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Family member-based supervision of patients with hypertension: a cluster randomized trial in rural China.

ABSTRACT: Empirical evidence has suggested that social support from family can help patients take their medicines correctly. This study aims to evaluate the role of a family member-based supervision package in the management of hypertension using a cluster randomized trial in rural China. We recruited patients with hypertension from four villages in Yangzhong and randomly allocated them to the control group (n=288) and the intervention group (n=266). A family member-based supervision package was applied to the intervention group, while the usual service was applied to the controls. Patients were followed for 12 months and completed face-to-face interviews at the end of 6 and 12 months. The primary outcomes were patients' medication adherence and frequency of blood pressure measurement. Secondary outcomes included changes in blood pressure, altered risk behaviours and occurrence of hypertension-related complications. To control for the effects of cluster randomization, multilevel mixed-effects regression models were used to compare group changes. We observed that the intervention improved patients' blood pressure measurement frequency (OR: 9.00, 95% CI: 4.52-17.91) and adherence to antihypertensive treatment (OR: 1.74, 95% CI: 0.91-3.32). Its effect on the blood pressure control rate was significant at the mid-term investigation (OR: 0.67, 95% CI: 0.40-0.93), but the long-term effect was not significant (OR: 0.89, 95% CI: 0.64-1.26). After 6 months of intervention, either systolic or diastolic blood pressure was significantly decreased in the intervention group. However, this difference was not significant at the final investigation. Findings from this study revealed that the family member-based supervised therapy may have positive effects on patients' adherence to blood monitoring and hypertensive medications.

SUBMITTER: Shen Y

PROVIDER: S-EPMC5144121 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Family member-based supervision of patients with hypertension: a cluster randomized trial in rural China.

Shen Y Y Peng X X Wang M M Zheng X X Xu G G Lü L L Xu K K Burstrom B B Burstrom K K Wang J J

Journal of human hypertension 20160225 1

Empirical evidence has suggested that social support from family can help patients take their medicines correctly. This study aims to evaluate the role of a family member-based supervision package in the management of hypertension using a cluster randomized trial in rural China. We recruited patients with hypertension from four villages in Yangzhong and randomly allocated them to the control group (n=288) and the intervention group (n=266). A family member-based supervision package was applied t ...[more]

PMID: 26911532

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Project description:BackgroundEffectiveness of integrated care management for common, comorbid physical and mental disorders has been insufficiently examined in low- and middle-income countries (LMICs). We tested hypotheses that older adults treated in rural Chinese primary care clinics with integrated care management of comorbid depression and hypertension (HTN) would show greater improvements in depression symptom severity and HTN control than those who received usual care.Methods and findingsThe study, registered with ClinicalTrials.gov as Identifier NCT01938963, was a cluster randomized controlled trial with 12-month follow-up conducted from January 1, 2014 through September 30, 2018, with analyses conducted in 2020 to 2021. Participants were residents of 218 rural villages located in 10 randomly selected townships of Zhejiang Province, China. Each village hosts 1 primary care clinic that serves all residents. Ten townships, each containing approximately 20 villages, were randomly selected to deliver either the Chinese Older Adult Collaborations in Health (COACH) intervention or enhanced care-as-usual (eCAU) to eligible village clinic patients. The COACH intervention consisted of algorithm-driven treatment of depression and HTN by village primary care doctors supported by village lay workers with telephone consultation from centrally located psychiatrists. Participants included clinic patients aged ≥60 years with a diagnosis of HTN and clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10). Of 2,899 eligible village residents, 2,365 (82%) agreed to participate. They had a mean age of 74.5 years, 67% were women, 55% had no schooling, 59% were married, and 20% lived alone. Observers, older adult participants, and their primary care providers (PCPs) were blinded to study hypotheses but not to group assignment. Primary outcomes were change in depression symptom severity as measured by the Hamilton Depression Rating Scale (HDRS) total score and the proportion with controlled HTN, defined as systolic blood pressure (BP) <130 mm Hg or diastolic BP <80 for participants with diabetes mellitus, coronary heart disease, or renal disease, and systolic BP <140 or diastolic BP <90 for all others. Analyses were conducted using generalized linear mixed effect models with intention to treat. Sixty-seven of 1,133 participants assigned to eCAU and 85 of 1,232 COACH participants were lost to follow-up over 12 months. Thirty-six participants died of natural causes, 22 in the COACH arm and 14 receiving eCAU. Forty COACH participants discontinued antidepressant medication due to side effects. Compared with participants who received eCAU, COACH participants showed greater reduction in depressive symptoms (Cohen's d [±SD] = -1.43 [-1.71, -1.15]; p < 0.001) and greater likelihood of achieving HTN control (odds ratio [OR] [95% CI] = 18.24 [8.40, 39.63]; p < 0.001). Limitations of the study include the inability to mask research assessors and participants to which condition a village was assigned, and lack of information about participants' adherence to recommendations for lifestyle and medication management of HTN and depression. Generalizability of the model to other regions of China or other LMICs may be limited.ConclusionsThe COACH model of integrated care management resulted in greater improvement in both depression symptom severity and HTN control among older adult residents of rural Chinese villages who had both conditions than did eCAU.Trial registrationClinicalTrials.gov Identifier NCT01938963 https://clinicaltrials.gov/ct2/show/NCT01938963.

Project description:BackgroundCommunity health workers (CHWs) can supplement professional medical providers, especially in rural settings where resources are particularly scarce. Yet, outcomes of studies evaluating CHWs effectiveness have been highly variable and lack impact when scaled nationally. This study examines if child and maternal outcomes are better when existing government CHWs, who are perinatal home visitors, receive ongoing enhanced supervision and monitoring, compared to standard care.Methods and findingsA cluster randomized controlled effectiveness trial was conducted comparing outcomes over 2 years when different supervision and support are provided. Primary health clinics were randomized by clinic to receive monitoring and supervision from either (1) existing supervisors (Standard Care (SC); n = 4 clinics, 23 CHWs, 392 mothers); or (2) supervisors from a nongovernmental organization that provided enhanced monitoring and supervision (Accountable Care [AC]; n = 4 clinic areas, 20 CHWs, 423 mothers). Assessments were conducted during pregnancy and at 3, 6, 15, and 24 months post-birth with high retention rates (76% to 86%). The primary outcome was the number of statistically significant intervention effects among 13 outcomes of interest; this approach allowed us to evaluate the intervention holistically while accounting for correlation among the 13 outcomes and considering multiple comparisons. The observed benefits were not statistically significant and did not show the AC's efficacy over the SC. Only the antiretroviral (ARV) adherence effect met the significance threshold established a priori (SC mean 2.3, AC mean 2.9, p < 0.025; 95% CI = [0.157, 1.576]). However, for 11 of the 13 outcomes, we observed an improvement in the AC compared to the SC. While the observed outcomes were not statistically significant, benefits were observed for 4 outcomes: increasing breastfeeding for 6 months, reducing malnutrition, increasing ARV adherence, and improving developmental milestones. The major study limitation was utilizing existing CHWs and being limited to a sample of 8 clinics. There were no major study-related adverse events.ConclusionsSupervision and monitoring were insufficient to improve CHWs' impact on maternal and child outcomes. Alternative strategies for staff recruitment and narrowing the intervention outcomes to the specific local community problems are needed for consistently high impact.Trial registrationClinicaltrials.gov, NCT02957799.

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.

Project description:BackgroundIn recent years, attempts have been made to use mobile phone text messaging (short message service, SMS) to achieve positive results for a range of health issues. Reports on the impact of maternal education programs based on this widely available, inexpensive, and instant communication tool are sparse.ObjectiveThis study aimed to explore the impact of a maternal education program through text messaging.MethodsWe conducted a cluster randomized trial in a remote region in the Chinese province of Hunan between October 1, 2011, and December 31, 2012. We used county as the unit of randomization (a total of 10 counties), with half of the counties randomly allocated to the intervention arm (with maternal education material adapted from the World Health Organization being delivered by text messaging to village health workers and pregnant women alike) and the other half to the control arm (normal care without text messaging). Data on maternal and infant health outcomes and health behaviors were collected and compared between the 2 arms, with maternal and perinatal mortality as the primary outcomes.ResultsA total of 13,937 pregnant women completed the follow-up and were included in the final analysis. Among them, 6771 were allocated to the intervention arm and 6966 were allocated to the control arm. At the county level, the mean (SD) of maternal mortality and perinatal mortality rate were 0.0% (0.1) and 1.3% (0.6), respectively, in the intervention arm and 0.1% (0.2) and 1.5% (0.4), respectively, in the control arm. However, these differences were not statistically significant. At the individual level, there were 3 maternal deaths (0.04%) and 84 perinatal deaths (1.24%) in the intervention arm and 6 maternal deaths (0.09%) and 101 perinatal deaths (1.45%) in the control arm. However, the differences were again not statistically significant.ConclusionsAdequate resources should be secured to launch large-scale cluster randomized trials with smaller cluster units and more intensive implementation to confirm the benefits of the text messaging-based maternal education program suggested by this trial.Trial registrationClinicalTrials.gov NCT01775150; https://clinicaltrials.gov/ct2/show/NCT01775150 (Archived by WebCite at http://www.webcitation.org/74cHmUexo).

Project description:BackgroundAdherence to and completion of tuberculosis (TB) treatment remain problematic in many high-burden countries. 99DOTS is a low-cost digital adherence technology that could increase TB treatment completion.Methods and findingsWe conducted a pragmatic stepped-wedge cluster-randomized trial including all adults treated for drug-susceptible pulmonary TB at 18 health facilities across Uganda over 8 months (1 December 2018-31 July 2019). Facilities were randomized to switch from routine (control period) to 99DOTS-based (intervention period) TB treatment supervision in consecutive months. Patients were allocated to the control or intervention period based on which facility they attended and their treatment start date. Health facility staff and patients were not blinded to the intervention. The primary outcome was TB treatment completion. Due to the pragmatic nature of the trial, the primary analysis was done according to intention-to-treat (ITT) and per protocol (PP) principles. This trial is registered with the Pan African Clinical Trials Registry (PACTR201808609844917). Of 1,913 eligible patients at the 18 health facilities (1,022 and 891 during the control and intervention periods, respectively), 38.0% were women, mean (SD) age was 39.4 (14.4) years, 46.8% were HIV-infected, and most (91.4%) had newly diagnosed TB. In total, 463 (52.0%) patients were enrolled on 99DOTS during the intervention period. In the ITT analysis, the odds of treatment success were similar in the intervention and control periods (adjusted odds ratio [aOR] 1.04, 95% CI 0.68-1.58, p = 0.87). The odds of treatment success did not increase in the intervention period for either men (aOR 1.24, 95% CI 0.73-2.10) or women (aOR 0.67, 95% CI 0.35-1.29), or for either patients with HIV infection (aOR 1.51, 95% CI 0.81-2.85) or without HIV infection (aOR 0.78, 95% CI 0.46-1.32). In the PP analysis, the 99DOTS-based intervention increased the odds of treatment success (aOR 2.89, 95% CI 1.57-5.33, p = 0.001). The odds of completing the intensive phase of treatment and the odds of not being lost to follow-up were similarly improved in PP but not ITT analyses. Study limitations include the likelihood of selection bias in the PP analysis, inability to verify medication dosing in either arm, and incomplete implementation of some components of the intervention.Conclusions99DOTS-based treatment supervision did not improve treatment outcomes in the overall study population. However, similar treatment outcomes were achieved during the control and intervention periods, and those patients enrolled on 99DOTS achieved high treatment completion. 99DOTS-based treatment supervision could be a viable alternative to directly observed therapy for a substantial proportion of patients with TB.Trial registrationPan-African Clinical Trials Registry (PACTR201808609844917).

Project description:BackgroundContact-based intervention has been documented and proved effective on reducing stigma of mental illness in high-income countries, but it is still unclear about the effectiveness of the contact-based intervention among family caregivers of persons with schizophrenia (FCPWS) in low- and middle-income countries including rural China.MethodsWe conducted a cluster randomized controlled trial in FCPWS in eight rural townships in Xinjin district of Chengdu city in Southwest China. The FCPWS in these townships were randomly allocated to the Enhancing Contact Model (ECM), Psychoeducational Family Intervention (PFI), or Treatment as Usual (TAU) group. FCPWS in three groups were provided specific interventions and follow-ups. By using a mixed-effect model, our goal was to examine the differences in affiliate self-stigma scale (ASSS) scores among three groups with the data collected at baseline (T0), post-intervention (T1), 3-month (T2), and 9-month (T3) follow-up timepoints, respectively. This trial is registered with ChiCTR, number ChiCTR2000039133.FindingsIn April 2019, 253 FCPWS from 8 townships were randomly assigned to receive either ECM (cluster=3, n=90), PFI (cluster=2, n=81), or TAU (cluster=3, n=82). Compared with participants in the TAU group, participants in the ECM group had statistically significantly lower ASSS scores at 9-month follow-up (estimated parameter [EP]= -5.51, 95% CI -10.27 to -0.74, p=0.02). There were no statistically significantly different ASSS scores at 9-month follow up between ECM and PFI groups. Compared with participants in the PFI group, younger (<60 years old), with higher monthly income and other caregiver (e.g., parent, sibling, child) participants in the ECM group had statistically significantly lower ASSS scores in the 3-month follow-up (EP = -5.66, 95% CI -10.13 to -1.19, p<0.01; EP = -7.82, 95% CI -11.87 to -3.78, p<0.001; EP = -6.79, 95% CI -10.69 to -2.90, p<0.001, respectively).InterpretationThis first trial in rural China shows that ECM intervention, a new anti-stigma intervention model, is a promising method for reducing affiliate stigma among FCPWS. The ECM intervention is more effective and stable than the PFI on reducing affiliate stigma among FCPWS. Further research needs to explore whether a long-term intervention could produce a more positive anti-stigma outcome trajectory.FundingGeneral Research Fund, University Grants Committee, Hong Kong SAR (GRF, Grant No. 17605618, 2018-2021, PI: Dr. M.S. Ran).

Dataset Information

Family member-based supervision of patients with hypertension: a cluster randomized trial in rural China.

Publications

Family member-based supervision of patients with hypertension: a cluster randomized trial in rural China.

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