NCT06938698Completed
PROMs From GEstIC Heart Failure Patients
PROMs From GEstIC Heart Failure Patients - PROFIC-HF Study
Source: ClinicalTrials.gov · Last updated 24 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 155 (actual)
- First submitted
- 7 Apr 2025
- Start date
- 12 Dec 2022
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- Centro Hospitalar do Porto
- Diseases
- Heart failure
- NCT number
- NCT06938698
What you commit to
- Study type: Observational
- Participants enrolled: 155
- From 12 Dec 2022 to the primary completion date, 15 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Inability to give the answers to the questions in the questionnaires,
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Hospitalar Universitario do Porto Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.