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NCT ID: NCT04437966 Recruiting - Hypertension Clinical Trials

Chronic Disease Self-management Program for Hypertension Control in Churches

CHIC
Start date: October 11, 2020
Phase: N/A
Study type: Interventional

In Barbados, levels of hypertension are high (40.7%) and cause of a high proportion of deaths due to cardiovascular diseases. In this study, the Stanford University-led Chronic Disease Self-Management Program (CDSMP) will be modified to form one of the basic components of a three-pronged intervention to improve blood pressure control. Our overall goal is to evaluate the effectiveness of a hypertension self-management program in community-based settings. With the advent of the Coronavirus disease 2019 (COVID-19) we recognize that it may be necessary to adapt the programme to accommodate virtual delivery. Our specific aims are to: 1. Adapt the Stanford (CDSMP) to ensure cultural appropriateness to Barbados. In view of the need to adhere to physical distance guidelines in the era of COVID-19 disease, modifications will be made to enhance virtual delivery while maintaining programme fidelity. We will engage stakeholders in performing modifications related to content, context and mode of delivery of the CDSMP program with the goal of ensuring cultural appropriateness. 2. Determine the clinical effectiveness of CDSMP combined with medication enhancement tools. We will conduct a cluster randomized trial in twelve faith-based organizations(FBOs) in Barbados. We are primarily interested in studying the changes in systolic blood pressure. Secondarily, we will also assess change in weight, medication adherence, dietary behavior and physical activity. 3. Understand the barriers and facilitators to implementation and sustainability of CDSMP plus self-monitoring tools in faith-based organizations. We will assess cost and sustainability of the intervention and qualitatively assess factors associated with barriers and facilitators of implementation in FBOs in Barbados. Impact and novelty: We aim to increase the proportion of patients with controlled hypertension leading to reduced illness and deaths from strokes and heart attacks in particular. Few studies have looked at a blended approach to CDSMP delivery and these will become more necessary in the era of COVID-19. Findings on the factors impacting implementation will be transferable to small island developing states and other predominantly black populations.

NCT ID: NCT04388540 Completed - Iodine Deficiency Clinical Trials

Caribbean Island Urinary Iodine Survey 2018

CRUISE
Start date: January 1, 2018
Phase:
Study type: Observational

Many of the Caribbean island nations have no data on iodine status in their populations. Iodine deficiency in children can reduce IQ but can be easily corrected through a program of salt iodization. The study will be located at 11 islands of the Caribbean region. At each of the 11 study sites, we will measure the iodine status in school-age children by collecting morning spot urine samples for measurement of urinary iodine concentration (UIC). We will also measure height and weight in all children. We will collect a repeat, next-day spot urine sample in 1/3rd of children to adjust for intra-individual variation in spot UIC and calculate the distribution of population intake.

NCT ID: NCT03536377 Recruiting - Clinical trials for Diabetes Mellitus Type 2 in Obese

Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community

Start date: February 11, 2019
Phase: N/A
Study type: Interventional

The complications associated with uncontrolled type-2 diabetes mellitus (T2DM) are numerous; reducing the quality of life for the patient and consuming a considerable portion of healthcare finances. The Health of the Nation (HotN) 2011 study reported that 50% of the Barbadian population >65years old had a diagnosis of T2DM and that two-thirds of the population were overweight - which is a risk factor for the development of T2DM. Encouraged by the success of the Counterpoint study in the United Kingdom (UK), the Barbados Diabetes Reversal Study 1 (BDRS1) was established using a similar protocol; the aim of which was to evaluate the feasibility of implementing a very low calorie diet to reverse T2DM in Barbados. At the end of the 8-week intervention period, the 25 participants had achieved an average weight loss of 10.1kg (22lbs). This was accompanied by an increase in the number of participants whose fasting blood sugars were now within normal range despite being off of their diabetes medication; and a decrease in the number of participants taking blood pressure medication. Participants transitioned to a solid diet over a 4-week period, with guidance on health dietary habits and regular exercise routines. The benefits accrued during the intervention phase were preserved at the end of the transition period. We now propose the Barbados Diabetes Remission Study 2 (BDRS2) as a sustainable community intervention - utilizing the local church as the community site. We hypothesize that this will enhance reach while reducing the cost of the study and will also facilitate the structures necessary for the social support of the participant.

NCT ID: NCT03258723 Recruiting - Diabetes Clinical Trials

Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

LIME
Start date: July 30, 2018
Phase: Phase 4
Study type: Interventional

Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes. Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle intervention, with escalation to Metformin therapy will lower the incidence of diabetes among the highest risk pre-diabetic individuals of Caribbean-descent.

NCT ID: NCT02321150 Unknown status - Pterygium Clinical Trials

A Novel Technique for the Removal of Pterygiums

Start date: December 2013
Phase: N/A
Study type: Interventional

The aim of this study is to introduce a new surgical technique for the removal of pterygiums that entails the use of bipolar electrocautery to secure the graft, rather than sutures. With this, the objective is to evaluate the benefits of a new technique for pterygium surgery with respect to postoperative patient comfort, surgery time, cost and recurrence rate.

NCT ID: NCT02313805 Recruiting - Diabetes Mellitus Clinical Trials

The Effect of a Checklist on the Quality of Education During Insulin Initiation by Trained Medical Students

Start date: July 2014
Phase: N/A
Study type: Interventional

Diabetes prevalence continues to rise worldwide, leading to the increasing use of insulin. This especially applies to developing countries where the needle-and-syringe method of administration remains the most affordable and effective form of hyperglycemic treatment. Competent health care professionals are required to ensure safe insulin initiation. The investigators will evaluate a teaching intervention on insulin initiation for medical students, and whether after experiencing that intervention the use of a checklist, during simulate insulin initiation, improves the education they provide to patients.

NCT ID: NCT02266303 Recruiting - Insulin Checklist Clinical Trials

The Effect of a Checklist on the Education of Simulated Patients During Insulin Initiation

Start date: July 2014
Phase: N/A
Study type: Interventional

The increasing prevalence of diabetes is associated with increased insulin use. In developing countries it is frequently necessary to use insulin, with the needle and syringe method of administration being the cheapest approach. Competence of health care professionals is required to safely initiate insulin. The investigators will evaluate whether using a checklist during insulin initiation with a needle and syringe, can improve the safety and efficacy of its use.

NCT ID: NCT02059122 Completed - Infectious Diseases Clinical Trials

Sensitivity Study of Diagnostic for Early Detection of Dengue Infection

Start date: April 2011
Phase:
Study type: Observational

This study is a multi-site trial assessing the sensitivity of DENV Detect™ NS1 ELISA versus standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US and internationally. The DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages of Dengue infection in patients with clinical symptoms consistent with Dengue infection. This test is intended to be used on sera obtained within the first 7 days of symptoms. DENV Detect™ NS1 ELISA results (positive or negative) must be confirmed by testing with a reference standard test. Subjects will be patients who present with symptoms consistent with dengue infection, such as fever and myalgia. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected. The first will be collected within the first 7 days of symptoms onset, and the second will be collected at least 7 days later, between the 10th and 21st days post-onset of symptoms. ELISA and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.

NCT ID: NCT01994811 Active, not recruiting - Cancer Clinical Trials

Eastern Caribbean Health Outcomes Research Network (ECHORN)

ECHORN
Start date: April 2013
Phase:
Study type: Observational

The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research study that examines the lifestyles, eating habits, and health behaviors associated with cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean.

NCT ID: NCT01002521 Not yet recruiting - Diabetes Mellitus Clinical Trials

Wound Healing In Diabetes (WHy) Study

WHy
Start date: December 2009
Phase: N/A
Study type: Observational

This observational study aims to identify risk factors and molecular mechanisms of impaired wound healing, to guide better foot care in the diabetic population.