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Completed

NCT Number: NCT06938698

PROMs From GEstIC Heart Failure Patients

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar Universitário do Porto

Porto, 4099-001, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PROM collection

Other

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).

Primary outcomes

  1. Health-related quality of life as measured by KCCQ-12 versus MLHFQ

    Time frame: Measurement at 0, 1 and 6 months after informed consent.

    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.

Secondary outcomes

  1. 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.

    Time frame: Measurement at 0, 1 and 6 months after informed consent.

    KCCQ-12 and MLHFQ are HF-specific quality of life questionnaires. Patients will either answer to only one of the questionnaires.

  2. Assessment the effect of HF hospitalizations in the quality of life of real world HF patients.

    Time frame: Measurement at 0, 1 and 6 months from discharge.

    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..

  3. Assessment of anxiety and depression by Hospital Anxiety and Depression Scale (HADS)

    Time frame: Measurement at 0, 1 and 6 months after informed consent.

    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.

Sponsors and collaborators

Lead sponsor

Centro Hospitalar do Porto

Other

Collaborators

  • EIT Health
  • Promptly Health

Registry information

Official study title

PROMs From GEstIC Heart Failure Patients - PROFIC-HF Study

Acronym: PROFIC-HF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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