Clinical trial NCT05558631: Longitudinal Study of Health Literacy in the Municipality of Leiria
Official title: Lisa Cohort Study: Longitudinal Study of Health Literacy in the Municipality of Leiria
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Health Literacy
Lead sponsor: Instituto Politécnico de Leiria
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 4003
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be composed by adults (≥ 18 years old) who are non-institutionalized and living in private households in Leiria. Because there is no reliable list of households in Portugal, a random selection of points in the map of each location will be performed. Addresses will be selected, and afterwards the "random-walks" will start. Interviewers will register each selected address and, if someone is at home, they will collect information on age and gender of the different people living in that address and will give information about the study. In order to assure the successful data collection, up to three visits to each address (one during the weekend) will be made. At each address, the person whose birthday is closest to the day of the visit (aged 18 years or older) will be selected for the interview and, if available, will be immediately asked to answer the questionnaire.

Brief summary: Health literacy (HL) is a topic of increasing importance todays' ever-changing world. Over the past few decades, HL has gained importance, as it is a factor related to health behaviors and outcomes. In Portugal, the last survey was in 2016 and 61% of the population had a problematic or inadequate level of HL in general. Lisa is a cohort study that will measure HL in the adult population residing in the municipality of Leiria over the next 4 years, with measurements every 2 years. Over the years we will promote activities and interventions adjusted to the needs of Leiria's population. At the end we want to understand the changes during the years and improve the health care provided.

Detailed description: The main aim of this study is to measure HL in the adult population residing in the municipality of Leiria over the next 10 years. As secondary objectives, it is intended to characterize anxiety and depression, metabolic risk, alcoholism, and smoking in the in the same population sample and over the same period. The research design follows a longitudinal, prospective closed cohort study of Leiria's residents during ten years. Strengthening the report of observational studies in epidemiology (STROBE) guidelines were applied in alignment of the research objectives. The frequency of data assessment is set to two years, so participants will be contacted five times during the study. The sample will consist of residents of the municipality of Leiria aged 18 years or over, having been determined a sample size of 4003 (2001 men and 2002 women).

The team that conducted the 1st wave survey will be composed by 32 interviewers, who will be recruited by the Center for Innovative Care and Health Technology (ciTechCare) coordination board through a selection process composed of 2 stages: interview selection plus a theoretical and practical training session. The follow-ups of the cohort were decided to be conducted every two years by call. In the 1st wave a face-to-face interview will be conducted with the Computer Assisted Personal Interview (CAPI) system: all interviewers have a tablet with the software (LimeSurvey) which provided the questionnaire, designed by ciTechCare research team, applied to all subjects. Surveys will be administered online via the LimeSurvey platform at baseline and at 2 years, 4 years, 6 years, and 8 years post baseline (5 waves). The baseline and follow-up surveys will comprise the same battery of validated questionnaires and instruments designed to collect information on sociodemographic, lifestyle aspects (tobacco and physical activity), anthropometric variables, auto-report chronic diseases, metabolic risk, anxiety and depression and HL. It will take approximately 30 minutes to complete the survey.

Metabolic risk is assessed by the Finnish Diabetes Risk Score (FINDRISC), to evaluate symptoms of anxiety and depression we applied the Hospital Anxiety and Depression Scale (HADS) Portuguese validated version and HL will be measured by European Health Literacy Survey Questionnaire (HLS-EU-Q47).

Descriptive statistics (mean, standard deviation, median, minimum, maximum, interquartile range, absolute and relative frequencies) will be computed to describe the cohorts' sociodemographic characteristics. At baseline comparisons between groups (eg with and without anxiety) will be undertaken using t-tests for continuous normally distributed variables or Wilcoxon for continuous non-normally distributed variables. Chi-squared tests will be used for categorical variables, and Fisher's Exact test will be used for categorical variables within smaller sample sizes. Comparison between more than two groups will be performed through one-way analysis of variance (ANOVA) for continuous variables and chi-squared test for categorical variables. Factors significantly associated with any disease group will be included in a logistic regression model for further analysis. The effect of specific conditions on HL will be assessed by linear regression, univariable and then multivariable, controlling for potential confounders and also analyzing potential effect modification. Taking into consideration follow-up, the changes in HL, anxiety and depression will be each evaluated by means of variance analysis with measurement repetition. After checking the statistical model pre-requisites, sociodemographic characteristics will be added by means of linear regression analysis in the final model.

Eligibility criteria: Inclusion Criteria:

* The study population will be composed by adults (≥ 18 years old) who are non-institutionalized and living in private households in Leiria.

Exclusion Criteria:

* Residing in hospitals, asylums, military barracks or prisons. Individuals who are unable to speak Portuguese or who reveal an inability to respond to the questionnaire, either directly or through a person who lives with them.

Primary outcomes:
measure: Health literacy
timeFrame: Health literacy: measuring change over the next 10 years
Secondary outcomes:
measure: Anxiety and depression
timeFrame: Anxiety and depression: measuring change over the next 10 years
measure: Metabolic risk
timeFrame: Metabolic risk: measuring change over the next 10 years
Other outcomes:
Locations:
Study officials:
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