ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

ENHEARTEN

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Coronary heart disease

Myocardial infarction

Condition category

Condition code

Cardiovascular

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]

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]

All-cause hospital admissions (unplanned) ascertained by data linkage with the Victorian Admitted Episodes Dataset (VAED)

Timepoint [1]

30 days, 6-months (primary timepoint), 12-months and 24-months following index hospital admission

Secondary outcome [1]

Cardiac-related hospital admissions (unplanned and planned) ascertained by data linkage with the Victorian Admitted Episodes Dataset (VAED)

Timepoint [1]

30 days, 6-months, 12-months and 24-months following index hospital admission

Secondary outcome [2]

All-cause hospital admissions (planned) ascertained by data linkage with the Victorian Admitted Episodes Dataset (VAED)

Timepoint [2]

30 days, 6-months, 12-months and 24-months following index hospital admission

Secondary outcome [3]

Emergency department presentations for chest pain ascertained by data linkage with the Victorian Emergency Minimum Dataset (VEMD)

Timepoint [3]

30 days and 6-months following index hospital admission

Secondary outcome [4]

Mortality ascertained by data linkage with the National Death Index database held by the Australian Institute of Health and Welfare (AIHW)

Timepoint [4]

30 days, 12-months and 24-months following index hospital admission

Secondary outcome [5]

Health-related quality of life using the validated EuroQoL questionnaire (EQ-5D-5L)

Timepoint [5]

At baseline (within 30-days of index hospital admission), and at 6- and 12-months following index hospital admission

Secondary outcome [6]

Attendance to cardiac rehabilitation collected via participant self-report or from cardiac rehabilitation coordinators

Timepoint [6]

6-months following index hospital admission

Secondary outcome [7]

Completion rates of cardiac rehabilitation collected via participant self-report or from cardiac rehabilitation coordinators

Timepoint [7]

6-months following index hospital admission

Secondary outcome [8]

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]

12-months following index hospital admission

Secondary outcome [9]

Patient activation, social support for health, health care provider engagement, and navigating the healthcare system using the validated health literacy questionnaire (HLQ)

Timepoint [9]

At baseline (within 30-days of index hospital admission), and at 6- and 12-months following index hospital admission

Secondary outcome [10]

Cardiac self-efficacy using the validated Cardiac Self-efficacy (CSE) Scale

Timepoint [10]

At baseline (within 30-days of index hospital admission), and at 6- and 12-months following index hospital admission

Secondary outcome [11]

Physical activity levels using the validated International Physical Activity Questionnaire (IPAQ-7) short form instrument

Timepoint [11]

At baseline (within 30-days of index hospital admission), and at 6- and 12-months following index hospital admission

Secondary outcome [12]

Medication adherence using the validated Medication Adherence Rating Scale (MARS-10)

Timepoint [12]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

The Northern Hospital - Epping

Recruitment hospital [3]

Ballarat Health Services (Base Hospital) - Ballarat Central

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3076 - Epping

Recruitment postcode(s) [3]

3350 - Ballarat Central

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

15 Sargeant Street,
Warragul, VIC 3820

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Level 2, I Block, Monash Medical Centre,
246 Clayton Road,
Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/05/2021

Approval date [1]

29/07/2021

Ethics approval number [1]

RES-21-0000-242A

Summary

Brief summary

Health literacy refers to a person's ability to find, understand and use health information. Many studies show that people with lower health literacy also have poorer health outcomes, yet this is relatively unexplored among people with heart disease. The aim of this research project is to see if health literacy affects people’s future hospital admissions, the cost of health care, and their quality of life following a heart attack. The study findings may help us identify how best to address health literacy barriers to lifestyle change following a heart attack.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Alison Beauchamp

Address

Monash Rural Health,
15 Sargeant Street,
Warragul VIC 3820

Country

Australia

Phone

+613 9902 7310

Fax

[email protected]

Contact person for public queries

Name

Dr Jason Talevski

Address

Sunshine Hospital, WCHRE Building (Level 3),
176 Furlong Road,
St Albans VIC 3021

Country

Australia

Phone

+61 401 679 657

Fax

[email protected]

Contact person for scientific queries

Name

Dr Alison Beauchamp

Address

Monash Rural Health,
15 Sargeant Street,
Warragul VIC 3820

Country

Australia

Phone

+613 9902 7310

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
12839	Study 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

Source	Title	Year of Publication	DOI
Embase	Health literacy and long-term health outcomes following myocardial infarction: Protocol for a multicentre, prospective cohort study (ENHEARTEN study).	2022	https://dx.doi.org/10.1136/bmjopen-2021-060480

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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