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Chronic Kidney DiseaseNCT07280325

Moxie Self-Management and Education Support Program

A study testing Moxie SMES Letters and Facilitated Relay Letter in people with Chronic Kidney Disease and Diabetes (DM), run by University of Calgary.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Health education and self-management support are key facilitators of health behaviours. Moxie is a mixed media, self-management, education and support program for Albertans living with cardiovascular-related chronic conditions. Read more about this study

Who is it for?
Ages 40 to 85 years
What is being tested?
Moxie SMES Letters and Facilitated Relay Letter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,000 participants
Where
No sites listed yet
Study dates
1 Jun 2026to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible participants will be adults aged 40-85 years who are being discharged to their home from general internal medicine or family medicine inpatient services (hospitalist) in one of 10 Alberta acute care facilities, whose admitting diagnosis was diabetes, coronary artery disease, heart failure, chronic kidney disease, or hypertension (see appendix for list of inclusion diagnoses).

Who cannot join

  • Individuals who live at the same address/household as a person who is already in the study and/or those discharged from hospitals to continuing care facilities, rehabilitation facilities or another hospital will not be eligible to take part in the study. Individuals whose goals of care at the time of discharge from acute care were oriented towards comfort (i.e. C1 or C2 Goals of Care) will not be eligible to take part in the study. Individuals with markers indicating lack of competency/capacity in their inpatient ConnectCare record such as anything but full capacity on the medical record (i.e. "incapacitated" or "needs review"), or presence of an alternative decision maker, agent, or legal guardian listed on the medical record.

About this study

Official title: Moxie: A Self-management Education and Support Program Using Advertising Principles to Reduce Rehospitalization for Cardiovascular-related Illnesses

Health education and self-management support are key facilitators of health behaviours. Moxie is a mixed media, self-management, education and support program for Albertans living with cardiovascular-related chronic conditions. Moxie is built upon our previous work within the ACCESS study (2015-21, n=4761), a RCT that previously tested the Moxie intervention in Alberta. Results demonstrated that MOXIE reduced the rate of hospitalizations (notably for hypertension, angina, hyper/hypoglycemia, heart failure decompensation, and acute kidney complications) by 34% in a population of low-income seniors living with cardiovascular-related chronic conditions.

However, before Moxie can be effectively implemented province-wide, another trial is necessary to determine whether benefits can be observed in a larger cohort of patients with cardiovascular-related chronic conditions recruited immediately after hospital discharge (n=9000). Furthermore, the effectiveness of the two components of the ACCESS trial intervention will be assessed individually:

Read more

(a) The Moxie Program, a tailored health and disease education component developed by a user-experience-centric design process incorporating patients, behavioural scientists, disease specialists, health system administrators and marketing/advertising professionals; and (b) the facilitated relay of clinical information to healthcare providers (letters).

The trial is designed as a 2x2 factorial pragmatic, individual-level randomized pragmatic trial of these different interventions. This would yield the following groups:

  1. Moxie SMES Program
  2. Facilitated Relay
  3. Moxie SMES Program and Facilitated Relay
  4. True control

Self-management education and support (SMES) intervention: This includes weekly physical mailers sent directly to patients' homes throughout the study containing information about chronic conditions, medication use, diet, physical activity, smoking cessation, and self-management/wellness principles. These messages will be refined by the social impact creative design partner and reviewed by clinicians and patients to ensure clinical safety and appropriate tone. Weekly mailers will encourage participants to enroll and consent to participate in the digital program by scanning a QR code or accessing a website where they will sign up for their own personalized Moxie mobile health app, complete a digital consent form and opt-in for electronic delivery of Moxie messages.

Facilitated relay intervention: Participants allocated to this intervention will receive letters by mail, one addressed to them, one to their primary care provider, and one to their pharmacist. The letters will not be sent to their primary care provider directly; rather, they will be sent to patients who will be encouraged to take them to their primary care provider and pharmacist should they decide to do so. We hope this will empower patients to start discussions with their healthcare providers. This also supports patient autonomy by enabling patients to decide whether they want to take them to their provider or not. If for whatever reason they do not feel that this is going to be beneficial or of interest, they are not required to do so. The letter would contain a note to the patient's healthcare provider stating that their patient is at-risk of cardiovascular disease and that evidence has shown that the pharmacotherapy is effective in improving outcomes for patients similar to the participant.

The primary outcome is readmission for cardiovascular-specific ambulatory care-sensitive conditions (ACSC) based on the most responsible diagnosis listed in CIHI Discharge Abstract Database-(DAD), using established algorithms within 12 months from randomization. This outcome includes all repeat admissions in the study period as recorded in the health record. This outcome is a count variable. We will calculate and compare each intervention arm's mean number and distribution of hospitalizations.

Being tested
Moxie SMES Letters, Facilitated Relay Letter
Keywords
Chronic Disease Self-Management, Pragmatic Trial, Chronic Disease Education
Medical subject headings
Renal Insufficiency, Chronic, Diabetes Mellitus, Heart Diseases, Stroke, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moxie SMES LettersBehavioural

    Weekly mailer for the Moxie SMES Program.

  • Facilitated Relay LetterBehavioural

    One-time Facilitated Relay letter for the participant to share with their healthcare provider.

Study groups in NCT07280325
Study groupRoleWhat they receive
Moxie SMES ProgramExperimentalParticipants randomized to this arm receive weekly mailers for the Moxie SMES Program and an invitation to participate in the digital health component.
Receives: Behavioral: Moxie SMES Letters
Facilitated RelayExperimentalParticipants randomized to this arm receive a one-time facilitated relay letter to share with their pharmacist and primary care provider.
Receives: Behavioral: Facilitated Relay Letter
Moxie SMES Program and Facilitated RelayExperimentalParticipants randomized to this arm receive weekly mailers for the Moxie SMES Program, an invitation to participate in the digital health component, and the one-time facilitated relay letter to share with their pharmacist and primary care provider.
Receives: Behavioral: Moxie SMES Letters; Behavioral: Facilitated Relay Letter
ControlNo interventionParticipants randomized to this arm receive standard of care only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital Readmissions

    Readmission for cardiovascular-specific ambulatory care-sensitive conditions (ACSC) based on the most responsible diagnosis listed in CIHI-DAD (23). This outcome includes all repeat admissions in the study period as recorded in the AHS record that is sent to CIHI for inclusion in the Discharge Abstract Database (DAD). This outcome is a count variable. We will calculate and compare each intervention arm's mean number and distribution of hospitalizations.

    Measured: Within 12 months from randomization.

Secondary outcomes (6)

  1. Overall Mortality

    Death, for the purpose of this study, refers to all-cause mortality. The data source for this outcome is the Canadian Vital Statistics Database (CVSD).

    Measured: Within 12 months of randomization.

  2. Cardiovascular-Kidney-Metabolic Death

    The CVSD also records an ICD-10 code for the most responsible cause of death provided by the most responsible healthcare provider (death in an inpatient facility) or the coroner's office (death in the community). This code can be used to identify those who die of relevant causes if the assigned ICD-10 code is within the following ranges: cardiovascular (I00-I99), diabetes (E10-E14), or kidney-related (N00-N29).

    Measured: Within 12 months from randomization.

  3. Cardioprotective Medication Initiation

    Using data from Alberta's pharmacy dispensation repository, we will identify when a patient with an indicated condition starts a new medication that they were not previously taking in the prior 12 months. The combination of conditions and medications we will assess for include:

    Heart Failure= ACE/ARB/ARNI, SGLT2 inhibitors, MRA, Statins Chronic kidney disease with proteinuria (no diabetes)= ACE/ARB/ARNI, SGLT2 inhibitors, Statins Chronic kidney disease with proteinuria and diabetes= ACE/ARB/ARNI, SGLT2 inhibitors, Statins, Finerenone Chronic kidney disease without proteinuria= ACE/ARB/ARNI, Statins Coranary artery disease= ACE/ARB/ARNI, Statins Type 2 Diabetes= ACE/ARB/ARNI, SGLT2i or GLP1RA inhibitors, Statins

    Measured: Within 12 months from randomization.

  4. Medication Adherence

    Adherence to medications such as \ACEi, ARBs, Statins, and other cardioprotective medications listed above will be assessed by calculating the proportion of days covered (calculated using the formula below) (sum of days covered in the period of interest (POI)) ÷ (number of days in the POI) × 100% (24). PDC of 80% or greater is considered adequate adherence. This data is sourced from the Pharmaceutical Information Network, which records information (date, drug name, DIN, strength, quantity, duration) for all dispensed prescriptions from outpatient pharmacies in Alberta.

    Measured: Within 12 months from randomization.

  5. Primary Care and Specialty Utilization

    Primary care and specialist visits are captured in the Physician Claims Database. Each encounter will be counted as one visit. This outcome is analysed as a count variable. We will calculate and compare the mean number and distribution of primary and specialist care visits.

    Measured: Within 12 months from randomization.

  6. Healthcare System Costs

    We will include costs for hospitalization and ED visits, physician claims (specialist and primary care physician visit and procedure billing costs), prescription medications, nonphysician ambulatory costs (day medicine and day surgery clinics), and outpatient diagnostic imaging and laboratory costs. The total costs will be calculated as the sum of these costs. Alberta Health uses Canadian Institute of Health Information case-mix grouper methods to estimate hospital costs and ambulatory-case costing methods to estimate emergency department costs. Physician claims will be based on the amount paid by Alberta Health. The cost of medications will be estimated by combining a database containing a comprehensive list of medications dispensed to all Alberta residents with a price list from Alberta Blue Cross, including dispensing fee. Diagnostic imaging and laboratory costs will be based on estimates provided by Alberta Health.

    Measured: Within 12 months from randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 May 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
9,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07280325
Sponsor's protocol ID
Pro00141473
Status last verified
May 2026
First submitted
1 Dec 2025
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Campbell DJ, Tonelli M, Hemmelgarn B, Mitchell C, Tsuyuki R, Ivers N, Campbell T, Pannu R, Verkerke E, Klarenbach S, King-Shier K, Faris P, Exner D, Chaubey V, Manns B; Interdisciplinary Chronic Disease Collaboration. Assessing outcomes of enhanced chronic disease care through patient education and a value-based formulary study (ACCESS)-study protocol for a 2x2 factorial randomized trial. Implement Sci. 2016 Sep 26;11(1):131. doi: 10.1186/s13012-016-0491-6.

    PubMed 27671037

  • "Statistics Canada Releases New Health of Canadians Report to Summarize the Current State of Health in the Country." Statistics Canadaa, 13 Sept. 2023, www.statcan.gc.ca/en/about/smr09/smr09_142. Accessed 13 Sept. 2023.

  • "A Canadian Peer-reviewed Journal of Population Health and Health Services Research." Statistics Canada, www150.statcan.gc.ca/n1/pub/82-003-x/82-003-x2020010-eng.htm. Accessed 21 Oct. 2020.

  • Sumithira, G., et al. "Incidence and prevalence of diabetes in patients with myocardial infarction: A study in a secondary care hospital." International Journal of Pharmaceutical Research (09752366) 12.3 (2020).

  • Canadian Institute for Health Information. Hospital Morbidity Database (HMDB) metadata. Accessed October 28, 2024.

  • Discharge abstract database metadata. Canadian Institute for Health Information. https://www.cihi.ca/en/dischargeabstract-database-dad-metadata. Published Unknown. Accessed October 17, 2023.

  • "TCPS 2 (2018) - Chapter 3: The Consent Process." Panel on Research Ethics, ethics.gc.ca/eng/tcps2-eptc2_2018_chapter3-chapitre3.html#7b. Accessed 22 Jan. 2020.

  • Ye C, Giangregorio L, Holbrook A, Pullenayegum E, Goldsmith CH, Thabane L. Data withdrawal in randomized controlled trials: Defining the problem and proposing solutions: a commentary. Contemp Clin Trials. 2011 May;32(3):318-22. doi: 10.1016/j.cct.2011.01.016. Epub 2011 Feb 4.

    PubMed 21300179

  • Tripepi G, Jager KJ, Dekker FW, Zoccali C. Selection bias and information bias in clinical research. Nephron Clin Pract. 2010;115(2):c94-9. doi: 10.1159/000312871. Epub 2010 Apr 21.

    PubMed 20407272

  • McCambridge J, Witton J, Elbourne DR. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol. 2014 Mar;67(3):267-77. doi: 10.1016/j.jclinepi.2013.08.015. Epub 2013 Nov 22.

    PubMed 24275499

  • Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.

    PubMed 36309746

  • Eisman AB, Kilbourne AM, Dopp AR, Saldana L, Eisenberg D. Economic evaluation in implementation science: Making the business case for implementation strategies. Psychiatry Res. 2020 Jan;283:112433. doi: 10.1016/j.psychres.2019.06.008. Epub 2019 Jun 7.

    PubMed 31202612

  • Chen W, Qian L, Shi J, Franklin M. Comparing performance between log-binomial and robust Poisson regression models for estimating risk ratios under model misspecification. BMC Med Res Methodol. 2018 Jun 22;18(1):63. doi: 10.1186/s12874-018-0519-5.

    PubMed 29929477

  • Prieto-Merino D, Mulick A, Armstrong C, Hoult H, Fawcett S, Eliasson L, Clifford S. Estimating proportion of days covered (PDC) using real-world online medicine suppliers' datasets. J Pharm Policy Pract. 2021 Dec 29;14(1):113. doi: 10.1186/s40545-021-00385-w.

    PubMed 34965882

  • Jones CL, Jensen JD, Scherr CL, Brown NR, Christy K, Weaver J. The Health Belief Model as an explanatory framework in communication research: exploring parallel, serial, and moderated mediation. Health Commun. 2015;30(6):566-76. doi: 10.1080/10410236.2013.873363. Epub 2014 Jul 10.

    PubMed 25010519

Questions about this trial

What is this clinical trial studying?

A study testing Moxie SMES Letters and Facilitated Relay Letter in people with Chronic Kidney Disease and Diabetes (DM), run by University of Calgary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Readmissions (time frame: Within 12 months from randomization.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07280325, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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