Clinical trials: Consent
Quality Improvement, Informed Consent
Quality Improvement Study on Operative Consent Forms
A Quality Improvement Project was undertaken to improve the completion of operative consent forms within a UK hospital plastic surgery department.
- Trial name
- NCT04493866
- Testing
- Messages to departmental employees to improve quality of consent form completion
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Barts & The London NHS Trust
Pregnancy, Down Syndrome
An Interactive Informed Consent and Education Program for Pregnant Women
The purpose of this study is to determine whether an interactive education program for prenatal testing is effective in improving pregnant women's understanding of and expectations towards prenatal screening and diagnosis.
- Trial name
- NCT01176019
- Testing
- Information about Prenatal Screening and Diagnosis
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Outcome Assessments (Health Care), Comprehension
Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers
Prior to the completion of biomedical research, any person undergoing it must receive a readable and intelligible information about this research, in order to give free and informed consent.
- Conditions
- Outcome Assessments (Health Care), Comprehension, Language
- Trial name
- NCT03105752
- Testing
- Questionnaire of understanding
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Parental Consent, Newborn
Recruiting to Clinical Trials on the Telephone
This study examined the use of the telephone for the purpose of informing expectant mothers about a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination.
- Conditions
- Parental Consent, Newborn, Vaccination
- Trial name
- NCT02570061
- Testing
- telephone, consultation face-to-face
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Gorm Greisen
HIV, PrEP
Self-Consent for PrEP Perspectives
This study involves a one-time, web-based quantitative structured self-complete ("web-based") survey for all subjects and a qualitative semi-structured ("qualitative") interview for a selected sub-sample of subjects to evaluate…
- Trial name
- NCT02801760
- Where
- 11 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
ST-segment Elevation Myocardial Infarction (STEMI), Cardiogenic Shock
The RECOVER IV Trial
The purpose of this study is to assess whether hemodynamic support with an Impella-based treatment strategy initiated prior to percutaneous coronary intervention (PCI) in patients with ST-Segment Elevation Myocardial Infarction…
- Trial name
- RECOVER IV (NCT05506449)
- Testing
- Impella CP®, Standard of Care
- Where
- 7 sites in United States, Denmark and 2 more
- Volunteers
- 4 people
- Sponsor
- Abiomed Inc.
Gastro-Intestinal Disorder
Can the SurgInfoBot Improve the Consent Process for Endoscopy? A Randomised Controlled Trial
Human-computer interactions or 'Chatbots' have been utilized in a variety of healthcare settings, including the promotion of positive healthcare behaviors, the deliverance of psychological therapy, and the performance of…
- Trial name
- NCT05159921
- Testing
- Access to an automated conversational agent (SurgInfoBot)
- Where
- Ireland
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Tallaght University Hospital
Consent of Patients, Coercion to Participate in Research
Coercion in Same-Day Research Consent
As a result of their unique practice patterns, many specialist physicians typically only meet patients on the date of an intervention such as surgery.
- Trial name
- NCT07380035
- Testing
- Invitation to Consent to Trial Participation
- Where
- Canada
- Volunteers
- 114 people
- Sponsor
- University of Toronto
Informed Consent, Procedural State Anxiety
Improving Informed Consent in Pediatric Endoscopy
Informed consent/assent in pediatric medicine is an accepted and important practice that has been rarely studied, tested for quality, or optimized for patient satisfaction.
- Conditions
- Informed Consent, Procedural State Anxiety, Subject's Satisfaction
- Trial name
- NCT00899392
- Testing
- Emmi Pediatric Upper Endoscopy Patient Education Module
- Where
- United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Critical Illness, Loss of Consciousness
Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials
This study aims to gather insights into the perceptions of legal representatives regarding the recruitment process for clinical trials in the intensive care setting when the patients cannot decide for themselves.
- Trial name
- NCT06471400
- Testing
- interview
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital Freiburg
Comprehension
Impact of Readability Improvements on the Comprehension of Written Information Given to Clinical Trial Patients: a RCT
The principle objective of this randomised controlled trial is to assess whether an improvement in lexico-syntactic readability combined with adherence to French recommendations for good practice in writing the Information and…
- Trial name
- LISYCOM (NCT00908557)
- Testing
- readability improvement and good practice redaction, Control
- Where
- France
- Volunteers
- 400 people
- Sponsor
- University Hospital, Grenoble
Papillomavirus Infection, Papillomavirus Vaccines
Impact of an e-Bug Educational Intervention on HPV Vaccine Uptake in Middle School Students
This study is a non-interventional observational pilot analysis assessing the possible impact of an educational programme (e-Bug) on parental consent and HPV vaccination uptake during the 2023-2024 and 2024-2025 national…
- Conditions
- Papillomavirus Infection, Papillomavirus Vaccines, Vaccination Coveage
- Trial name
- NCT07266857
- Testing
- Consent for HPV vaccination
- Where
- France
- Volunteers
- 11,000 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Aged, 80 and Over, Critical Illness
Intensive Care of Elderly: What do They Wish for Themselves?
Do very elderly adults wish intensive care in the event of acute life-threatening illness and are their next of kin able to predict these preferences? Very elderly patients are a steeply increasing patient population in intensive…
- Trial name
- NCT05149040
- Testing
- survey "Intensive care of very elderly: What do they wish for themselves?"
- Where
- Norway
- Volunteers
- 1,472 people
- Sponsor
- Haukeland University Hospital
Chronic Kidney Diseases, Genetic Predisposition
APOL1 Genetic Testing Program for Living Donors, Part 2
Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves.
- Trial name
- NCT04999436
- Testing
- APOL1 Counseling Training Program
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Northwestern University
Stroke, Stroke (CVA) or Transient Ischemic Attack
Optimized Recruitment to Drive Equitable Research in Stroke, Empowering Decision-making (ORDERed)
Stroke is a major health issue, especially for women, who are more likely than men to have worse outcomes and lower quality of life after a stroke.
- Trial name
- ORDERed (NCT07576647)
- Testing
- Supported, women-centred and aphasia-friendly recruitment process (ORDERed), Traditional recruitment processes (TRADITIONAL)
- Where
- 3 sites in Canada
- Volunteers
- 1,600 people
- Sponsor
- McMaster University
Cancer, Alzheimer Disease
Implement and Test Visual Consent Template and Process
The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level.
- Trial name
- NCT06804837
- Testing
- Visual consent, Standard consent
- Where
- 3 sites in United States
- Volunteers
- 266 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Improving Informed Consent Process
Use of a Multimedia Presentation for Informed Consent
This is a prospective cohort study in which the standard verbal informed consent process for ketamine sedation is compared to a multimedia informed consent process.
- Trial name
- NCT01955070
- Testing
- Multimedia Presentation for Ketamine sedation
- Where
- United States
- Volunteers
- 184 people
- Sponsor
- Nationwide Children's Hospital
Organ Donation
A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation
The purpose of this study is to evaluate the efficacy and generalizability of a communication intervention (Communication Effectively about Donation (CEaD)) for Organ Procurement Organization (OPO) staff requesters and to compare…
- Trial name
- NCT02138227
- Testing
- Assisted CEaD Condition, Autonomous CEaD Condition
- Where
- 9 sites in United States
- Volunteers
- 273 people
- Sponsor
- Temple University
Cancer
Seeking Informed Consent to Phase I Cancer Clinical Trials: Identifying Oncologists'Communication Styles
The purpose of this study is to examine doctor-patient communication about treatment options which may include an experimental, new treatment for cancer.
- Trial name
- NCT00582192
- Testing
- Consult visit
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Anxiety, Depression
Informed Consent Using a Spinal Model
Informed consent is the first step in every medical procedure. It is important for the patient to clearly understand how the procedure will be performed, what to expect from the process, and the possible complications.
- Conditions
- Anxiety, Depression, Pain
- Trial name
- NCT06417866
- Testing
- informed consent, spine model
- Where
- Turkey (Türkiye)
- Volunteers
- 168 people
- Sponsor
- Ankara University