PROMs From GEstIC Heart Failure Patients (PROFIC-HF)

Centro Hospitalar do Porto

Status: Completed

Conditions: Heart Failure

Treatments: Other: PROM collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06938698

2020.032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written Informed Consent (IC) signed before any study- specific procedure,
• Adult patients diagnosed with HF, undergoing treatment at GEstIC,
• Ability and willingness to understand the proposed questionnaires, per physician judgment and
• Ability and willingness to access the platform for completing the data by themselves or with the help of a caregiver (proxy)

Exclusion criteria

• Inability to give the answers to the questions in the questionnaires,
• Moderate or severe cognitive impairment that precludes the understanding of the questions, per physician judgment,
• Malignancy or other non-cardiac condition limiting life-expectancy to < 12 months, per physician judgment or
• Any other condition or therapy that would make the subject unsuitable to this study and would not allow participation for the full planned study period, in the judgment of the investigator.

Trial design

155 participants in 1 patient group

Heart Failure patients

Description:

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.

Treatment:

Other: PROM collection