NCT05558631

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,003

participants targeted

Target at P75+ for all trials

Timeline
82mo left

Started Nov 2022

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Nov 2022Jan 2033

First Submitted

Initial submission to the registry

September 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2033

Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

10.3 years

First QC Date

September 16, 2022

Last Update Submit

September 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health literacy

    HL will be measured by European Health Literacy Survey Questionnaire (HLS-EU-Q16). HLS-EU-Q16 was developed to measure HL in populations, based on a conceptual framework. Each item in the questionnaire assesses the perceived difficulty of a specific health-related task for the respondent. The HLS-EU-Q16 was translated and validated for Portuguese population. The scale contains 16 items that measure HL. Each item assesses the perceived difficulty of completing a specific health-related task by asking "On a scale from very difficult to very easy, how easy would you say it is to \[e.g, find information on symptoms of illnesses that concern you\]?" Each item is rated on a 4-point Likert-type scale (1, very difficult; 2, fairly difficult; 3, fairly easy; 4, very easy). A higher difficulty score is assumed with lower HL.

    Health literacy: measuring change over the next 10 years

Secondary Outcomes (2)

  • Anxiety and depression

    Anxiety and depression: measuring change over the next 10 years

  • Metabolic risk

    Metabolic risk: measuring change over the next 10 years

Study Arms (1)

Residents of the municipality of Leiria aged 18 years or more.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Batalha MJ, Gabriel T, Valentim A, Soledade A, Gomes C, Alves B, Dos Santos ES, Passadouro R, Dias SS. Health literacy - study protocol for LiSa cohort study. BMC Public Health. 2024 Jun 29;24(1):1737. doi: 10.1186/s12889-024-19148-8.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 28, 2022

Study Start

November 1, 2022

Primary Completion (Estimated)

January 31, 2033

Study Completion (Estimated)

January 31, 2033

Last Updated

September 28, 2022

Record last verified: 2022-09