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 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

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 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


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.


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.


2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950


2021 ◽  
pp. 019394592110207
Author(s):  
Min Wen ◽  
Yaqin Liang ◽  
Qianqian Shen ◽  
Juping Yu ◽  
Pingping He ◽  
...  

This cluster randomized controlled trial aimed to investigate the effects of an intervention to teach resourcefulness on depression and coping style of patients with coronary heart disease (CHD). A convenience sample of 72 patients in community settings took part. Participants in the intervention group (n = 36) received an 8-week intervention based on the concept of resourcefulness, plus routine health education. Participants in the control group (n = 36) received routine health education only. After the intervention, participants in the intervention group had significantly higher scores on resourcefulness and coping styles, and lower scores on depression than those in the control group (both ps < .001). The findings suggest that a well-developed intervention to teach resourcefulness could help patients with CHD to be more resourceful, improve their level of depression, and choose more effective strategies to cope with stress.


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