COVID-19, Patients' Evolution and the Influence of the Pandemic on Health Care and Outcomes in Chronic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,220
- 试验地点
- 5
- 主要终点
- Patient reported outcome measurements changes
研究概览
简要总结
Objectives: 1.- To evaluate the changes in health care and use of services in patients with chronic diseases such as chronic obstructive pulmonary disease (COPD), heart failure and major depression between 2017-2019 and the years 2020-2022, COVID pandemic period, and to see their relationship with clinical outcomes (in terms of mortality, admissions, death, current situation of his disease) and changes in health-related quality of life. 2- To evaluate the health care provided to a cohort of patients diagnosed with SARSCOV-2 (COVID-19 positive) during 2020 based on accessibility, equity and outcomes obtained. 3-To evaluate the evolution of the cohort of patients diagnosed with SARSCOV-2 after two years of follow-up since their diagnosis and create clinical prediction rules for the persistence of symptoms.
Methodology. Four cohorts already created in previous projects are included: three of chronic patients, COPD, heart failure, major depression, all of 2017, and for which baseline information is available for follow-up of the health care they received in the 2017-19 period compared to that received during the 2020-22 period and to see the changes in their health-related quality of life from baseline based on generic and specific questionnaires for each of the pathologies included. Another cohort of positive and admitted patients for COVID-19 in 2020 is included, in whom the services received will be evaluated and recorded symptoms persistency that may have had up to two years after their index admission to develop tools for predicting the persistence of symptoms in the medium-long term.
详细描述
DESIGN. Cohort study with prospective follow-up of 4 preformed cohorts between years 2017 and 2020 which will be followed until 2022.
SUBJECTS OF STUDY. SELECTION CRITERIA. DESCRIPTION OF THE COHORTS OF CHRONIC PATIENTS.
-
- COHORT OF PATIENTS WITH HEART FAILURE (HF) (Clinicaltrials.gov # NCT03300791).
Selection criteria: A. Inclusion criteria: patients admitted for insufficiency syndrome acute cardiac arrest including acute (de novo) heart failure and heart failure (HF) previously diagnosed but that has a progressive or rapid worsening of symptoms that requires urgent intervention. (ICD-9 code: 428.x; some of 402.x). Patients over 18 years. Patients who agree to participate and sign the informed consent.
B. Exclusion criteria: a) patients who develop an episode of HF during admission, if they have been admitted for another reason, b) patients transferred from other health centers c) myocardial infarction or cerebrovascular accident in the 4 weeks prior to admission, d) life expectancy less than one year, due to HF in terminal state or due to a different cause according to the assessment of the study physicians e) impossibility to complete the questionnaires or with external help (reviewer, family, social help) due to sensorineural cause, dementia or lack of knowledge of the language
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •patients over 18 years of age diagnosed with depressive disorder, admitted by heart failure or COPD, or positive to COVID-19
排除标准
- •patients with pathologies organic or psychiatric that prevent collaboration in the study; illiterate or deficit patients sensory that prevent the completion of the outcome measurement instruments included in the study, or who refuse to participate
结局指标
主要结局
Patient reported outcome measurements changes
时间窗: 2 years
Changes in generic and specific patient-reported outcome measure (PROMs) in the study period
Health services use
时间窗: 2 years
Visits to primary care physician, specialist, outpatient care, emercengy room, hospital admissions
Death
时间窗: 2 years
Death during follow up
次要结局
未报告次要终点
研究者
JOSE M QUINTANA-LOPEZ, MD PhD
Head of the Research Unit
Hospital Galdakao-Usansolo