EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality

NCT03987633 | Recruiting DMC

• 1 other identifier: EMPOWER-1
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

Brief Summary

Health inequality and genetic disparity are a significant issue in the United Kingdom (UK). This study focuses on diseases that are associated with significant morbidity and mortality in the UK, and specifically examines the extent and basis of treatment failure in different patient populations. The vast majority of drug registration clinical trials have under-representation of ethnic minority populations. In addition, the wider Caucasian populations have reasonably different clinical characteristics to the population that participated in the drug licencing clinical trials. A consequence of this is that drugs are licensed for use in real-world general patient populations where the clinical trial results are simply not statistically significant to specifically demonstrate efficacy or safety in populations that were either absent or under-represented in the drug registration clinical trials. When these facts are considered alongside data that supports significant under-reporting of adverse events in the real-world setting within the UK (and globally, e.g the USA and Europe), it highlights that pharmacovigilance systems are unable to capture drug effectiveness and safety data in a manner that can reasonably assure appropriate prescribing in the wider patient populations. This large real-world research study aims to identify whether commonly prescribed drugs are effective in treating illnesses that cause significant poor health and death in the different patient populations that represent the UK. The goal of this study is to generate large quantitative data-sets that may inform clinical practice to reduce the existing health inequality and genetic disparity in the UK.

Conditions

Atrial Fibrillation; Coronary Heart Disease; Cardiovascular Diseases; Heart Failure; Hypertension; Peripheral Arterial Disease; Stroke, Ischemic; Asthma; Chronic Obstructive Pulmonary Disease; Obesity; Cancer; Chronic Kidney Diseases; Diabetes Mellitus; Dementia; Depression; Epilepsy; Mental Health Disorder; Rheumatoid Arthritis; Blood Pressure; Breast Cancer Risk; Prostate Cancer; Lung Cancers

Keywords

genetic disparity; health inequality; genetics; health outcomes; equality

Outcome Measures

Primary Outcomes (1)

• Ethnic disparities in treatment failure

  Identify ethnic disparities in treatment failures for any of the 19 disease states under investigation. The primary outcome is treatment failure, as measured by the discontinuation of a treatment regimen by a clinician in the absence of the cure of the disease, for the most common treatment in each of the 19 diseases.

  Ongoing review of data, anticipated completion of primary outcome analysis 4 years post launch

Secondary Outcomes (2)

• Ethnic disparities in disease incidence

  Ongoing review of data, anticipated completion of analysis 5 years post launch

• Identification of candidate genetic variants associated with observed disparities in treatment failure.

  Ongoing review of data, anticipated completion of analysis 5 years post launch

Study Arms (2)

Displaying trait of interest

There are 19 disease areas under investigation. Enrolled patients are segmented into cohorts based on data collected through questionnaires and medical histories. This data-driven approach does not allow for precisely predefined cohorts for the diseases under investigation. Therefore, as a default, the two general predefined cohorts are set as either displaying or not displaying a trait that would form the basis of an investigation.

Not displaying trait of interest

Please see above.

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who are registered as UK NHS patients.

You may qualify if:

• Patients or their relative/family member is diagnosed with the illness being investigated by this study.
• All NHS patients that are associated with a participating study site, but do not fall under the first bullet point above, may participate with a view that they may potentially contribute to a case control population in the research study.
• Subjects agree to:
• Gift biological samples, i.e. saliva. Where practical, blood or other biological samples may be voluntarily provided by the patient.
• Provide Consent for access to medical records.
• Complete disease specific, quality of life, and study associated questionnaires.

You may not qualify if:

• Patient does not provide a valid consent for study participation.
• Patient is not registered with the NHS for care.
• Patient lacking capacity, who does not have an illness that is being specifically investigated by this clinical research study.
• Person lacks capacity and where the personal consultee has not advised that the Person may enrol, in accordance with the Mental Health Act 2005.

Sponsors & Collaborators

• Future Genetics Limited: lead

Study Sites (1)

Future Genetics, The Science Centre, Wolverhampton Science Park

Wolverhampton, West Midlands, WV10 9RU, United Kingdom

RECRUITING

Related Links

• FUTURE GENETICS website

Biospecimen

Retention: SAMPLES WITH DNA

Saliva. Where practical, blood or other biological samples may also be voluntarily provided by the patient.

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Disease; Cardiovascular Diseases; Heart Failure; Hypertension; Peripheral Arterial Disease; Ischemic Stroke; Asthma; Pulmonary Disease, Chronic Obstructive; Obesity; Neoplasms; Renal Insufficiency, Chronic; Diabetes Mellitus; Dementia; Depression; Epilepsy; Mental Disorders; Arthritis, Rheumatoid; Prostatic Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Neurocognitive Disorders; Behavioral Symptoms; Behavior; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms

Study Officials

• Dr Mohammed Kamran

  Future Genetics Limited

  STUDY DIRECTOR

Central Study Contacts

Dr Mohammed Kamran

CONTACT

00441216673007; director@futuregenetics.co.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: February 1, 2020
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)