Clinical trial NCT06938698: PROMs From GEstIC Heart Failure Patients
Official title: PROMs From GEstIC Heart Failure Patients - PROFIC-HF Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Patient-Reported Outcome Measures
Clinical Outcomes
Quality of Life
Telemedicine
Feasibility Studies
Lead sponsor: Centro Hospitalar do Porto
Sponsor class: OTHER
Collaborators: name: Promptly Health
name: EIT Health
First posted: 2025-04-22
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with Heart Failure, undergoing treatment at GEstIC. Eligible patients will be identified by GEstIC physicians/investigators in HF hospital appointments.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life as measured by KCCQ-12 versus MLHFQ
timeFrame: Measurement at 0, 1 and 6 months after informed consent.
Secondary outcomes:
measure: 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.
timeFrame: Measurement at 0, 1 and 6 months after informed consent.
measure: Assessment the effect of HF hospitalizations in the quality of life of real world HF patients.
timeFrame: Measurement at 0, 1 and 6 months from discharge.
measure: Assessment of anxiety and depression by Hospital Anxiety and Depression Scale (HADS)
timeFrame: Measurement at 0, 1 and 6 months after informed consent.
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário do Porto
Study officials:
affiliation: Centro Hospitalar do Porto
name: Irene Marques, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, Filippatos GS, Hardman S, Hoes AW, Hutchison S, Jessup M, Kinsella T, Knapton M, Lam CSP, Masoudi FA, McIntyre H, Mindham R, Morgan L, Otterspoor L, Parker V, Persson HE, Pinnock C, Reid CM, Riley J, Stevenson LW, McDonagh TA. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC Heart Fail. 2020 Mar;8(3):212-222. doi: 10.1016/j.jchf.2019.09.007. Epub 2019 Dec 11.
citation: Marques, I., Gomes, C., Viamonte, S., Ferreira, G. e Mendonça, C. 2017. Clínica Multidisciplinar de Insuficiência Cardíaca: Como Implementar. Medicina Interna. 24, 4 (Dez. 2017), 308-317. DOI:https://doi.org/10.24950/rspmi/R58/17/2017.