scholarly journals Development and evaluation of a package to improve hypertension control in Nigeria [DEPIHCON]: study protocol for a cluster randomized controlled trial

2021 ◽  
Author(s):  
IkeOluwapo Oyeneye Ajayi ◽  
Oyediran Emmanuel Oyewole ◽  
Okechukwu S Ogah ◽  
Joshua Odunayo Akinyemi ◽  
Mobolaji Modinat Salawu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Controlled Trial ◽  
Hypertension Control ◽  
Cvd Risk Factors ◽  
Cvd Risk ◽  
Community Based ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
And Control

Abstract Background: Nigeria’s healthcare system capacity to stem the increasing trend in hypertension is limited in coverage, scope and manpower. Use of trained community-based care providers demonstrated to be an effective complement in improving access to, and supporting healthcare delivery has not been adequately examined for hypertension care in Nigeria. This study is proposed to evaluate the effectiveness of using trained Community-based Oriented Resource Persons (CORPs) to improve hypertension control in Nigeria. Methods: An intervention study will be conducted in three states using mixed method design. First, is a baseline survey using a semi-structured pre-tested questionnaire to collect information on demographics, clinical data, knowledge, occurrence and risk factors of hypertension among 1,704 adults ≥18 years. Focus Group Discussions (FGD) and Key Informant Interviews (KII) will be conducted to explore community’s experience of hypertension, challenges with hypertension management, and support required to improve control in 10 selected communities in each state. The second is a cluster randomized controlled trial to evaluate effect of a package on reduction of blood pressure (BP) and prevention of cardiovascular (CVD) risk factors among 200 hypertensive patients to be followed up in intervention and control arms over a six-month period in each state. The package will include trained CORPs conducting community-based screening of BP and referral, diagnosis confirmation and initial treatment in the health facility, followed by monthly home-based follow-up care and provision of health education on hypertension control and healthy lifestyle enhanced by phone voice message reminders. In the control arm, the usual care (diagnosis, treatment and follow up care in hospital of patient’s choice) will continue. Third, an end-line survey will be conducted in both intervention and control communities to evaluate changes in mean BP, control, knowledge, and proportion of other CVD risk factors. In addition, FGD and KII will be used to assess participants’ perceived quality and acceptability of the interventions as delivered by CORPs.Discussion: This research is expected to create awareness, improve knowledge, perception, behaviours, attitude and practices that will reduce hypertension in Nigeria. Advocacy for buy-in and scale up of using CORPs in hypertension care by the government is key if found to be effective. Trial registration: PACTR Registry- PACTR202107530985857. Registered on 26 July 2021Url – https://pactr.samrc.ac.za

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.

1107Reduction of cardiovascular disease risk factors in rural, medically under-served, socioeconomically distressed, high-risk individuals: a randomized controlled trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Moser ◽  
M L Chung ◽  
F Feltner ◽  
T A Lennie ◽  
M J Biddle
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Risk Reduction ◽  
Controlled Trial ◽  
Self Care ◽  
Density Lipoprotein ◽  
Control Group ◽  
Cvd Risk Factors ◽  
Cvd Risk ◽  
Randomized Controlled

Abstract Background People in rural, socioeconomically distressed areas of the world suffer from marked cardiovascular disease (CVD) disparities. Despite the CVD disparities seen in rural, distressed areas, efforts directed toward CVD risk reduction and prevention are limited. We conducted a randomized, controlled trial to determine the effect of an individualized, culturally appropriate, self-care CVD risk reduction intervention (HeartHealth) compared to referral of patients to a primary care provider for usual care on the following CVD risk factors: tobacco use, blood pressure, lipid profile, body mass index, depressive symptoms, and physical activity levels. Methods The study protocol and intervention were developed with a community advisory board of lay community members, business owners, local government officials, church leaders, and healthcare providers. We enrolled 355 individuals living in Appalachia with two or more CVD risk factors. The intervention was delivered in person to groups of 10 or fewer individuals over 12 weeks. In the first session, participants chose their CVD risk reduction goals. HeartHealth was designed to provide participants with self-care skills targeting CVD risk reduction while reducing barriers to risk reduction found in austere rural environments. The targeted CVD risk factors were measured at baseline and 4 and 12 months post-intervention. Repeated measures data were analyzed with mixed models. Results More individuals in the intervention group compared to the control group met their lifestyle change goal (50% vs 16%, p<0.001). The intervention produced a positive impact on systolic blood pressure (p=0.002, time X group effect), diastolic blood pressure (p=0.001, time x group), total cholesterol (p=0.026, time x group), high density lipoprotein (p=0.002, time x group), body mass index (p=0.017, time x group), smoking status (p=0.01), depressive symptoms (p=0.01, time x group), and steps per day (p=0.001, time x group). Compared to the control group, improvement was seen at 4 months in these risk factors and the positive changes were maintained through 12 months. There were no differences seen across time by group in low density lipoprotein or triglyceride levels. Conclusion Interventions like HeartHealth that focus on self-care and that are derived in collaboration with the community of interest are effective in medically underserved, socioeconomically distressed rural areas. Acknowledgement/Funding Patient Centered Outcomes Research Institute

scholarly journals Efficacy of optimal long-term management of multiple cardiovascular risk factors (CVD) on walking and quality of life in patients with peripheral artery disease (PAD): Protocol for randomized controlled trial

2012 ◽  
Vol 17 (1) ◽  
pp. 17-28 ◽  
Author(s):  
Roberta K Oka ◽  
Michael S Conte ◽  
Christopher D Owens ◽  
Joseph Rapp ◽  
Gordon Fung ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Risk Factors ◽  
Controlled Trial ◽  
Cvd Risk Factors ◽  
Peripheral Artery ◽  
Cvd Risk ◽  
Randomized Controlled ◽  
Artery Disease

Peripheral artery disease (PAD) is an understudied chronic illness most prevalent in elderly individuals. PAD patients experience substantial walking impairment due to symptoms of limb ischemia that significantly diminishes quality of life (QOL). Cardiovascular disease (CVD) morbidity and mortality is increased in this population because of aggressive atherosclerosis resulting from untreated CVD risk factors. Despite current national guidelines recommending intensive CVD risk factor management for PAD patients, untreated CVD risk factors are common. Interventions that bridge this gap are imperative. The Vascular Insufficiency – Goals for Optimal Risk Reduction (VIGOR2) study is a randomized controlled trial (RCT) that examines the effectiveness of a long-term multifactor CVD risk reduction program on walking and quality of life in patients with PAD. The purpose of this article is to provide a detailed description of the design and methods of VIGOR2. Clinical Trial Registration – URL: http://clinicaltrials.gov/ct2/show/NCT00537225

scholarly journals Community-based intervention for prevention and management of chronic obstructive pulmonary disease in Nepal (COBIN-P trial): study protocol for a cluster-randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Tara Ballav Adhikari ◽  
Dinesh Neupane ◽  
Arjun Karki ◽  
Arne Drews ◽  
Brendan Cooper ◽  
...  
Keyword(s):  
Risk Factors ◽  
Chronic Obstructive Pulmonary Disease ◽  
Randomized Controlled Trial ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Community Based ◽  
Obstructive Pulmonary Disease ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal. Risk factors like indoor and outdoor air pollution, a high prevalence of smoking, and the lack of awareness of COPD make it a serious public health concern. However, no attempt has been made in Nepal to estimate its burden and address the disease at the community level. Method This study aims to evaluate the effect of a community-based health educational intervention administered by Female Community Health Volunteers (FCHVs) on the prevention and management of COPD. An open-label, two-group, community-based, cluster-randomized controlled trial will be implemented in the semi-urban area of Pokhara Metropolitan city (former Lekhnath Municipality) located in the Kaski district of Nepal. The estimated sample size of the intervention will be 1143. The unit of randomization is the ward (administrative unit) of the study area. The follow-up survey will be conducted immediately after 12 months of FCHVs-led interventions. The difference in the rate of decline of forced expiratory volume in 1 s (FEV1) and FEV1/FVC (forced vital capacity) ratio are the primary outcomes and the change in the proportion of modifiable risk factors of COPD, health-related quality of life scores, and change in knowledge of COPD will be secondary outcomes. Discussion This study will estimate the burden of COPD, the magnitude of risk factors and generate evidence to mobilize community health workers for COPD prevention and management at the community level in Nepal. Trial registration ClinicalTrials.gov NCT03797768. Registered on January 9, 2019.

scholarly journals Effects of a health educational intervention on cardiovascular disease knowledge, motivation and behavioral skills: A cluster randomized controlled trial

2019 ◽  
Author(s):  
John Amoah ◽  
Salmiah Md. ◽  
Lekhraj Rampal ◽  
Rosliza A Manaf ◽  
Normala Ibrahim ◽  
...  
Keyword(s):  
Risk Factors ◽  
Health Education ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
School Students ◽  
Behavioral Skills ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Cardiovascular diseases (CVD) are the number one public health challenge of the 21st century. Globally, the disease causes more deaths than any other cause. Unfortunately, many people are not aware of CVDs and its risk factors and because of this the disease burden keeps on rising. Objective of this study was to develop, implement and evaluate the effects of a health education program to improve CVD knowledge, motivation, and behavioral skills among secondary school students in Ghana. Methods A parallel single-blind cluster randomized controlled trial was carried out for a period of six-months with baseline and post intervention evaluations. Participants (n=848) were secondary school students of ages of 14-19 years from four schools (clusters) in Brong Ahafo, Ghana. Students in the intervention group received health education intervention whereas those of the control group received no intervention. The intervention included information on cardiovascular diseases and its risk factors, motivation, and behavioral skills modules. At six months, a follow-up data using same questionnaire were collected after the intervention was completed. The generalized linear mixed model (GLMM) was used to assess the overall effects of the intervention. Results Of the 848 students, 836 completed the follow-up assessment immediately after six-month. The GLMM showed the intervention was significant in improving 6.85(p<0.001), 0.90(p<0.001), 0.94(p<0.001) higher total CVD knowledge, motivation, and behavioral skills scores respectively for the intervention group when compared to the control group. Conclusions The intervention was effective in increasing CVD knowledge, motivation, and behavioral skills of students in the intervention arm of the study. It is recommended that the health education module be implemented into secondary schools education curricula in Ghana to improve CVD knowledge, motivation, and behavioral skills. Equipping students with the IMB will reduce CVD risk factors and prevent the onset of CVDs in future.

scholarly journals Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial

2018 ◽  
Vol 9 (6) ◽  
pp. 3185-3194 ◽  
Author(s):  
Sheau C. Chai ◽  
Kristina Davis ◽  
Regina S. Wright ◽  
Marie F. Kuczmarski ◽  
Zugui Zhang
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Controlled Trial ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Low Density Lipoprotein Cholesterol ◽  
Cvd Risk Factors ◽  
Cvd Risk ◽  
Randomized Controlled ◽  
Cherry Juice

Hypertension and dyslipidemia are major risk factors for cardiovascular disease (CVD). Common treatments for high blood pressure (BP) and dyslipidemia include medications, but there is question as to whether natural sources may be adequate to reduce CVD risk factors.

scholarly journals Effects of a Paleolithic Diet on Cardiovascular Disease Risk Factors: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 10 (4) ◽  
pp. 634-646 ◽  
Author(s):  
Ehsan Ghaedi ◽  
Mohammad Mohammadi ◽  
Hamed Mohammadi ◽  
Nahid Ramezani-Jolfaie ◽  
Janmohamad Malekzadeh ◽  
...  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Cardiovascular Disease ◽  
Lipid Profile ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cvd Risk Factors ◽  
Paleolithic Diet ◽  
Cvd Risk ◽  
Randomized Controlled

ABSTRACTThere is some evidence supporting the beneficial effects of a Paleolithic diet (PD) on cardiovascular disease (CVD) risk factors. This diet advises consuming lean meat, fish, vegetables, fruits, and nuts and avoiding intake of grains, dairy products, processed foods, and added sugar and salt. This study was performed to assess the effects of a PD on CVD risk factors including anthropometric indexes, lipid profile, blood pressure, and inflammatory markers using data from randomized controlled trials. A comprehensive search was performed in the PubMed, Scopus, ISI Web of Science, and Google Scholar databases up to August 2018. A meta-analysis was performed using a random-effects model to estimate the pooled effect size. Meta-analysis of 8 eligible studies revealed that a PD significantly reduced body weight [weighted mean difference (WMD) = −1.68 kg; 95% CI: −2.86, −0.49 kg], waist circumference (WMD = −2.72 cm; 95% CI: −4.04, −1.40 cm), BMI (in kg/m2) (WMD = −1.54; 95% CI: −2.22, −0.87), body fat percentage (WMD = −1.31%; 95% CI: −2.06%, −0.57%), systolic (WMD = −4.75 mm Hg; 95% CI: −7.54, −1.96 mm Hg) and diastolic (WMD = −3.23 mm Hg; 95% CI: −4.77, −1.69 mm Hg) blood pressure, and circulating concentrations of total cholesterol (WMD = −0.23 mmol/L; 95% CI: −0.42, −0.04 mmol/L), triglycerides (WMD = −0.30 mmol/L; 95% CI: −0.55, −0.06 mmol/L), LDL cholesterol (WMD = −0.13 mmol/L; 95% CI: −0.26, −0.01 mmol/L), and C-reactive protein (CRP) (WMD = −0.48 mg/L; 95% CI: −0.79, −0.16 mg/L) and also significantly increased HDL cholesterol (WMD = 0.06 mmol/L; 95% CI: 0.01, 0.11 mmol/L). However, sensitivity analysis revealed that the overall effects of a PD on lipid profile, systolic blood pressure, and circulating CRP concentrations were sensitive to removing some studies and to the correlation coefficients, hence the results must be interpreted with caution. Although the present meta-analysis revealed that a PD has favorable effects on CVD risk factors, the evidence is not conclusive and more well-designed trials are still needed.

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