Active — Not RecruitingNot Applicable

Evaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study

Canada350 participantsStarted 2022-10-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 years of age or older
. 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).
. 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.
. 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.)
. Able to read, write and speak English or have a caregiver who is able to do so on their behalf.
. Patients must have been discharged from hospital within 2 weeks during their recruitment into the study (or will be recruited prior to their discharge).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focuses on people managing multiple serious conditions at once — like heart failure, depression, diabetes, COPD, and hypertension — so is my specific combination of conditions a good fit for what this study is actually designed to address?
2The trial uses nurse-led care with telemonitoring, which likely means regular remote check-ins and home monitoring devices — can you walk me through what that day-to-day commitment would actually look like, and whether it would realistically fit my lifestyle?
3Since the study is no longer actively recruiting, does that mean there's no longer an option to join, or are there any circumstances where late enrollment might still be considered?
4The primary outcome being tracked is death and unplanned hospital readmissions — based on my current health history, do you think a structured nurse-led approach like this could genuinely change those risks for me compared to my current care plan?
5Are there standard-of-care programs already available to me — like existing chronic disease management or telemonitoring services — that might offer similar benefits to what this trial is testing, without the requirements of being part of a research study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Death and/or all-cause unplanned readmission

Timeframe: 30 days

Trial details

NCT IDNCT05543720

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Heart Failure，Congestive trials