Clinical trials: Patient-Reported Outcomes
Pediatric Acute Myeloid Leukemia
Home Away From Home - Quality of Life Surveys
Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications.
- Trial name
- Aim 3 (NCT02777021)
- Where
- 15 sites in United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Other Cancer, Gastrointestinal Cancer
Symptom Management Implementation of Patient Reported Outcomes in Oncology
Deficits in the management of common symptoms cause substantial morbidity for cancer patients.Because the health care delivery system is structured to be reactive and not proactive, there are missed opportunities to optimize…
- Conditions
- Other Cancer, Gastrointestinal Cancer, Thoracic Cancer, Gynecologic Cancer
- Trial name
- SIMPRO (NCT03850912)
- Testing
- Stakeholder Survey (Control Period), Stakeholder Survey (Intervention Period), Qualitative Interview
- Where
- 6 sites in United States
- Volunteers
- 42,808 people
- Sponsor
- Dana-Farber Cancer Institute
Metastatic Cancer
Electronic Patient Reporting of Symptoms During Cancer Treatment
The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.
- Trial name
- PRO-TECT (NCT03249090)
- Testing
- Patient Self-Reporting of Symptoms, Usual Care Delivery
- Where
- 45 sites in United States
- Volunteers
- 1,197 people, healthy volunteers welcome
- Sponsor
- Alliance Foundation Trials, LLC.
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Chronic Hepatitis C, Genotype 1 or 4
Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium
The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in…
- Trial name
- NCT02581163
- Testing
- Ombitasvir/paritaprevir/ritonavir, Dasabuvir, Ribavirin
- Volunteers
- 314 people
- Sponsor
- AbbVie
Pulmonary Disease, Chronic Obstructive
A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD
The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs)…
- Trial name
- NCT05655832
- Testing
- Vivalink wearable device
- Where
- 11 sites in Germany
- Volunteers
- 77 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Asthma
PackHealth: Asthma Engagement Tool
The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and…
- Trial name
- NCT02413684
- Testing
- Patient engagement toolkit
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Duke University
PROMs, Waitlist
Effectiveness of Telepsychiatry With Randomized Waitlist Control Utilizing Patient Reported Outcome Measures
The utilization of patient reported outcome measures (PROMs) during in-person care allows for on-going assessment of the severity of mental illness and patient outcomes across treatment.
- Conditions
- PROMs, Waitlist, Telemedicine, Mental Health Disorder
- Trial name
- PROMs (NCT05274958)
- Testing
- Patient-rated outcome measures and educational videos
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Carilion Clinic
Relapsing Remitting Multiple Sclerosis
Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates…
- Trial name
- EPOC (NCT01534182)
- Testing
- Fingolimod, Interferon beta - 1a (IFN), Glatiramer acetate (GA)
- Where
- 26 sites in Russia
- Volunteers
- 298 people
- Sponsor
- Novartis Pharmaceuticals
Excessive Sleepiness
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved…
- Trial name
- NCT01080807
- Testing
- Armodafinil
- Where
- 63 sites in United States
- Volunteers
- 385 people
- Sponsor
- Cephalon
Pulmonary Disease, Chronic Obstructive
Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.
- Trial name
- NCT03954132
- Testing
- Spiolto® Respimat®, Triple-Therapy (LAMA/LABA/ICS)
- Where
- 75 sites in Germany
- Volunteers
- 469 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C, Chronic, Liver Diseases
The Patient-Reported Outcomes Project of HCV-TARGET
The PROP UP research study is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate all-oral treatment regimens for chronic hepatitis C…
- Trial name
- PROP-UP (NCT02601820)
- Where
- 11 sites in United States
- Volunteers
- 1,601 people
- Sponsor
- University of North Carolina, Chapel Hill
Polycythemia Vera
Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieve a clinically…
- Trial name
- NCT01632904
- Testing
- Ruxolitinib, Hydroxyurea (HU)
- Where
- 70 sites in United States, Belgium and 5 more
- Volunteers
- 110 people
- Sponsor
- Incyte Corporation
Heart Failure, Anemia
RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in…
- Conditions
- Heart Failure, Anemia, Cardiovascular Disease, Ventricular Dysfunction
- Trial name
- NCT00358215
- Testing
- Darbepoetin alfa
- Where
- 754 sites in United States, Argentina and 34 more
- Volunteers
- 2,278 people
- Sponsor
- Amgen
Rheumatoid Arthritis
App-based Education and GOal-setting in Rheumatoid Arthritis
The purpose of this pragmatic, investigator-initiated, multicentre randomised controlled trial is to study the effectiveness and feasibility of a mobile app-based self-management intervention for patients with rheumatoid…
- Trial name
- AEGORA (NCT05888181)
- Testing
- Mobile app-based self-management intervention
- Where
- 2 sites in Belgium
- Volunteers
- 128 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Kidney Disease, End-Stage
Electronic Patient-Reported Outcomes in Clinical Kidney Practice (ePRO Kidney)
People living with end-stage kidney disease (ESKD) need dialysis or transplantation in order to stay alive. This illness and treatment significantly impact peoples' health, emotions, work and relationships.
- Trial name
- NCT03149328
- Testing
- Educational Support
- Where
- 2 sites in Canada
- Volunteers
- 594 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Prostate Cancer
Patient-Reported Erectile Recovery and Quality of Life Outcomes With Lyopreserved Placental Tissue Applied Directly Over Neurovascular Bundle During Nerve Sparing Radical Prostatectomy Versus Standard of Care
Surgical implantation of Lyopreserved Placental Tissue (LPT) is FDA approved and has been used extensively in wound care. The use is expanding and more recently, LPT has been used in the management of diabetic foot ulcers, acute…
- Trial name
- NCT05366842
- Testing
- Stravix lyopreserved placental tissue (LPT), Radical prostatectomy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Johns Hopkins University
Fallopian Tube Cancer, Ovarian Cancer
Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
This study is being done to see if most patients are willing and able to report how they are feeling after surgery using the internet, and if this information can help doctors and nurses detect concerning symptoms after surgery.
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer, Uterine Cancer
- Trial name
- NCT00870233
- Testing
- online platform WEBCORE
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Chronic Low Back Pain
Virtual Reality Therapy for Chronic Low Back Pain
This study will test the efficacy of an evidence-based virtual reality (VR) therapy program as a non-pharmacological supplement for the management of chronic lower back pain.
- Trial name
- NCT04409353
- Testing
- Distraction-Based VR, Skills-Based VR, Activity Tracker
- Where
- United States
- Volunteers
- 413 people
- Sponsor
- Cedars-Sinai Medical Center
Chronic Heart Failure With Preserved Ejection Fraction
Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after…
- Trial name
- VITALITY-HFpEF (NCT03547583)
- Testing
- Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
- Where
- 177 sites in United States, Argentina and 19 more
- Volunteers
- 789 people
- Sponsor
- Bayer