NCT06938698

PROMs From GEstIC Heart Failure Patients

PROMs From GEstIC Heart Failure Patients - PROFIC-HF Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Centro Hospitalar do Porto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Heart failure (HF) is a chronic condition with substantial morbidity, and understanding its effects on patients' quality of life is essential. Patient-reported outcomes (PROs) are any result of a disease or treatment that comes directly from the patient, without any interpretation from clinicians, using standardized scientifically-validated medical questionnaires, PROMs. Patient-reported outcome measures (PROMs) are the tools used to capture PRO information usually in the form of questionnaires. The PROMs from GEstIC Heart Failure Patients (PROFIC-HF) study aims to assess the feasibility of digitally recording Patient-Reported Outcome Measures (PROMs) at home in real-world patients enrolled in a multidisciplinary heart failure clinic. Two HF-specific PROMs - Kansas City Questionnaire (KCCQ-12) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) - and a 2 PROMs for anxiety and depression assessment - Patient Health Questionnaire -2 (PHQ-2) and The Hospital Anxiety and Depression Scale (HADS) will be collected remotely using a digital platform that can be accessed online using a smartphone or a computer. This study will also evaluate the correlation between quality of life changes (measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12) versus Minnesota Living with Heart Failure Questionnaire) and changes in clinical reported outcomes: assess the quality of life of real world HFpatients followed in a multidisciplinary heart failure clinic and quantify the impact of hospitalization events on patients' quality of life.

Detailed description

PROFIC-HF will randomize 75 participants to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and 75 to complete the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The trial will pilot the use of the digital PROMs system, collected from the consultation waiting room and/or with the patient at home. PROMs will be based on the HF Standard Set created by the International Consortium of Health Outcomes Measurements (ICHOM), adapted to the patient follow-up program already in use by GEstIC.

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	PROM collection	PROM collection using a digital health web application. PROMs will be based on the HF Standard Set created by the International Consortium of Health Outcomes Measurements (ICHOM), adapted to the patient follow-up protocol already in use by GEstIC. Half the participants will complete the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and the other half will complete the Minnesota Living with Heart Failure Questionnaire (MLHFQ).

Timeline

• Start date: 2022-12-12
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2025-04-22
• Last updated: 2025-04-24

Locations

1 site across 1 country: Portugal