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Peer support for patients with type 2 diabetes in rural communities of China: protocol for a cluster randomized controlled trial.

ABSTRACT: The prevalence of diabetes has been growing rapidly in developing countries. This causes devastating economic burdens and increases demands on the health care system. Therefore, there is an urgent need to find a cost-effective and multi-faceted approach for diabetes care. Peer support models provide a potentially low-cost, flexible means which complements the current existing health care services. In this way, trained peer leaders can become qualified extensions to a formal healthcare system, capable of assisting education delivery and bolstering the efforts of professional staff. As such, creating a cultural specific peer support program and determining whether it is acceptable and cost-effective in rural communities of China is crucial. This study aims to implement and evaluate biophysical and psychosocial outcomes of peer support program for people with type 2 diabetes in rural communities, and to explore the program's feasibility and sustainability in China.This study is a cluster randomised controlled trial. All consenting patients will be randomised by community staff members to receive either peer support or the control care. The data collection and analysis including social demographics, health status, psychosocial status, economic status and biomedical measures will be collected at baseline, 6 months, and 12 months. The primary indicator measured is the change in HbA1c, whereas secondary indicators include biophysical, psychosocial functioning and other lifestyle factors. Finally, economic evaluations will determine whether the program is cost effective.This protocol is a cluster randomized, controlled trial of group-based peer support for people with type 2 diabetes in the community settings of rural China. Results from this trial may provide evidence to the effectiveness of peer support; furthermore, they will provide valuable information concerning the acceptability and feasibility of a new approach to improve diabetes self-management among resource-constrained settings.ClinicalTrials.gov Identifier: NCT02119572, April 18, 2014.

SUBMITTER: Xie B

PROVIDER: S-EPMC4132925 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Peer support for patients with type 2 diabetes in rural communities of China: protocol for a cluster randomized controlled trial.

Xie Bo B Ye Xiu-li XL Sun Zi-lin ZL Jia Min M Jin Hui H Ju Chang-ping CP Yao Li L De Vladmir Carvalho Husni Da Costa CH Yang Yanxiaoxiao Y

BMC public health 20140723

<h4>Background</h4>The prevalence of diabetes has been growing rapidly in developing countries. This causes devastating economic burdens and increases demands on the health care system. Therefore, there is an urgent need to find a cost-effective and multi-faceted approach for diabetes care. Peer support models provide a potentially low-cost, flexible means which complements the current existing health care services. In this way, trained peer leaders can become qualified extensions to a formal he ...[more]

PMID: 25056813

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Project description:ObjectiveTo test the effectiveness of peer support for patients with type 2 diabetes.DesignCluster randomised controlled.Setting20 general practices in the east of the Republic of Ireland.Participants395 patients (192 in intervention group, 203 in control group) and 29 peer supporters with type 2 diabetes.InterventionAll practices introduced a standardised diabetes care system. The peer support intervention ran over a two year period and contained four elements: the recruitment and training of peer supporters, nine group meetings led by peer supporters in participant's own general practice, and a retention plan for the peer supporters.Main outcome measuresHbA(1c); cholesterol concentration; systolic blood pressure; and wellbeing score.ResultsThere was no difference between intervention and control patients at baseline. All practices and 85% (337) of patients were followed up. At two year follow-up, there were no significant differences in HbA(1c) (mean difference -0.08%, 95% confidence interval -0.35% to 0.18%), systolic blood pressure (-3.9 mm Hg, -8.9 to 1.1 mm Hg), total cholesterol concentration (-0.03 mmol/L, -0.28 to 0.22 mmol/L), or wellbeing scores (-0.7, -2.3 to 0.8). While there was a trend towards decreases in the proportion of patients with poorly controlled risk factors at follow-up, particularly for systolic blood pressure (52% (87/166) >130 mm Hg in intervention v 61% (103/169) >130 mm Hg in control), these changes were not significant. The process evaluation indicated that the intervention was generally delivered as intended, though 18% (35) of patients in the intervention group never attended any group meetings.ConclusionsA group based peer support intervention is feasible in general practice settings, but the intervention was not effective when targeted at all patients with type 2 diabetes. While there was a trend towards improvements of clinical outcomes, the results do not support the widespread adoption of peer support. Trial registration Current Controlled Trials ISRCTN42541690.

Project description:BackgroundThe major efficacy trials on diabetes prevention have used resource-intensive approaches to identify high-risk individuals and deliver lifestyle interventions. Such strategies are not feasible for wider implementation in low- and middle-income countries (LMICs). We aimed to evaluate the effectiveness of a peer-support lifestyle intervention in preventing type 2 diabetes among high-risk individuals identified on the basis of a simple diabetes risk score.Methods and findingsThe Kerala Diabetes Prevention Program was a cluster-randomized controlled trial conducted in 60 polling areas (clusters) of Neyyattinkara taluk (subdistrict) in Trivandrum district, Kerala state, India. Participants (age 30-60 years) were those with an Indian Diabetes Risk Score (IDRS) ?60 and were free of diabetes on an oral glucose tolerance test (OGTT). A total of 1,007 participants (47.2% female) were enrolled (507 in the control group and 500 in the intervention group). Participants from intervention clusters participated in a 12-month community-based peer-support program comprising 15 group sessions (12 of which were led by trained lay peer leaders) and a range of community activities to support lifestyle change. Participants from control clusters received an education booklet with lifestyle change advice. The primary outcome was the incidence of diabetes at 24 months, diagnosed by an annual OGTT. Secondary outcomes were behavioral, clinical, and biochemical characteristics and health-related quality of life (HRQoL). A total of 964 (95.7%) participants were followed up at 24 months. Baseline characteristics of clusters and participants were similar between the study groups. After a median follow-up of 24 months, diabetes developed in 17.1% (79/463) of control participants and 14.9% (68/456) of intervention participants (relative risk [RR] 0.88, 95% CI 0.66-1.16, p = 0.36). At 24 months, compared with the control group, intervention participants had a greater reduction in IDRS score (mean difference: -1.50 points, p = 0.022) and alcohol use (RR 0.77, p = 0.018) and a greater increase in fruit and vegetable intake (?5 servings/day) (RR 1.83, p = 0.008) and physical functioning score of the HRQoL scale (mean difference: 3.9 score, p = 0.016). The cost of delivering the peer-support intervention was US$22.5 per participant. There were no adverse events related to the intervention. We did not adjust for multiple comparisons, which may have increased the overall type I error rate.ConclusionsA low-cost community-based peer-support lifestyle intervention resulted in a nonsignificant reduction in diabetes incidence in this high-risk population at 24 months. However, there were significant improvements in some cardiovascular risk factors and physical functioning score of the HRQoL scale.Trial registrationAustralia and New Zealand Clinical Trials Registry ACTRN12611000262909.

Project description:Although China has a large number of older people living with diabetes and hypertension, the primary care system is underdeveloped and so management of these conditions in community care settings is suboptimal. Studies have shown that the collaborative care model across care settings that address both pharmacology and nonpharmacology interventions can achieve hypertension control for older people with diabetes. Barriers to implementing and evaluating this model of care are widely recognized in low and middle-income countries including China. This study will therefore test the hypothesis that a hypertension management program built on collaboration between hospitals and community health service centers in China can improve blood pressure control in people aged 60 years and older with diabetes as compared to usual care.A cluster randomized controlled trial will randomly allocate 10 wards from four hospitals in Nanchang to either an intervention group (N?=?5) or a usual care group (N?=?5). At least 27 participants will be recruited from each ward and the estimated sample size will be 135 patients in each group. The intervention includes individualized self-care education prior to discharge and 6-month follow-up in community health service centers. Health professionals from both hospitals and community health service centers will be resourced to collaborate on the implementation of the postdischarge interventions that reinforce self-care. The primary outcome is systolic blood pressure at 6-month follow-up adjusted for baseline value. Secondary outcomes are self-care knowledge, treatment adherence, HbA1c and lipid levels, quality of life, the incidence of adverse events and the incidence of unplanned hospital readmission at 6-month follow-up adjusted for baseline value. A multilevel mixed-effect linear regression model will be used to compare the changes in health outcomes between the intervention and usual care groups.This study will determine whether collaborative care among health professionals between hospitals and community health service centers will improve hypertension management for older people with diabetes in the study sites. The program, if effective, will have an immediate application to hypertension management in the healthcare system in China.Australia New Zealand Clinical Trials Registry, ACTRN12617001352392 . Retrospectively registered on 26 September 2017.

Project description:ObjectiveComorbid depression is associated with increased health care utilization and cost. We examined the effects of peer support on acute care (AC) and hospital utilization in individuals with diabetes with or without depressive symptoms.Research design and methodsThis was a cluster-randomized controlled trial conducted in 2010-2012, with the clusters being practices and their surrounding communities. Adults with type 2 diabetes who wanted help with self-management were eligible to participate. Those without a doctor, with limited life expectancy, with plans to move within the next year, and with an unwillingness to work with a peer advisor were excluded. Intervention participants received 1 year of peer support. Control participants received usual care. The Patient Health Questionnaire (PHQ-8) (range 0-24; 5 indicates mild and 10 indicates moderate depressive symptoms) assessed depressive symptoms. AC and hospital utilization were measured by self-report. Data were collected at baseline, 6 months, and 12 months. Quasi-Poisson regression using generalized estimating equations examined differences in utilization per year attributable to the intervention for those with and without mild depressive symptoms (and separately, moderate depressive symptoms), controlling for imbalance across treatment arms.ResultsAt baseline, half of the sample reported mild depressive symptoms (52% intervention and 48% control, P = 0.37), a quarter reported moderate depressive symptoms (25% intervention and 26% control, P = 1.0), and there were no significant differences in utilization. A total of 168 intervention (six clusters) and 187 control (five clusters) participants had follow-up data. In individuals with mild depressive symptoms, the incident rate ratio (IRR) for hospitalization among intervention compared with control was 0.26 (95% CI 0.08-0.84) per 10 patient-years. The IRR for AC was 0.55 (95% CI 0.28-1.07) per 10 person-years. Findings were similar for individuals with moderate depressive symptoms.ConclusionsPeer support lowered AC visits and hospitalizations for individuals with depressive symptoms but not for those without depressive symptoms; these findings can guide resource allocation for population health management.

Project description:BACKGROUND:Physical activity (PA) has demonstrated a decreased risk in various cancers and other chronic diseases; however, rural residents are less likely to attain recommended levels of PA compared to urban and suburban counterparts. Given rural residents make up 15% of the United States population, there is a need for novel approaches to increase PA among this population. The goal of the present study is to investigate the effectiveness of a multilevel intervention to increase PA rates among rural residents. METHODS/DESIGN:Guided by an ecological framework, a group-randomized design will be used to evaluate the effects of a three-level intervention for increasing PA among adult residents residing in 6 rural communities (n?=?600) along with 6 control communities (n?=?600). The intervention includes components at the individual (short message service [SMS] text messages), interpersonal (social support in walking groups), and community levels (events at existing trails). Innovative methods to encourage participation will be employed as well as a focus on life priorities (family, recreation, hobbies) other than health. Aim 1 includes a literature review and key informant interviews to determine the local contexts for intervention adaptation. Aim 2 will employ a set of interventions at the individual, interpersonal, and community-levels to evaluate their impact on moderate-to-vigorous PA as measured by self-reported (telephone survey) and objectively assessed (accelerometry) measures. These data are supplemented by location based on Global Positioning System and community audits, which provide information on recreational amenities, programs/policies, and street segments. DISCUSSION:This study is among the first of its kind to test a multilevel intervention in a rural setting, address life priorities that compliment health outcomes, and examine moderation between behavioral interventions and the natural environments where people are physically active. Our results will influence the field by enhancing the ability to scale-up innovative, PA interventions with the potential to reach high-risk, rural populations. TRIAL REGISTRATION:Clinical Trials NCT03683173 , September 25, 2018.

Project description:BackgroundPeer support has been shown to improve diabetes self-management and control, but no standard exists to link peer support interventions to clinical care.ObjectiveTo compare a community-based diabetes self-management education (DSME) plus mobile health (mHealth)-enhanced peer support intervention to community-based diabetes self-management education (DSME) alone for African American adults with poorly controlled type 2 diabetes.DesignA randomized controlled trial.ParticipantsAfrican American adults, age > 19 years, receiving care within a safety-net healthcare system in Jefferson County, Alabama, with a diagnosis of type 2 diabetes and a hemoglobin A1c (A1C) ≥ 7.5%.InterventionsParticipants in the intervention group received community-based diabetes self-management education (DSME) plus 6 months of mHealth-enhanced peer support, including 12 weekly phone calls, then 3 monthly calls from community health workers, who used a novel web application to communicate with participants' healthcare teams. In the control group, participants received community-based DSME alone.Main measuresThe primary outcome was A1C; secondary outcomes included diabetes distress, depressive symptoms, self-efficacy or confidence in their ability to manage diabetes, and social support. We used mixed models repeated measures analyses to assess for between-arm differences and baseline to follow-up changes.Key resultsOf 120 participants randomized, 97 completed the study. Participants in intervention and control groups experienced clinically meaningful reduction in A1C, 10.1 (SD 1.7) to 9.6 (SD 1.9) and 9.8 (SD 1.7) to 9.1 (SD 1.9) respectively, p = 0.004. Participants in the intervention group experienced a significantly larger reduction in diabetes distress compared to the control, 2.7 (SD 1.2) to 2.1 (1.0) versus 2.6 (SD 1.1) to 2.3 (SD 1.0) p = 0.041.ConclusionsCommunity-based DSME with and without peer support led to improved glycemic control. Peer support linked to clinical care led to a larger reduction in diabetes distress, which has important implications for the overall wellbeing of adults with type 2 diabetes.

Project description:BackgroundDiabetes self-management education and support (DSMES) is a crucial component of diabetes care associated with improved clinical, psychosocial, and behavioral outcomes. The American Association of Diabetes Care and Education Specialists, the American Diabetes Association, and the American Academy of Family Physicians all recommend DSMES yet accessing linguistically and culturally appropriate DSMES is challenging in rural areas. The Diabetes One-Day (D1D) program is an established DSMES group intervention that has not been adapted or evaluated in rural communities.ObjectiveThe specific aims of this paper are (1) to adapt the existing D1D program for use in rural communities, called rural D1D (R-D1D); and (2) to conduct a patient-level randomized controlled trial to examine the effects of R-D1D and standard patient education, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework.MethodsThis is a protocol for a pilot type II hybrid implementation-effectiveness trial of a culturally adapted virtual DSMES program for rural populations, R-D1D. We will use Boot Camp Translation, a process grounded in the principles of community-based participatory research, to adapt an existing DSMES program for rural populations, in both English and Spanish. Participants at 2 rural primary care clinics (4 cohorts of N=16 plus care partners, 2 in English and 2 in Spanish) will be randomized to the intervention or standard education control. The evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Patient-level effectiveness outcomes (hemoglobin A1c, diabetes distress, and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A1c test kit. Practice-level and patient-level acceptability and feasibility will be assessed using surveys and interviews.ResultsThis study is supported by the National Institute of Nursing. The study procedures were approved, and the adaptation processes have been completed. Recruitment and enrollment started in July 2021.ConclusionsTo our knowledge, this will be the first study to evaluate both effectiveness and implementation outcomes for virtually delivered DSMES, culturally adapted for rural populations. This research has implications for delivery to other rural locations where access to specialty diabetes care is limited.Trial registrationClinicalTrials.gov NCT04600622; https://clinicaltrials.gov/ct2/show/NCT04600622.International registered report identifier (irrid)DERR1-10.2196/34255.

Project description:BACKGROUND:In 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. OBJECTIVE:This study aimed to explore the impact of a maternal education program through text messaging. METHODS:We 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. RESULTS:A 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. CONCLUSIONS:Adequate 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 REGISTRATION:ClinicalTrials.gov NCT01775150; https://clinicaltrials.gov/ct2/show/NCT01775150 (Archived by WebCite at http://www.webcitation.org/74cHmUexo).

Project description:IntroductionUp to 80% of patients with respiratory tract infections (RTI) attending healthcare facilities in rural areas of China are prescribed antibiotics, many of which are unnecessary. Since 2009, China has implemented several policies to try to reduce inappropriate antibiotic use; however, antibiotic prescribing remains high in rural health facilities.Methods and analysisA cluster randomised controlled trial will be carried out to estimate the effectiveness and cost effectiveness of a complex intervention in reducing antibiotic prescribing at township health centres in Anhui Province, China. 40 Township health centres will be randomised at a 1:1 ratio to the intervention or usual care arms. In the intervention group, practitioners will receive an intervention comprising: (1) training to support appropriate antibiotic prescribing for RTI, (2) a computer-based treatment decision support system, (3) virtual peer support, (4) a leaflet for patients and (5) a letter of commitment to optimise antibiotic use to display in their clinic. The primary outcome is the percentage of antibiotics (intravenous and oral) prescribed for RTI patients. Secondary outcomes include patient symptom severity and duration, recovery status, satisfaction, antibiotic consumption. A full economic evaluation will be conducted within the trial period. Costs and savings for both clinics and patients will be considered and quality of life will be measured by EuroQoL (EQ-5D-5L). A qualitative process evaluation will explore practitioner and patient views and experiences of trial processes, intervention fidelity and acceptability, and barriers and facilitators to implementation.Ethics and disseminationEthical approval was obtained from the Biomedical Research Ethics Committee of Anhui Medical University (Ref: 20180259); the study has undergone due diligence checks and is registered at the University of Bristol (Ref: 2020-3137). Research findings will be disseminated to stakeholders through conferences and peer-reviewed journals in China, the UK and internationally.Trial registration numberISRCTN30652037.

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Peer support for patients with type 2 diabetes in rural communities of China: protocol for a cluster randomized controlled trial.

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Peer support for patients with type 2 diabetes in rural communities of China: protocol for a cluster randomized controlled trial.

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