Clinical trials: PROMs
Quality of Life, Gynaecological Cancer
Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
The goal of this randomized study is to assess the impact on self-perceived quality of life (QoL) of systematic screening and early treatment of aftereffects in patients with gynaecological cancers.
- Conditions
- Quality of Life, Gynaecological Cancer, Lymphedema, Lower Limb, Sexual Dysfunction
- Trial name
- HALIS (NCT05918770)
- Testing
- systematic screening and early treatment
- Volunteers
- 168 people
- Sponsor
- Hospital Universitario 12 de Octubre
Diabetes
Satisfaction of Specific Modes Related to Physical Activity in People Living With Type 1 Diabetes and Using an Hybrid Closed-loop System
The BF-ACT study is a single-center, non-interventional (RIPH3) descriptive study conducted at CHU Grenoble Alpes. It aims to evaluate the satisfaction of adults with type 1 diabetes using closed-loop insulin delivery systems…
- Trial name
- BF-ACT (NCT07567170)
- Testing
- Questionnar
- Where
- France
- Volunteers
- 900 people
- Sponsor
- University Hospital, Grenoble
Neoplasia Prostate
PALLiON - PALLiative Care In ONcology
A major concern in today's oncology is the complexity of treatment that increases costs. A main contributor is the increasing use of chemo- and radiotherapy during end of life (EoL: the last 12 months of life).
- Trial name
- PALLiON (NCT03088202)
- Testing
- Educational program, Standardized care pathways, Early palliative care
- Where
- 12 sites in Norway
- Volunteers
- 659 people
- Sponsor
- Oslo University Hospital
Diabetes Mellitus, Type 1
Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes
To evaluate the impact of the DBLG1 hybrid closed-loop system on glycemic control and patient-reported outcomes in adults living with type 1 diabetes under real-life conditions.
- Trial name
- INLOOP (NCT06154135)
- Where
- 12 sites in Belgium
- Volunteers
- 165 people
- Sponsor
- Erasme University Hospital
Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Assessment of the Effectiveness, Socio-economic Impact and Implementation of a Digital Solution for Severe Patients
ADLIFE is a EU-funded project developing innovative digital health solutions to support healthcare planning and care delivery for patients with advanced chronic conditions (chronic obstructive pulmonary disease and/or heart…
- Conditions
- Heart Failure NYHA Class III, Heart Failure NYHA Class IV, Chronic Obstructive Pulmonary Disease Severe
- Trial name
- ADLIFE (NCT05575336)
- Testing
- ADLIFE intervention
- Where
- 7 sites in Denmark, Germany and 3 more
- Volunteers
- 185 people
- Sponsor
- Biosistemak Institute for Health Systems Research
Quality of Life
Compliance With PROMs Detection Through Digital Support and Correlation Compared to Standard Outpatient PROMs Detection in Hip Prosthetics (DIG-PROMs-h)
Two methods for detecting outcomes after hip prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (WOMAC Score) VS detection using digital questionnaires created…
- Trial name
- DIG-PROMs-h (NCT04749511)
- Testing
- Extrambulatory digital PROMs detection
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Ortopedico Rizzoli
Pancreas Neoplasms, Pancreatitis
PROMs After Pancreatectomy
The standard of care for a patient with resectable pancreatic is to perform pancreatic resection which, even in the modern era is associated with significant complications and impact on quality of life, often in the setting of…
- Conditions
- Pancreas Neoplasms, Pancreatitis, Pancreatic Cyst
- Trial name
- PERSPECTIVE (NCT07173257)
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- University of Arizona
Pain, Postoperative
Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment
PROMPT aims at improving management of acute and chronic pain by identifying a core set of PROMs (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials.
- Trial name
- PROMPT (NCT03834922)
- Testing
- Prospective data collection
- Where
- Germany
- Volunteers
- 3,322 people
- Sponsor
- Prof. Dr. Winfried Meissner
Ventricular Tachycardia, ICD
Improving Patient Reported Outcome Measures in Catheter Ablation
This study will assess whether more frequent measurement of patient reported outcome measures (PROMs) - specifically health related quality of life (HRQL) - can improve the evaluation of the clinical effectiveness and…
- Conditions
- Ventricular Tachycardia, ICD, Quality of Life
- Trial name
- NCT04499326
- Testing
- Validated quality of life questionnaire (EQ-5D & C-CAP)
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- Barts & The London NHS Trust
Transgenderism, Erectile Dysfunction
Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons
This study aims to explore sexual satisfaction among transgender men and their partners following the placement of erectile prostheses after phalloplasty.
- Conditions
- Transgenderism, Erectile Dysfunction, Prosthesis Durability, Gender Dysphoria
- Trial name
- NCT06639776
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- University Hospital, Ghent
Osteoarthritis, Knee, Osteoarthritis, Hip
Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJA
In this pilot study, we will test the hypothesis that a POPOP for currently ineligible UAMS orthopedic surgery patients wanting hip or knee replacement improves markers of preoperative health, ability to reach a BMI threshold <40…
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Avascular Necrosis, Rheumatoid Arthritis
- Trial name
- NCT04910048
- Testing
- POPOP (preoperative patient optimization program), SOC (standard of care)
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- University of Arkansas
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
Non-small Cell Lung Cancer (NSCLC), Stage IV
Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients
Unfortunately, most patients are already at a very advanced stage when they are diagnosed with lung cancer, i.e. the cancer has already spread outside the lungs forming metastases.
- Trial name
- salVage (NCT06114108)
- Testing
- Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy), Surgery, Radiotherapy
- Where
- 7 sites in Switzerland
- Volunteers
- 128 people
- Sponsor
- Swiss Cancer Institute
IBD, Inflammatory Bone Disease
Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data
The proposed study will use a PROM (Patient report Outcome Measurement)-tool in combination with clinical and biochemical data to train and validate a Relapse Prediction Model for individual patients.
- Trial name
- PrePro (NCT05578768)
- Testing
- No intervention
- Where
- Netherlands
- Volunteers
- 400 people
- Sponsor
- Leiden University Medical Center
Myocardial Infarct, Remodeling, Left Ventricle
Heart Attack Blood Oxygen Therapy Trial
'Heart attack', known as acute ST-segment elevation myocardial infarction, is a leading cause of heart failure and death. A lack of blood and oxygen damages the heart muscle potentially causing heart failure and premature death.
- Trial name
- SSO2 Radial MI (NCT06662890)
- Testing
- Supersaturated oxygen
- Where
- United Kingdom
- Volunteers
- 56 people
- Sponsor
- NHS National Waiting Times Centre Board
Clavicle Fracture
The Scandinavian Displaced Lateral Clavicle Trial
A multicentre multinational RCT to investigate whether non-surgical treatment is non-inferior to surgical treatment for displaced extraarticular lateral clavicle fractures in adults.
- Trial name
- ScanDiLaC (NCT06981065)
- Testing
- Simple Sling and Physiotherapy, Surgical treatment
- Where
- 11 sites in Denmark, Finland and 2 more
- Volunteers
- 96 people
- Sponsor
- Uppsala University
Hematologic Neoplasm, Hematopoietic Stem Cell Transplantation
HematoCare: Feasibility of a Survivorship Care Plan for Hematologic Cancer Patients Undergoing HSCT
This is a feasibility study to implement a Survivorship Care (SC) Plan for patients with hematologic cancer undergoing hematopoietic stem cell transplantation (HSCT).
- Conditions
- Hematologic Neoplasm, Hematopoietic Stem Cell Transplantation, Survivorship, Cancer Survivorship
- Trial name
- HematoCare (NCT07579065)
- Testing
- Survivorship Care (SC) Plan
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
Knee Osteoarthritis, Total Knee Arthroplasty
A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty
The primary objectives of this study are to: 1) develop an educational tool known as the Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the options for patients considering total knee…
- Trial name
- NCT03240913
- Testing
- Baseline and Follow-up Surveys, Patient Reported Outcome Measure informed Decision Aid, Pamphlet
- Where
- Canada
- Volunteers
- 163 people
- Sponsor
- University of Calgary
Patellofemoral Pain Syndrome, Patellofemoral Osteoarthritis
Measurement Properties of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS
The purpose of this study is to translate and culturally adapt the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) into Turkish, and to determine the measurement…
- Conditions
- Patellofemoral Pain Syndrome, Patellofemoral Osteoarthritis, PROMs
- Trial name
- NCT06060730
- Where
- Turkey (Türkiye)
- Volunteers
- 55 people
- Sponsor
- Gazi University
Acetabular Fracture, PROMs
The Utility of Mobile Based Patient Reported Outcome Measures in Patients With Acetabular Fractures: A Randomized Controlled Trial.
Acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation.
- Conditions
- Acetabular Fracture, PROMs, Mobile Phone Use
- Trial name
- NCT04393571
- Testing
- Mobile application
- Volunteers
- 138 people
- Sponsor
- Assiut University