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NCT ID: NCT03447340 Recruiting - Hypertension Clinical Trials

Nepal Pioneer Worksite Intervention Study

Start date: November 9, 2016
Phase: N/A
Study type: Interventional

The proposed project will develop, implement, and test methodology for the design of an acceptable, effective intervention for diabetes prevention in a real-world setting. By determining the effectiveness of the intervention, the study will serve to guide the translation of research into routine public health prevention programs and policy. And, the hands-on experience will directly support the development of expertise, tools and training to advance translational science as a discipline. The study aims to test the effectiveness of an environmental and individual level intervention to prevent diabetes at Dhulikhel Hospital-Kathmandu University Hospital (DH-KUH), Nepal. Specific aims are to measure: Effectiveness of a canteen intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) [HbA1c decrease ≥0.5%; a systolic blood pressure decrease (SBP) ≥5 mm Hg; and plasma triglycerides decrease ≥10 mg/dl] Effectiveness of a behavioral intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) [HbA1c decrease ≥0.5%; SBP decrease ≥5 mm Hg; and plasma triglycerides decrease ≥10 mg/dl] Effectiveness of a canteen intervention on change in HbA1C and healthy food intake after six months of the canteen only (CO) intervention compared to the change over six months during the control period. Effectiveness of a behavioral intervention on change in Hba1c and healthy food intake after six months of behavioral intervention plus the canteen (CB) intervention compared to the change over six months during CO. We will recruit 366 adult employees of DH-KUH. At baseline (T1), 6 months (T2), 12 months (T3) and 18 months (T4), we will administer a standard questionnaire to record relevant characteristics of the participants (age, sex, education, income, marital status, and family history of CVD, physical activity, smoking, alcohol intake and diet). We will abstract food consumption data from the administrative database in DH-KUH. Blood samples will be collected and analyzed for HbA1c, fasting glucose, and lipid profile (HDL, LDL, total cholesterol, triglycerides). We will measure height, weight, waist circumference, hip circumference, and blood pressure. After 6 months of control period, the participants will receive the canteen intervention: (a) form and train a canteen improvement team; (b) train canteen staff on healthy cooking; (c) add healthy food and remove unhealthy food; (d) information and communication of canteen changes to employees; (e) monitoring of the interventions. After six months of the canteen intervention, half of the participants will be randomized to receive the behavioral intervention. The behavior intervention will be a combination of intensive education sessions, group counselling, goal setting and monitoring based on the Diabetes Prevention Program (DPP). The primary analysis will use χ^2test use to compare (a) Proportion of individual with score ≥ 2 during CO intervention to the proportion of individual with score ≥ 2 during the control period; (b) Proportion of individual with score ≥ 2 during CB intervention to the proportion of individual with score ≥ 2 during CO intervention. We will conduct a logistic regression with the proportion of individual with score ≥ 2 as outcome and CO vs CB as exposure at T4. Secondary analysis will use paired t-test to compare (a) the change in healthy food intake and HbA1c during CO to the change in healthy food intake and HbA1C during the control period (b) the change in healthy food intake and HbA1C% during CB to the change in healthy food intake and HbA1C% during CO period. We will conduct linear regression with HbA1c% as the outcome and CO vs CB as the exposure variable at T4. Further analysis will adjust for confounding in time-varying variables and assess effect modification.

NCT ID: NCT03427502 Not yet recruiting - Nasal Polyps Clinical Trials

Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

Start date: April 2018
Phase: N/A
Study type: Interventional

Postoperative agitation is an important complication of general anesthesia, moreover, it has been found with high incidence in ear, nose, throat (ENT) surgeries. We aim to study whether anterior ethmoidal nerve block will be successful in reducing postoperative agitation in those patients. Study population will be randomized into two groups, treatment and control group. Anterior ethmoidal nerve block will be done in treatment group and postoperative agitation compared between these two groups. Agitation score will be scored with Riker Sedation-Agitation Scale (SAS). Ho: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is equal in those with ethmoidal nerve block as compared to those without the block. Ha: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is not equal in those with ethmoidal nerve block as compared to those without the block.

NCT ID: NCT03382548 Not yet recruiting - Clinical trials for Ventilator Associated Pneumonia

Defining Antibiotic Treatment Duration for Ventilator - Associated Lung Infection

Start date: June 2018
Phase: Phase 3
Study type: Interventional

Intensive care units (ICUs), with high antibiotic consumption, are epicentres of antimicrobial resistance (AMR). Ventilator associated pneumonia (VAP) is the commonest hospital-acquired infection (HAI) in ICUs and is associated with a high morbidity and mortality in these vulnerable patients despite antibiotic therapy. No well-designed clinical trials studying antibiotic duration for VAP caused by predominantly non-fermenting Gram-negative bacteria have been conducted to date. Shortening antibiotic duration has the potential to improve individual patient outcomes and indirectly benefit other patients by reducing the selection pressure for multidrug resistant (MDR) bacteria within the ICU. This study aims to show non-inferiority of short antibiotic treatment duration (7 days or less) versus long antibiotic therapy (8 days or more) for VAP. Patients who have been ventilated for more than 48 hours will be screened daily for signs and symptoms of VAP according to the US Centers for Disease Control and Prevention VAP criteria. Recruited patients will be reviewed daily for clinical signs of stability including temperature <38°C for 48 hours, systolic blood pressure >90mmHg without inotropes. Recruited patients will be randomised once they fulfill these clinical criteria of stability. In the intervention arm, antibiotics should be stopped within 7 days once the above criteria are fulfilled. In the control arm, antibiotics should be at least 7 days with the exact duration decided by the managing physicians. The primary outcome of the study is a combined endpoint of mortality and VAP recurrence at day 60 of recruitment. The study hypothesis is that a shorter duration of treatment for VAP (7 days or less depending on clinical response) is noninferior to a longer duration (8 days or more). The secondary outcomes of the study include clinical parameters such as rate of acquisition of MDRO hospital-acquired infections, duration of ventilation and hospitalization and days of antibiotics use. The study team will also characterise the microbiome changes in study participants according to the type and duration of antibiotics. MDROs collected will undergo whole genome sequencing for transmission dynamics study. The study is a multinational multicenter study involving hospitals in Asia.

NCT ID: NCT03371186 Recruiting - Clinical trials for Reproductive, Maternal, Newborn, and Child Health

Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot

Start date: February 2016
Phase: N/A
Study type: Interventional

The investigators will conduct a cluster-controlled, stepped wedge implementation science trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery intervention within an approximate population of 300,000 people in rural Nepal. This intervention integrates five evidence-based approaches for reproductive, maternal, newborn, and child health focused on the "golden 1000 days" from conception through age two: 1) Community Health Worker model of home-based care to monitor and increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers; 2) Continuous surveillance of all pregnancies and children via an integrated electronic medical record; 3) Delivering community-based integrated management of newborn and childhood illness (CB-IMNCI) via CHWs; 4) Group antenatal and postnatal care to improve care delivery and reduce mortality during the "golden 1000 days" from conception to age two; and 5) Balanced counseling to increase post-partum contraception.

NCT ID: NCT03367130 Recruiting - HIV Infections Clinical Trials

Improving Clinic Attendance for Medication Collection Among HIV Positive Individuals in Nepal

Start date: December 5, 2017
Phase: N/A
Study type: Interventional

Antiretroviral therapy (ART) has been a game changer in the context of HIV-epidemic. From 2005 to 2015, HIV-related deaths have fallen by 45% thanks to ART. However, ART's success heavily depends on HIV-positive individuals' high adherence to it. This includes clinic attendance for various purposes. It is necessary among HIV-positive individuals for their antiretroviral (ARV) pills pick up, monitoring of their treatment outcomes, and treatment of their opportunistic infections. Among them, ARV pills pick up is the major reason for the ART clinic attendance. Improving clinic attendance for pills pick up remains one of the key challenges to ART programs. The World Health Organization (WHO) recommends more than 90% on-time ARV pills pick up as per the early warning indicators of HIV-drug resistance. Among six Asian countries, none of the 1048 clinics under the study could meet the WHO target. Among HIV-positive individuals, clinic attendance for pills pick can be improved by using mobile phones. Those who receive mobile phone reminders are two times more likely to attend their clinics regularly than those who did not receive such reminders. Nepal belongs to a low-income country and is facing a similar problem, too. In 2015, approximately 39,000 people were estimated to be living with HIV and ART coverage was limited to only 31.5%. In the same year, only 32% of the HIV-positive individuals attended their clinics regularly for ARV pills pick up. Like other countries, one of the potential strategies is to use mobile phones effectively in Nepal. Mobile phones have been very widely used in Nepal. In 2016, Nepal had 27.9 million mobile phone users, against the population of 26.5 million. Under such a context, mobile phone reminders can be effective to improve clinic attendance among HIV-positive individuals. However, the effectiveness of such interventions barely remains examined by using a randomized controlled trial. This study evaluates the effectiveness of mobile phone reminder intervention on improving clinic attendance for ARV pills pick up and medication adherence among HIV-positive individuals on ART following the implementation of test and treat strategy in Nepal.

NCT ID: NCT03359915 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries

Start date: December 2017
Phase: N/A
Study type: Interventional

This study will randomise people with clinically significant COPD (GOLD Grade B-D) to usual care or provision of a self-management action plan supported by monthly follow-up visits from a community health worker trained in the use of the action plan. The primary outcome will be health-status: a comparison of the change in St. George's Respiratory Questionnaire (SGRQ) between baseline and 12 months in the two groups. We will randomise 240 people from three low- and middle-income countries, namely Nepal, Peru and Uganda. We will also examine the feasibility of implementing our self-management action plan intervention at scale.

NCT ID: NCT03359486 Recruiting - Depression Clinical Trials

Pilot Feasibility Study of Psychosocial Support to Improve Well-being of Adults in Humanitarian Crises in Nepal

Start date: December 17, 2017
Phase: N/A
Study type: Interventional

This is a pilot feasibility study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate feasibility and acceptability of the intervention to determine procedures and content for a subsequent full trial using a cluster-randomized design of group problem management plus versus enhanced treatment as usual.

NCT ID: NCT03349736 Recruiting - Clinical trials for Urinary Incontinence

Pelvic Floor Muscle Training of Pregnant Women in Nepal: Feasibility, Compliance and Outcome

Start date: June 25, 2017
Phase: N/A
Study type: Interventional

To our knowledge, no studies in Nepal have reported the feasibility of performing the Pelvic Floor Muscle Training (PFMT) in Nepalese women. The aim of the study is to develop and implement a Pelvic Floor Muscle(PFM) physiotherapy program based on information, education and exercise in order to prevent or reduce Pelvic organ prolapse(POP) and Urinary Incontinence (UI) in pregnant Nepalese women The women will receive information (leaflet, video, posters) and instruction/guidance on PFM exercise. Following this, the women are advised to perform daily home PFM exercise Women will record their home PFM exercises using an exercise diary. Further, pre and post study design will be conducted to assess the change in PFM activation.

NCT ID: NCT03346629 Not yet recruiting - Clinical trials for Abortion in Second Trimester

Outpatient Service for Mid-trimester Termination of Pregnancy

Start date: December 2017
Phase: Phase 4
Study type: Interventional

This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose of 200 mg mifepristone to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally every three hours until the abortion is achieved.

NCT ID: NCT03304158 Active, not recruiting - Clinical trials for Type 2 Diabetes Mellitus

Community Based Management of Diabetes in Nepal

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Type 2 diabetes is the largest growing concern across the globe, and this is particularly apparent in developing countries, including Nepal. Despite the growing burden and chronic nature of diabetes, prevention and control of this disease is far from adequate setting in Nepal. Moreover, there is lack of evidence on effectiveness and affordability of a population approach on reducing blood glucose level among diabetes persons. The main aim of this study is to determine the effect of Female Community Health Volunteers' (FCHVs)-led family-based health education and screening on blood sugar level in adults at community level in Nepal. This is a community-based cluster randomized controlled trial involving family based health education through FCHVs in Nepal. People ≥25 years of age listed in the Community-Based Management of Hypertension (COBIN) study and who were diabetics are eligible for eligible for participation in the study. FCHVs will conduct family based health education and fasting blood glucose measurements in the treatment arm vs not any interventions in the control arm. Independent assessors will conduct the baseline and end line assessment of the intervention. Intention to treat analysis and per protocol analysis will be used in analysis to detect significant differences between treatment and control group participants at baseline and follow up. For individual outcomes, proportions will be compared using Chi-square test and continuous measures will be compared using t-tests. Random effect mixed regression analysis will be adjusted for age and sex. Since randomisation will be at the cluster level in the study, a random-effect model will be used to account for clustering effect. Effectiveness of the intervention will be tested by analysis of covariance, which will allow us to adjust for baseline differences between groups. It is anticipated that the study can give valuable information regarding effectiveness, acceptability, and feasibility of an innovative way to improve diabetes management. Assessing the FCHVs' ability to address diabetes may contribute to develop a policy that can be scaled-up to a national level.