A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study

Wu, Na; Gong, Enying; Wang, Bo; Gu, Wanbing; Nan, Ding; Zhang, Zhuoran; Chen, Mengyao; Yan, Lijing L.; Oldenburg, Brian; Xu, Li-Qun

doi:10.2196/13503

Cited by 27 publications

(41 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Such a design could reduce contamination within clusters and enhance the feasibility of implementation. Over a 1-year period in preparation for the trial, we conducted extensive contextual field research on intervention design, technology development, and a 3-month pilot study in 4 villages [ 15 , 18 , 19 ]. We then conducted the main trial in 50 rural villages in rural China to evaluate the effectiveness of the intervention with embedded process evaluation and economic evaluation.…”

Section: Methodsmentioning

confidence: 99%

“…The study is reported according to the CONSORT guidance for reporting cluster-randomized trial ( S1 Checklist ) [ 20 ]. The trial protocol, technological development, and statistical analysis plan were published in detail [ 15 , 18 , 19 , 21 ]. We describe a condensed version below.…”

Section: Methodsmentioning

confidence: 99%

“…The SINEMA intervention package was developed with careful contextual research and pilot study lasting for 1-year long. The contents were consistent with China’s clinical guidelines for stroke prevention in a primary care setting [ 26 ] and tailored to the local context with special intervention focus on medication adherence and physical activities by considering the capacity and available resources [ 18 , 19 ]. In brief, the intervention included both provider-side components and patient-facing components and were supported by a digital health system consisted of an Android-based smart phone application— SINEMA App —for providers and linked with a voice messages system for patients (see S1 Fig for a diagram depicting the intervention design).…”

Section: Methodsmentioning

confidence: 99%

“…Stroke is the leading cause of death and disability in rural China where primary care lacks the capacity to provide guideline-based essential care to stroke patients, and community-based management for secondary prevention of stroke is far from adequate [ 16 , 17 ]. We performed extensive feasibility and contextual research to adopt this model for stroke management in the setting of resource-limited areas in rural China [ 15 , 18 , 19 ]. We hypothesized that the SINEMA intervention would be more effective in improving blood pressure (BP) control and other health outcomes than usual care among stroke patients.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial

Yan

Gong

et al. 2021

PLoS Med

Self Cite

View full text Add to dashboard Cite

Background Managing 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 findings Based 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. Conclusions In 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 registration The SINEMA trial is registered at ClinicalTrials.gov NCT03185858.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial

Yan

Gong

et al. 2021

PLoS Med

Self Cite

View full text Add to dashboard Cite

show abstract

“…Team-based care involving specialists and community health workers to empower, encourage, and facilitate care processes for patients with a prior acute CVD event has shown improvements in medication adherence and systolic blood pressure [11]. Prior studies have also demonstrated the feasibility of implementing quality improvement (QI) strategies, leading to improvements in cardiovascular risk factor control, prescription of guideline-directed medical therapy, and quality of life among patients with a prior acute coronary syndrome event or stroke and among those at high predicted cardiovascular disease risk [12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Collaborative Care in Secondary Prevention of Cardiovascular Disease in India: Findings From A Multi-Stakeholder, Qualitative Analysis

Singh

Huffman²,

Tandon

et al. 2021

Preprint

View full text Add to dashboard Cite

Background. Cardiovascular disease (CVD) is pervasive in India, and little is known about the perception of patients and providers about collaborative care in secondary prevention of CVD. To fill this gap, we performed a needs assessment and investigated the barriers and facilitators of the collaborative quality improvement (C-QIP) strategy for secondary prevention of CVD in India.Methods. Between September 2019 – February 2020, we conducted semi-structured in-depth interviews with providers, health administrators, patients and caregivers to understand the challenges and facilitators of the C-QIP strategy consisting of electronic health records-decision support system (EHR-DSS), non-physician health worker and text messages for healthy lifestyle. Also, data were analyzed from the lens of consolidated framework for implementation research (CFIR) to guide effective implementation of the C-QIP strategy. We used an iterative approach for qualitative data analysis based on the framework method. Results. We interviewed 38 physicians, 14 non-physician health workers (nurses, community health workers, pharmacists), 4 health administrators, 16 patients and their caregivers. Challenges perceived from providers’ and health administrators’ perspectives to implement quality in CVD care were related to CFIR actors and inner and outer settings: high patient volume, too few specialists, time-constraints, physician burnout, lack of robust communication system or referral linkage, paucity of electronic health records, lack of patient counsellors, polypharmacy and lack of sustainable financing schemes for outpatient services. In addition, low health literacy, high cost of treatment, misinformation bias, and difficulty in maintaining lifestyle changes were key barriers from patients’ and caregivers’ perspectives. Potential benefits of the C-QIP strategy emerged, such as standardized treatment protocol to minimize variation in care, reduced medication errors, improved physician-patient relationships, and enhanced self-care management. However, concerns were raised about feasibility, adoption, and implementation of EHR-DSS across heterogenous healthcare settings, including related to interoperability, patient confidentiality and data security, appropriateness across diverse patient groups, and care delivery costs.Conclusions. Our findings reveal context-specific, patient-, provider- and health system factors that will influence C-QIP strategy implementation in India. Strategies to optimize chronic care of CVD need to be low-cost, culturally acceptable, targeted, and integrated into existing systems and care pathways to be successful.

show abstract

Primary Care–Based Digital Health–Enabled Stroke Management Intervention

Tan,

Gong,

Gallis

et al. 2024

JAMA Netw Open

View full text Add to dashboard Cite

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

show abstract

A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study

Cited by 27 publications

References 31 publications

Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial

Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial

Collaborative Care in Secondary Prevention of Cardiovascular Disease in India: Findings From A Multi-Stakeholder, Qualitative Analysis

Primary Care–Based Digital Health–Enabled Stroke Management Intervention

Contact Info

Product

Resources

About