Check-BackV2 Rural Chronic Disease Intervention, 208 Participants

Trial Review

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Registration number

ACTRN12626000514303 Ethics application status

Approved Date submitted

18/03/2026 Date registered

24/04/2026 Date last updated

24/04/2026 Date data sharing statement initially provided

24/04/2026 Type of registration

Prospectively registered
Titles & IDs Public title Evaluation of a patient communication resource (Check-Backv2) in rural chronic disease settings Query! Scientific title Evaluation of a patient communication resource (Check-Backv2) for patients in rural chronic disease settings Query! Additional trial identifiers [1] 316801 0 Nil Query! Universal Trial Number (UTN) Query! Trial acronym Query! Related trial records This study is building on the check-back intervention registered on ACTRN12623000378628. Query!
Health condition Health condition(s) studied: Arthritis 341132 0 Query! Asthma 341364 0 Query! Back pain 341365 0 Query! Cancer 341366 0 Query! Cardiovascular disease 341367 0 Query! Chronic obstructive pulmonary disease 341368 0 Query! Diabetes 341369 0 Query! Chronic kidney disease 341370 0 Query! Osteoporosis 341371 0 Query! Condition category Condition code Musculoskeletal 337241 337241 0 0 Query! Osteoarthritis Query!

Respiratory 337657 337657 0 0 Query! Asthma Query!

Musculoskeletal 337660 337660 0 0 Query! Other muscular and skeletal disorders Query!

Cancer 337661 337661 0 0 Query! Any cancer Query!

Cardiovascular 337662 337662 0 0 Query! Coronary heart disease Query!

Respiratory 337663 337663 0 0 Query! Chronic obstructive pulmonary disease Query!

Metabolic and Endocrine 337664 337664 0 0 Query! Diabetes Query!

Renal and Urogenital 337665 337665 0 0 Query! Kidney disease Query!

Musculoskeletal 337666 337666 0 0 Query! Osteoporosis Query!

Intervention/exposure Study type Interventional Query! 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. Query! Intervention code [1] 333490 0 Treatment: Other Query! Description of the comparator or control The usual care group will receive no check-back intervention or reminders during the study period. Query! Control group Active Query!
Outcomes Primary outcome [1] 344762 0 Patient activation Query! Timepoint [1] 344762 0 Baseline (6-10 weeks prior to planned health appointment) and 12-weeks after planned health appointment Query! Secondary outcome [1] 459125 0 Feeling understood by healthcare providers Query! Timepoint [1] 459125 0 Baseline (6-10 weeks prior to planned health appointment), 2-weeks & 12-weeks after planned health appointment Query! Secondary outcome [2] 459126 0 Have sufficient information Query! Timepoint [2] 459126 0 Baseline (6-10 weeks prior to planned health appointment), 2-weeks & 12-weeks after planned health appointment Query! Secondary outcome [3] 459127 0 Engage with providers Query! Timepoint [3] 459127 0 Baseline (6-10 weeks prior to planned health appointment), 2-weeks & 12-weeks after planned health appointment Query! Secondary outcome [4] 459128 0 Navigating the healthcare system Query! Timepoint [4] 459128 0 Baseline (6-10 weeks prior to planned health appointment), 2-weeks & 12-weeks after planned health appointment Query! Secondary outcome [5] 459129 0 Medication adherence Query! Timepoint [5] 459129 0 Baseline (6-10 weeks prior to planned health appointment) and 12-weeks after planned health appointment Query! Secondary outcome [6] 459130 0 Hospital admission Query! Timepoint [6] 459130 0 2-weeks & 12-weeks after planned health appointment Query! Secondary outcome [7] 459131 0 ED presentation Query! Timepoint [7] 459131 0 2-weeks & 12-weeks after planned health appointment Query! Secondary outcome [8] 459132 0 Health appointments Query! Timepoint [8] 459132 0 2-weeks & 12-weeks after planned health appointment Query! Secondary outcome [9] 459918 0 Patient perspectives about the intervention. Query! Timepoint [9] 459918 0 12-weeks after their planned health appointment Query! Secondary outcome [10] 459919 0 Clinician perspectives about the intervention. Query! Timepoint [10] 459919 0 At the conclusion of the study Query!
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. Query! Minimum age 18 Years Query! Query! Maximum age No limit Query! Query! Sex Both males and females Query! Can healthy volunteers participate? No Query! Key exclusion criteria None Query!
Study design Purpose of the study Educational / counselling / training Query! Allocation to intervention Randomised controlled trial Query! Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures) Sealed opaque envelopes Query! Methods used to generate the sequence in which subjects will be randomised (sequence
generation) Permuted block allocation (blocks of 6 participants) Query! Masking / blinding Blinded (masking used) Query! Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data Query! Query! Query! Query! Intervention assignment Query! Other design features Query! Phase Not Applicable Query! Type of endpoint/s Efficacy Query! 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
Query!
Recruitment Recruitment status Not yet recruiting Query! Date of first participant enrolment Anticipated 27/04/2026 Query! Actual Query! Date of last participant enrolment Anticipated 31/12/2026 Query! Actual Query! Date of last data collection Anticipated 26/03/2027 Query! Actual Query! Sample size Target 208 Query! Accrual to date Query! Final Query! Recruitment in Australia Recruitment state(s) TAS,VIC Query! Recruitment hospital [1] 29271 0 Ballarat Health Services (Base Hospital) - Ballarat Central Query! Recruitment hospital [2] 29272 0 East Grampians Health Service - Ararat - Ararat Query! Recruitment hospital [3] 29274 0 North West Regional Hospital - Burnie Query! Recruitment hospital [4] 29275 0 Ballarat Health Services - Queen Elizabeth Centre - Ballarat Query! Recruitment postcode(s) [1] 45581 0 3350 - Ballarat Central Query! Recruitment postcode(s) [2] 45582 0 3377 - Ararat Query! Recruitment postcode(s) [3] 45584 0 7320 - Burnie Query! Recruitment postcode(s) [4] 45585 0 3350 - Ballarat Query!
Funding & Sponsors Funding source category [1] 321393 0 Government body Query! Name [1] 321393 0 Australian Government Department of Health and Aged Care - Medical Research Future Fund Query! Country [1] 321393 0 Australia Query! Primary sponsor type Individual Query! Name Associate Professor Alison Beauchamp, School of Rural Health, Monash University Query! Address Query! Country Australia Query! Secondary sponsor category [1] 324137 0 None Query! Name [1] 324137 0 Query! Address [1] 324137 0 Query! Country [1] 324137 0 Query!
Ethics approval Ethics application status Approved Query! Ethics committee name [1] 319934 0 Monash Health Human Research Ethics Committee A Query! Ethics committee address [1] 319934 0 https://monashhealth.org/research/resources/resource-library/ Query! Ethics committee country [1] 319934 0 Australia Query! Date submitted for ethics approval [1] 319934 0 18/11/2025 Query! Approval date [1] 319934 0 26/02/2026 Query! Ethics approval number [1] 319934 0 HREC/122557/MonH-2026-521248 Query!
Summary Brief summary The primary aim of this study is to investigate if a co-designed communication training resource for health consumers (Check-BackV2) improves patient activation levels in rural patients with chronic disease 12 weeks after a planned appointment with a health professional. The intervention is the Check-BackV2 package which has been developed to help rural patients 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). Participants in the intervention group will also be sent two SMS reminders to use check-back during their next planned health appointment. The usual care group will receive no intervention during the study period. Expected outcomes are that the intervention group will have a greater improvement in patient activation, health literacy, medication adherance, and lower emergency department presentations and hospital admissions compared to the control group at follow-up time-points. Query! Trial website Query! Trial related presentations / publications Query! Public notes Query!
Contacts Principal investigator Name 148870 0 A/Prof Alison Beauchamp Query! Address 148870 0 School of Rural Health, Monash University, 15 Sargeant St, Warragul, VIC 3820 Query! Country 148870 0 Australia Query! Phone 148870 0 +610399027310 Query! Fax 148870 0 Query! Email 148870 0 [email protected] Query! Contact person for public queries Name 148871 0 Denise Azar Query! Address 148871 0 School of Rural Health, Monash University, 15 Sargeant St, Warragul, VIC 3820 Query! Country 148871 0 Australia Query! Phone 148871 0 +610399027331 Query! Fax 148871 0 Query! Email 148871 0 [email protected] Query! Contact person for scientific queries Name 148872 0 Denise Azar Query! Address 148872 0 School of Rural Health, Monash University, 15 Sargeant St, Warragul, VIC 3820 Query! Country 148872 0 Australia Query! Phone 148872 0 +610399027331 Query! Fax 148872 0 Query! Email 148872 0 [email protected] Query!
Data sharing statement Will the study consider sharing individual participant data? No

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