This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting

Integrated Care

Sponsor:

University Health Network, Toronto

Code:

NCT05543720

Conditions

Heart Failureļ¼ŒCongestive

Mental Health (Depression)

Diabetes Mellitus

Chronic Obstructive Pulmonary Disease

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medly

Study Details

Brief summary:

In Canada, 3 out of 4 Canadians aged 65 and older have at least one chronic condition, while 1 in 4 seniors reported having three or more. Caring for complex patients who usually have multiple chronic conditions (MCC) is one of the biggest challenges facing our healthcare system. For patients, the lack of coordination and continuity of care as they transfer between healthcare settings and healthcare providers (HCPs) often results in a higher risk of readmission, suboptimal and fragmented care plans, delays in required medical intervention, inadequate self-care, and confusion on whom they should contact when they have questions. For the patient's care team, they often have no indication how patients are doing between clinic visits unless the patient can provide a log of their home measurements (e.g., blood pressure). Therefore, they are unable to detect and intervene if their patient's health is worsening between visits.

In order to address this increasing need to bridge the current gap in clinical management and self-care of complex patients during their transition from healthcare settings to home care, our team aims to design, implement and evaluate the SMaRT (Safe, Managed, and Responsive Transitions) Clinic, a nurse-led integrated care model facilitated by telemonitoring (TM). Specifically, the SMaRT Clinics aim to meaningfully introduce a nurse (or nurse practitioner) role to improve clinical coordination across patient care teams and reinforce proper self-care education through the use of telemonitoring. This project will be conducted in two phases across four years; Phase I: Design and Development, and Phase II: Implementation and Effectiveness Evaluation. Phase II research activities include enrolling 350 patients with complex chronic conditions in the SMaRT clinics across four study sites. The implementation and effectiveness of the SMaRT clinics will be evaluated through a mix of semi-structured interviews, ethnographic observation, patient questionnaires, and analyses of health utilization outcomes using propensity-matched controls from the ICES provincial database.

Conditions

Heart Failureļ¼ŒCongestive

Mental Health (Depression)

Diabetes Mellitus

Chronic Obstructive Pulmonary Disease

Hypertension

Study ID

NCT05543720

Start date

Oct 17, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years of age or older
2. Discharged from hospital or seen within 48 hours of discharge at Health Sciences North (HSN), William Osler Health Systems (WOHS), Women's College Hospital (WCH), and Markham Stouffville Hospital (MSH).
3. Have at least one complex chronic condition (i.e., heart failure, complex obstructive pulmonary disease (COPD), hypertension, diabetes, and/or depression) that would benefit if monitored through telemonitoring.
4. Able to comply with use of the telemonitoring application and applicable peripheral devices (e.g., able to stand on the weight scale, able to answer symptom questions, etc.)
5. Able to read, write and speak English or have a caregiver who is able to do so on their behalf.
6. Patients must have been discharged from hospital within 2 weeks during their recruitment into the study (or will be recruited prior to their discharge).

Exclusion Criteria:

1\. Patients who are discharged from hospital with the intent to be admitted to a long-term care facility will be excluded.

Study Design

Enrollment

350 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Control

Control groups will be compared to 350 patients who received standard of care via propensity-matched controls from the ICES provincial database.

experimental: Telemonitoring (Medly MCC)

Medly is a smartphone application allows patients with heart failure, diabetes, depression, hypertension, and/or COPD to measure and record their daily self-reported symptoms. This monitoring information is then transmitted wirelessly to a data server where an algorithm is used to generate an alert to a healthcare provider as necessary. The patient also receives an automated self-care message based on their measurements and reported symptoms.

Interventions

Medly

Medly will enable patients with HF, COPD, Hypertension, Mental Health, or Diabetes to input measurements with wireless home medical devices and to answer symptom questions on the smartphone. The measurements will be automatically and wirelessly transmitted to the mobile phone and then to a data server. Automated self-care instructions/messages will be sent to the patient based on the readings and reported symptoms. If there are signs of their status deteriorating, an alert will be sent to a clinician that is responsible for the particular chronic condition of concern. The clinicians will have all the relevant patient data sent to them and will be able to access (through a secure web portal) to view historical and trending data for their patients.

Primary outcome measure

  • Death and/or all-cause unplanned readmission [ Time Frame: 30 days ]

Central Contacts and Locations

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 1, 2026

Last verified

Apr, 2026

Keywords

  • Telemonitoring
  • Smartphone application
  • Chronic disease management
  • Remote monitoring
  • Multiple chronic conditions
  • mHealth
  • Nurse-led
  • Holistic care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.