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

PLoS Medicine ◽  
2021 ◽  
Vol 18 (4) ◽  
pp. e1003582
Author(s):  
Lijing L. Yan ◽  
Enying Gong ◽  
Wanbing Gu ◽  
Elizabeth L. Turner ◽  
John A. Gallis ◽  
...  
Keyword(s):  
Primary Care ◽  
Mobile Health ◽  
Rural China ◽  
Controlled Trial ◽  
Health Intervention ◽  
Activity Level ◽  
Timed Up And Go ◽  
And Performance ◽  
Cluster Randomized

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.

scholarly journals Statistical analysis plan for management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: the SingHypertension pragmatic cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
John C. Allen ◽  
◽  
Benjamin Halaand ◽  
Rupesh M. Shirore ◽  
Tazeen H. Jafar
Keyword(s):  
Risk Factors ◽  
Primary Care ◽  
Statistical Analysis ◽  
Usual Care ◽  
Statistical Analysis Plan ◽  
Activity Level ◽  
Uncontrolled Hypertension ◽  
Primary Care Clinics ◽  
Cluster Randomized

Abstract Introduction Cardiovascular disease remains the leading cause of death in Singapore. Uncontrolled hypertension confers the highest attributable risk of CVD and remains a significant public health issue with sub-optimal blood pressure (BP) control rates. The aim of the trial is to evaluate the effectiveness and cost-effectiveness of a multicomponent intervention (MCI) versus usual care on lowering BP among adults with uncontrolled hypertension visiting primary care clinics in Singapore. This article describes the statistical analysis plan for the primary and secondary objectives related to intervention effectiveness. Methods The study is a cluster randomized trial enrolling 1000 participants with uncontrolled hypertension aged ≥ 40 years from eight primary care clinics in Singapore. The unit of randomization is the clinic, with eight clusters (clinics) randomized in a 1:1 ratio to either MCI or usual care. All participants will be assessed at baseline, 12 months, and 24 months with measurements of systolic and diastolic BP, antihypertensive and statin medication use, medication adherence, physical activity level, anthropometric parameters, smoking status, and dietary habits. The primary objective of this study is to assess the effectiveness of MCI versus usual care on mean SBP at the 2-year follow-up. The primary outcome is SBP at 24 months. SBP at baseline, 12, and 24 months will be modeled at the subject level using a likelihood-based, linear mixed-effects model repeated measures (MMRM) analysis with treatment group and follow-up as fixed effects, random cluster (clinic) effects, Gaussian error distribution, and adjustment to degrees of freedom using the Satterthwaite approximation. Secondary outcomes will be analyzed using a similar modeling approach incorporating generalized techniques appropriate for the type of outcome. Discussion The trial will allow us to determine whether the MCI has an impact on BP and cardiovascular risk factors over a 2-year follow-up period and inform recommendations for health planners in scaling up these strategies for the benefit of society at large. A pre-specified and pre-published statistical analysis plan mitigates reporting bias and data driven approaches. Trial registration ClinicalTrials.gov NCT02972619. Registered on 23 November 2016.

scholarly journals Using a brief web-based 5A intervention to improve weight management in primary care: results of a cluster-randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Franziska D. Welzel ◽  
Jonathan Bär ◽  
Janine Stein ◽  
Margrit Löbner ◽  
Alexander Pabst ◽  
...  
Keyword(s):  
Primary Care ◽  
Weight Management ◽  
Controlled Trial ◽  
Obesity Management ◽  
Online Tutorial ◽  
Low Threshold ◽  
Cluster Randomized

Abstract Background The primary health care setting is considered a major starting point in successful obesity management. However, research indicates insufficient quality of weight counseling in primary care. Aim of the present study was to implement and evaluate a 5A online tutorial aimed at improving weight management and provider-patient-interaction in primary health care. The online tutorial is a stand-alone low-threshold minimal e-health intervention for general practitioners based on the 5As guidance for obesity management by the Canadian Obesity Network. Methods In a cluster-randomized controlled trial, 50 primary care practices included 160 patients aged 18 to 60 years with obesity (BMI ≥ 30). The intervention practices had continuous access to the 5A online tutorial for the general practitioner. Patients of control practices were treated as usual. Primary outcome was the patients’ perspective of the doctor-patient-interaction regarding obesity management, assessed with the Patient Assessment of Chronic Illness Care before and after (6/12 months) the training. Treatment effects over time (intention-to-treat) were evaluated using mixed-effects linear regression models. Results More than half of the physicians (57%) wished for more training offers on obesity counseling. The 5A online tutorial was completed by 76% of the physicians in the intervention practices. Results of the mixed-effects regression analysis showed no treatment effect at 6 months and 12 months’ follow-up for the PACIC 5A sum score. Patients with obesity in the intervention group scored lower on self-stigma and readiness for weight management compared to participants in the control group at 6 months’ follow-up. However, there were no significant group differences for weight, quality of life, readiness to engage in weight management, self-stigma and depression at 12 months’ follow-up. Conclusion To our knowledge, the present study provides the first long-term results for a 5A-based intervention in the context of the German primary care setting. The results suggest that a stand-alone low-threshold minimal e-health intervention for general practitioners does not improve weight management in the long term. To improve weight management in primary care, more comprehensive strategies are needed. However, due to recruitment difficulties the final sample was smaller than intended. This may have contributed to the null results. Trial registration The study has been registered at the German Clinical Trials Register (Identifier: DRKS00009241, Registered 3 February 2016).

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

2021 ◽  
Vol 9 ◽  
Author(s):  
Enying Gong ◽  
Lixin Sun ◽  
Qian Long ◽  
Hanzhang Xu ◽  
Wanbing Gu ◽  
...  
Keyword(s):  
Primary Care ◽  
Data Analysis ◽  
Process Evaluation ◽  
Mobile Health ◽  
Program Implementation ◽  
Quantitative Data ◽  
Rural China ◽  
Health Intervention ◽  
Evaluation Framework ◽  
The Future

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.

scholarly journals Detection of Domestic Violence and Abuse by Community Mental Health Teams Using the BRAVE Intervention: A Multicenter, Cluster Randomized Controlled Trial

2021 ◽  
pp. 088626052110041
Author(s):  
Roos Ruijne ◽  
Cornelis Mulder ◽  
Milan Zarchev ◽  
Kylee Trevillion ◽  
Roel van Est ◽  
...  
Keyword(s):  
Mental Health ◽  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Referral Rates ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
And Control ◽  
Domestic Violence And Abuse

Despite increased prevalence of domestic violence and abuse (DVA), victimization through DVA often remains undetected in mental health care. To estimate the effectiveness of a system provider level training intervention by comparing the detection and referral rates of DVA of intervention community mental health (CMH) teams with rates in control CMH teams. We also aimed to determine whether improvements in knowledge, skills and attitudes to DVA were greater in clinicians working in intervention CMH teams than those working in control teams. We conducted a cluster randomized controlled trial in two urban areas of the Netherlands. Detection and referral rates were assessed at baseline and at 6 and 12 months after the start of the intervention. DVA knowledge, skills and attitudes were assessed using a survey at baseline and at 6 and 12 months after start of the intervention. Electronic patient files were used to identify detected and referred cases of DVA. Outcomes were compared between the intervention and control teams using a generalized linear mixed model. During the 12-month follow-up, detection and referral rates did not differ between the intervention and control teams. However, improvements in knowledge, skills and attitude during that follow-up period were greater in intervention teams than in control teams: β 3.21 (95% CI 1.18-4.60). Our trial showed that a training program on DVA knowledge and skills in CMH teams can increase knowledge and attitude towards DVA. However, our intervention does not appear to increase the detection or referral rates of DVA in patients with a severe mental illness. A low detection rate of DVA remains a major problem. Interventions with more obligatory elements and a focus on improving communication between CMH teams and DVA services are recommended.

How Does Green Dot Bystander Training in High School and Beyond Impact Attitudes Toward Violence and Sexism in a Prospective Cohort?

2021 ◽  
pp. 088626052110063
Author(s):  
Ann L. Coker ◽  
Heather M. Bush ◽  
Zhengyan Huang ◽  
Candace J. Brancato ◽  
Emily R. Clear ◽  
...  
Keyword(s):  
High School ◽  
Prospective Cohort ◽  
Controlled Trial ◽  
Ambivalent Sexism ◽  
Cluster Rct ◽  
Attitudes Toward Violence ◽  
Scale Scores ◽  
Cluster Randomized ◽  
Over Time

Bystander interventions are recognized as “promising” programming to reduce sexual violence. Gaps in current evaluations include limited follow-up post-training (beyond 24 months) and knowledge of additional bystander training during follow-up. In this prospective cohort study, nested in a cluster randomized controlled trial (RCT), three cohorts of high school (HS) seniors were recruited (Fall 2013-2015) and followed through Spring 2018 ( n = 1,831). Training was based on their school cluster RCT assignment and receipt of additional Green Dot (GD) training after HS. Training was hypothesized to be associated with lower scores indicating less acceptance of violence or sexism. Sixty percent reported GD training after HS (68.7% of 986 in intervention and 50% of 845 in control conditions). No significant differences ( p < .05) were observed by GD training for four of the five violence acceptance or sexism attitudinal measures at recruitment or final surveys. For “ambivalent sexism” alone was there a significant reduction in scale scores over time in the intervention versus control condition. Additional GD training after the RCT significantly reduced neither violence acceptance nor sexism scores over time. GD training does not appear to have a consistent longer-term impact on reducing violence acceptance and sexism.

scholarly journals Effect of faecal calprotectin testing on referrals for children with chronic gastrointestinal symptoms in primary care: study protocol for a cluster randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e045444
Author(s):  
Sophie Ansems ◽  
Marjolein Berger ◽  
Patrick van Rheenen ◽  
Karin Vermeulen ◽  
Gina Beugel ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Cluster Randomised Controlled Trial ◽  
Referral Rate ◽  
Faecal Calprotectin ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionChildren with chronic gastrointestinal symptoms are frequently seen in primary care, yet general practitioners (GPs) often experience challenges distinguishing functional gastrointestinal disorders (FGID) from organic disorders. We, therefore, aim to evaluate whether a test strategy that includes point-of-care testing (POCT) for faecal calprotectin (FCal) can reduce the referral rate to paediatric specialist care among children with chronic gastrointestinal symptoms. The study findings will contribute to improving the recommendations on FCal use among children in primary care.Methods and analysisIn this pragmatic cluster randomised controlled trial, we will randomise general practices into intervention and control groups. The intervention group will use FCal-POCT when indicated, after completing online training about its indication, interpretation and follow-up as well as communicating an FGID diagnosis. The control group will test and treat according to Dutch GP guidelines, which advise against FCal testing in children. GPs will include children aged 4–18 years presenting to primary care with chronic diarrhoea and/or recurrent abdominal pain. The primary outcome will be the referral rate for children with chronic gastrointestinal symptoms within 6 months after the initial assessment. Secondary outcomes will be evaluated by questionnaires completed at baseline and at 3- and 6-month follow-up. These outcomes will include parental satisfaction and concerns, gastrointestinal symptoms, impact of symptoms on daily function, quality of life, proportion of children with paediatrician-diagnosed FGID referred to secondary care, health service use and healthcare costs. A sample size calculation indicates that we need to recruit 158 GP practices to recruit 406 children.Ethics and disseminationThe Medical Research Ethics Committee (MREC) of the University Medical Center Groningen (The Netherlands) approved this study (MREC number: 201900309). The study results will be made available to patients, GPs, paediatricians and laboratories via peer-reviewed publications and in presentations at (inter)national conferences.Trial registration numberThe Netherlands Trial Register: NL7690 (Pre-results)

Sign in / Sign up

Export Citation Format

Share Document