Moxie Self-Management and Education Support Program

NCT07280325 | Not Yet Recruiting

• 1 other identifier: Pro00141473
• Study Type: interventional
• Target: 9,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Kidney Disease; Heart Disease; Stroke; Chronic Disease; Diabetes (DM)

Keywords

Chronic Disease Self-Management; Pragmatic Trial; Chronic Disease Education

Outcome Measures

Primary Outcomes (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.

  Within 12 months from randomization.

Secondary Outcomes (6)

• Overall Mortality

  Within 12 months of randomization.

• Cardiovascular-Kidney-Metabolic Death

  Within 12 months from randomization.

• Cardioprotective Medication Initiation

  Within 12 months from randomization.

• Medication Adherence

  Within 12 months from randomization.

• Primary Care and Specialty Utilization

  Within 12 months from randomization.

Study Arms (4)

Moxie SMES Program

EXPERIMENTAL

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

Facilitated Relay

EXPERIMENTAL

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

Moxie SMES Program and Facilitated Relay

EXPERIMENTAL

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; Behavioral: Facilitated Relay Letter

Control

NO INTERVENTION

Participants randomized to this arm receive standard of care only.

Interventions

Moxie SMES Letters BEHAVIORAL

Weekly mailer for the Moxie SMES Program.

Moxie SMES Program; Moxie SMES Program and Facilitated Relay

Facilitated Relay Letter BEHAVIORAL

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

Facilitated Relay; Moxie SMES Program and Facilitated Relay

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Emergence Creative: collaborator

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MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus; Heart Diseases; Stroke; Chronic Disease

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share