跳至主要内容
临床试验/NCT07280325
NCT07280325尚未招募不适用

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

University of Calgary0 个研究点目标入组 9,000 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
9,000
主要终点
Hospital Readmissions

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Moxie SMES Letters (Behavioral)

Facilitated Relay

Experimental

Participants randomized to this arm receive a one-time facilitated relay letter to share with their pharmacist and primary care provider.

干预措施: Facilitated Relay Letter (Behavioral)

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.

干预措施: Moxie SMES Letters (Behavioral)

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.

干预措施: Facilitated Relay Letter (Behavioral)

Control

No Intervention

Participants randomized to this arm receive standard of care only.

结局指标

主要结局

Hospital Readmissions

时间窗: 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.

次要结局

  • 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.)
  • Healthcare System Costs(Within 12 months from randomization.)

研究者

申办方类型
Other
责任方
Sponsor

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