Clinical trials: Consent
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
Informed Consent, Awareness
Patients' Readings of Pre-operative Informed Consent Forms
Patient informed consent is a form which contains the patient's probable outcome of the procedure to be performed, and the probable risk and benefit of the patient's knowledge of the illness.
- Trial name
- NCT03555760
- Testing
- Observation of informed consent form readings of all patients who are scheduled for surgery
- Where
- Turkey (Türkiye)
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Ankara University
Sexual and Reproductive Health and Rights, Violence Against Women and Girls
Right to Health and Freedom From Violence
Bangladesh has the earliest patterns of marriage in the current developing world, high adolescent fertility and high rates of spousal violence against women and girls.
- Trial name
- SAFE (NCT03280680)
- Testing
- Female+male group sessions, Female group sessions, No group sessions
- Volunteers
- 11,340 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Maternal Anxiety, Prenatal Diagnosis
Effect of Video -Based vs Standard ınformation on Maternal Anxiety and Procedure Decision in Pregnant Woman Offered Amniocentesis or Cvs
This prospective study evaluates the impact of video-based patient education compared to standard verbal informed consent on state anxiety levels and procedure acceptance rates in pregnant women undergoing invasive prenatal…
- Conditions
- Maternal Anxiety, Prenatal Diagnosis, Amniocentesis, Chorionic Villus Sampling
- Trial name
- NCT07876726
- Testing
- Multilingual Video-Based Patient Education, Standard Verbal Informed Consent
- Where
- Turkey (Türkiye)
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Ankara City Hospital Bilkent
Labour Pain
Spoken Animation for Labour Epidural
The purpose of this study is to evaluate a new animated information film as a tool for introducing the concept of epidural as a method of labour pain relief to expectant women.
- Trial name
- SALE (NCT07202221)
- Testing
- Participant views Epidural animation before reading gold standard written information, Participant receives current gold standard written information alone
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Chelsea and Westminster NHS Foundation Trust
Understanding of Consent in Clinical Research, Implementation of Consent in Clinical Research
Facilitating Learning Health Care (LHC) and Neonatal Research: Effects of a Brief Introductory Discussion Between a Neonatologist and the Parents of Eligible Infants
The primary purpose of this pilot quality improvement study is to assess the impact of a brief introductory discussion about Learning Health Care (LHC) and clinical research between a neonatologist and the mothers (and the…
- Trial name
- NCT05541536
- Testing
- Consultation meeting, Pamphlet, Usual Care
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Informed Consent
Informed Consent and Clinical Trials
To understand the patients' meaning of the informed consent process in clinical trials. Objective of the study is: to assess, in a cohort of subjects included in clinical trials, whether the information and the informed Consent…
- Trial name
- NCT01635842
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Azienda Usl di Bologna
Endometrium Cancer, Sentinel Lymph Node
Multimedia Aid Gynecologic Counseling and Consent
This is an interventional trial to introduce two short animated videos into preoperative counseling/consent and to compare patient comprehension and satisfaction with a multimedia approach compared to standard of care currently.
- Conditions
- Endometrium Cancer, Sentinel Lymph Node, Perioperative/Postoperative Complications
- Trial name
- NCT03899441
- Testing
- Video
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Rheumatoid Arthritis
Consortium of Early Arthritis Cohorts USA
Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it is estimated that as many as 3 million adults may suffer from the disease.
- Trial name
- CATCH-US (NCT02386527)
- Where
- United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Hospital for Special Surgery, New York
Literacy, Information Disclosure
ECA vs E-Document Explanation
This study will investigate how consent forms and other health care documents are explained to patients. The findings will be used to create a computer program that can successfully explain consent and other health-related forms…
- Trial name
- NCT03381911
- Testing
- Embodied Conversational Agent
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Boston Medical Center
Informed Consent
Effectiveness of Immersive Virtual Reality in Nursing Students' Learning
Teaching using VR for basic cardiopulmonary resuscitation and patient examination (experimental group) will not result in differences in knowledge and skill acquisition compared to traditional classroom-based simulation teaching…
- Trial name
- UBUJIRV25 (NCT06839573)
- Testing
- Experience with virtual reality glasses
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Universitat Jaume I
Consent Form
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
This study evaluates a visual Informed Consent Form (ICF) compared to a standard, text-only ICF as an approach to achieving meaningful consent into a clinical trial.
- Trial name
- NCT07122960
- Testing
- Visual ICF, Text-only ICF
- Where
- South Africa
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Columbia University
Aneuploidy, Birth Defect
Use of Videos to Improve Patient Knowledge on Prenatal Genetics
This is a randomized controlled trial of a low income and low health literacy population of pregnant women from a diverse racial and ethnic background to assess the effectiveness of a pre-visit educational video on prenatal…
- Trial name
- VPE (NCT03816423)
- Testing
- video
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Cancer
Improving Consent Experiences in Clinical Trials
This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of…
- Trial name
- NCT07293520
- Testing
- Standard Consent Form, Visual Key Information (VKI) page
- Volunteers
- healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Informed Consent
Enhancing Quality of Informed Consent (EQUIC-DP) Developmental Phase
Patients in 'parent' cooperative studies projects are interviewed about their experiences in the informed consent process.
- Trial name
- NCT00032552
- Where
- 18 sites in United States
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Dry Needling
Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling
As Dry Needling (DN) continues to see increased use in the clinic, there is a need to establish adverse events that could occur as a result of DN intervention.
- Trial name
- DNICNGT (NCT05560100)
- Testing
- Nominal Group Technique - 2 to 3 hour virtual meeting
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Youngstown State University
Patient Education
Rapid Prototyping Models for Patient Education
Pre-made rapid prototyping models will be used to increase patient education versus current methodologies.
- Trial name
- NCT02718807
- Testing
- RP model explanation and questionnaire
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Milton S. Hershey Medical Center
Risk
Remembering Risk Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery
Disclosure of anticipated risks to individuals considering undergoing an elective operative procedure is an important aspect of informed consent process.
- Trial name
- NCT05098535
- Testing
- Visual Aid, Scripted Risk Discussion
- Where
- Canada
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Queen's University
Adolescent Behavior
Simplified Consent for HIV Vaccine Trials
The main goal of this project is to develop and evaluate a simplified version of an HIV vaccine trial consent form designed for high-risk adolescents.
- Trial name
- NCT00105339
- Where
- 3 sites in United States
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Scleroderma
Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at Scleroderma (SSc) Patients Compared Healthy Peoples
The aim is to find the presence of anti vitamin D antibodies in scleroderma patients and compare with control. A second goal is anti vitamin D levels in serum of scleroderma patients in relation to the clinical manifestations of…
- Trial name
- SSc (NCT01553890)
- Testing
- Blood sample
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Meir Medical Center