Background Immunocompromised people (ICP) and elderly individuals (older than 80 years) are at increased risk for severe coronavirus infections. To protect against serious infection with SARS-CoV-2, ICP are taking precautions that may include a reduction of social contacts and participation in activities which they normally enjoy. Furthermore, for these people, there is an uncertainty regarding the effectiveness of the vaccination. The COVID-19 Contact (CoCo) Immune study strives to characterize the immune response to COVID-19 vaccination in immunocompromised, elderly people, and patients with hematological or oncological diseases. The study uses blood-based screenings to monitor the humoral and cellular immune response in these groups after vaccination. Questionnaires and qualitative interviews are used to describe the level of social participation. Methods The CoCo Immune Study is a mixed methods prospective, longitudinal, observational study at two large university hospitals in Northern Germany. Starting in March 2021, it monitors anti-SARS-CoV-2 immune responses and collects information on social participation in more than 600 participants, at least 18 years old. Inclusion criteria and subcohorts: Participants with (1) regularly intake of immunosuppressive medication (ICP-cohort) or (2) age ≥ 80 years (80 + -cohort). Additionally, patients with current or former (3) myeloid, (4) lymphatic disease or (5) solid tumor under checkpoint inhibition (3–5: HO-cohort). Exclusion criteria: (1) refusal to give informed consent, (2) contraindication to blood testing, (3) inability to declare consent. Participants complete a questionnaire at four different time points: prior to full vaccination, and 1, 6 and 12 months after completed vaccination. In addition, participants draw blood samples themselves or through a local health care provider and send them with their questionnaires per post at the respective time points after vaccination. Patients of the HO cohort dispense additional blood samples at week 3 to 12 and at month 6 to 9 after 2nd vaccination to gain additional knowledge in B and T cell responses. Selected participants are invited to qualitative interviews about social participation. Discussion This observational study is designed to gain insight into the immune response of people with weakened immune systems and to find out how social participation is affected after COVID-19 vaccination. Trial registration: This study was registered with German Clinical Trial Registry (registration number: DRKS00023972) on 30th December 2020.
Background:Restrictions to contain the COVID-19 pandemic affect the social participation of people worldwide. Especially those at high risk for a severe disease tend to abstain from social gatherings. While there are a few questionnaires to measure social participation in elderly or chronic patients, a valid survey instrument that includes pandemic-related social participation is needed.MethodsWe developed a social participation questionnaire that aims to assess pandemic-related restrictions in social participation. Items were developed using a theory and literature-based approach and then compiled in a discursive process involving experts and lay people. This was followed by the validation of the questionnaire through a cross-sectional survey on 431 individuals. Items with low item-total correlations and low factor loadings using exploratory factor analysis [EFA] were excluded. Using EFA on the remaining items, the factor structure was retrieved and tested with a confirmatory factor analysis [CFA]. Internal consistency was assessed with Chronbachs α.ResultsInitially, 27 items were developed which were used for validation. 13 items were excluded due to low item-total correlations and factors loadings. EFA of the remaining 14 items revealed three factors which were identified as domains “active social participation,” “wellbeing,” and “restrictions”. CFA showed an acceptable model fit using the three-dimensional structure. Chronbachs α of 0.81 and McDonalds Ω of 0.87 indicate good internal consistency. Correlation analysis showed an association between the developed questionnaire and previously-established participation and mental health scales.ConclusionThis study suggests that our 14 item questionnaire is of high reliability and validity and can be used to measure social participation during a pandemic.
Immunocompromised persons are at an increased risk for a severe SARS-CoV-2 infection and their safety behaviors may influence their social participation. Vaccinated persons have a lower incidence of infection and severe disease when infected compared to non-vaccinated persons. Therefore, their behavior may change and their social participation may increase after a complete vaccination. The aim of this study was to explore social participation of immunocompromised persons before and after complete COVID-19 vaccination. Between March and September 2021, 274 immunocompromised participants were recruited. Survey data were collected at baseline and follow-up from 194 participants including the Index for the Assessment of Health Impairments [IMET], Patient Health Questionnaire-4 [PHQ-4], subjective health status and quality of life. At baseline, participants were not yet completely vaccinated. Complete vaccination was achieved prior to the follow-up questionnaire. IMET scores decreased significantly at follow-up, indicating a higher social participation after complete vaccination. PHQ-4, subjective health status and quality of life did not differ between baseline and follow-up. There were no significant differences across sociodemographic factors. Significant PHQ-4 differences were observed regarding the population size of the participants' home community. Social participation of immunocompromised persons in our study increased after COVID-19 vaccination. Therefore, social participation should be explored further, especially with regards to the impact of vaccination on groups with a high health risk.
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