PROMs From GEstIC Heart Failure Patients - PROFIC-HF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Health-related quality of life as measured by KCCQ-12 versus MLHFQ
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Health-related quality of life as measured by KCCQ-12 versus MLHFQ
时间窗: 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.
次要结局
- 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.(Measurement at 0, 1 and 6 months after informed consent.)
- Assessment the effect of HF hospitalizations in the quality of life of real world HF patients.(Measurement at 0, 1 and 6 months from discharge.)
- Assessment of anxiety and depression by Hospital Anxiety and Depression Scale (HADS)(Measurement at 0, 1 and 6 months after informed consent.)
研究者
Irene Marques
Internal Medicine Senior Consultant
Centro Hospitalar do Porto