Clinical Trials Logo

Filter by:
  • Not yet recruiting  
  • Page [1] ·  Next »
NCT ID: NCT06253676 Not yet recruiting - Clinical trials for Post Partum Depression

Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

StandStrong
Start date: April 2024
Phase: N/A
Study type: Interventional

In certain low- and middle- income country settings, there is a disproportionate level of untreated postpartum depression that presents both acute and long-term risks to a mother's well-being. Although there is increasing willingness among health systems to involve non-specialists, such as community health workers, in the delivery of psychosocial interventions for postpartum depression, the effectiveness of these interventions has been mixed. The incorporation of digital technology, though, has the potential to improve the effectiveness of non-specialist-delivered interventions. The goal of this clinical trial is to evaluate the acceptability and clinical efficacy of the StandStrong intervention- a non-specialist, passive sensing technology-informed (i.e., digital) mental health intervention- as compared to a standard non-specialist mental health intervention among postpartum-depressed mothers in Nepal. Successful completion of the trial will contribute to the optimization of psychosocial intervention delivery for the postpartum context in low- and middle-income country settings.

NCT ID: NCT06230835 Not yet recruiting - Hypertension Clinical Trials

Community Health Worker Led Hypertension Prevention and Control

CHPC
Start date: April 2024
Phase: N/A
Study type: Interventional

With its high prevalence and concomitant increased risk of cardiovascular disease (CVD), hypertension (HTN) is a major global public health challenge. About 13.5% of premature deaths, 54% of incident stroke and 47% of incident coronary heart disease (CHD) worldwide are attributed to high blood pressure (BP). In Nepal, the prevalence of HTN among adults is 25% is similar to the global prevalence. In Nepal, however, a comparatively larger proportion of adults (44%) are unaware of their HTN status, 33% of HTN patients are receiving treatment, and only 12% of the patients have their BP under control. There are proven evidence-based interventions that have been recommended for the prevention and control of HTN including weight loss; healthy diet incorporating reduced sodium, increased fruits and vegetables, and reduced saturated fats; increased physical activity; lowered alcohol; and anti-HTN medications. Despite the availability of these proven effective lifestyle changes and low-cost anti-HTN treatment in preventing major vascular events and total mortality, these recommendations have not been translated into practice to improve population health. In Nepal, the Package of Essential Non Communicable Diseases (PEN) Implementation Plan (2016-2020) was adopted in line with the Multi-sectoral Action Plan for the prevention and control of non communicable diseases (NCD). The PEN includes protocols to detect and manage HTN at the basic health facilities that provide primary health care incorporating all of the above-mentioned evidence-based interventions. However, our just-concluded study to evaluate the implementation of PEN in Nepal (1R21TW011718-01) demonstrated major implementation barriers at multiple levels that cannot be addressed by just health facility-based PEN: (a) Individual level: b) Interpersonal level (c) Community level (d) Organizational level. In response to these multi-level implementation barriers, investigators propose to implement and evaluate a new task-shifting strategy to community health workers (CHW), leading to improved HTN prevention and control. Task-shifting has been proposed as a potential solution to not only address an overburdened health care system but also as a viable method for implementing primary and secondary prevention at the community-level. There is growing evidence that HTN patients can be cared for by CHW in other settings.

NCT ID: NCT06145113 Not yet recruiting - Clinical trials for Acute Mountain Sickness

The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness

Start date: March 10, 2024
Phase: N/A
Study type: Interventional

Acute Mountain Sickness (AMS) is a common condition affecting individuals traveling to elevations greater than 2500 meters (8200 feet). While more gradual ascent profiles, as well as the use of acetazolamide, have been shown to decrease the incidence of AMS, it remains a common condition that can affect anyone who travels to altitude. Many pharmacologic options for treatment of AMS exist, however these are not always effective or able to be taken by all patients. Continuous positive airway pressure (CPAP) has been shown in some small studies and reports to be a potential non-pharmacologic method of both preventing and treating AMS. No large trials to validate the efficacy of CPAP in altitude related illness have been done. This study aims to evaluate the degree to which CPAP can improve symptoms of AMS, as well as improve oxygen saturation among individuals traveling in a high altitude location.

NCT ID: NCT06129253 Not yet recruiting - HPV Infection Clinical Trials

Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)

HPV
Start date: November 2023
Phase:
Study type: Observational

This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk (HR) HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women. The data to fulfill the objectives will be collected through a series of Cross-Sectional Surveys (CSS) and Longitudinal Studies (LS) in all 8 countries 3 South Asian countries including Bangladesh, Pakistan, Nepal and 5 sub-Saharan African countries including Sierra Leone, Tanzania, Ghana, Zambia and DR Congo. Qualitative sub-studies (QS) will be conducted in selected countries and populations following the CSS to further understand and unpack risk factors for HPV infection as well as to explore how gender-related dynamics including perceptions of gender norms and stigma, influence HPV burden and/or create barriers that shape girls/women access to and uptake of HPV prevention, screening, and treatment services. Specific study protocols and corresponding ethical applications for the qualitative sub-studies will be developed separately.

NCT ID: NCT06081010 Not yet recruiting - Hypertension Clinical Trials

FCHV-HTN Implementation Trail in Nepal

CHPC
Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this hybrid type III study incorporating a cluster-randomized trial is to assess the effect of a community health worker-led hypertension prevention and control program (CHPC) on the implementation outcomes and clinical outcomes among patient with hypertension in central Nepal. The main questions it aims to answer are: 1. What is the level of implementation outcomes, including reach, adoption, implementation fidelity, and maintenance of the CHPC implementation strategy at the patient, provider, and health system levels? 2: What is the effectiveness of the CHPC implementation strategy compared to facility-based intervention on systolic BP via a cluster randomized controlled trial. 3: What is the implementation cost and cost-effectiveness of the CHPC implementation strategy? Participants will receive counseling and blood pressure monitoring services at their home every four months for a year by a community health worker. Researchers will compare if there is a significant difference in systolic blood pressure between those who receive this intervention and those who do not receive the intervention in the same community.

NCT ID: NCT06026527 Not yet recruiting - Post-operative Pain Clinical Trials

Intra-operative Magnesium Sulphate for Post-operative Pain in Patients Undergoing Total Abdominal Hysterectomy Under General Anesthesia

Start date: October 2023
Phase: Phase 3
Study type: Interventional

Post-operative pain management is a complex entity. It is one of the most critical parameters in the enhanced recovery after surgery protocol. Adequate postoperative pain relief leads to earlier mobilisation, shortened hospital stay, reduced hospital costs and increased patient satisfaction. For post-operative analgesia, opioids have long been the mainstay of drugs used; however, they produce unwanted side effects, such as respiratory depression, nausea, vomiting and dependence. The major goal in postoperative pain management is to minimise the dose of a single medication and lessen its side effects, while still providing adequate analgesia by the use of multimodal analgesia. Paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), regional techniques like epidural analgesia, different kind of blocks and local wound infiltration are some of the components of multimodal approach to post- operative analgesia. Besides, there are some drugs that may be used as adjuvants to opioids to enhance the analgesic efficacy and facilitate opioid sparing with a reduction in opioid related side effects. Magnesium sulphate, due to its N- Methyl D- Aspartate (NMDA) blocking property, has been studied as one of such non opioid adjuvants. The outcome of many of these studies is in favour of magnesium sulphate but there are negative reports as well. So, in this study the investigators aim to evaluate the efficacy of intra-operative intravenous magnesium sulphate for post-operative pain and opioid use in patients undergoing abdominal hysterectomy under general anaesthesia.

NCT ID: NCT05979168 Not yet recruiting - Hypertension Clinical Trials

Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal

TelTex4BP
Start date: August 2023
Phase: N/A
Study type: Interventional

Despite evidence of preventing cardiovascular disease (CVD) risk through lifestyle changes, many patients with hypertension (HTN) do not comply with this and suffer from CVD and other complications. A previous study using a structured lifestyle intervention program has reported a 14% decrease in the 10-year risk of developing CVD at one year among hypertensive and diabetes patients. Low and Middle-Income countries (LMICs) struggle with a shortage of health workers to deliver such interventions. In this context, mobile phones can contribute to bridging this gap by incorporating them into the health system for health intervention delivery. There is a need to develop contextual mHealth intervention adapted to local needs and culture and test its effectiveness in LMIC settings like Nepal. Our previous small-scale pilot mHealth (text messages) study reported promising evidence in reducing blood pressure among hypertensive patients in the intervention arm [adjusted reduction in systolic blood pressure (BP) -6.50 (95% CI, -12.6; -0.33) and diastolic BP -4.60 (95% CI, -8.16; -1.04)], with a greater proportion achieving target BP (70% vs 48% in the control arm, p = 0.006)] and improving treatment compliance (p < 0.001) in Nepal. This finding supports the expansion to a large-scale trial of a structured mHealth intervention to see its long-term effectiveness and sustainability for patients with HTN to improve BP control and reduce CVD risk. Hence, this study aims to assess the effectiveness of a behavioural intervention through mHealth (telephone/mobile phone calls and text messages) informed by the RE-AIM framework for improving blood pressure control among patients with hypertension in a hospital (Manamohan Cardiothoracic Vascular and Transplant Center) of Kathmandu, Nepal.

NCT ID: NCT05921526 Not yet recruiting - Pneumonia Clinical Trials

Effectiveness of Point-of-care Lung Ultrasound for the Management of Childhood Lower Respiratory Infections

ELUS
Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effectiveness of point-of-care lung ultrasound versus chest X-ray for the management of childhood lower respiratory infections in a low-resource setting. The main question it aims to answer is: Is point-of-care lung ultrasound as effective as chest X-ray for the management of childhood LRIs in a low-resource setting? Participants will be assigned to either a point-of-care lung ultrasound group (intervention) or a chest X-ray group (control), to compare the effect on overall case management and various clinical outcomes (time to symptom resolution, rate of antibiotic use, length of stay, treatment costs).

NCT ID: NCT05697822 Not yet recruiting - Maternal Health Clinical Trials

Using Advanced Data Systems to Improve Health in Early Life in Rural Nepal

CITH
Start date: March 2023
Phase: N/A
Study type: Interventional

The goal of this cluster randomized controlled trial is to study the effect of a mobile-phone based application used by pregnant women on maternal and newborn health indicators. The main objective is to compare the rates of institutional deliveries in the intervention and control arms. Ancillary objectives are to compare the birth-preparedness and complication readiness parameters, severe maternal morbidity rates and neonatal adverse outcomes rates in the two arms. The participants are pregnant women. In the intervention arm pregnant women will be given a smart mobile phone with an application that they will use to input information related to their health. This information can be shared with their healthcare workers. The healthcare workers will also be able to access all the health-related details of the pregnant women and mothers under their care by accessing this app in their mobile phones and be in touch with their patients through the mobile phone application. The control arm will adhere to existing practices of pregnant woman and health worker communication without the use of a smart mobile phone with an existing application. Records related to the pregnant woman will be kept in paper-based forms as is the usual norm. The investigators will compare the intervention arm and the control arm to see if there are differences in the rates of the outcomes.

NCT ID: NCT05525429 Not yet recruiting - Undernutrition Clinical Trials

Enhancing Milk Consumption by Vulnerable Household Members in Rural Nepal

Start date: February 2024
Phase: N/A
Study type: Interventional

Diet quality is generally poor in rural Nepal, especially among vulnerable household members. Consumption of milk (and other animal source foods [ASF]) could contribute to improvements in diet quality. However, multiple cultural, structural and economic barriers constrain the inclusion of ASF in the diet in these households, even though most raise dairy animals. This study will 1. characterize these barriers in detail 2. conduct a randomized controlled trial to test a multi-dimensional behavior change intervention designed to increase ASF/milk consumption by young children 6-60 months, adolescent girls 10-15 years, and women of child-bearing age (WCBA). Matched clusters of villages in Kapilbastu and Nawalparasi districts (Nepal) will be randomized to Intervention or Control status. Household surveys will be conducted at baseline and 12 months later to collect demographic, diet, feeding practices, nutrition knowledge, etc. Fathers and adolescent girls will respond to mini-surveys. Growth parameters of children, adolescent girls, and WCBA will be assessed. The intervention consists of 4 components: 1) didactic training (mothers, fathers, adolescent girls), 2) participatory learning activities (mothers, fathers, adolescent girls), 3) model kitchens (mothers, adolescent girls), and 4) Nutrition Club (adolescent girls). The primary outcome will be the impact of the intervention on diet, household feeding practices, and nutrition knowledge.