PROMs From GEstIC Heart Failure Patients

About this trial

Last updated a year ago

Study ID

2020.032

Status

Completed

Type

Observational

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 2 years ago

What is this trial 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.

What are the participation requirements?

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.