Moxie Self-Management and Education Support Program

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorUniversity of Calgary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

9,000 Participants
are divided into 4 treatment groups
Group A: Moxie SMES ProgramExperimental treatment 1 intervention
Group B: Facilitated RelayExperimental treatment 1 intervention
Group C: Moxie SMES Program and Facilitated RelayExperimental treatment 2 interventions
Group D: ControlNo intervention 0 interventions

Trial outcomes

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.

Time frame
Within 12 months from randomization.

Secondary outcomes

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).

Time frame
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).

Time frame
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

Time frame
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.

Time frame
Within 12 months from randomization.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Emergence Creative

Collaborator

This trial is not recruiting at the moment. You can still explore other options: