Moxie Self-Management and Education Support Program

Sponsor
University of Calgary
Study ID
NCT07280325
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Moxie SMES Letters — BEHAVIORAL
    Weekly mailer for the Moxie SMES Program.
  • Facilitated Relay Letter — BEHAVIORAL
    One-time Facilitated Relay letter for the participant to share with their healthcare provider.

Study Details

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.

Key Dates

First listed
Dec 12, 2025
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
May 1, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
9,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • 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.
  • Experimental: Facilitated Relay
    Participants randomized to this arm receive a one-time facilitated relay letter to share with their pharmacist and primary care 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.
  • No Intervention: Control
    Participants randomized to this arm receive standard of care only.

Primary Outcome Measure

Hospital Readmissions [ Time Frame: Within 12 months from randomization. ]

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