The Implementation of a Primary Care-Based Integrated Mobile Health Intervention for Stroke Management in Rural China: Mixed-Methods Process Evaluation.

Background: There is a lack of evidence concerning the effective implementation of strategies for stroke prevention and management, particularly in resource-limited settings. A primary-care-based integrated mobile health intervention (SINEMA intervention) has been implemented and evaluated via a 1-year-long cluster-randomized controlled trial. This study reports the findings from the trial implementation and process evaluation that investigate the implementation of the intervention and inform factors that may influence the wider implementation of the intervention in the future. Methods: We developed an evaluation framework by employing both the RE-AIM framework and the MRC process evaluation framework to describe the implementation indicators, related enablers and barriers, and illustrate some potential impact pathways that may influence the effectiveness of the intervention in the trial. Quantitative data were collected from surveys and extracted from digital health monitoring systems. In addition, we conducted quarterly in-depth interviews with stakeholders in order to understand barriers and enablers of program implementation and effectiveness. Quantitative data analysis and thematic qualitative data analysis were applied, and the findings were synthesized based on the evaluation framework. Results: The SINEMA intervention was successfully implemented in 25 rural villages, reached 637 patients with stroke in rural Northern China during the 12 months of the trial. Almost 90% of the participants received all follow-up visits per protocol, and about half of the participants received daily voice messages. The majority of the intervention components were adopted by village doctors with some adaptation made. The interaction between human-delivered and technology-enabled components reinforced the program implementation and effectiveness. However, characteristics of the participants, doctor-patient relationships, and the healthcare system context attributed to the variation of program implementation and effectiveness. Conclusion: A comprehensive evaluation of program implementation demonstrates that the SINEMA program was well implemented in rural China. Findings from this research provide additional information for program adaptation, which shed light on the future program scale-up. The study also demonstrates the feasibility of combining RE-AIM and MRC process evaluation frameworks in process and implementation evaluation in trials. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03185858.

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

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: ClinicalTrials.gov NCT03185858.

Hypertension Care Coordination and Feasibility of Involving Female Community Health Volunteers in Hypertension Management in Kavre District, Nepal: A Qualitative Study.

Background: Hypertension and related complications are major contributors to morbidity and mortality in Nepal. Community health workers have been proposed as promising health cadres to meet the growing healthcare demand for non-communicable disease management in other developing countries. Objective: We aimed to explore existing workflows, needs and challenges for hypertension care coordination and to assess the feasibility of establishing a Female Community Health Volunteer (FCHV)-based hypertension management program in Kavre, Nepal. Design: We conducted one focus group discussion with eight FCHVs and twenty-three in-depth interviews with four FCHVs not attending FGD, nine individuals with hypertension, six health workers, and four health officials in two village development committees of Kavre District, Nepal. Applied thematic analysis was performed using NVivo 12. Results: Health literacy related to hypertension was low among both community members and FCHVs. Delay in treatment initiation and loss to follow-up were common patterns despite anti-hypertensive medication compliance. Major health system-related barriers included underutilization of primary healthcare institutions, communication gaps and lack of grass-roots level educational campaigns. Community pharmacies, monthly health camps and increasing governmental attention to NCDs were favorable for improving hypertension management. This study also supports that FCHVs should be provided with adequate training and financial incentives to promote hypertension education, screening and referral in their catchments. Conclusions: Barriers and facilitators identified in this study provide important implications for future hypertension management in Nepal. We recommend hypertension education and screening across Nepal at a grass-root level through FCHVs. Providing professional training and proper financial incentives for FCHVs are warranted. Highlights: Health literacy related to hypertension was low among both community members and Female Community Health Volunteers in Nepal.Delay in treatment initiation and loss to follow-up were common despite relatively high anti-hypertensive medication compliance.Health system-related barriers in research sites included underutilization of primary healthcare institutions, communication gaps, and lack of grass-roots level educational campaigns.Female Community Health Volunteers should be provided with adequate training and financial incentives to promote hypertension management.

Development and Local Contextualization of Mobile Health Messages for Enhancing Disease Management Among Community-Dwelling Stroke Patients in Rural China: Multimethod Study.

BACKGROUND: Rural China has experienced an increasing health burden because of stroke. Stroke patients in rural communities have relatively poor awareness of and adherence to evidence-based secondary prevention and self-management of stroke. Mobile technology represents an innovative way to influence patient behaviors and improve their self-management. OBJECTIVE: This study is part of the System-Integrated Technology-Enabled Model of Care (the SINEMA trial) to improve the health of stroke patients in resource-poor settings in China. This study aimed to develop and pilot-test a mobile phone message-based package, as a component of the SINEMA intervention. METHODS: The SINEMA trial was conducted in Nanhe County, Hebei Province, China. A total of 4 villages were selected for pretrial contextual research and pilot study. The 5 stages for developing the mobile phone messages were as follows: (1) conducting literature review on existing message banks and analyzing the characteristics of these banks; (2) interviewing stroke patients and caregivers to identify their needs; (3) drafting message contents and designing dispatching algorithms for a 3-month pilot testing; (4) collecting feedback from pilot participants through questionnaire survey and in-depth interviews on facilitators and barriers related to their acceptance and understanding of messages; and (5) finalizing the message-based intervention based on participants' feedback for the SINEMA trial. RESULTS: On the basis of 5 existing message banks screened out of 120 papers and patients' needs identified from 32 in-depth interviews among stroke patients and caregivers, we developed a message bank containing 224 messages for a pilot study among 54 community-dwelling stroke patients from 4 villages. Of 54 participants, 51 (response rate: 94.4%) completed the feedback survey after receiving daily messages for 3 months. Participants' mean age was 68 years (SD 9.2), and about half had never been to school. We observed a higher proportion of participants who were in favor of voice messages (23/42, 54%) than text messages (14/40, 35%). Among participants who received voice messages (n=43) and text messages (n=40), 41 and 30, respectively, self-reported a full or partial understanding of the contents, and 39 (39/43, 91%) and 32 (32/40, 80%), respectively, rated the messages as helpful. Analyses of the 32 interviews further revealed that voice messages containing simple and single-theme content, in plain language, with a repeated structure, a slow playback speed, and recorded in local dialect, were preferred by rural stroke patients. In addition, the dispatching algorithm and tools may also influence the acceptance of message-based interventions. CONCLUSIONS: By applying multiple methodologies and conducting a pilot study, we designed and fine-tuned a voice message-based intervention package for promoting secondary prevention among community-dwelling stroke patients in rural China. Design of the content and dispatching algorithm should engage both experts and end users and adequately consider the needs and preferences of recipients.

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

BACKGROUND: Mobile health (mHealth) technologies hold great promise in improving the delivery of high-quality health care services. Yet, there has been little research so far applying mHealth technologies in the context of delivering stroke care in resource-limited rural regions. OBJECTIVE: This study aimed to introduce the design and development of an mHealth system targeting primary health care providers and to ascertain its feasibility in supporting the delivery of a System-Integrated techNology-Enabled Model of cAre (SINEMA) service for strengthening secondary prevention of stroke in rural China. METHODS: The SINEMA mHealth system was designed by a multidisciplinary team comprising public health researchers, neurologists, and information and communication technology experts. The iterative co-design and development of the mHealth system involved the following 5 steps: (1) assessing the needs of relevant end users through in-depth interviews of stakeholders, (2) designing the functional modules and evidence-based care content, (3) designing and building the system and user interface, (4) improving and enhancing the system through a 3-month pilot test in 4 villages, and (5) finalizing the system and deploying it in field trial, and finally, evaluating its feasibility through a survey of the dominant user group. RESULTS: From the in-depth interviews of 49 relevant stakeholders, we found that village doctors had limited capacity in caring for village-dwelling stroke patients in rural areas. Primary health care workers demonstrated real needs in receiving appropriate training and support from the mHealth system as well as great interests in using the mHealth technologies and tools. Using these findings, we designed a multifaceted mHealth system with 7 functional modules by following the iterative user-centered design and software development approach. The mHealth system, aimed at 3 different types of users (village doctors, town physicians, and county managers), was developed and utilized in a cluster-randomized controlled trial by 25 village doctors in a resource-limited county in rural China to manage 637 stroke patients between July 2017 and July 2018. In the end, a survey on the usability and functions of the mHealth system among village doctors (the dominant group of users, response rate=96%, 24/25) revealed that most of them were satisfied with the essential functions provided (71%) and were keen to continue using it (92%) after the study. CONCLUSIONS: The mHealth system was feasible for assisting primary health care providers in rural China in delivering the SINEMA service on the secondary prevention of stroke. Further research and initiatives in scaling up the SINEMA approach and this mHealth system to other resource-limited regions in China and beyond will likely enhance the quality and accessibility of essential secondary prevention among stroke patients. CLINICALTRIAL: ClinicalTrials.gov NCT03185858; https://clinicaltrials.gov/ct2/show/NCT03185858. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.ahj.2018.08.015.

Caregiver-Delivered Stroke Rehabilitation in Rural China.

Background and Purpose- Stroke disability is a major health burden in rural China where rehabilitation services are inadequate. We aimed to determine the effectiveness of a novel nurse-led, caregiver-delivered model of stroke rehabilitation in rural China. Methods- A multicenter prospective, randomized open, blinded outcome assessed, controlled trial was conducted in 3 rural county hospitals in China: Zhangwu, Liaoning Province (Northeast); Qingtongxia, Ningxia Hui Autonomous Region (Northwest); and Dianjiang, Chongqing Municipality (Southwest). Adult patients (age 18-79 years) with residual disability (Barthel Index score ≤80/100) after a recent acute stroke were randomized to a new service model or usual care. The new intervention was multifaceted and was based on a task-shifting / training-the-trainers model, supported by a custom-designed smartphone application, where patients and caregivers received evidence-based in-hospital education and stroke rehabilitation training (focus on mobility, self-care, and toileting), delivered by trained nurses before hospital discharge, and 3 postdischarge support telephone calls. Outcome assessments were undertaken before hospital discharge and at 3 and 6 months. Primary outcome was physical functioning (Barthel Index scores) at 6 months, assessed by research staff blind to treatment allocation, adjusted for baseline covariates in an intention-to-treat analysis. Secondary outcomes included measures of mobility, health-related quality of life, mood, and caregiver burden. The study included a process evaluation that assessed intervention fidelity. Results- From November 2014 to December 2016, 246 stroke patients were randomized to intervention (n=118) or control (n=128) groups. There was no statistically significant difference in adjusted 6-month Barthel Index scores between groups (70.1 versus 74.1, mean difference, -4.0 [95% CI, -10.0 to 2.9]), nor any differences across the other outcome measures. Process evaluation interviews revealed that the intervention was desirable and positively accepted by nurses, caregivers, and patients but was considered too complex despite efforts to simplify materials for the rural context. Key strategies identified for future studies included the use of community health workers, smartphone application enhancement, and simpler and more frequent training for nurses, caregivers, and patients. Conclusions- A novel nurse-led, digital supported, caregiver-delivered stroke rehabilitation program did not improve patient physical functioning after stroke in rural China. Further stroke rehabilitation research suitable for resource-poor settings is required, with several components being suggested through stakeholder interviews in our study. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02247921.

System-integrated technology-enabled model of care to improve the health of stroke patients in rural China: protocol for SINEMA-a cluster-randomized controlled trial.

BACKGROUND: Despite the significant burden of stroke in rural China, secondary prevention of stroke is suboptimal. This study aims to develop a SINEMA for the secondary prevention of stroke in rural China and to evaluate the effectiveness of the model compared with usual care. METHODS: The SINEMA model is being implemented and evaluated through a 1-year cluster-randomized controlled trial in Nanhe County, Hebei Province in China. Fifty villages from 5 townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual care) with a target to enroll 25 stroke survivors per village. Village doctors in the intervention arm (1) receive systematic cascade training by stroke specialists on clinical guidelines, essential medicines and behavior change; (2) conduct monthly follow-up visits with the support of a mobile phone application designed for this study; (3) participate in virtual group activities with other village doctors; 4) receive performance feedback and payment. Stroke survivors participate in a health education and project briefing session, receive monthly follow-up visits by village doctors and receive a voice message call daily as reminders for medication use and physical activities. Baseline and 1-year follow-up survey will be conducted in all villages by trained staff who are blinded of the randomized allocation of villages. The primary outcome will be systolic blood pressure and the secondary outcomes will include diastolic blood pressure, medication adherence, mobility, physical activity level and quality of life. Process and economic evaluation will also be conducted. DISCUSSION: This study is one of very few that aim to promote secondary prevention of stroke in resource-constrained settings and the first to incorporate mobile technologies for both healthcare providers and patients in China. The SINEMA model is innovative as it builds the capacity of primary healthcare workers in the rural area, uses mobile health technologies at the point of care, and addresses critical health needs for a vulnerable community-dwelling patient group. The findings of the study will provide translational evidence for other resource-constrained settings in developing strategies for the secondary prevention of stroke.