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Trial registered on ANZCTR


Registration number
ACTRN12616000213448
Ethics application status
Approved
Date submitted
5/02/2016
Date registered
17/02/2016
Date last updated
17/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development and evaluation of an Australian adult health literacy program for socially disadvantaged adults attending TAFE
Scientific title
Development and evaluation of an Australian adult health literacy program for socially disadvantaged adults attending TAFE
Secondary ID [1] 288421 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
health literacy 297437 0
Condition category
Condition code
Public Health 297623 297623 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An 18-week (semester-long) health literacy program embedded in an exisiting adult language, literacy, and numeracy (LLN) program at TAFE NSW. Core topics cover reading medicine and food labels, communicating with health professionals and shared decision making, and understanding serve size. Non-core topics cover immunisation and screening, understanding prescriptions and talking to the pharmacist, completing medical forms, being active, understanding diet and nutritional information. Teachers can select non-core topics based on learner needs and interests.

The program has been planned on the basis of 2x3 hour lessons per week, for 18 weeks; however, not all TAFE colleges will fit that model. A suggested lesson plan is included in the “Study Manual”, given to all participating teachers. It includes an overview of the trial and suggested time to cover each core topic. Students (even within the same class) will vary in their language, literacy, numeracy, and communication skills – and teachers are responsible for tailoring their teaching to suit their students’ needs. For this reason the intervention program was designed to be flexible, with a relatively small number of “core” units.

Every effort will be made to match class size and student characteristics; however, class composition is determined by student enrolments and consent. Class sizes are expected to range from 5 to 20 students.

Intervention teachers were instructed to cover 10 ”core” topics, and to use their discretion when selecting other topics. The 2 course manuals ("Being Healthy" and "Staying Healthy") invite teachers to rate each activity as they teach it, and return the completed ratings sheet to the study centre. This enables us to monitor which activities and topics are taught. Qualitative interviews with students and teachers also assess course content and topics covered.
Intervention code [1] 293736 0
Other interventions
Comparator / control treatment
Control students receive usual care - a semester-long adult language, literacy, and numeracy program that does not cover health content.
Control group
Active

Outcomes
Primary outcome [1] 297173 0
Purpose designed measure informed by the intervention course core content with marking scheme developed a priori. :

a) How to use a thermometer, 3 items (score range 0- 3)

Assessed using both dichotomous and continuous scoring schemes.
Timepoint [1] 297173 0
Baseline and immediately following the intervention.
Primary outcome [2] 297329 0
Purpose designed measure informed by the intervention course core content with marking scheme developed a priori. :

b. Interpretation of a medicine label, 5 items (score range 0-5)

Assessed using both dichotomous and continuous scoring schemes.
Timepoint [2] 297329 0
Baseline and immediately following intervention
Primary outcome [3] 297330 0
Purpose designed measure informed by the intervention course core content with marking scheme developed a priori. :

c) Interpretation of a food label, 9 items (score range 0-10)

Assessed using both dichotomous and continuous scoring schemes.
Timepoint [3] 297330 0
Immediately following intervention
Secondary outcome [1] 320231 0
Confidence in health skills –10 confidence items, measured on a 5-point scale ranging from “extremely” to “not at all” confident.
1. Telling the doctor what is wrong;
2. Understanding your doctor;
3. Reading and understanding medicine labels;
4. Filling out medical forms by yourself;
5. Preventing problems with your health;
6. Taking care of your family and friends’ health;
7. Reading and understanding food labels;
8. Planning healthy meals;
9. Using a thermometer;
10. Asking the doctor questions
Timepoint [1] 320231 0
Baseline, immediately following the intervention, and six months following intervention.
Secondary outcome [2] 320232 0
The Health Literacy Questionnaire (HLQ) comprises 9 independent subscales to assess different aspects of health literacy. We measure 5 scales relevant to the learning objectives of the study intervention program (Having sufficient information to manage my health; Actively managing my health; Ability to engage with healthcare providers; Navigating the healthcare system; Understanding health information well enough to know what to do) rated on a 4-point scale or 5-point scale (25 items total).
Timepoint [2] 320232 0
Baseline, immediately following the intervention, and six months following intervention.
Secondary outcome [3] 320233 0
The 13-item generic Patient Activation Measure includes self-reported ability of the individual to enact skills of health literacy using items assessing patients’ skills and confidence in managing their health.
Timepoint [3] 320233 0
Immediately following the intervention.
Secondary outcome [4] 320234 0
Student satisfaction with the health literacy program. We will ask students to rate their course experience using 5-point Likert scale items: 1. overall rating (Excellent-Very poor); 2. if the course was (a) easy to understand, (b) helped them to understand their health (strongly agree-strongly disagree); 3. if they would recommend the course to family and friends (yes, definitely-definitely not).
Timepoint [4] 320234 0
Immediately following the intervention.
Secondary outcome [5] 320239 0
Health knowledge using a 12-item curriculum based measure to assess retention of core components of health knowledge. 7 items related to health information and services, and 5 items about serve sizes.
Healthy lifestyle using self-report questions of daily: fruit and vegetable intake (number of serves); daily walking and moderate, and hard physical activity. These measures were taken from the 45 and Up Study.
Timepoint [5] 320239 0
Six months following intervention
Secondary outcome [6] 320242 0
Proportion of adults enrolled in the program who complete the entire program. Assessed by teacher records or data linkage to TAFE student records
Timepoint [6] 320242 0
Immediately following intervention
Secondary outcome [7] 320739 0
Enrolment in further TAFE adult education programs. Measured with data linkage to TAFE enrolment records
Timepoint [7] 320739 0
12 months following intervention
Secondary outcome [8] 320740 0
Shared decision making

a. A purpose-developed 14-item curriculum-based SDM knowledge questionnaire that covers SDM competencies including comprehension of SDM terms and concepts, probabilities and risk information. (Score range 0-15)
Timepoint [8] 320740 0
Immediately following intervention
Secondary outcome [9] 320741 0
Shared decision making

b. Open-ended (free-response) written self-reports by students: questions students considered important to discuss with their doctor. Coded by researcher using content analysis.
Timepoint [9] 320741 0
Immediately following intervention
Secondary outcome [10] 320742 0
Shared decision making

c. Free-reponse recall of the 3 AskShareKnow questions students learned in class (intervention only).
Timepoint [10] 320742 0
Immediately following intervention and 6 months following intervention
Secondary outcome [11] 320743 0
Shared decision making

d. Decisional conflict using the SURE scale
Legare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M et al. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Canadian family physician Medecin de famille canadien. 2010;56(8):e308-14
Timepoint [11] 320743 0
6 months following intervention
Secondary outcome [12] 320744 0
Shared decision making

e. Decision making preferences using the Control Preferences scale

Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. The Canadian journal of nursing research = Revue canadienne de recherche en sciences infirmieres. 1997;29(3):21-43.
Timepoint [12] 320744 0
6 months following intervention
Secondary outcome [13] 320745 0
Shared decision making

f. Self-report use of Ask Share Know questions in health-care consultations
Timepoint [13] 320745 0
6 months following intervention
Secondary outcome [14] 320878 0
Proportion of recorded attendances (present/ absent) at classes during the study intervention period for each student. This is routine data collected by TAFE teachers.
Timepoint [14] 320878 0
Immediately following intervention

Eligibility
Key inclusion criteria
Participants will be recruited following standard TAFE processes for enrolling students. Participating TAFE teachers will invite 300 adults assessed at ACSF level 2, seeking basic education at TAFE in NSW to join the study. As part of standard procedures, students literacy and numeracy levels are assessed by TAFE teachers on enrolment day.

We will recruit classes from TAFE Institutes in metropolitan and regional centres across NSW, Australia, including multiple Sydney districts, and Illawarra, Hunter, New England, and Southern NSW.

Eligible classes will be learning basic language, literacy and numeracy at Australian Core Skills Framework level 2 (in one of 4 eligible course codes). Intervention and standard LLN classes will be matched on typical demographic characteristics including age, sex, English proficiency, literacy skills, course code, and region.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Refusal to provide informed, written consent (or failure to provide consent from a parent or guardian for students under 16 years). It is a requirement of the ethics committees of TAFE and the University of Sydney that additional consent be obtained for students under 18 years.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participating Institute will be required to contribute (at least) 2 classes that are matched on course code, time of day (i.e. day or evening) and typical student characteristics. At enrolment, students will be allocated to classes following normal TAFE procedures. Matched classes will be randomised centrally into “intervention” or “standard LLN” groups by the University of Sydney team.
At campuses holding only one class participating in the study, all enrolling students will be allocated to that class. At larger metropolitan campuses with more than one participating class, students will be randomised into classes on enrolment day, by selecting an “odd” or “even” paper ticket. Matched classes at the same location will be held on different days to minimise risk of contamination between intervention and standard groups.

Students will be invited to participate in a research trial but will be blinded as far as possible to its aims. Students will be informed simply that the study is about a new adult literacy program, the “Living Literacy Program” but will not be informed that its purpose is to evaluate a health literacy program. Detail about the purpose of the trial will be given in a debrief statement following the final data collection session (6 months after course conclusion).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Class-level randomisation was done by coin toss.
Individual-level randomisation was done by asking participants to select a folded numbered (odd or even) ticket from an envelope
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary outcome for sample size calculation is the functional health literacy score used in our pilot study. We estimate that 86 students are required per group to detect a difference in the mean total score between the intervention and standard LLN groups of 0.5 standard deviation (SD) with 90% power at the two-sided 5% significance level. An established systematic review indicates that a half-standard deviation is the ‘threshold of discrimination’, or the minimally important difference, for changes to psychosocial outcomes in chronic disease assessment. To allow for clustering within a class and using an intra-cluster correlation coefficient of 0.05 and an average class size of 10, the required sample size is 125 students. Allowing for 15% loss to follow-up, we aim to recruit 150 participants in each arm (n=300 in total; 15 pairs of classes of approximately 10 students per class). This sample size will also be sufficient to detect a difference in retention of at least 20% between the intervention and standard LLN group, with 80% power. Due to the unpredictability of TAFE enrolments, unequal cluster sizes are assumed.

Analysis will be by intention to treat. We will compare outcomes between the intervention and standard LLN arms for the primary outcome using a regression analysis and will account for clustering through the use of generalised estimating equations.
We will also conduct secondary analyses to adjust for baseline health literacy and numeracy (measured with NVS) and language spoken at home. We will conduct these analyses separately. We will also conduct the same set of analyses for the primary outcomes, but using the intervention as actually received.
For the secondary outcomes, we will only conduct intention to treat analyses, and we will also conduct further analyses that adjust for NVS and language spoken at home.
The statistician will be blinded to the allocated group definitions (i.e., health literacy vs standard LLN) until completion of the statistical analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292773 0
Government body
Name [1] 292773 0
Australian Research Council
Address [1] 292773 0
Level 2, 11 Lancaster Place
Canberra Airport ACT 2609
Country [1] 292773 0
Australia
Primary sponsor type
University
Name
Sydney School of Public Health, University of Sydney
Address
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 291506 0
Government body
Name [1] 291506 0
NSW Health
Address [1] 291506 0
73 Miller Street
North Sydney NSW 2060
Country [1] 291506 0
Australia
Secondary sponsor category [2] 291507 0
Government body
Name [2] 291507 0
National Prescribing Service
Address [2] 291507 0
Level 7, 418A Elizabeth St
Surry Hills NSW 2010
Country [2] 291507 0
Australia
Secondary sponsor category [3] 291508 0
Government body
Name [3] 291508 0
Clinical Excellence Commission
Address [3] 291508 0
Level 17, McKell Building
2-24 Rawson Place,
Sydney NSW 2000.
Country [3] 291508 0
Australia
Other collaborator category [1] 278790 0
Other Collaborative groups
Name [1] 278790 0
TAFE NSW - South Western Sydney
Address [1] 278790 0
500 Chapel Road (PO Box 3035 Bankstown Square)
Bankstown NSW 2200
Country [1] 278790 0
Australia
Other collaborator category [2] 278801 0
University
Name [2] 278801 0
University of NSW
Address [2] 278801 0
University of NSW
High St
Kensington, NSW, 2052
Country [2] 278801 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294268 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 294268 0
University of Sydney NSW 2006
Ethics committee country [1] 294268 0
Australia
Date submitted for ethics approval [1] 294268 0
21/10/2013
Approval date [1] 294268 0
03/12/2013
Ethics approval number [1] 294268 0
2013/938

Summary
Brief summary
ABSTRACT
Background: People with low literacy and low health literacy have poorer health outcomes. Literacy and health literacy are distinct but overlapping constructs that impact wellbeing. Interventions that target both could improve health outcomes.
Methods & Design
This is a cluster randomised controlled trial with a qualitative component. Participants are 300 adults enrolled in basic language, literacy and numeracy programs at adult education centres across New South Wales, Australia. Each adult education institute (regional administrative centre) contributes (at least) two classes matched for student demographics, which may be at the same or different campuses. Classes (clusters) are randomly allocated to receive either the health literacy intervention (an 18-week program with health knowledge and skills embedded in language, literacy, and numeracy training (LLN)), or the standard Language Literacy and Numeracy (LLN) program (usual LLN classes, specifically excluding health content).
The primary outcome is functional health literacy skills – knowing how to use a thermometer, and read and interpret food and medicine labels. The secondary outcomes are self-reported confidence, health literacy; shared decision making skills, patient activation, health knowledge and self-reported health behaviour. Data is collected at baseline, and immediately and 6 months post intervention.
A sample of participating teachers, students, and community health workers will be interviewed in-depth about their experiences with the program.
Ethics and dissemination
The study has ethical approval from the University of Sydney and 10 NSW Institutes of TAFE. Results will be published in peer reviewed journals, and reported to partner organisations.
Trial website
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 63086 0
Prof Kirsten McCaffery
Address 63086 0
Room 301F, Edward Ford Building A27
The University of Sydney NSW 2006
Country 63086 0
Australia
Phone 63086 0
+61 2 9351 7220
Fax 63086 0
Email 63086 0
kirsten.mccaffery@sydney.edu.au
Contact person for public queries
Name 63087 0
Prof Kirsten McCaffery
Address 63087 0
Room 301F, Edward Ford Building A27
The University of Sydney NSW 2006
Country 63087 0
Australia
Phone 63087 0
+61 2 9351 7220
Fax 63087 0
Email 63087 0
kirsten.mccaffery@sydney.edu.au
Contact person for scientific queries
Name 63088 0
Prof Kirsten McCaffery
Address 63088 0
Room 301F, Edward Ford Building A27
The University of Sydney NSW 2006
Country 63088 0
Australia
Phone 63088 0
+61 2 9351 7220
Fax 63088 0
Email 63088 0
kirsten.mccaffery@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary