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NCT ID: NCT04834999 Not yet recruiting - Mental Disorder Clinical Trials

Validation of Instruments for Clinical Trial on Patients With Bipolar Disorder in Rwanda

Start date: April 15, 2021
Phase:
Study type: Observational

This study evaluates the cultural and linguistic sensitivity and psychometric properties of a set of four adapted measurement instruments essential to determining the efficacy of group-psychoeducation for patients with bipolar disorder in Rwanda, and one screening tool for bipolar disorder. The four well-known instruments are; The Young Mania Rating Scale (YMRS), The Medical Adherence Scale (MARS), The Internalized Stigma of Mental Illness Scale-9 (ISMI-9), and the Mood disorder Questionnaire (MDQ). Each instrument will be culturally adapted and validated using a forward-backward translation, consensus conference, and cognitive interviews.

NCT ID: NCT04671225 Recruiting - Bipolar Disorder Clinical Trials

Psychoeducation for Patients With Bipolar Disorder in Rwanda

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

Background: Mental health- and neurological disorders constitute 13% of the global burden of disease. Alarmingly this burden has risen by 41% in the last 20 years. In low-and-middle-income countries as few as 10% of people living with bipolar disorder receive care. In western countries, the efficacy of psychoeducation, as an add-on treatment to pharmacotherapy in the treatment of symptoms and in relapse prevention initiatives with respect to bipolar disorder, is well documented. Yet, few studies on psychosocial interventions for bipolar disorder have been conducted in a low-income country. Aim: To determine the effect, feasibility and acceptability of psychoeducation for patients with bipolar disorder on all three levels of the health care system in Rwanda - at the community health centre, district- and university hospital. Methods: Patients will be randomized into either group A) group-psychoeducation at a referral hospital; or B) group-psychoeducation for both patients and relatives or C) waiting list. Moreover a district trial will test the impact and feasibility of psychoeducation at the district level. Outcomes: Reduction in symptom severity and incidence of relapse, improved quality of life, medical adherence and knowledge, as well as reduced self-stigmatization. Perspectives: If proven successful, this is of importance for closing the huge treatment gap in mental health particularly affecting low- and middle-income countries and may reduce the mortality and increase quality of life in the population suffering from bipolar disorder. Furthermore, potential positive outcomes may be implemented in similar low-resource settings elsewhere.

NCT ID: NCT04648982 Recruiting - Mental Disorder Clinical Trials

Psychiatric Inpatient Discharge Data - Rwanda

Start date: February 1, 2020
Phase:
Study type: Observational

The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda

NCT ID: NCT04567693 Enrolling by invitation - Hiv Clinical Trials

Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV

Start date: October 22, 2020
Phase: N/A
Study type: Interventional

The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). PLWH are currently required to visit the health center monthly for ART and clinical appointments for the first 18 months on ART, after which they can attend quarterly. Reducing the time to spaced-out appointments from 18 to 6 months has the potential to reduce the burden on patients and the health system, but may lead to suboptimal treatment outcomes. To better understand the effects of early spaced-out appointments as well as the degree of viral load monitoring needed to determine stability on ART, the investigators will conduct a 3-arm pilot intervention study. The investigators will randomize participants to 1) 6-month advancement to spaced-out appointments after 1 viral load measurement; 2) 6-month advancement to spaced-out appointments after 2 viral load measurements; or 3) usual care. The investigators will compare the study arms with respect to viral suppression at 12 months after enrollment in ART care (primary outcome) and appointment/ pharmacy adherence (secondary outcome).

NCT ID: NCT04556526 Recruiting - Healthy Clinical Trials

A Study of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women

INGABO
Start date: October 5, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is: a) to assess adverse maternal/fetal outcomes in pregnant women randomized to receive the 2- dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo [Group A]) and in control women (unvaccinated pregnant women [Group B]); and b) to assess adverse neonatal/infant outcomes in neonates/infants born to women randomized to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo [Group A]) and in neonates/infants born to control women (unvaccinated during pregnancy [Group B]).

NCT ID: NCT04521101 Completed - Clinical trials for To Determine the Change in Demonstrated Anesthesia Non-technical Skills After Delivery of the VAST Course

Can we Make a VAST Improvement? Promoting Anaesthetists' Non-technical Skills Through the Vital Anaesthesia Simulation Training Course in a Low-resource Setting

Start date: August 24, 2018
Phase: N/A
Study type: Interventional

Rationale: The World Health Assembly resolution 68.15 identified surgical and anesthesia care as core components of universal health coverage. However, about 5 billion people worldwide lack access to essential surgical and anesthesia services. Of the 313 million procedures undertaken each year only 6% occur in the poorest countries with an estimated 30% of all deaths globally associated with common surgical conditions. Patient safety in low-resource settings is hindered by severe workforce shortages, lack of essential resources, hierarchical culture and few opportunities for professional development. Non-technical skills (NTS), such as communication, team working, and task coordination, are vital to patient safety. Up to 70-80% of untoward events in health care are associated with errors in NTS8. The Anaesthetists' Non-Technical Skills framework (ANTS) describes behaviour markers for NTS in anesthesia. This framework has been found applicable in low-resource settings. Simulation-based education is widespread for NTS training in well-resourced countries. Traditionally, high costs have prohibited this modality in low-resource settings. Foundational work in Rwanda and at Dalhousie University has demonstrated that effective training in ANTS can be achieved through simple low-cost simulation. The Vital Anaesthesia Simulation Training (VAST) Course is a three-day simulation-based program designed de-novo to focus on core clinical practices and NTS that promote safe perioperative care in low-resource settings. The course uses low-cost materials in an immersive simulated environment to replicate common cases managed in district hospitals in low-resource settings. Realism is created with simple mannequins, iPads with the SimMon App functioning as monitoring, basic props (e.g., airway equipment, syringes, drapes), photographs of pathology, and briefing cards for scenario role-play. Purpose: To assess the impact of the VAST Course on ANTS and explore factors that influence long-term retention of ANTS amongst anesthesia providers in a low-resource setting.

NCT ID: NCT04442152 Enrolling by invitation - Stress Clinical Trials

Impact of COVID-19 on Family Dynamics on Bandebereho Study Participants

Start date: June 2020
Phase: N/A
Study type: Interventional

This proposed study will assess how COVID-19 and the associated 'stay at home' orders are affecting low-income Rwandan couples' relationships and family dynamics. The study builds on an existing randomized controlled trial of the Bandebereho fathers/couples intervention (NCT02694627), which will allow us to assess not only the current conditions in households, but also whether or how the significant impacts of the intervention are sustained under extreme stress.

NCT ID: NCT04283929 Active, not recruiting - Clinical trials for HIV/AIDS and Infections

Evaluation of Clinical Impacts and Costs of eHealth in Rwanda

Start date: September 15, 2018
Phase: N/A
Study type: Interventional

This study will estimate the impact of a suite of clinical decision-support tools on structural, process, and clinical outcomes related to HIV care. The "enhanced EMR" package under investigation will include EMR monitoring tools, data quality control procedures and support, patient reports, alerts, and reminders about patient care. This intervention will be delivered by the Ministry of Health and Rwanda Biomedical Centre and monitored by the study team led by University of Rwanda's School of Public Health and Brown University.

NCT ID: NCT04257383 Not yet recruiting - Child Development Clinical Trials

The Sugira Muryango PLAY Collaborative

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The Research Program on Children and Adversity (RPCA) has successfully grown its evidence-based home-visiting program-Sugira Muryango (SM)-in Rwanda, as policies and programs aligned with the Rwandan social protection system have evolved. The current study submission seeks to test an evidence-based implementation strategy, the PLAY Collaborative, to engage local stakeholders and frontline providers and supervisors to ensure quality improvement and sustainability of Sugira Muryango and to repeat our previous intervention to include Ubudehe 1 families with children 0-36 months in Nyanza, Ngoma, and Rubavu Districts in Rwanda.

NCT ID: NCT04230161 Recruiting - Malaria Clinical Trials

Estimating the Malaria Prevention Impact of New Nets: Observational Analyses to Evaluate the Evidence Generated During Piloted New Net Distributions in Rwanda

Start date: February 24, 2020
Phase:
Study type: Observational

The use of insecticide-treated bed nets (ITNs) has contributed to the substantial reduction in malaria cases and deaths. This progress is threatened by increasing resistance in mosquito populations to commonly used insecticides. Newly developed, next-generation ITNs using two insecticides or an insecticide synergist and an insecticide are effective against resistant mosquitoes, but large-scale uptake of these nets has been slow due to higher costs and lack of enough evidence to support broad policy recommendations. This observational study will occur alongside a pilot distribution of next-generation ITNs and collect data over three years on their entomological and epidemiological impact as well as anthropological factors that influence their uptake and use. Enhanced data collection will occur in three districts: one district that will receive Interceptor G2 ® ITN (BASF) and two comparator districts, one that will receive standard pyrethroid-only ITNs and one that will receive standard pyrethroid-only ITNs and indoor residual spraying (IRS). Data will be collected on malaria vector bionomics, disease epidemiology, and human behaviors in order to help better demonstrate the public health value of next-generation ITNs and to support donors, policymakers, and National Malaria Control Programs in their ITN decision-making and planning processes.