Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05168722 |
| Other study ID # |
PI21/00824 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 28, 2022 |
| Est. completion date |
January 31, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Hospital Galdakao-Usansolo |
| Contact |
Josune Martin, PhD |
| Phone |
+34 944007105 |
| Email |
jmartin[@]kronikgune.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
1. - 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
Scope: Participating hospitals: Basurto (Bilbao), Donostia (San Sebastian), and
Galdakao-Usansolo (Galdakao, Vizcaya). There were 1093 patients. Comité de Ética de la
Investigación con medicamentos/ Ethics Committee for Drug Research (CEIm) approval
Basque Country baseline study reference PI2015151:
2. - COHORT OF PATIENTS WITH COPD (Clinicaltrials.gov # NCT03227211).
- Inclusion criteria: episodes of patients with COPD exacerbation who can be admitted
with 2 presentations: A) Known case of COPD: Episodes of patients with a previous
diagnosis of COPD (FEV1 / forced vital capacity (FVC) <70%) presenting with an
exacerbation of COPD. B) New case of COPD: Episodes of patients whose clinical history
and anamnesis suspect a COPD: (smokers or ex-smokers of more than 15 packs / year, with
basal dyspnea, cough, expectoration for more than three months of the year), who present
symptoms compatible with an exacerbation. The diagnosis was confirmed in the pulmonology
control consultation within two months after hospital discharge or emergency room, by
performing spirometry and always bearing in mind that the patient had to be stable.
Exclusion criteria: Patients admitted with ventilatory failure obstructive or
restrictive due to a different disease (asthma, tuberculosis sequelae, pachypleuritis,
restrictive diseases). All COPD cases finally admitted for any other cause, other than
exacerbation or complicated COPD. Patients with serious organic or psychopathological
problems or in a terminal or neurosensory situation that prevent them from giving their
consent and / or completing the questionnaires used in the study. Patients who do not
understand the Spanish language and cannot complete the questionnaires. Or that they do
not wish to participate or that they do not sign the informed consent that all patients
will be passed. There were 1,400 patients from the hospitals of Araba, Donostia, Cruces,
Basurto, Santa Marina and Galdakao. CEIm approval Basque Country baseline study
reference: 912015124
3. -COHORT OF PATIENTS WITH MAJOR DEPRESSION (ISCIII Reference: PI13 / 00560). Selection
criteria. Patients with a diagnosis of depressive disorder (DSM-IV criteria).
Inclusion criteria : patients over 18 years of age diagnosed with depressive disorder, and
who after being informed of the objective of the study agree to participate. Exclusion
criteria: patients with organic or psychiatric pathologies that prevent them to collaborate
in the study; illiterate or patients with sensory deficit that prevent the completion of the
outcome measurement instruments included in the study, or patients with bipolar disorder,
dysthymia or postpartum depression. There were 433 patients recruited from: Basurto Hospital,
Galdakao Hospital, and Mental Health Centers of Basauri, Galdakao, Derio, Uribe, and
Ortuella. CEIm approval Basque Country baseline study reference: 12014050) 1.-COHORT OF
COVID-19 POSITIVE PATIENTS (Clinicaltrials.gov # NCT04463706). Admitted patients (confirmed
cases) of COVID-19 during 2020, excluding the pediatric population. A case of infection by
severe acute respiratory syndrome by Corona Virus-2 (SARS-CoV-2) is defined as the one that
meets the laboratory criteria: polymerase chain reaction amplification (PCR) positive at a
specific gene [RNA-dependent RNA polymerase (RdRp) or S gene] or PCR positive for at least 2
genes used as screening [E or N gene].
SCOPE: Patients admitted for COVID-19 in hospitals in the Basque Country, from 03/01/2020 to
on 31/12/2020. There were 3038 patients, 1865 and 1173 registered patients from the first and
second wave of the pandemic, respectively. CEIm Basque Country approval baseline study
reference: PI2020059.
SAMPLE SIZE. It is based on the previously created cohorts, with sample sizes that range from
slightly more than 400 people in the cohort with the smallest sample size to more than 3,000
in the the one that more patients are included.
CALCULATION OF SAMPLE SIZE. Due to the sample sizes that the investigators have in all the
cohorts the investigators guarantee being able to respond to the hypotheses of the study with
a power of 80% and an alpha error of 0.05 for paired data. Thus, for example, for a decrease
in the quality of life of the EuroQol-5D (EQ-5D) of 0.1 points (with a standard deviation of
0.4) 128 people would be needed. Likewise, assuming a change in the proportion of visits that
drops by 15% or more would require 165 people for each cohort. In all cases, this estimated
sample size is exceeded by our samples. In the case of models predictive predictors of
persistence of symptoms, if there is at least 10% of the sample with this persistence of
symptoms, with the more than 3000 people in this cohort, this is enough to develop and
validate a predictive model.
METHODOLOGY Variables for which the investigators already have information at baseline: In
all cases there are sociodemographic data, clinical information (background, associated
diseases, level of severity of study disease, baseline treatments, imaging tests, and
analytical data when appropriate) and quality of life questionnaires, both generic and
specific.
Follow-up. Variables common to all the cohorts that the investigators will collect from the
period 2017 to 2019. Apart from the previous baseline information that is already available
for each cohort, the investigators will complement it with data on associated diseases to
present to patients during this period as well as all prescribed long-term treatments.
Health services use during the study period will be collected on the number of consultations
with their primary care physician, primary care nurse, consultations with specialists,
participation in telemedicine programs, continuity of care, admission in residence, telematic
consultations, laboratory and imaging tests requested, consultations with others specialists,
visits to hospital and out-of-hospital emergencies, hospital admissions (with diagnosis at
discharge), ICU admissions, or death.
Variables that the investigators will collect in the follow-up until 2022 (including 2020 and
2021) Similarly, the data on the clinical situation of the patients of the various cohorts
will be updated.
Information will be collected on the use of social health services during the study period on
the number of consultations with their primary care doctor, primary care nurse, consultations
with specialists, participation in telemedicine programs, continuity of care, telematic
consultations, laboratory and imaging tests requested, consultations with other specialists,
visits to hospital and out-of-hospital emergencies, hospital admissions ((with diagnosis at
discharge), admissions in ICU, admission to residence, or death.
Variables to be collected in the follow-up of patients diagnosed as COVID positive during the
2020-2022 period. Symptoms that persist over time: fatigue, shortness of breath, cough, joint
pain, chest pain, muscle pain or headache, fast heartbeat
, loss of smell or taste, memory problems, concentration or trouble sleeping (insomnia),
dizziness tingling, tinnitus, earaches discomfort, diarrhea, stomach pain, loss of appetite,
fever, sore throat, rash or hair loss. More serious complications: Cardiovascular:
inflammation of the heart muscle. Respiratory: abnormalities in lung function. Renal: Acute
kidney injury Dermatological: skin rash, hair loss. Neurological: smell problems and taste,
sleep problems, difficulty concentrating, memory problems Psychiatric: depression, anxiety,
mood swings. Follow-up tests performed. Imaging tests; function tests pulmonary; of cardiac
function. Blood test. Specific treatments established by complications of COVID. COVID
vaccination. Time off work (date of incorporation to the job); Need for help (family or
social) or admission to a residence.
DATA COLLECTION. All alive patients who agree to participate in this new phase will be
contacted. Once they accept and sign the Informed consent, the following sources of
information will be used.
- Computer records of tabulated information (data exploitation system in the case of
variables which are tabulated: Oracle Analytics Server (OAS)).
- Clinical electronic records: for information that is not indexed in the previous data
bases and requires a manual review of the history.
Data mining in OAS will be done by a data analyst. Manual data extraction will perform a data
manager, both to be hired in charge of this project, under the supervision of the principal
investigator (PI) and clinical collaborators. All data collected by the various sources of
information will be entered in a database created in a ad hoc data base, hosted on our
administration servers to guarantee their security and confidentiality. Once the information
has been extracted from both sources of information, the data analyst will create a common
database for further analysis.
STATISTIC ANALYSIS. A descriptive analysis of the entire sample will be carried out (means
and standard deviations for continuous variables or frequencies and percentages, for
categorical variables) and the differences between the samples of the two times of each
cohort will be evaluated by means of the analysis paired data using the paired t or the
Wilcoxon paired nonparametric test, if normality is not fulfilled, for continuous variables,
and by means of the McNemar test for categorical variables. A univariable analysis will be
performed to determine potential factors or variables. related to the outcome variables of
interest. Regression will be used for the multivariable analysis conditional logistics or
generalized linear models for paired data (GEE). In the case of analysis of unpaired data,
the usual statistics for continuous data (t-test, ANOVA) or categorical (Chi-Square, Fisher's
exact test). For predictive models, in the case of variables dichotomous dependent
(persistent symptoms) multilevel logistic regression models will be used, whose predictive
capacity will be measured by the area under the receiver operating characteristic (ROC) curve
(AUC) and the calibration of the model using the Hosmer and Lemeshow test; for continuous
dependent variables (changes in their quality of life) multilevel generalized linear models
will be used. Adjustment variables: diagnostic, severity of the disease, associated diseases,
procedures and treatments performed, quality of life related to baseline health. Statistical
significance will be assumed when p <0.05 and all Analysis will be carried out using the
statistical programs Statistical Analysis System (SAS) v9.4 and R.
