scholarly journals Conquering Hypertension in Vietnam- Solutions at Grassroots Level: Study Protocol of a Cluster Randomized Controlled Trial

2020 ◽  
Author(s):  
Duc Ha ◽  
Oanh Tran ◽  
Hoa Nguyen ◽  
Robert Goldberg ◽  
German Chiriboga ◽  
...  

Abstract BackgroundVietnam has been experiencing an epidemiologic transition to that of a low-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster-randomized trial design. MethodsSixteen communities will be randomized to either an intervention (8 communities) or comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services; (2) home blood pressure (BP) self-monitoring; and (3) a “storytelling intervention.”. which consists of interactive, literacy-appropriate, and culturally sensitive multimedia storytelling modules for motivating behavior change through the power of patients speaking in their own voice. The storytelling intervention will be delivered by DVD, with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well.DiscussionResults from this full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam.Trial registration: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).Protocol version: 6. Date: 08/15/2019

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Duc A. Ha ◽  
Oanh T. Tran ◽  
Hoa L. Nguyen ◽  
Germán Chiriboga ◽  
Robert J. Goldberg ◽  
...  

Abstract Background Vietnam has been experiencing an epidemiologic transition to that of a lower-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster randomized trial design. Methods Sixteen communities will be randomized to either an intervention (8 communities) or a comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services, (2) home BP self-monitoring, and (3) a “storytelling intervention,” which consists of interactive, literacy-appropriate, and culturally sensitive multi-media storytelling modules for motivating behavior change through the power of patients speaking in their own voices. The storytelling intervention will be delivered by DVDs with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well. Discussion Results from this full-scale trial will provide health policymakers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam. Trial registration ClinicalTrials.gov NCT03590691. Registered on July 17, 2018. Protocol version: 6. Date: August 15, 2019.


2020 ◽  
Author(s):  
Duc Ha ◽  
Oanh Tran ◽  
Hoa Nguyen ◽  
Robert Goldberg ◽  
German Chiriboga ◽  
...  

Abstract Background Vietnam has been experiencing an epidemiologic transition to that of a lower-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster-randomized trial design. MethodsSixteen communities will be randomized to either an intervention (8 communities) or comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services; (2) home BP self-monitoring; and (3) a “storytelling intervention”, which consists of interactive, literacy-appropriate, and culturally sensitive multimedia storytelling modules for motivating behavior change through the power of patients speaking in their own voices. The storytelling intervention will be delivered by DVDs with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well.DiscussionResults from this full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam.Trial registration: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).Protocol version: 6. Date: 08/15/2019


Author(s):  
Monika Sharma ◽  
Sita Thakur ◽  
Kamal Singh ◽  
Shashank Shekhar

Background: Hypertensive diseases are commonly seen during pregnancy and remain one of the leading causes of maternal morbidity and mortality. Mostly commonly preferred drugs by health care providers for treatment of severe hypertension during pregnancy are labetalol and hydralazine. However, they require proper storage, intravenous access, and adequately trained staff for usage. Oral nifedipine in contrast is easier to use and widely available.  Objective of this study was to report the efficacy and safety of oral nifedipine as compared to intravenous labetalol for treatment of severe hypertension during pregnancy.Methods: It was an open label randomized controlled trial in which 100 women with severe hypertension during pregnancy were enrolled. They were randomized to receive either incremental doses of intravenous labetalol every 20 minutes (total 300 mg) or 10 mg oral nifedipine every 20 minutes (up to 50 mg) to lower the blood pressure to safer levels.Results: Women receiving oral nifedipine took significantly less time to achieve target blood pressure [(37.6±23.3) minutes (SD) as compared to those receiving intravenous labetalol (52.0 minutes±27.95 (SD)]. Women receiving nifedipine for treatment also required significantly lesser doses to control the blood pressure [mean dose 1.8±1.1 (SD) versus 2.6±1.2 (SD) p=0.006]. There were two failures in labetalol group and one failure in nifedipine group. No serious adverse events were reported in either group.Conclusions: Oral nifedipine is equally efficacious to I.V. labetalol for treatment of severe hypertension during pregnancy and is easier to use in low resource settings.


2021 ◽  
Vol 14 (1) ◽  
pp. 600-604
Author(s):  
Ramin Parvizrad ◽  
Ghasem Mosayebi ◽  
Nader Zarinfar ◽  
Morteza Mousavi-Hasanzadeh ◽  
Seyedeh Zahra Razavi ◽  
...  

Background: Although there is a growing consensus that hydroxychloroquine may not be effective in the treatment of COVID-19 patients, there is still little high-quality evidence about the prophylactic effects of this medication. In this study, we aimed to evaluate the efficiency of hydroxychloroquine in preventing COVID-19 infection among healthcare workers. Methods: In this clinical trial, 90 healthcare providers from two referral hospitals of COVID-19 were divided into the hydroxychloroquine group (400 mg/week for eight weeks) and the routine-care group. Serum CRP levels and the frequency of T-helper (CD4+ cells) and T-cytotoxic (CD8+ cells) were assessed at the beginning and end of the study. The groups were compared in terms of White Blood cells (WBCs), polymorph nuclear cells (PMNs), lymphocytes (LYM), hemoglobin (Hb), and platelets (Plt.). Results: The results revealed no significant differences between the two groups in terms of WBC, PMN, LYM, Hb, Plt., CD4, and CD8. The mean difference of the CD4:CD8 ratio showed a significantly higher decrease (P=0.05) in hydroxychloroquine group than in the control group (0.18 vs. 0.02). The incidence of COVID-19 was 15% (95%CI: 12-18%) in the control group and 10% (95%CI: 8-12%) in the intervention group; however, no significant difference was observed between the two groups in this regard (P=0.45). Conclusion: Our study findings boost an increasing level of evidence that hydroxychloroquine is not an effective prophylactic medication against COVID-19 and might even exacerbate the profile of pandemic containment efforts by adding more pain to patients’ life and healthcare services.


2015 ◽  
Vol 5 (3) ◽  
pp. 166-176 ◽  
Author(s):  
Tamar Kabakian-Khasholian ◽  
Rawan Shayboub ◽  
Mona Kanaan ◽  
Ziyad Mahfoud ◽  
Faysal El Kak

This study examined the effect of providing evidence-based information to women and enabling them to use effective communication skills on requesting changes in maternity care. A cluster randomized controlled trial was conducted where pregnant women, from 65 private obstetric clinics, were recruited from 2 regions in Lebanon. The intervention consisted of 2 prenatal sessions on evidence-based care and effective communication skills. Women in the intervention arm were more likely to request not to have an enema (odds ratio [OR] = 5.57; confidence interval [CI] = 2.44–12.71), to request keeping their infants for prolonged time in their room (OR= 2.1; CI = 1.43–3.09), and to actually being able to keep their infants in their rooms for longer periods (OR= 2.39; CI = 1.13–5.04), compared to women in the control arm. Knowledge on best practices was significantly improved. Informing women about best practices and enhancing communication skills with providers of care can facilitate change in the provision of health services. More consideration needs to be given to the commitment of health care providers and senior staff within hospitals to ensure the scaling up of such interventions.


2021 ◽  
pp. 019394592110276
Author(s):  
Ebru Cayir ◽  
Tim Cunningham ◽  
Ryne Ackard ◽  
Julie Haizlip ◽  
Jeongok Logan ◽  
...  

Contemplative practices promote well-being, work engagement and resilience among health care providers. We examined the impact of The Pause, a brief contemplative intervention, on health care providers’ physiological stress response. Participants were randomly assigned to either The Pause or the control group. They participated in a high-fidelity, stressful medical simulation. Following the simulation, intervention group practiced The Pause. Outcome measures were heart rate variability, heart rate, and blood pressure. We adjusted for baseline physiological variables, sociodemographic variables, self-care practices, and perceived stress. Participants in the intervention group had a standard deviation of the normal-to-normal RR intervals (heart rate variability indicator) that was 13.8 (95% CI 4.0, 23.5; p < .01) points higher than those in the control group. There were no significant effects of The Pause on heart rate or blood pressure. The Pause may reduce stress reactivity, increase heart rate variability, and enhance resilience in health care providers.


2020 ◽  
Vol 35 (Supplement_1) ◽  
pp. i65-i75
Author(s):  
Afrah Mohammedsanni Omer ◽  
Demewoz Haile ◽  
Bilal Shikur ◽  
Erlyn Rachelle Macarayan ◽  
Seifu Hagos

Abstract The World Health Organization (WHO) recommends the need for a strong nutrition training package for practitioners, including antenatal care (ANC) providers. Without such a training package, ANC visits remain a missed opportunity to address nutritional problems among pregnant women. This study evaluated the effectiveness of an in-service nutrition education and counselling package on the providers’ counselling skills during ANC visits. A cluster randomized controlled trial was conducted in Addis Ababa, Ethiopia. All health-care providers working in ANC units across 20 health centres participated in this study. Health centres were allocated to intervention and control arms using a matched-pair randomization technique. An in-service nutrition education and counselling package, including training for ANC providers, supportive supervision and provision of modules, pamphlets and job aids, was provided for health centres assigned to the intervention arm. Observation checklists were used to assess the counselling skills of health-care providers. We used mixed-effect linear regression to evaluate the impact of the intervention. Significantly more health-care providers in the intervention arm informed pregnant women about the need to have one additional meal (Difference in proportion [DP] 49.17% vs −0.84%; DID 50.0%), about minimum required dietary diversity (DP 72.5% vs −2.5%; DID 75.0%) and about gestational weight gain (DP 68.33% vs −8.33%; DID 76.6%). Furthermore, providers improved in identifying key difficulties that pregnant women face (DP 28.34% vs −2.5%; DID 30.8%), and in recommending simple achievable actions on nutrition during pregnancy (DP 20.8% vs −10.9%; DID 31.6%). The intervention did not have statistically significant effects on how providers informed women about early initiation of breastfeeding (DP 6.67% vs 9.17%; DID −2.5%). The comprehensive in-service nutrition education and counselling package improved how ANC providers engaged with pregnant women and delivered nutrition messages during ANC consultations. This trial was registered in the Pan African Clinical Trial (PACTR registry, PACTR20170900 2477373; Date issued 21 September 2017).


2018 ◽  
Vol 7 (3) ◽  
pp. 301-305
Author(s):  
Morvarid Ghasab Shirazi ◽  
Shahnaz Kohan ◽  
Firoozeh Firoozehchian ◽  
Elham Ebrahimi

Objectives: Childbearing is considered as a great event in the lives of many women while the effect of pain on this event is undeniable. Thus, the think of pain and how to overcome it has engaged the minds of women, their family, and health-care providers. The birth ball is one of the non-invasive methods of pain control. Therefore, the present study aimed to evaluate the effect of the birth ball on the pain and self-efficacy of pregnant women during the childbirth process. Materials and Methods: This study was a randomized clinical trial. A total of 178 participants were selected based on the specific selection criteria and randomly allocated to control and intervention groups. The women in the intervention group were asked to join a planned exercise with the birth ball including a 20-minute well-defined exercise three times a week for 6–8 weeks at home whereas those in the control group followed up the routine prenatal cares. The questionnaires were completed by the participants at the four and eight-centimeter cervical dilations. Results: Based on the results, birth ball exercises could significantly improve childbirth self-efficacy and pain so that labour pain was lower in this group of women as compared to the other group (P<0.001 in both cervical dilatations). In addition, the score of selfefficacy was higher in the intervention group compared to the control group (P<0.001). Further, the result of generalized estimating equation model showed that birth ball exercise can decrease the childbirth pain. However, part of this effect may be related to an increase in the patients’ self-efficacy (30%-40%). Conclusions: In general, although birth ball exercise could decrease the childbirth pain, part of this effect was probably associated with an increase in self-efficacy of the patients.


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