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Trial registered on ANZCTR


Registration number
ACTRN12621001224819
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
13/09/2021
Date last updated
2/02/2022
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An Investigation Into the Relationship Between Health Literacy and Health Outcomes in Patients After a Heart Attack
Scientific title
Investigating the Association Between Health Literacy and Health Outcomes in Adults Hospitalised with an Incident Myocardial Infarction: A Multi-Center Prospective Cohort Study
Secondary ID [1] 305021 0
None
Universal Trial Number (UTN)
Trial acronym
ENHEARTEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 323194 0
Myocardial infarction 323511 0
Condition category
Condition code
Cardiovascular 320776 320776 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with coronary heart disease that are hospitalized with an incident myocardial infarction (MI). Participants will be required to take part in a survey at three different times: within 30-days after their MI; 6-months post-MI; and 12-months post-MI. Each survey will take about 20 minutes and can be completed online, or over the phone. The survey will consist of the European Health Literacy Survey-Q12 (HLS19-Q12) to measure health literacy; the validated EuroQoL questionnaire (EQ-5D-5L) to measure health-related quality of life; 2 questions about cardiac rehabilitation attendance; Scale 3,4,5 and 6 of the health literacy questionnaire (HLQ) to measure patient activation, social support for health, health care provider engagement, and navigating the healthcare system; the Cardiac Self-efficacy (CSE) Scale to measure cardiac self-efficacy; the International Physical Activity Questionnaire (IPAQ-7) to measure physical activity; and the Medication Adherence Rating Scale (MARS-10) to measure medication adherence. All other assessments will be obtained without participant involvement by data linkage with the Victorian Admitted Episodes Dataset, the Victorian Emergency Minimum Dataset, the National Death Index, and Services Australia up to 2 years post-MI hospital admission.
Intervention code [1] 321419 0
Diagnosis / Prognosis
Comparator / control treatment
There is no control group in this study, although, as the aim of the study is to describe differences in outcomes between participants with lower vs. higher health literacy, health literacy will be observed as a predictor variable. Health literacy will be determined using the validated European Health Literacy Survey-Q12 (HLS19-Q12) and measured at baseline (within 30 days following index hospital admission) and at 6 and 12-months post-admission. Validated cut-off points have also been provided to group total scores into three categories from low to high health literacy.
Control group
Active

Outcomes
Primary outcome [1] 328587 0
All-cause hospital admissions (unplanned) ascertained by data linkage with the Victorian Admitted Episodes Dataset (VAED)
Timepoint [1] 328587 0
30 days, 6-months (primary timepoint), 12-months and 24-months following index hospital admission
Secondary outcome [1] 399540 0
Cardiac-related hospital admissions (unplanned and planned) ascertained by data linkage with the Victorian Admitted Episodes Dataset (VAED)
Timepoint [1] 399540 0
30 days, 6-months, 12-months and 24-months following index hospital admission
Secondary outcome [2] 399541 0
All-cause hospital admissions (planned) ascertained by data linkage with the Victorian Admitted Episodes Dataset (VAED)
Timepoint [2] 399541 0
30 days, 6-months, 12-months and 24-months following index hospital admission
Secondary outcome [3] 399542 0
Emergency department presentations for chest pain ascertained by data linkage with the Victorian Emergency Minimum Dataset (VEMD)
Timepoint [3] 399542 0
30 days and 6-months following index hospital admission
Secondary outcome [4] 399543 0
Mortality ascertained by data linkage with the National Death Index database held by the Australian Institute of Health and Welfare (AIHW)
Timepoint [4] 399543 0
30 days, 12-months and 24-months following index hospital admission
Secondary outcome [5] 399544 0
Health-related quality of life using the validated EuroQoL questionnaire (EQ-5D-5L)
Timepoint [5] 399544 0
At baseline (within 30-days of index hospital admission), and at 6- and 12-months following index hospital admission
Secondary outcome [6] 399545 0
Attendance to cardiac rehabilitation collected via participant self-report or from cardiac rehabilitation coordinators
Timepoint [6] 399545 0
6-months following index hospital admission
Secondary outcome [7] 400638 0
Completion rates of cardiac rehabilitation collected via participant self-report or from cardiac rehabilitation coordinators
Timepoint [7] 400638 0
6-months following index hospital admission
Secondary outcome [8] 400639 0
Health care service use (including costs) during the 12-months following index hospital admission collected via data linkage with Services Australia, the Pharmaceutical Benefits Scheme (PBS), and the Medicare Benefits Schedule (MBS)
Timepoint [8] 400639 0
12-months following index hospital admission
Secondary outcome [9] 400640 0
Patient activation, social support for health, health care provider engagement, and navigating the healthcare system using the validated health literacy questionnaire (HLQ)
Timepoint [9] 400640 0
At baseline (within 30-days of index hospital admission), and at 6- and 12-months following index hospital admission
Secondary outcome [10] 400641 0
Cardiac self-efficacy using the validated Cardiac Self-efficacy (CSE) Scale
Timepoint [10] 400641 0
At baseline (within 30-days of index hospital admission), and at 6- and 12-months following index hospital admission
Secondary outcome [11] 400642 0
Physical activity levels using the validated International Physical Activity Questionnaire (IPAQ-7) short form instrument
Timepoint [11] 400642 0
At baseline (within 30-days of index hospital admission), and at 6- and 12-months following index hospital admission
Secondary outcome [12] 400643 0
Medication adherence using the validated Medication Adherence Rating Scale (MARS-10)
Timepoint [12] 400643 0
At 6- and 12-months following index hospital admission

Eligibility
Key inclusion criteria
- Aged 18 years or above
- Hospitalized with an incident myocardial infarction (primary or secondary discharge ICD-10 codes of 121 or 122)
- Able to understand one of the following languages: English, Arabic, Chinese (Simplified), Greek, Italian or Vietnamese
- Have the ability to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A history of myocardial infarction
- Cognitive impairment (determined from the medical records or the nurse in charge)
- Discharged home with diagnosis of heart failure, or on specific targeted therapy for heart failure
- B-type natriuretic peptide >=100 ng/L or left ventricular ejection fraction <25% at discharge
- Discharged to a nursing home or residential aged care facility
- Other significant in-hospital complication including major stroke
- HIV positive
- Active cancer with <1 year life expectancy
- Renal impairment (Creatinine >200 mg/dL or Glomerular Filtration Rate>30)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Base on previous studies, we expect to find a difference of 15% in the rate of 6-month unplanned all-cause hospital admissions between the lowest and highest tertiles of health literacy (15% readmission rate in highest health literacy group, and 30% in lowest health literacy group). At 80% power and two-sided confidence interval of 95%, this equates to a sample size of 134 in each tertile of health literacy (n=402). Allowing for an attrition rate of 10%, the sample size is inflated to 442; this will be rounded up to 450.

The absolute difference in 6-month hospital admission rates will be summarized with a two-sided 95% confidence interval (CI). This will be performed using binomial regression with an identity link function to estimate the risk difference. Secondary outcomes will be compared across the two health literacy groups (high vs. low) using regression models. Binary outcomes will use log-binomial regression to estimate risk ratios together with 95% CIs. Count outcomes will use Poisson regression with robust standard errors to account for overdispersion. Skewed continuous outcomes will be summarized as median and interquartile ranges and difference between medians with 95% CIs computed via quantile regression. Time to event outcomes will be tested across groups using the Gehan-Wilcoxon test and hazard ratios estimated using Cox proportional hazards regression.

A mediation analysis will be undertaken using Baron and Kenny’s method to explore whether certain variables are potential mediators of the relationship between health literacy and primary and secondary outcomes. These variables include: Patient activation assessed at baseline, and at 6- and 12-months post-index hospital admission using Scale 3 of the health literacy questionnaire (HLQ); Social support for health assessed at baseline, and at 6- and 12-months post-index hospital admission using Scale 4 of the HLQ; Health care provider engagement assessed at baseline, and at 6- and 12-months post-index hospital admission using Scale 6 of the HLQ; Navigating the healthcare system assessed at baseline, and at 6- and 12-months post-index hospital admission using Scale 7 of the HLQ; Cardiac self-efficacy measured at 6- and 12-months post-index hospital admission using the valid and reliable Cardiac Self-efficacy (CSE) Scale; Physical activity levels measured at baseline, and at 6- and 12-months post-index hospital admission using the validated International Physical Activity Questionnaire (IPAQ-7) short form instrument; and Medication adherence assessed at 6- and 12-months post-index hospital admission using the valid and reliable Medication Adherence Rating Scale (MARS-10). In this model, the independent variable (health literacy) is proposed to influence the mediator variables (health competence, social support, health behaviors), which in turn influence the dependent variables (all-cause/cardiac hospital admissions, ED presentations, mortality, HRQoL, cardiac rehabilitation attendance, healthcare costs).

The cost analysis will be undertaken from the health sector perspective and a limited societal perspective. Analysis of health care costs associated with low vs. high health literacy in patients with first MI will include: 1) hospital costs for public and private inpatient services (for all-causes, and unplanned or planned admissions); 2) ED admissions for ischaemic/non-ischaemic chest pain and all other causes and for participants who provide consent for data linkage to MBS and PBS; 3) total MBS costs, including costs for GP and specialist consultations related to cardiac health and all other causes; and 4) total PBS costs for cardiac-related medications and all other medications. Hospitalization costs will be valued using the National Hospital Cost Data Collection for each admitted Australian refined diagnosis-related group (AR-DRG). The reference year for the analysis will be 2021.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/09/2021
Actual
1/11/2021
Date of last participant enrolment
Anticipated
2/06/2023
Actual
Date of last data collection
Anticipated
2/06/2025
Actual
Sample size
Target
450
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20216 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 20217 0
The Northern Hospital - Epping
Recruitment hospital [3] 20218 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment postcode(s) [1] 34946 0
3168 - Clayton
Recruitment postcode(s) [2] 34947 0
3076 - Epping
Recruitment postcode(s) [3] 34948 0
3350 - Ballarat Central

Funding & Sponsors
Funding source category [1] 309376 0
Government body
Name [1] 309376 0
National Health and Medical Research Council
Country [1] 309376 0
Australia
Primary sponsor type
University
Name
Monash University
Address
15 Sargeant Street,
Warragul, VIC 3820
Country
Australia
Secondary sponsor category [1] 310380 0
None
Name [1] 310380 0
Address [1] 310380 0
Country [1] 310380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309192 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 309192 0
Ethics committee country [1] 309192 0
Australia
Date submitted for ethics approval [1] 309192 0
06/05/2021
Approval date [1] 309192 0
29/07/2021
Ethics approval number [1] 309192 0
RES-21-0000-242A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113294 0
Dr Alison Beauchamp
Address 113294 0
Monash Rural Health,
15 Sargeant Street,
Warragul VIC 3820
Country 113294 0
Australia
Phone 113294 0
+613 9902 7310
Fax 113294 0
Email 113294 0
alison.beauchamp@monash.edu
Contact person for public queries
Name 113295 0
Jason Talevski
Address 113295 0
Sunshine Hospital, WCHRE Building (Level 3),
176 Furlong Road,
St Albans VIC 3021
Country 113295 0
Australia
Phone 113295 0
+61 401 679 657
Fax 113295 0
Email 113295 0
jason.talevski@monash.edu
Contact person for scientific queries
Name 113296 0
Alison Beauchamp
Address 113296 0
Monash Rural Health,
15 Sargeant Street,
Warragul VIC 3820
Country 113296 0
Australia
Phone 113296 0
+613 9902 7310
Fax 113296 0
Email 113296 0
alison.beauchamp@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics approval to share individual participant data (IPD).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12839Study protocol    The protocol paper is currently being drafted and ... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHealth literacy and long-term health outcomes following myocardial infarction: Protocol for a multicentre, prospective cohort study (ENHEARTEN study).2022https://dx.doi.org/10.1136/bmjopen-2021-060480
N.B. These documents automatically identified may not have been verified by the study sponsor.