Clinical trials: Patient Reported Outcome Measurements
Asthma, Severe Asthma
National Validation and Sensitivity to Change of the SAQ
DESIGN A multi-centre mixed methods study of a new asthma specific quality of life questionnaire including limited clinic data. AIMS To collect further quantitative data to validate a new asthma quality of life scale, the Severe…
- Trial name
- NCT04031261
- Where
- 5 sites in United Kingdom
- Volunteers
- 410 people
- Sponsor
- University Hospital Plymouth NHS Trust
HIV Infections
Electronic Capture of Adherence Barriers for HIV Care
Adherence to antiretroviral therapy (ART) remains problematic. Our team has thus developed a new patient-reported measure of barriers to ART adherence (the I-Score) which will be completed by HIV patients through the Opal patient…
- Trial name
- CTNPT039 (NCT04702412)
- Testing
- The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measure
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Inflammatory Disease, Immune System Disorder
Cross-condition Validation of the Steroid PRO
Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions
- Conditions
- Inflammatory Disease, Immune System Disorder, Gastrointestinal Diseases, Dermatologic Disease
- Trial name
- NCT06314451
- Testing
- Cognitive Interview
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of the West of England
Substance Use Disorders, Opioid Use Disorder
Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting
Performance measure can improve quality of care at the patient, provider, and systems level of care, and patient-reported outcome measures bring a needed patient-centered focus.
- Trial name
- RecoveryPROM (NCT05388045)
- Testing
- Patient Reported Outcome Measure
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Brandeis University
Thyroid Diseases
Health-Related Quality of Life for Thyroid Patients
Background: Thyroid diseases are frequent. They include both metabolic changes and gland enlargement (goitre). Previous research and clinical suspicion indicate that the life quality of many patients is reduced despite successful…
- Trial name
- NCT00150033
- Where
- Denmark
- Volunteers
- 1,200 people
- Sponsor
- Odense University Hospital
Dyspepsia, Dyspepsia and Other Specified Disorders of Function of Stomach
ESM in Functional Dyspepsia
Background: Reliable patient reported outcome measures (PROM's) for symptom assessment in functional dyspepsia (FD) are essential in order to evaluate dyspeptic symptoms, identify potential symptom triggers and optimize…
- Trial name
- MEASuRE-D (NCT04204421)
- Testing
- Experience Sampling Method (ESM)
- Where
- Netherlands
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Peripheral Arterial Disease, Aging
SMART Exercise for PAD
Supervised exercise therapy (SET), consisting of treadmill exercise conducted three times weekly at a center while supervised by healthcare personnel, is first line therapy for people disabled by lower extremity peripheral artery…
- Conditions
- Peripheral Arterial Disease, Aging, Peripheral Vascular Diseases, Walking, Difficulty
- Trial name
- NCT06032065
- Testing
- Supervised Treadmill Exercise, Home-Based Exercise, Nitrate-rich beetroot Juice
- Where
- 3 sites in United States
- Volunteers
- 210 people
- Sponsor
- Northwestern University
Fibromyalgia, Pain, Chronic
Pain Severity in Fibromyalgia Syndrome
Fibromyalgia Syndrome (FMS) is a complex syndrome that mainly includes the musculoskeletal system and is characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions…
- Trial name
- NCT05481086
- Testing
- No Interventions
- Where
- Turkey (Türkiye)
- Volunteers
- 93 people
- Sponsor
- Kutahya Health Sciences University
Stress
Web-based Patient Reported Outcome Measurement Information System (PROMIS ) to Explore Burden and Stress in Cancer Caregivers (BaSiC2)
Background: Caring for a loved one is often stressful. Some studies show it may affect health and emotions. Researchers want to know more about this but do not know the best way to gather data.
- Trial name
- NCT01981538
- Where
- United States
- Volunteers
- 139 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
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
Celiac Disease in Children, Celiac Disease
Development of CELIAC-Q KIDS: A Patient-Reported Outcome Measure for Pediatric Celiac Disease
A multicentre, prospective observational study to develop the CELIAC-Q KIDS patient reported outcome measure for children and adolescents with celiac disease.
- Conditions
- Celiac Disease in Children, Celiac Disease, Patient-reported Outcome Measures
- Trial name
- NCT05548166
- Testing
- Interview and scale development
- Where
- 2 sites in Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- McMaster University
Vulvovaginal Atrophy, Menopause
Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM
The goal of this study is to perform a quantitative assessment of the psychometric properties of the Vulvovaginal Atrophy Questionnaire (VVAQ), a novel patient reported outcome measure (PROM), through a REDCap survey of…
- Conditions
- Vulvovaginal Atrophy, Menopause, Genitourinary Syndrome of Menopause
- Trial name
- NCT04746456
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Massachusetts General Hospital
Multiple Sclerosis
The MS-LINK™ Outcomes Study
The Multiple Sclerosis (MS) Leadership and Innovation Network (MS-LINK™) is comprised of networks working cooperatively to advance Multiple Sclerosis (MS) science and improve MS participant outcomes.
- Trial name
- NCT04735406
- Where
- 9 sites in United States
- Volunteers
- 2,182 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Scleroderma, Systemic Sclerosis (SSc)
Evaluating the Effect of Questionnaire Context on the Reporting of Somatic Items Among People With Systemic Sclerosis
There is concern that self-reported depression questionnaires that contain items assessing somatic symptoms may result in biased scores in people with a chronic disease due to symptoms that overlap with their physical disease.
- Conditions
- Scleroderma, Systemic Sclerosis (SSc), Scleroderma (Limited and Diffuse)
- Trial name
- NCT06772896
- Testing
- Reordered PHQ-8
- Where
- 2 sites in Canada
- Volunteers
- 851 people
- Sponsor
- Lady Davis Institute
Substance Use Disorder (SUD)
Identifying Substance Use Consequences
The goal of this study is to develop a new tool for measuring substance use disorder treatment outcome. We will start by interviewing people and gathering advisory groups to develop the items for this new tool.
- Trial name
- NCT07503067
- Testing
- none, there is no intervention in this study
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mclean Hospital
Post-ERCP Acute Pancreatitis
PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms
The aim of this study is to use a validated patient-reported outcome measure to evaluate how many patients have symptoms of pancreatitis after ERCP and how it correlates with their quality of life and productivity.
- Trial name
- PAN-PROMISE (NCT05310409)
- Where
- 2 sites in United States
- Volunteers
- 700 people
- Sponsor
- University of Pennsylvania
Knee Osteoarthritis, Total Knee Arthroplasty
Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN
This multicenter prospective observational study aims to evaluate whether preoperative clinical variables and wearable sensor-derived gait features can predict postoperative improvement after total knee arthroplasty (TKA).
- Trial name
- NCT07367789
- Testing
- Instrumented Insole Gait Assessment
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Yonsei University
Type1 Diabetes Mellitus
DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes
The aim of this study is to investigate the effect of the use of DiabetesFlex in diabetes care compared to standard care in relation to patient involvement and relevance for specific group of persons with T1DM.
- Trial name
- NCT03202732
- Testing
- DiabetesFlex
- Where
- Denmark
- Volunteers
- 344 people
- Sponsor
- Annesofie Lunde Jensen
Lupus Erythematosus, Systemic
Validation of Patient E-tool to Measure Systemic Lupus Activity
Validation of a self-questionnaire (SLEDAI-P/LUPIN) completed by the patient to measure the activity of the systemic lupus, in order to improve the patient's empowerment.
- Trial name
- OPTIMISE (NCT05763225)
- Where
- 31 sites in France, Guadeloupe and 1 more
- Volunteers
- 450 people
- Sponsor
- Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+)
Chronic Obstructive Pulmonary Disease (COPD)
Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)
The purpose of the protocol is to develop final draft PRO instruments of physical activity in daily life to be used and evaluated in the further validation studies measuring physical activity in chronic obstructive pulmonary…
- Trial name
- NCT01388218
- Where
- 5 sites in Belgium, Greece and 2 more
- Volunteers
- 236 people
- Sponsor
- Barcelona Institute for Global Health