NCT06971393

Brief Summary

Health Literacy is one's ability to understand health information well enough to make informed decisions about their health. Limited health literacy makes it hard for people to understand complex health issues and follow health care recommendations. Limited health literacy is associated with adverse health outcomes such as higher mortality, increased risk of emergency department visits and hospital admissions leading to higher medical costs. Although there are tools to assess health literacy, they are not widely used, so many healthcare providers do not measure their patients' health literacy levels adequately. Health care workers tend to overestimate their patients' health literacy. This is especially important for older adults who often have memory problems and multiple illnesses. This study will evaluate how doctors and team members in a geriatric clinic estimate their patient's health literacy and determine if this matches with the patients' health literacy as measured by a simple validated questionnaire. The investigators will also look at how a patient's relative or caregiver estimates their health literacy using a similar short questionnaire. The research team plans to follow up with a telephone call in 6 months, to see which health concerns if any have occurred since the clinic visit.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

December 8, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 26, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 18, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 8, 2024

Last Update Submit

May 14, 2025

Conditions

Keywords

Health LiteracyGeriatric health literacy assessmentHealth literacy in tertiary care settingsCorrelation of health literacy and health outcomesBRIEF health literacy questionnaireVisual Analogue Scale quality of life measureEmergency room visits and hospitalization tracking in geriatric populationPatient-provider health literacy perception agreementPatient, caregiver, and geriatric team health literacy alignment

Outcome Measures

Primary Outcomes (4)

  • Patient self-identified HL

    The patient's self-identified health literacy based on the BRIEF, a 4-item measure of health literacy that has been validated for older adults.

    At enrollment

  • Caregiver's perception of patient's HL

    The caregiver's perception of the patient's health literacy based on the BRIEF-C, a tool based on the BRIEF, constructed to reflect the caregiver's perception of the patient's HL.

    At enrollment

  • Patient self-identified quality of life

    The patient's self-identified quality of life measured by the EQ-VAS, a visual analogue scale measuring quality of life on a scale of 0 to 100

    At enrollment

  • Geriatric Team's assessment of patient's HL

    Geriatric Team will report HL as Adequate/marginal/inadequate. Level of adequacy (1,2,3) is optional

    At enrollment

Secondary Outcomes (13)

  • Medication adherence

    At enrollment

  • Number of participants with existing community home care planning

    At enrollment

  • Number of participants with long-term care planning

    At enrollment

  • Number of patients with code status discussion

    At enrollment

  • Power of Attorney designation

    At enrollment

  • +8 more secondary outcomes

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been referred by their primary care or other physicians, to the Geriatric Clinic at the St. Peter's Hospital site of Hamilton Health Sciences Corporation. All patients, including new referrals and follow up patients will be invited to participate in the study.

You may qualify if:

  • Patients (both new and follow up) attending St. Peter's Hospital Geriatric Clinic
  • Willingness to participate in the study (caregiver can rate HL for patient if patient unable to)
  • Consenting to study (by patient or caregiver)

You may not qualify if:

  • Behavior (e.g. behavioral and psychological symptoms of dementia) which may be aggravated by additional questions
  • Acute illness preventing participation
  • Terminal illness that would prevent 6-month telephone follow up
  • Previous participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Peter's Geriatric Clinic

Hamilton, Ontario, L8M 1W9, Canada

RECRUITING

Related Publications (25)

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    PMID: 38572002BACKGROUND
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    PMID: 24081873BACKGROUND
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    PMID: 15005955BACKGROUND
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    PMID: 19885705BACKGROUND
  • Federman AD, Sano M, Wolf MS, Siu AL, Halm EA. Health literacy and cognitive performance in older adults. J Am Geriatr Soc. 2009 Aug;57(8):1475-80. doi: 10.1111/j.1532-5415.2009.02347.x. Epub 2009 Jun 8.

    PMID: 19515101BACKGROUND
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    PMID: 16696742BACKGROUND
  • Voigt-Barbarowicz M, Brutt AL. The Agreement between Patients' and Healthcare Professionals' Assessment of Patients' Health Literacy-A Systematic Review. Int J Environ Res Public Health. 2020 Mar 31;17(7):2372. doi: 10.3390/ijerph17072372.

    PMID: 32244459BACKGROUND
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    PMID: 17140758BACKGROUND
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    PMID: 30498837BACKGROUND
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    PMID: 34178013BACKGROUND
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    PMID: 36367863BACKGROUND
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    PMID: 19644651BACKGROUND
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    PMID: 21768583BACKGROUND
  • Kobayashi LC, Wardle J, Wolf MS, von Wagner C. Aging and Functional Health Literacy: A Systematic Review and Meta-Analysis. J Gerontol B Psychol Sci Soc Sci. 2016 May;71(3):445-57. doi: 10.1093/geronb/gbu161. Epub 2014 Dec 11.

    PMID: 25504637BACKGROUND
  • Haun J, Luther S, Dodd V, Donaldson P. Measurement variation across health literacy assessments: implications for assessment selection in research and practice. J Health Commun. 2012;17 Suppl 3:141-59. doi: 10.1080/10810730.2012.712615.

    PMID: 23030567BACKGROUND

Central Study Contacts

Christopher Patterson, Professor of Medicine

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2024

First Posted

May 14, 2025

Study Start

February 26, 2025

Primary Completion

June 1, 2025

Study Completion

December 31, 2025

Last Updated

May 18, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

IPD for this health literacy study will not be shared in order to protect participant privacy and maintain confidentiality, given the sensitivity of the data related to personal health literacy levels, caregiver insights, and healthcare team perceptions.

Locations