This is a cross-sectional study with Cross-sectional study with web-based online survey by invitation that was conducted among COVID-19 patients hospitalized in selected hospitals from 15th April until 30th June 2020.
Sampling design and sample size
- Target population
The target population was all COVID-19 patients hospitalized in two referral hospital at klang valley, one COVID-19 designated hospital at Johore and one Low-Risk Patient Quarantine & Treatment centre. The sampled population was the proportion of stable COVID-19 patients at hospitals who were selected via quota sampling technique.
- Sampling frame
The sampling frame for the study was the list of all the COVID-19 patients admitted to the general wards (non-intensive) who were in a stable condition.
- Sample size determination
The sample size was calculated using the Sample Size Calculation Formula for prevalence with finite population correction study as per the primary objective (4). The sample size calculation was based on the reported prevalence of depression among MERS-CoV patients in Korea, 40.7% (5). The calculation was done with a margin of error of 0.05 and Type 1 error determined at 5% with a finite population of 500 (2).
Selection of respondents
Patients who have been diagnosed as COVID-19 and in stable condition were listed in the sampling frame. Screening for eligible respondent among COVID-19 patients in each hospital started on 15th April 2020. An eligible respondent must be of age 18 years and above, has been diagnosed with COVID-19 but in a stable condition, has been admitted in the ward for more than 24 hours and able to read and understand Malay or English. Quota sampling technique was utilized in this study whereby the first 400 eligible patients who responded to the screening were recruited in this study. Participation in this study was on a voluntary basis as each respondent has the right to refuse or withdraw from the study at any point of time during the survey. If the respondent refused, all details of the respondent, as well as any response given, would then be deleted.
Structured questionnaires were used to collect data on the scopes of the survey. The questionnaires are in Malay and English, programmed into the Google form for data collection. The front page (1st part) of the Google form is the Patient Information Sheet and Consent Form. The 2nd part of the Google form is the socio-demographic profile of respondents and factors contributing to mental health (Section A & Section B). The 3rd part (Section C) is the Patient Health Questionnaire (PHQ-9) to assess for probable depression with a cut-off score of 10 and above, the 4th part (Section D) consisted of Generalized Anxiety Disorder questionnaire (GAD-7) to assess for probable anxiety with a cut-off score of 8 and above. The 5th part (Section E) is the coping strategies via Brief COPE (Coping Orientation to Problems Experienced). Psychometric measurements for all three questionnaires (PHQ-9, GAD-7 & Brief COPE) were locally validated beforehand (6-8).
A total of 8 Research Assistants (RAs) were hired for this survey and training was given. Two RAs were in-charged for central team in Institute for Public Health (IPH) and the remaining were stationed in the psychiatric department with two RAs per hospital .The RAs in hospitals conducted a briefing to all matrons or staff in charge of COVID-19 ward and Google Form link for the survey was given to them which then disseminated to the eligible respondent of COVID-19 patient.
Responses in the cloud server were downloaded daily by the central team in IPH and scoring was performed for PHQ-9 with the inclusion of suicidal ideation (item no. 9) score and GAD-7. Positive cases that require further assessment for diagnosis and management were referred within 24 hours to the psychiatrist in-charge at the respective hospital.
Data management, Quality Control (QC), Privacy and Confidentiality
Data processing activities were centralized at the Institute for Public Health (IPH) including data collection, data cleaning and data analysis. A minimum of 30 different responses tested the system (Google form) by various respondents started on the 15th April 2020 to ensure its reliability. The changes were made as per the feedback received from the respondents of the pilot study.
In order to ensure the privacy and confidentiality of data, the data gathered in the database was kept in a secure manner. The access control of the dataset in any format was managed by assigning unique password to each file. Only central team researchers were able to assess the personal particulars of participants and the data will be conserved.
All data were cleaned and analyzed by the research team. A meaningful combination of categories was done as per indicated. Data was analyzed using SPSS version 23.0. Descriptive statistics analysis were performed to determine prevalence of depression and anxiety among stable hospitalized COVID 19 patients. Multivariate statistics via multiple logistic regression were performed to evaluate risk factors associated with prevalence of depression and anxiety.