Moxie Self-Management and Education Support Program

May 8, 2026 updated by: University of Calgary

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:

(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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moxie SMES Program
Participants randomized to this arm receive weekly mailers for the Moxie SMES Program and an invitation to participate in the digital health component.
Behavioral: Moxie SMES Letters
Weekly mailer for the Moxie SMES Program.
Experimental: Facilitated Relay
Participants randomized to this arm receive a one-time facilitated relay letter to share with their pharmacist and primary care provider.
Behavioral: Facilitated Relay Letter
One-time Facilitated Relay letter for the participant to share with their healthcare provider.
Experimental: Moxie SMES Program and Facilitated Relay
Participants 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.
Behavioral: Moxie SMES Letters
Weekly mailer for the Moxie SMES Program.
Behavioral: Facilitated Relay Letter
One-time Facilitated Relay letter for the participant to share with their healthcare provider.
No Intervention: Control
Participants randomized to this arm receive standard of care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Readmissions
Time Frame: Within 12 months from randomization.
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.
Within 12 months from randomization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Mortality
Time Frame: Within 12 months of randomization.
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).
Within 12 months of randomization.
Cardiovascular-Kidney-Metabolic Death
Time Frame: Within 12 months from randomization.
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).
Within 12 months from randomization.
Cardioprotective Medication Initiation
Time Frame: Within 12 months from randomization.

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
Within 12 months from randomization.
Medication Adherence
Time Frame: Within 12 months from randomization.
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.
Within 12 months from randomization.
Primary Care and Specialty Utilization
Time Frame: Within 12 months from randomization.
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.
Within 12 months from randomization.
Healthcare System Costs
Time Frame: Within 12 months from randomization.
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.
Within 12 months from randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Emergence Creative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00141473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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