An observational study in Heart Failure, sponsored by Centro Hospitalar do Porto. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Centro Hospitalar do Porto · Observational
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.
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.
Adult patients diagnosed with Heart Failure, undergoing treatment at GEstIC. Eligible patients will be identified by GEstIC physicians/investigators in HF hospital appointments.
Exclusion Criteria:
Patients of the GEstIC Heart Failure clinic will use a digital PROMs system, collecting information on the consultation waiting room and/or with the patient at home using a web based application that runs on the smartphone or computer with internet connection.
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).
Health-related quality of life as measured by KCCQ-12 versus MLHFQ
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and Minnesota living with Heart Failure (MLHFQ) are a quality of life (QoL) questionnaires specific for heart failure. Patients will be randomized to answer to only one of the questionnaires. KCCQ consists of 12 questions specific to HF and appraises QoL over the last two weeks; scores range from 0 to 100, where higher score means better QoL. The MLHFQ consists of 21 questions and appraises QoL over the previous month. Questions are answered using a Likert scale ranging from 0-5; score range is 0-105, with higher score representing a poorer QoL.
Time frame: Measurement at 0, 1 and 6 months after informed consent.
Correlation between quality of life changes, measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12) versus Minnesota Living with Heart Failure Questionnaire (MLHFQ), and changes in clinical reported outcomes.
KCCQ-12 and MLHFQ are HF-specific quality of life questionnaires. Patients will either answer to only one of the questionnaires.
Time frame: Measurement at 0, 1 and 6 months after informed consent.
Assessment the effect of HF hospitalizations in the quality of life of real world HF patients.
Measurement of quality of life after HF hospitalizations, using Kansas City Cardiomyopathy Questionnaire (KCCQ-12) versus Minnesota living with Heart Failure (MLHFQ). Patients will be randomized to answer to only one of the questionnaires. KCCQ consists of 12 questions specific to HF and appraises QoL over the two weeks; scores range from 0 to 100, where higher score means better QoL. The MLHFQ consists of 21 questions and appraises QoL over the previous month. Questions are answered using a Likert scale ranging from 0-5; score range is 0-105, with higher score representing a poorer QoL..
Time frame: Measurement at 0, 1 and 6 months from discharge.
Assessment of anxiety and depression by Hospital Anxiety and Depression Scale (HADS)
HADS will be used to assess anxiety and depression. HADS is a 14-item scale, in which all items are rated on a 4-point Likert scale, and scores are 19 computed by summing the scores of each subscale, for anxiety or depression. Scores range from 0 to 20, where higher scores indicate more anxiety or depression symptoms.
Time frame: Measurement at 0, 1 and 6 months after informed consent.
Plan to share: Undecided
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Centro Hospitalar do Porto