Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
155 participants
OBSERVATIONAL
2022-12-12
2024-03-15
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Heart Failure patients
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.
PROM collection
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).
Interventions
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PROM collection
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Promptly Health
INDUSTRY
EIT Health
OTHER
Centro Hospitalar do Porto
OTHER
Responsible Party
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Irene Marques
Internal Medicine Senior Consultant
Principal Investigators
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Irene Marques, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Hospitalar do Porto
Locations
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Centro Hospitalar Universitário do Porto
Porto, , Portugal
Countries
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References
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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.
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.
Other Identifiers
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2020.032
Identifier Type: -
Identifier Source: org_study_id
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