corona COVID19
Conditions
Interventions
The efficacy of a personalized counselling intervention will be investigated in
a nested study. Half of the patients will receive a personalized counselling
intervention based on dietary quality and
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: for Patients: -Age: 40-65 years -Proven ex-COVID-19: Hospitalised: Positive PCR / serology for SARS-CoV2 or CORADS score 4/5, Non-hospitalised: Positive PCR / serology for SARS-CoV2. -Able to provide informed consent -Access to internet (either at home or via relatives/friends). -Understanding of Dutch language for healthy volunteers: - age 18-65 - For the recovered healthy volunteers: proven ex-COVID-19: with a positive PCR / serology for SARS-CoV2Able to provide informed consent - Understanding of Dutch language
Exclusion criteria
Exclusion criteria: -Inability to provide informed consent -History or suspicion of inability to cooperate adequately -Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study or during the study; -Investigator*s uncertainty about the willingness or ability of the patient to comply with the protocol requirements -Patients with terminal illness;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A) Lung damage assessed by CT scans at approximately t = 3-6 months and t = 12-18 months after SARS-COV2 infection and the association of this damage with biomarkers and the exposome. B) Difference in EQ-5D Index Score between intervention and control groups at t = 12 months after SARS-COV2 infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in CT scan assessed lung damage between t = 3-6 months and t = 12-18 months. - The development of symptoms fulfilling the International Consensus Criteria (ICC) for ME/CSF diagnosis. - Quality of life measure by EuroQol-5D. - Fatigue measured by Checklist individual strength (CIS). - Body height and weight to calculate the body mass index (BMI). - Body composition by bioelectrical impedance analysis (BIA). - Dietary intake by a 24h food diary - Physical activity by accelerometry - Motivational profiling questionnaire (self-determination theory questionnaire (SDT)) - Psychosocial functioning questionnaire (HADS) - (Change in) exhaled breath profile assessed by eNose and GC-MS - Lung function assessed by spirometry, diffusion capacity, maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) - (Change in) transcriptome, genome, epigenome, metabolome and microbiome. | — |
Countries
Netherlands
Outcome results
None listed