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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 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

GECo2
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 Not yet recruiting - Depression Clinical Trials

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

PM+
Start date: December 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

COBIN-D
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.

NCT ID: NCT03285399 Completed - Clinical trials for Malnutrition, Infant

Bhaktapur Maternal and Child Micronutrient Study

Start date: January 12, 2008
Phase: N/A
Study type: Observational

Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were randomly selected in this nutritional survey. The dietary intake, nutritional status of several nutrients, growth, and breastfeeding habits were measured in both the women and their infants.The objective of this first phase was to estimate the intake and status of several nutrients in relation to breastfeeding. These mother-child pairs were revisited around the child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of this phase was to create a cohort study where factors in infancy could be related with health outcomes and development 5 years later.

NCT ID: NCT03275935 Completed - COPD Asthma Clinical Trials

Evaluation of Inhalation Technique in Patients With COPD, Asthma or ACOS Using a Dry Powder Device (DPI)

Start date: March 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

This study analyzes the prevalence of patients using inhalation devices via incorrect technique and access the adherence of patients to correct inhalation technique when taught along with their subjective improvement of symptoms.

NCT ID: NCT03231761 Recruiting - Depression Clinical Trials

Impact of Video Presentations on Medical Students' Attitudes Toward Mental Illness

Start date: August 21, 2017
Phase: N/A
Study type: Interventional

This is a randomized controlled trial examining the impact of videos on medical students' implicit and explicit attitudes and knowledge related to mental illness in Nepal. Medical students are randomized to one of three conditions: (a) no video, (b) a didactic video based on the mental health Gap Action Programme (mhGAP) modules for depression and psychosis; and (c) videos with personal testimonials from mental health service users with depression and psychosis.