Clinical trials: Patient Reported Outcome Measures
Hallux Valgus
Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).
- Trial name
- NCT03846687
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Ipsen
Shoulder Injuries and Disorders, Elbow Injuries and Disorders
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
The Functional Arm Scale for Throwers (FAST) is a patient-reported outcome measure that assesses upper extremity function in overhead throwing athletes.
- Conditions
- Shoulder Injuries and Disorders, Elbow Injuries and Disorders, Athletic Injuries
- Trial name
- NCT07893899
- Where
- Turkey (Türkiye)
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Elif Turgut
Obesity
Reporting Patient Generated Health Data and Patient Reported Outcomes With Health Information Technology
This study will assess the feasibility of using patient-centered, commercial off-the-shelf (COTS) health information technology (IT) solutions to collect patient generated health data (PGHD) and patient-reported outcomes (PROs)…
- Trial name
- NCT03386773
- Testing
- 16-week program, Patient generated health data
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Denver Health and Hospital Authority
Ovarian Cancer, Breast Cancer
Comprehensive Outcomes for After Cancer Health
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer.
- Conditions
- Ovarian Cancer, Breast Cancer, Lung Cancer, Gastric Cancer
- Trial name
- COACH (NCT05349227)
- Testing
- Digital Health Coaching Program, Fitbit
- Where
- 7 sites in United States
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Pack Health
Quality of Life, Cardiac Rehabilitation
Patient-Reported Outcome Measures in Cardiac Rehabilitation: Impact on Health Care
Cardiac Rehabilitation (CR) programs are a multidisciplinary process aimed at patient recovery after an acute cardiovascular event or with chronic heart disease, reducing mortality and morbidity, optimising functional capacity…
- Conditions
- Quality of Life, Cardiac Rehabilitation, Patient-Reported Outcome Measures, Rehabilitation Exercise
- Trial name
- PROM_R (NCT06032013)
- Testing
- Cardiac rehabilitation program (PROMs)
- Where
- Portugal
- Volunteers
- 5 people
- Sponsor
- José Manuel Afonso Moreira
Kidney Failure, Chronic, Frailty
Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol
This study looks at how the physical and emotional health of people changes while they wait for a kidney transplant. Waiting for an organ can take a long time.
- Conditions
- Kidney Failure, Chronic, Frailty, Quality of Life, Kidney Transplantation
- Trial name
- NCT07607041
- Testing
- Longitudinal Frailty Assessment, Electronic Patient-Reported Outcome Measures (ePROMs)
- Volunteers
- 150 people
- Sponsor
- Hospital del Mar
HIV, Patient-Reported Outcomes (PRO)
A Patient Portal and PROMs to Improve Health Problem Detection and Retention in HIV Care: The DRHIVe Study
Too often, people living with HIV (PLHIV) face challenges, including additional health and psychosocial problems, that complicate self-care, like medication-taking and medical appointment attendance.
- Conditions
- HIV, Patient-Reported Outcomes (PRO), Screening, Patient Portals
- Trial name
- NCT06928961
- Testing
- Patient portal with patient-reported outcome measure administration, appointment calendar and reminders, access to lab test results, and educational material
- Where
- Canada
- Volunteers
- 360 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Tooth Loss / Rehabilitation
DEntal implaNt Set: Development and Implementation of a Standardized Outcome Set in Implant Dentistry
Rationale Over the past decades, the placement of dental implants and prosthetic rehabilitation has revolutionised dentistry overwhelmingly.
- Trial name
- DENS (NCT07337057)
- Testing
- Implantology
- Where
- Netherlands
- Volunteers
- 1,000 people
- Sponsor
- Erasmus Medical Center
Primary Sclerosing Cholangitis
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.
- Trial name
- NCT02247934
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
Vulvodynia
Validation of Patient Reported Outcome Measures for Use in Vulvodynia
The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric…
- Trial name
- NCT03770169
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Ipsen
Sarcoma
Burden and Medical Care of Sarcoma in Germany
The main objective of the study is to assess the treatment situation of sarcoma patients in Germany and to investigate their potential influence on Quality of Life (and other Patient Reported Outcomes) of the affected persons.
- Trial name
- PROSa (NCT03521531)
- Where
- Germany
- Volunteers
- 1,309 people
- Sponsor
- Technische Universität Dresden
Bone Augmentation, Alveolar Ridge Augmentation
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
When a tooth is removed, the surrounding bone and gum tissue naturally shrink over time. This shrinkage can make it harder to place a dental implant later and may affect the appearance of the smile.
- Trial name
- NOVAMAG-2024 (NCT07646795)
- Testing
- NOVAMag®
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Martina Stefanini
Patient Engagement, Patient Activation
At-home Breast Oncology Care Delivered With E-health Solutions
The COVID-19 pandemic has significantly impacted healthcare service delivery, highlighting the need for high quality virtual patient care.
- Conditions
- Patient Engagement, Patient Activation, Patient Reported Outcome Measures
- Trial name
- ABODE (NCT05989477)
- Testing
- At-home Breast Oncology care Delivered with E-health solutions - ABODE
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- University Health Network, Toronto
Inflammatory Bowel Diseases, Contraception
Hormonal Influences on Inflammatory Bowel Diseases
Of the 1.8 million females with inflammatory bowel diseases (IBD) in the US, over half of those who are premenopausal suffer from cyclical menstrual-related IBD symptoms, regardless of how well their disease is controlled.
- Conditions
- Inflammatory Bowel Diseases, Contraception, Menstrual Problem
- Trial name
- NCT05610527
- Testing
- Proposed study design and randomization scenarios, Repeated measures of validated Inflammatory Bowel Disease Patient Reported Outcome Instruments, Inflammatory marker collection and assessment for correlation with PRO responses and menstrual timing
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Utah
Breast Disease, Breast Cancer
Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
The PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR).
- Conditions
- Breast Disease, Breast Cancer, Patient Satisfaction, Surgery
- Trial name
- PROM-Q (NCT04842240)
- Testing
- Pre- or sub-pectoral implant based immediate breast reconstruction
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
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
Growth Hormone Deficiency in Children
Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy
The aim of the study is to examine the suitability, the so-called validation, of a questionnaire, with which one can grasp the reasons why injections of growth hormones are omitted by patients ("non-adherence").
- Trial name
- NCT03672617
- Testing
- No treatment given
- Where
- Germany
- Volunteers
- 321 people
- Sponsor
- Novo Nordisk A/S
Functional Impairment, Frailty
A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings
Maintaining functional status, or the ability to perform daily activities, is central to older adults' quality of life, health, and ability to remain independent.
- Trial name
- NCT06404970
- Testing
- Screening intervention, Standard bundle of implementation strategies, Enhanced bundle of implementation strategies
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- VA Office of Research and Development
Bariatric Surgery, Metabolic Surgery
Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs
This long-term, nationwide observational data collection repository will obtain patient-reported outcomes from metabolic and bariatric surgery patients.
- Conditions
- Bariatric Surgery, Metabolic Surgery, Weight Reduction
- Trial name
- MBSAQIP-PROM (NCT02749305)
- Testing
- Collection of patient-reported outcome measures
- Where
- United States
- Volunteers
- 11,146 people
- Sponsor
- Massachusetts General Hospital
Non-small Cell Lung Cancer Stage IV
Improvement of Personalized Lung Cancer Care Through Digital Connection and Patient Participation (DigiNet)
The aim of the DigiNet project is to improve the treatment of patients with advanced non-small cell lung cancer (NSCLC) in Germany. The project promotes the transfer of the latest scientific knowledge into standard care.
- Trial name
- DigiNet (NCT05818449)
- Testing
- DigiNet intervention
- Where
- 41 sites in Germany
- Volunteers
- 850 people
- Sponsor
- University of Cologne