Health LiteracyNCT06971393
Health Literacy in Geriatric Patients
An observational study of Health Literacy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Health Literacy
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 26 Feb 2025to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Peter's Geriatric Clinic
Hamilton, Ontario, L8M 1W9
Karen Research Coordinator, BA, MA, (905) 521-2100 ext. ext. 77939, thompsokar@hhsc.ca
Christopher Patterson, PhD
About this study
Official title: A Comparison of Health Literacy Estimates Among Patients, Caregivers and a Geriatric Team
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.
Read the detailed description
As treatments become more sophisticated and the healthcare system becomes more complex, health literacy (HL) assumes an ever-greater importance in the therapeutic alliance between healthcare professionals and patients.
Limited health literacy causes difficulty in understanding one's health condition. As a result, it is associated with less adherence to self-care behaviours, increased mortality, increased hospitalizations, other adverse health outcomes, and high healthcare costs. In those over aged 65, health literacy is positively influenced by levels of educational attainment and literacy practices in the home, male gender, and weakly by informal learning and self-study and adult education experience. Negative associations include being foreign-born and failure to learn from exposure to various contexts. Understanding the health literacy of patients is particularly vital for geriatricians as older adults referred to geriatric medicine clinics already experience barriers to high quality care due to the frequent presence of cognitive impairment and multiple comorbidities.
The interaction among these variables and health literacy in a tertiary care setting for older adults with cognitive impairment remains under-explored. Given the dependent state of many cognitively impaired individuals, the responsibility lies with geriatricians to adjust their communication and care strategies according to the HL levels of their patients. Studying the association between the accuracy of geriatrician-perceived HL and health outcomes could reveal the extent to which physician communication impacts these outcomes. Given these intertwined factors, a 6-month follow-up is crucial to capture the longitudinal associations of HL on patient outcomes, providing a more comprehensive picture of how these variables interact over time.
This study's primary outcome is the evaluation of patient health literacy and the level of agreement between the geriatric team's perception and objectively measured health literacy. The secondary outcome is assessing how patient health literacy is associated with medication adherence and future planning. As well, the investigators hope to assess how patient health literacy is associated with emergency department visits, hospitalizations, hospital length of stay, remaining home, long-term care admission and mortality within 6 months.
- Conditions
- Health Literacy
- Keywords
- Health Literacy, Geriatric health literacy assessment, Health literacy in tertiary care settings, Correlation of health literacy and health outcomes, BRIEF health literacy questionnaire, Visual Analogue Scale quality of life measure, Emergency room visits and hospitalization tracking in geriatric population, Patient-provider health literacy perception agreement, Patient, caregiver, and geriatric team health literacy alignment
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: At enrollment
Secondary outcomes (13)
Medication adherence
Low medication adherence is predictive of poor health outcomes for older adults and is associated with education level, health literacy, patient satisfaction, and sufficient communication. However, associations have not been delineated in an outpatient setting or using a validated HL scale.
Adherence will be measured by dichotomous outcome (80% adherent vs non-adherent) according to the consultation note.
Measured: At enrollment
Number of participants with existing community home care planning
Home and community care includes access to long-term or short-term nursing, home support, and other services. As well, the use of these services has a significant effect on healthy aging in place. However, it is currently unknown the extent to which HL may influence an individual's ability to obtain home care.
Measured: At enrollment
Number of participants with long-term care planning
Long term care planning includes discussion about or application to long term care facility admission.
Measured: At enrollment
Number of patients with code status discussion
Statement about advance directives or POST in medical record.
Measured: At enrollment
Power of Attorney designation
Whether a patient has discussed and identified a power of attorney.
Measured: At enrollment
Number of patients remaining home
Whether the patient is living in community residence
Measured: At enrollment
Falls
Number of Falls in the past year
Measured: At enrollment
Number of ED visits
Number of ED visits during follow up period (6 months)
Measured: 6 months
Number of hospitalizations
Number of hospital admissions during follow up period (6 months)
Measured: 6 months
Hospital length of stay
Number of days patient admitted to hospital during follow up period (6 months)
Measured: 6 months
Long-term care admission
Whether the patient was admitted to long-term care at follow up
Measured: 6 months
Mortality
Whether patient died during the follow up period (6 months)
Measured: 6 months
Injurious Falls
Frequency of falls experienced by the patient before the follow up period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start26 Feb 2025
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Patterson, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971393
- Sponsor's protocol ID
- 17823
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Kobayashi LC, Wardle J, von Wagner C. Internet use, social engagement and health literacy decline during ageing in a longitudinal cohort of older English adults. J Epidemiol Community Health. 2015 Mar;69(3):278-83. doi: 10.1136/jech-2014-204733. Epub 2014 Nov 26.
PubMed 25428933Chesser AK, Keene Woods N, Smothers K, Rogers N. Health Literacy and Older Adults: A Systematic Review. Gerontol Geriatr Med. 2016 Mar 15;2:2333721416630492. doi: 10.1177/2333721416630492. eCollection 2016 Jan-Dec.
PubMed 28138488Lu J, Sun S, Gu Y, Li H, Fang L, Zhu X, Xu H. Health literacy and health outcomes among older patients suffering from chronic diseases: A moderated mediation model. Front Public Health. 2023 Jan 10;10:1069174. doi: 10.3389/fpubh.2022.1069174. eCollection 2022.
PubMed 36703841Li H, Tao S, Sun S, Xiao Y, Liu Y. The relationship between health literacy and health-related quality of life in Chinese older adults: a cross-sectional study. Front Public Health. 2024 Mar 20;12:1288906. doi: 10.3389/fpubh.2024.1288906. eCollection 2024.
PubMed 38572002Geboers B, Uiters E, Reijneveld SA, Jansen CJM, Almansa J, Nooyens ACJ, Verschuren WMM, de Winter AF, Picavet HSJ. Health literacy among older adults is associated with their 10-years' cognitive functioning and decline - the Doetinchem Cohort Study. BMC Geriatr. 2018 Mar 20;18(1):77. doi: 10.1186/s12877-018-0766-7.
PubMed 29558890Suppiah SD, Malhotra R, Tan YW, Jessup RL, Chew LST, Tang WE, Beauchamp A. Prevalence of health literacy and its correlates from a national survey of older adults. Res Social Adm Pharm. 2023 Jun;19(6):906-912. doi: 10.1016/j.sapharm.2023.02.013. Epub 2023 Feb 27.
PubMed 36898905Wang Q, Fan K, Li P. Effect of the Use of Home and Community Care Services on the Multidimensional Health of Older Adults. Int J Environ Res Public Health. 2022 Nov 21;19(22):15402. doi: 10.3390/ijerph192215402.
PubMed 36430119Jin H, Kim Y, Rhie SJ. Factors affecting medication adherence in elderly people. Patient Prefer Adherence. 2016 Oct 19;10:2117-2125. doi: 10.2147/PPA.S118121. eCollection 2016.
PubMed 27799748Lapid MI, Rummans TA, Boeve BF, McCormick JK, Pankratz VS, Cha RH, Smith GE, Ivnik RJ, Tangalos EG, Petersen RC. What is the quality of life in the oldest old? Int Psychogeriatr. 2011 Aug;23(6):1003-10. doi: 10.1017/S1041610210002462. Epub 2011 Feb 1.
PubMed 21281556Feng Y, Parkin D, Devlin NJ. Assessing the performance of the EQ-VAS in the NHS PROMs programme. Qual Life Res. 2014 Apr;23(3):977-89. doi: 10.1007/s11136-013-0537-z. Epub 2013 Oct 1.
PubMed 24081873Shmueli A. The relationship between the visual analog scale and the SF-36 scales in the general population: an update. Med Decis Making. 2004 Jan-Feb;24(1):61-3. doi: 10.1177/0272989X03261562.
PubMed 15005955Rawson KA, Gunstad J, Hughes J, Spitznagel MB, Potter V, Waechter D, Rosneck J. The METER: a brief, self-administered measure of health literacy. J Gen Intern Med. 2010 Jan;25(1):67-71. doi: 10.1007/s11606-009-1158-7. Epub 2009 Nov 3.
PubMed 19885705Federman 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.
PubMed 19515101Sudore RL, Mehta KM, Simonsick EM, Harris TB, Newman AB, Satterfield S, Rosano C, Rooks RN, Rubin SM, Ayonayon HN, Yaffe K. Limited literacy in older people and disparities in health and healthcare access. J Am Geriatr Soc. 2006 May;54(5):770-6. doi: 10.1111/j.1532-5415.2006.00691.x.
PubMed 16696742Voigt-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.
PubMed 32244459
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Health Literacy Estimates Among Patients, Caregivers and a Geriatric Team
- ClinicalTrials.gov ID
- NCT06971393
- Acronym / sponsor ID
- 17823
- Conditions
- Health Literacy
- Keywords
- Health Literacy, Geriatric health literacy assessment, Health literacy in tertiary care settings, Correlation of health literacy and health outcomes, BRIEF health literacy questionnaire, Visual Analogue Scale quality of life measure, Emergency room visits and hospitalization tracking in geriatric population, Patient-provider health literacy perception agreement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As treatments become more sophisticated and the healthcare system becomes more complex, health literacy (HL) assumes an ever-greater importance in the therapeutic alliance between healthcare professionals and patients.
Limited health literacy causes difficulty in understanding one's health condition. As a result, it is associated with less adherence to self-care behaviours, increased mortality, increased hospitalizations, other adverse health outcomes, and high healthcare costs. In those over aged 65, health literacy is positively influenced by levels of educational attainment and literacy practices in the home, male gender, and weakly by informal learning and self-study and adult education experience. Negative associations include being foreign-born and failure to learn from exposure to various contexts. Understanding the health literacy of patients is particularly vital for geriatricians as older adults referred to geriatric medicine clinics already experience barriers to high quality care due to the frequent presence of cognitive impairment and multiple comorbidities.
The interaction among these variables and health literacy in a tertiary care setting for older adults with cognitive impairment remains under-explored. Given the dependent state of many cognitively impaired individuals, the responsibility lies with geriatricians to adjust their communication and care strategies according to the HL levels of their patients. Studying the association between the accuracy of geriatrician-perceived HL and health outcomes could reveal the extent to which physician communication impacts these outcomes. Given these intertwined factors, a 6-month follow-up is crucial to capture the longitudinal associations of HL on patient outcomes, providing a more comprehensive picture of how these variables interact over time.
This study's primary outcome is the evaluation of patient health literacy and the level of agreement between the geriatric team's perception and objectively measured health literacy. The secondary outcome is assessing how patient health literacy is associated with medication adherence and future planning. As well, the investigators hope to assess how patient health literacy is associated with emergency department visits, hospitalizations, hospital length of stay, remaining home, long-term care admission and mortality within 6 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient self-identified HL
Time frame: At enrollment
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.
Caregiver's perception of patient's HL
Time frame: At enrollment
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.
Patient self-identified quality of life
Time frame: At enrollment
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
Geriatric Team's assessment of patient's HL
Time frame: At enrollment
Geriatric Team will report HL as Adequate/marginal/inadequate. Level of adequacy (1,2,3) is optional
13 secondary outcomes
Medication adherence
Time frame: At enrollment
Number of participants with existing community home care planning
Time frame: At enrollment
Number of participants with long-term care planning
Time frame: At enrollment
Number of patients with code status discussion
Time frame: At enrollment
Power of Attorney designation
Time frame: At enrollment
Number of patients remaining home
Time frame: At enrollment
Falls
Time frame: At enrollment
Number of ED visits
Time frame: 6 months
Number of hospitalizations
Time frame: 6 months
Hospital length of stay
Time frame: 6 months
Long-term care admission
Time frame: 6 months
Mortality
Time frame: 6 months
Injurious Falls
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 25428933Kobayashi LC, Wardle J, von Wagner C. Internet use, social engagement and health literacy decline during ageing in a longitudinal cohort of older English adults. J Epidemiol Community Health. 2015 Mar;69(3):278-83. doi: 10.1136/jech-2014-204733. Epub 2014 Nov 26.
- Background: PubMed 28138488Chesser AK, Keene Woods N, Smothers K, Rogers N. Health Literacy and Older Adults: A Systematic Review. Gerontol Geriatr Med. 2016 Mar 15;2:2333721416630492. doi: 10.1177/2333721416630492. eCollection 2016 Jan-Dec.
- Background: PubMed 36703841Lu J, Sun S, Gu Y, Li H, Fang L, Zhu X, Xu H. Health literacy and health outcomes among older patients suffering from chronic diseases: A moderated mediation model. Front Public Health. 2023 Jan 10;10:1069174. doi: 10.3389/fpubh.2022.1069174. eCollection 2022.
- Background: PubMed 38572002Li H, Tao S, Sun S, Xiao Y, Liu Y. The relationship between health literacy and health-related quality of life in Chinese older adults: a cross-sectional study. Front Public Health. 2024 Mar 20;12:1288906. doi: 10.3389/fpubh.2024.1288906. eCollection 2024.
- Background: PubMed 29558890Geboers B, Uiters E, Reijneveld SA, Jansen CJM, Almansa J, Nooyens ACJ, Verschuren WMM, de Winter AF, Picavet HSJ. Health literacy among older adults is associated with their 10-years' cognitive functioning and decline - the Doetinchem Cohort Study. BMC Geriatr. 2018 Mar 20;18(1):77. doi: 10.1186/s12877-018-0766-7.
- Background: PubMed 36898905Suppiah SD, Malhotra R, Tan YW, Jessup RL, Chew LST, Tang WE, Beauchamp A. Prevalence of health literacy and its correlates from a national survey of older adults. Res Social Adm Pharm. 2023 Jun;19(6):906-912. doi: 10.1016/j.sapharm.2023.02.013. Epub 2023 Feb 27.
- Background: PubMed 36430119Wang Q, Fan K, Li P. Effect of the Use of Home and Community Care Services on the Multidimensional Health of Older Adults. Int J Environ Res Public Health. 2022 Nov 21;19(22):15402. doi: 10.3390/ijerph192215402.
- Background: PubMed 27799748Jin H, Kim Y, Rhie SJ. Factors affecting medication adherence in elderly people. Patient Prefer Adherence. 2016 Oct 19;10:2117-2125. doi: 10.2147/PPA.S118121. eCollection 2016.
- Background: PubMed 21281556Lapid MI, Rummans TA, Boeve BF, McCormick JK, Pankratz VS, Cha RH, Smith GE, Ivnik RJ, Tangalos EG, Petersen RC. What is the quality of life in the oldest old? Int Psychogeriatr. 2011 Aug;23(6):1003-10. doi: 10.1017/S1041610210002462. Epub 2011 Feb 1.
- Background: PubMed 24081873Feng Y, Parkin D, Devlin NJ. Assessing the performance of the EQ-VAS in the NHS PROMs programme. Qual Life Res. 2014 Apr;23(3):977-89. doi: 10.1007/s11136-013-0537-z. Epub 2013 Oct 1.
- Background: PubMed 15005955Shmueli A. The relationship between the visual analog scale and the SF-36 scales in the general population: an update. Med Decis Making. 2004 Jan-Feb;24(1):61-3. doi: 10.1177/0272989X03261562.
- Background: PubMed 19885705Rawson KA, Gunstad J, Hughes J, Spitznagel MB, Potter V, Waechter D, Rosneck J. The METER: a brief, self-administered measure of health literacy. J Gen Intern Med. 2010 Jan;25(1):67-71. doi: 10.1007/s11606-009-1158-7. Epub 2009 Nov 3.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Literacy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Patterson, Professor of Medicine ((905) 521-2100 ext. 77939, pattec4@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient self-identified HL (time frame: At enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06971393, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.