Clinical trials: PROMs
PROM
H2O-F - A PROSPECTIVE, MULTI-COUNTRY, MULTI-CENTRE, MULTI-CONDITION FEASIBILITY STUDY EVALUATING THE ESTABLISHMENT OF THE NATIONAL HEALTH OUTCOMES OBSERVATORY (H2O) ECOSYSTEM
The primary objective of this study is to assess the progress of the national H2O Health Outcomes Observatory ecosystem towards a fully functional and operational state.
- Trial name
- H2O (NCT06833892)
- Where
- Austria
- Sponsor
- IRCCS San Raffaele
Postoperative Recovery, Cardiac Surgery
Development, Validation and Clinical Application of a Recovery Scale After Cardiac Surgery: the Fuwai-CRS (Fuwai- Cardiac Recovery Scale)
Improving patient recovery after cardiac surgery is a critical priority. While improved surgical techniques have substantially reduced procedural mortality over the past decades, the inherent physiological insult of median…
- Conditions
- Postoperative Recovery, Cardiac Surgery, PROM
- Trial name
- NCT05782036
- Where
- China
- Volunteers
- 3,043 people
- Sponsor
- China National Center for Cardiovascular Diseases
ERAS, Pancreas Cancer
Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes
The purpose of this study is to evaluate the impact of compliance with enhanced recovery after surgery (ERAS) program on patient reported outcomes (PROs), surgery-specific outcomes and stress response after pancreatic surgery.
- Conditions
- ERAS, Pancreas Cancer, Pancreas; Fistula, Delayed Gastric Emptying
- Trial name
- NCT05518643
- Testing
- ERAS protocol
- Where
- Greece
- Volunteers
- 120 people
- Sponsor
- University of Thessaly
Quality of Life (QOL), Patient-Reported Outcome Measures (PROMs)
Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China
The goal of this observational study is to validate the EQ-5D-Y-3L and EQ-5D-Y-5L in measuring health-related quality of life (HRQoL) for paediatric patients with different health conditions in China.
- Conditions
- Quality of Life (QOL), Patient-Reported Outcome Measures (PROMs), Pneumonia Childhood, Neuroblastoma (NB)
- Trial name
- NCT06873672
- Where
- China
- Volunteers
- 360 people
- Sponsor
- RenJi Hospital
Postoperative Recovery, Quality of Recovery From Anaesthesia
Validation of the Greek Postoperative Quality of Recovery Score 15
The goal of this observational study is to translate a patient questionnaire about recovery after an operation into Greek and assess how accurate, reliable, acceptable, and feasible this Greek version is.
- Conditions
- Postoperative Recovery, Quality of Recovery From Anaesthesia, PROMs, Validation Study
- Trial name
- (QoR-15Gr) (NCT06699823)
- Testing
- Greek version of QoR-15
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- IASO Thessalias
Radiotherapy Side Effect, PROMs
Patient Experience Data in Radiation Oncology
The project is part of the overarching goal of improving patient-centric radiation oncology. This pilot project aims to develop an instrument that can be used to collect clinically relevant patient-reported outcome data on…
- Trial name
- PEDRO (NCT05224297)
- Testing
- external beam photon therapy
- Where
- Austria
- Volunteers
- 6,000 people
- Sponsor
- Medical University of Vienna
THA, Dislocation, Hip
The Q-REDUCE Study
The purpose of this study is to design a fast-track pathway for patients referred to the University Hospital of Southern Denmark, Esbjerg, with high probability of having a dislocated hip prosthesis with the primary aim to reduce…
- Conditions
- THA, Dislocation, Hip, PROM
- Trial name
- NCT06639334
- Testing
- Fasttrack pathway for THA/HE prosthesis reduction, Standard pathway for THA/HE prosthesis reduction
- Volunteers
- 120 people
- Sponsor
- University of Southern Denmark
PROM (Pregnancy), Induced; Birth
Effects of Acupuncture in Spontaneous Rapture of Membranes: Applicability and Effectiveness
The aim of the study is to investigate the effects of acupuncture in women presenting with spontaneous rapture of membranes (PROM) at term and negative swab for Streptococcus Agalactie to promote a spontaneous onset of labour and…
- Conditions
- PROM (Pregnancy), Induced; Birth, Acupuncture, Labour
- Trial name
- NCT06623175
- Testing
- Acupuncture needles
- Where
- Italy
- Volunteers
- 131 people
- Sponsor
- Prof. Fabio Facchinetti
PROM, PREM
Trends of Patient-reported Outcome Measures (PROMs) in Multimorbid Medical Patients Hospitalized for an Acute Illness
currently, PROMs and PREMs are not routinely collected and compared among medical inpatients of Swiss university hospitals, nor is a standard set of PROMs and PREMs available for use in Swiss hospitals.
- Conditions
- PROM, PREM, Quality of Care, Internal Medicine
- Trial name
- TRADUCE (NCT06597318)
- Testing
- Hospitalization
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- University of Lausanne Hospitals
PROMs, Total Ankle Replacement
Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement
The arthritic pathology of the tibio-tarsal joint has a prevalence of approximately 1% in the general population, and its incidence has been increasing over the years.
- Conditions
- PROMs, Total Ankle Replacement, Italian Forgotten Joint Score
- Trial name
- NCT06091397
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- Istituto Ortopedico Rizzoli
Knee Arthroplasty, Patient Engagement
Limited Market Release - MotionSense Clinical Use Evaluation
Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.
- Conditions
- Knee Arthroplasty, Patient Engagement, Patient-Reported Outcome Measures (PROMs)
- Trial name
- FS5 (NCT05091918)
- Testing
- MotionSense
- Where
- 2 sites in United States
- Volunteers
- 101 people
- Sponsor
- Orthosensor, Inc.
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
PROM, Satisfaction, Patient
Assessment of the Humanisation of Care in Hospitals in Andalusia-Spain
Observational assessment through patient interviews of relational, structural and organisational aspects related to the humanisation of health care.
- Conditions
- PROM, Satisfaction, Patient, Satisfaction, Personal, Stress
- Trial name
- HUMANCUIDA (NCT06174844)
- Testing
- No intervention applied
- Where
- Spain
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- University of Seville
PROM
Pitocin or Oral Misoprostol for PROM IOL
Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term. A delay from PROM to labor is associated with an increased risk of intrauterine infection and associated maternal and fetal morbidity…
- Trial name
- POM PROM (NCT04028765)
- Testing
- Misoprostol, Oxytocin
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Lung Cancer, PROM
Impact of COVID-19 on Lung Cancer Patients
During the COVID-19 pandemic, people's lives have changed dramatically. People with lung cancer who are shielding may have been particularly affected as they may be unable to carry out many of their normal daily activities, such…
- Conditions
- Lung Cancer, PROM, Covid19, Psychological
- Trial name
- NCT04538456
- Testing
- questionnaire and optional interview
- Where
- United Kingdom
- Volunteers
- 296 people, healthy volunteers welcome
- Sponsor
- The Christie NHS Foundation Trust
PROM, Preterm (Pregnancy)
Outcome of Conservative Management in Cases of Pre Mature Rupture of Membranes (PROM) Between 20 and 28 Weeks of Pregnancy in Sohag City Hospitals
Prospective observational study
- Trial name
- NCT06271863
- Where
- Egypt
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Sohag University
PROMs, PREMs
Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact
There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such…
- Conditions
- PROMs, PREMs, Implementation Research, Impact Evaluation
- Trial name
- PROMs & PREMs (NCT06272552)
- Testing
- PROMs and PREMs, PREMs, Control
- Where
- Spain
- Volunteers
- 1,440 people
- Sponsor
- Parc de Salut Mar
Pancreas Disease, Complication,Postoperative
Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist)
Main indications for distal pancreatectomy (DP) are pancreatic body and tail tumors including ductal adenocarcinoma, neuroendocrine tumors, and cystic neoplasms.
- Conditions
- Pancreas Disease, Complication,Postoperative, PROMs, Pancreatic Fistula
- Trial name
- Early-Dist (NCT04609137)
- Testing
- Early drain removal, Standard drain removal
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- IRCCS San Raffaele
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
Musculoskeletal Pain, Musculoskeletal Pain Disorder
Dutch Version Fear-Avoidance Component Scale (FACS)
Chronic musculoskeletal disorders such as low back and neck pain are responsible for an enormous global burden. Fear-avoidance (FA) can be a predictor for the transition from subacute to chronic low back pain.
- Conditions
- Musculoskeletal Pain, Musculoskeletal Pain Disorder, Fear of Pain, Fear of Injury
- Trial name
- NCT03994861
- Testing
- Assessment of disability and behavior (by questionnaires)
- Where
- Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hasselt University