Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05421637 |
Other study ID # |
UW/FP/IC/PSICOLOGIA/2021/003 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 15, 2020 |
Est. completion date |
May 15, 2021 |
Study information
Verified date |
June 2022 |
Source |
Universidad Westhill, Facultad de Psicología |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This was a non-experimental, descriptive, prospective and cross-sectional study, for which
the CHERRIES checklist was used to report the study in order to improve the quality of the
report of such designs. The open-ended survey was voluntary, consisted of 18 items and four
sections, the items were not randomized and the survey was estimated to last approximately
five minutes.
Description:
Sampling:
A non-experimental sampling is carried out by voluntary subjects, since the subjects will
come to the study by a call for applications.
Sample size
The formula of infinite population of qualitative variables will be used, because we will
work with ordinal variables and because the total number of observation units that integrate
it is unknown or when its population is greater than 100,000 and the formula is the
following:
The sample size for 100,000 people should be 384 people, so that 95% of the time the data you
want to measure is in the interval ±5% with respect to the data observed in the evaluation.
Data management plan:
Data dictionary design
Training will be provided and data dictionary will be developed describing the properties of
variables such as data type (e.g. string and number), variable size, data encoding, and
constraints and validations attached to a given variable (Annex).
Data collection
The research data will be obtained through the Google forms, which has "SOC 2" accreditation
that meet best practices and security, as they are transmitted over a secure HTTPS connection
and that user logins were protected through TLS. Furthermore, data is encrypted using
industry and research standard encryption algorithms.
Data Retention
The database will be generated in Excel for further analysis in R studio, which will be kept
at the University on an encrypted USB stick for data security and the password to this stick
will only be held by the project manager.
Standards that provide data integrity, accuracy and coherence
The International Classification of Diseases (ICD- 11) will be used to present data
consistency, accuracy and completeness through the optimal definition of mental health
entities. On the other hand, the standards for data use recommended by The Global Health
Training Centre will be used:
(a) The column heading (variable) is not changed between data. b) The same terminology is
maintained for all variables. c) There is a consistent format and standard definition for
subject identification.
d) The name of the datasets is always the same. e) Name of the form / CRF section, e.g.,
demographic data f) A list of data objects (names and definitions) g) Description of the data
element in natural language h) Detailed properties of the data elements (data type, size,
nullability, optionality, indexes) i) Response options, e.g., check box, radio button, text
j) Validation rule(s), e.g., required field, range checking k) Relationship of data elements
to other data elements. l) Details about the privacy and security restrictions that should be
associated with the element, e.g., Protected Health Information status.
Methodological guidelines for reporting the study:
The guide to improve the quality of methodological reporting of cross-sectional online
studies called CHERRIE will be used.
Data analysis
Descriptive statistics were used to analyze the central tendency frequencies of the
participants' characteristics. Non-parametric analyses will be applied because the data do
not meet the criteria of normality in the analysis of their distribution, the type of
variable and the number of participants; therefore, Spearman correlations will be used to
contrast ordinal data. On the other hand, we plan to use odds ratio analysis to determine the
possibility that knowledge of evidence-based psychology is present in one population group
with more studies than in another.