Table 2.
Schedule of enrolment and assessments in BaCoM: study group and control groups
| Construct | Timepoint | Baseline | FU1–FUx |
| Instrument | Enrolment | 6 months after PCR test | |
| Sociodemographic information*† | Questionnaire | ||
| Age, sex, migration background, educational level, professional life/activity, income, marital status, health insurance, insurance number | x | ||
| Care-specific parameters with reference to the need for care†* | Questionnaire | ||
| Care level (I–V)/frailty level and onset date of the need for care/frailty | Clinical Frailty Scale21 22 | x | x |
| Diagnosis justifying care | x | x | |
| Capacity for giving consent/legal guardian | x | x | |
| Care setting (outpatient/inpatient care) | x | x | |
| Change of care level/frailty level and care setting since start of the pandemic | x | x | |
| Provision of aids/therapies (Which are needed? Which ones are not supplied/prescribed due to the pandemic, etc? Which individual solution is used?) | x | x | |
| Measures involving deprivation of freedom (before pandemic/during pandemic) | x | x | |
| Pressure ulcer (before pandemic/during pandemic) | x | x | |
| respiration | x | x | |
| Self-rated pain levels | Rating scale1–10 | x | x |
| Activities of daily living (ADL) | Barthel Index35 | x | x |
| Nursing diagnoses in terms of NANDA-I (Definitions and Classification 2018–2020)34 *† | Questionnaire | ||
| Stability of respiratory parameters38 | Likert Scale | ||
| Impaired gas exchange | x | x | |
| Impaired spontaneous breathing | x | x | |
| Ineffective airway clearance | x | x | |
| Sense of smell and taste | Likert Scale | ||
| Smells all primary odours | x | x | |
| Tasting all substance spectra | x | x | |
| Social interaction34 39 | Likert Scale | ||
| Mobility, ability to walk | x | x | |
| Communication verbal/via electronics (impaired/reports needs) |
x | x | |
| Family processes (before and since the beginning of the pandemic) | Likert Scale | ||
| Continuous family processes (before and since the beginning of the pandemic) | x | x | |
| Interrupted family processes (before and since the beginning of the pandemic) | x | x | |
| Social isolation34 39 | Likert Scale | ||
| Feeling of being alone (during the COVID-19 pandemic, as imposed by others) | x | x | |
| Feeling of being alone (before and since the beginning of the pandemic) | x | x | |
| Can explain current situation of the pandemic | x | x | |
| Can place current challenges in the context of the pandemic | x | x | |
| Can get help to cope with current life situation | x | x | |
| Can cope with tasks and challenges themselves | x | x | |
| Feeling of powerlessness/helplessness | x | x | |
| Physical health status† | |||
| Height, weight, body mass index, smoking status | Questionnaire | x | x |
| Blood sampling: laboratory parameters, serostatus survey, long-term storage24 40 | Measurement | x | x |
| Vital parameters (blood pressure, pulse, breath rate, O2-saturation, body temperature) | Measurement | x | x |
| Identification of patients at risk from sepsis | Quick sepsis-related organ failure assessment (qSofa)41 42 | x | x |
| Measurement of pulmonary function PEF, FEV1, FVC, FEV0.75, FEV0.5, FEV1/FVC, FEF75, FEF25-75, FEF50, FV-curve |
Spirometry (mySpiroSense, mobile spirometer) |
x | x |
| Cognitive short test | Six-Item-Screener20 | x | x |
| Cognitive Impairment | MoCA-BLIND23 | x | x |
| Mobility | Timed-Up&Go Test43 | x | x |
| Medication | Medication list | x | x |
| Diagnosis | Diagnosis list | x | x |
| Vaccination status (COVID-19/influenza/pneumococcus) | Vaccination certificate | x | x |
| Characteristics of a COVID-19 disease course (Study+Control group 2)/Characteristics of the course of the respiratory infection (control group 1)*†‡ | Questionnaire | ||
| Date of positive/negative: SARS-CoV-2 PCR test / rapid SARS-CoV-2 antigen test + nucleocapsid antibodies | x | x | |
| Symptomatic/asymptomatic infection | x | x | |
| Time of onset of COVID-19 symptoms/symptoms of the respiratory infection | |||
| COVID-19 symptoms/symptoms of the respiratory infection24 § | x | x | |
| Duration of symptoms (long-COVID/post-COVID)¶ | x | x | |
| COVID-19 specific clinical complications/complications of the respiratory infection (diagnoses)24 | x | x | |
| New medication since PCR Test | x | x | |
| Mortality (time/cause of death, autopsy findings) | |||
| Use of medical care facilities (since PCR test)*†‡ | Questionnaire | ||
| Inpatient medical care (days/diagnosis): Hospitalisation (with intensive care unit)/rehabilitation/ psychatry Number of general practitioner/other specialists contacts |
x | x | |
| Ambulatory medical care (days/diagnosis): Number of general practitioner/other specialists contacts /treatment in emergency rooms | x | x | |
| Psychosocial health status* | Questionnaire | ||
| Health-related generic quality of life | EQ-5D-5L and EQ-VAS25–27 | x | x |
| Depressiveness | PHQ-9(29) | x | x |
| Post-traumatic stress disorder (PTSD) | Impact of Event Scale (IES-R)31 | x | x |
| Anxiety | GAD-7(30) | x | x |
| Health literacy | HLS-EU-Q1633 | x | x |
| Coping/self-management/self-efficacy | SES6G32 | x | x |
| Healthcare utilisation | Claims data** | ||
| Medical diagnoses | ICD-10 codes | x | x |
| Planned and emergency hospital admissions | ICD-10 codes | x | x |
| Medication dispensed by community pharmacies | ATC codes | x | x |
| Level of care applications/assessments | Standardised assessment templates | x | x |
*Survey of the person in need of care or support.
†Survey by medical/nursing staff, (caring) relatives.
‡Patient record/care record.
§Main symptoms according to the National Research Network of University Medicine on COVID-19: German Corona Consensus Data Set24: Disturbance of the sense of smell and/or taste, abdominal pain, disturbance of consciousness/confusion, diarrhoea, vomiting, cough, shortness of breath (dyspnoea), nausea, fever, headache, fatigue, etc.
¶Long-COVID syndrome is defined as health complaints that persist beyond the acute illness phase of a SARS-CoV-2 infection of 4 weeks or are new. Post-COVID syndrome refers to symptoms that persist for more than 12 weeks after the onset of SARS-CoV-2 infection and cannot be explained otherwise.44 45
**Data are provided by the statutory health insurance of study participants and linked nursing care assessment services (Medizinischer Dienst). Data linkage is provided by a dedicated trust centre.
BaCoM, Bavarian ambulatory COVID-19 Monitor; EQ-5D-5L, EuroQol; EQ-VAS, EQ visual analogue scale; FEF, Forced expiratory flow; FEV, Forced expiratory volume; FU, follow-up; FVC, Forced vital capacity; FV-curve, Flow volume-curve; GAD-7, Generalised Anxiety Disorder Screener; HLS-EU-Q16, European Health Literacy Survey; NANDA, North American Nursing Diagnosis Association; PEF, Peak expiratory Flow; PHQ-9, Patient Health Questionnaire; SES6G, Six-item Self-Efficacy Scale.