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PROMs From GEstIC Heart Failure Patients

NCT06938698 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 155

Last updated 2025-04-24

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Promptly Health

    collaborator INDUSTRY

  • EIT Health

    collaborator OTHER

  • Centro Hospitalar do Porto

    lead OTHER

Principal Investigators

  • Irene Marques, MD · Centro Hospitalar do Porto

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2024-03-15
Completion
2024-03-15

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06938698 on ClinicalTrials.gov