycaemic control (mean HbA1C difference -0.33%, 95% CI -0.48 to -0.17; p = 0.00025 and mean fasting plasma glucose difference -0.58 mmol, 95% CI -0.89 to -0.27; p = 0.00013). There were no changes in blood pressure and LDL-cholesterol levels.InterpretationA multifaceted digital health intervention improved T2DM risk factor control rates, particularly in rural communities where there may be stronger relationships between patients and doctors and greater family member support.FundingNational Health and Medical Research CouncilGlobal Alliance for Chronic Diseases (ID 1094712).
| S-EPMC11269311 | biostudies-literature
Project description:Accessing primary care is often difficult for newly insured Medicaid beneficiaries. Tailored text messages may help patients navigate the health system and initiate care with a primary care physician. We conducted a randomized controlled trial of tailored text messages with newly enrolled Medicaid managed care beneficiaries. Text messages included education about the importance of primary care, reminders to obtain an appointment, and resources to help schedule an appointment. Within 120 days of enrollment, we examined completion of at least one primary care visit and use of the emergency department. Within 1 year of enrollment, we examined diagnosis of a chronic disease, receipt of preventive care, and use of the emergency department. 8432 beneficiaries (4201 texting group; 4231 control group) were randomized; mean age was 37 years and 24% were White. In the texting group, 31% engaged with text messages. In the texting vs control group after 120 days, there were no differences in having one or more primary care visits (44.9% vs. 45.2%; difference, -0.27%; p = 0.802) or emergency department use (16.2% vs. 16.0%; difference, 0.23%; p = 0.771). After 1 year, there were no differences in diagnosis of a chronic disease (29.0% vs. 27.8%; difference, 1.2%; p = 0.213) or appropriate preventive care (for example, diabetes screening: 14.1% vs. 13.4%; difference, 0.69%; p = 0.357), but emergency department use (32.7% vs. 30.2%; difference, 2.5%; p = 0.014) was greater in the texting group. Tailored text messages were ineffective in helping new Medicaid beneficiaries visit primary care within 120 days.
| S-EPMC7884833 | biostudies-literature
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.
| S-EPMC3842709 | biostudies-literature
Project description:BackgroundManaging noncommunicable diseases through primary healthcare has been identified as the key strategy to achieve universal health coverage but is challenging in most low- and middle-income countries. Stroke is the leading cause of death and disability in rural China. This study aims to determine whether a primary care-based integrated mobile health intervention (SINEMA intervention) could improve stroke management in rural China.Methods and findingsBased on extensive barrier analyses, contextual research, and feasibility studies, we conducted a community-based, two-arm cluster-randomized controlled trial with blinded outcome assessment in Hebei Province, rural Northern China including 1,299 stroke patients (mean age: 65.7 [SD:8.2], 42.6% females, 71.2% received education below primary school) recruited from 50 villages between June 23 and July 21, 2017. Villages were randomly assigned (1:1) to either the intervention or control arm (usual care). In the intervention arm, village doctors who were government-sponsored primary healthcare providers received training, conducted monthly follow-up visits supported by an Android-based mobile application, and received performance-based payments. Participants received monthly doctor visits and automatically dispatched daily voice messages. The primary outcome was the 12-month change in systolic blood pressure (BP). Secondary outcomes were predefined, including diastolic BP, health-related quality of life, physical activity level, self-reported medication adherence (antiplatelet, statin, and antihypertensive), and performance in "timed up and go" test. Analyses were conducted in the intention-to-treat framework at the individual level with clusters and stratified design accounted for by following the prepublished statistical analysis plan. All villages completed the 12-month follow-up, and 611 (intervention) and 615 (control) patients were successfully followed (3.4% lost to follow-up among survivors). The program was implemented with high fidelity, and the annual program delivery cost per capita was US$24.3. There was a significant reduction in systolic BP in the intervention as compared with the control group with an adjusted mean difference: -2.8 mm Hg (95% CI -4.8, -0.9; p = 0.005). The intervention was significantly associated with improvements in 6 out of 7 secondary outcomes in diastolic BP reduction (p < 0.001), health-related quality of life (p = 0.008), physical activity level (p < 0.001), adherence in statin (p = 0.003) and antihypertensive medicines (p = 0.039), and performance in "timed up and go" test (p = 0.022). We observed reductions in all exploratory outcomes, including stroke recurrence (4.4% versus 9.3%; risk ratio [RR] = 0.46, 95% CI 0.32, 0.66; risk difference [RD] = 4.9 percentage points [pp]), hospitalization (4.4% versus 9.3%; RR = 0.45, 95% CI 0.32, 0.62; RD = 4.9 pp), disability (20.9% versus 30.2%; RR = 0.65, 95% CI 0.53, 0.79; RD = 9.3 pp), and death (1.8% versus 3.1%; RR = 0.52, 95% CI 0.28, 0.96; RD = 1.3 pp). Limitations include the relatively short study duration of only 1 year and the generalizability of our findings beyond the study setting.ConclusionsIn this study, a primary care-based mobile health intervention integrating provider-centered and patient-facing technology was effective in reducing BP and improving stroke secondary prevention in a resource-limited rural setting in China.Trial registrationClinicalTrials.gov NCT03185858.
| S-EPMC8115798 | biostudies-literature