Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000514303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
18/03/2026
Date registered
Help: Date registered
24/04/2026
Date last updated
Help: Date last updated
24/04/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/04/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a patient communication resource (Check-Backv2) in rural chronic disease settings
Scientific title
Evaluation of a patient communication resource (Check-Backv2) for patients in rural chronic disease settings
Additional trial identifiers [1] 316801 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records
This study is building on the check-back intervention registered on ACTRN12623000378628.

Health condition
Health condition(s) studied:
Arthritis 341132 0
Asthma 341364 0
Back pain 341365 0
Cancer 341366 0
Cardiovascular disease 341367 0
Chronic obstructive pulmonary disease 341368 0
Diabetes 341369 0
Chronic kidney disease 341370 0
Osteoporosis 341371 0
Condition category
Condition code
Musculoskeletal 337241 337241 0 0
Osteoarthritis
Respiratory 337657 337657 0 0
Asthma
Musculoskeletal 337660 337660 0 0
Other muscular and skeletal disorders
Cancer 337661 337661 0 0
Any cancer
Cardiovascular 337662 337662 0 0
Coronary heart disease
Respiratory 337663 337663 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 337664 337664 0 0
Diabetes
Renal and Urogenital 337665 337665 0 0
Kidney disease
Musculoskeletal 337666 337666 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is the Check-BackV2 package which has been developed to help rural patients with chronic diseases or carers of someone with a chronic disease build their skills and confidence to engage in active, two-way discussions with clinicians. The Check-BackV2 package comprises a 6-page pamphlet, a wallet card and postcard with reminders to use check-back and a link to the revised check-back website (the latter for optional viewing). The pamphlet, wallet card and postcard include a brief description of what Check-back is and how to use it in health appointments. The resources have been designed specifically for this study. Participants in the intervention group will also be sent two SMS reminders (at weeks 4 and 5 after the intervention pack is sent) to use check-back during their next planned health appointment. These resources and revisions to the check-back website have been co-designed with consumers and clinicians as part of The Check-Back study (ACTRN12623000378628). The Check-BackV2 website will be a modified version of the current check-back website (https://checkback.org/). This website is self-administered, includes videos, animations and a personal action plan, and takes approximately 15 minutes to complete. The Check-BackV2 package will be mailed to participants in the intervention group at once recruitment is finalised. Participants will be able to read the pamphlet and view the website as often as they wish.
We will collect survey data at weeks 2 and 12 following their health appointment, and 10 participants will be interviewed. Clinicians who work within chronic disease services at a participating health service will also be invited to be interviewed. These clinicians may or may not have provided care to participants during the study period. The primary purpose of these interviews will be to inform the implementation aspects of the process evaluation, based on the RE-AIM framework.
Intervention code [1] 333490 0
Treatment: Other
Description of the comparator or control
The usual care group will receive no check-back intervention or reminders during the study period.
Control group
Active

Outcomes
Primary outcome [1] 344762 0
Patient activation
Timepoint [1] 344762 0
Baseline (6-10 weeks prior to planned health appointment) and 12-weeks after planned health appointment
Secondary outcome [1] 459125 0
Feeling understood by healthcare providers
Timepoint [1] 459125 0
Baseline (6-10 weeks prior to planned health appointment), 2-weeks & 12-weeks after planned health appointment
Secondary outcome [2] 459126 0
Have sufficient information
Timepoint [2] 459126 0
Baseline (6-10 weeks prior to planned health appointment), 2-weeks & 12-weeks after planned health appointment
Secondary outcome [3] 459127 0
Engage with providers
Timepoint [3] 459127 0
Baseline (6-10 weeks prior to planned health appointment), 2-weeks & 12-weeks after planned health appointment
Secondary outcome [4] 459128 0
Navigating the healthcare system
Timepoint [4] 459128 0
Baseline (6-10 weeks prior to planned health appointment), 2-weeks & 12-weeks after planned health appointment
Secondary outcome [5] 459129 0
Medication adherence
Timepoint [5] 459129 0
Baseline (6-10 weeks prior to planned health appointment) and 12-weeks after planned health appointment
Secondary outcome [6] 459130 0
Hospital admission
Timepoint [6] 459130 0
2-weeks & 12-weeks after planned health appointment
Secondary outcome [7] 459131 0
ED presentation
Timepoint [7] 459131 0
2-weeks & 12-weeks after planned health appointment
Secondary outcome [8] 459132 0
Health appointments
Timepoint [8] 459132 0
2-weeks & 12-weeks after planned health appointment
Secondary outcome [9] 459918 0
Patient perspectives about the intervention.
Timepoint [9] 459918 0
12-weeks after their planned health appointment
Secondary outcome [10] 459919 0
Clinician perspectives about the intervention.
Timepoint [10] 459919 0
At the conclusion of the study

Eligibility
Key inclusion criteria
For patients/carers, inclusion criteria are:
- Adults (18 years and over);
- Living with one or more chronic diseases (arthritis, asthma, back pain, cancer, cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, and osteoporosis);
- A patient/carer of outpatient services at a participating health service;
- Has an upcoming health appointment within the next 6-10 weeks (can be telehealth or in-person). This time-frame allows sufficient time for recruitment and consent processes, and (for the intervention group), time to become familiar with the Check-BackV2 package.
- Lives in a Modified Monash Model 3-5 area (designated as rural/remote). They can be attending a health appointment at a larger regional or metropolitan centre as long as they live in a rural/remote area.
- Able to understand and speak English as the Check-BackV2 package is only available in English at this stage;
- Able to provide informed consent.
For clinician interviews, inclusion criteria are a clinician working within chronic disease outpatient services at a participating health service.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
None

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block allocation (blocks of 6 participants)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcome of patient activation (measured using the PAM-13), a sample size of 186 subjects, 93 per arm, is sufficient to conclude a clinically important difference of 4% between groups with 80% power and a 2-sided 5% level of significance if the true underlying difference between groups is 10%, using an independent groups t-test. This assumes a standard deviation of 14.5%. Considering a dropout rate of 10% the sample size required is 208 (104 per group).
To evaluate contextual factors affecting implementation and use of Check-BackV2 in rural chronic disease settings, 10 patients who received the intervention and 10 clinicians will be invited to take part in a 15–20-minute telephone interview. This is considered to be a sufficient sample size to achieve data saturation.
Data analysis will be conducted using Stata V18. A p-value of <0.05 will be used to indicate statistical significance for the primary objective. Patient demographics will be described by randomised group. The primary outcome will be changes in the Patient Activation Measure (PAM-13) between baseline and 12-weeks after the participants’ planned health appointment. Differences between the intervention and usual care groups will be compared using linear regression, controlling for baseline PAM-13 scores as a covariate.
For secondary outcomes, differences between the two groups will be analysed using logistic and linear regression models for categorical and continuous variables, respectively. Where appropriate, 95% confidence intervals and effect sizes will be reported. Findings for the secondary objectives will be considered to be hypothesis generating only.
Qualitative interview data will be thematically analysed using the domains of the RE-AIM framework to identify factors affecting implementation and key themes related to patient and clinician perspectives of the Check-BackV2 package. This framework has 5 domains relevant to effective implementation at both the patient and health service level

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/04/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
26/03/2027
Actual
Sample size
Target
208
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment hospital [1] 29271 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [2] 29272 0
East Grampians Health Service - Ararat - Ararat
Recruitment hospital [3] 29274 0
North West Regional Hospital - Burnie
Recruitment hospital [4] 29275 0
Ballarat Health Services - Queen Elizabeth Centre - Ballarat
Recruitment postcode(s) [1] 45581 0
3350 - Ballarat Central
Recruitment postcode(s) [2] 45582 0
3377 - Ararat
Recruitment postcode(s) [3] 45584 0
7320 - Burnie
Recruitment postcode(s) [4] 45585 0
3350 - Ballarat

Funding & Sponsors
Funding source category [1] 321393 0
Government body
Name [1] 321393 0
Australian Government Department of Health and Aged Care - Medical Research Future Fund
Country [1] 321393 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Alison Beauchamp, School of Rural Health, Monash University
Address
Country
Australia
Secondary sponsor category [1] 324137 0
None
Name [1] 324137 0
Address [1] 324137 0
Country [1] 324137 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319934 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 319934 0
Ethics committee country [1] 319934 0
Australia
Date submitted for ethics approval [1] 319934 0
18/11/2025
Approval date [1] 319934 0
26/02/2026
Ethics approval number [1] 319934 0
HREC/122557/MonH-2026-521248

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

Contacts
Principal investigator
Name 148870 0
A/Prof Alison Beauchamp
Address 148870 0
School of Rural Health, Monash University, 15 Sargeant St, Warragul, VIC 3820
Country 148870 0
Australia
Phone 148870 0
+610399027310
Fax 148870 0
Email 148870 0
[email protected]
Contact person for public queries
Name 148871 0
Denise Azar
Address 148871 0
School of Rural Health, Monash University, 15 Sargeant St, Warragul, VIC 3820
Country 148871 0
Australia
Phone 148871 0
+610399027331
Fax 148871 0
Email 148871 0
[email protected]
Contact person for scientific queries
Name 148872 0
Denise Azar
Address 148872 0
School of Rural Health, Monash University, 15 Sargeant St, Warragul, VIC 3820
Country 148872 0
Australia
Phone 148872 0
+610399027331
Fax 148872 0
Email 148872 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.