Nurse-Led Telemonitoring for Chronic Conditions

Recruiting at 4 trial locations

Overseen By Denise Ng, MHI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Long-term care admission

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new approach for assisting individuals with complex chronic conditions such as heart failure, diabetes, or depression. It focuses on telemonitoring, using a smartphone app to track symptoms and send alerts to healthcare providers when necessary. This method could enhance care coordination and ensure patients receive needed assistance between doctor's visits. Individuals who have been hospitalized and have one of these chronic conditions might be suitable candidates, particularly if they can use a smartphone app to monitor their health. As an unphased trial, this study offers participants the chance to contribute to innovative healthcare solutions and improve their own care management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the trial focuses on telemonitoring for chronic conditions.

What prior data suggests that telemonitoring is safe for managing chronic conditions?

Research has shown that telemonitoring is generally safe for managing long-term health conditions. Studies have found that telemonitoring can lower the risk of death and hospital visits for patients with heart failure. By monitoring symptoms and notifying healthcare providers when necessary, it allows for quick action.

A review of multiple studies found that patients using telemonitoring devices often experience better outcomes, such as lower death rates, compared to those who do not use them. This suggests the technology is not only effective but also well-accepted by patients.

While every treatment has potential risks, current evidence indicates that telemonitoring is a safe option for managing chronic diseases like heart failure, diabetes, and COPD (chronic obstructive pulmonary disease). Those considering joining a trial involving telemonitoring can feel confident about its safety based on past research findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about telemonitoring for chronic conditions because it offers a new way to manage multiple health issues like heart failure, diabetes, depression, hypertension, and COPD using a smartphone app. Unlike traditional treatments that rely on regular in-person visits to track symptoms and adjust care, this approach allows patients to monitor and report their symptoms daily from home. The app, Medly MCC, sends this data wirelessly to healthcare providers, who can respond promptly if needed, and provides patients with personalized self-care messages. This could lead to faster, more personalized care and better health outcomes by catching potential problems early.

What evidence suggests that telemonitoring is effective for managing chronic conditions?

This trial will compare a nurse-led telemonitoring system, specifically the Medly MCC, with standard care. Research has shown that telemonitoring systems like the Medly MCC can help manage long-term health issues. Studies have found that using telemonitoring can lower the chances of death and hospital visits for people with heart failure. It also helps track conditions like diabetes, high blood pressure, and COPD, allowing for quick medical responses. Specifically, people with chronic heart failure who use this technology have shown lower death rates. This system enables healthcare providers to monitor symptoms daily and alerts them when medical help might be needed, improving overall patient care. ^{2 3 6 7 8}

Who Is on the Research Team?

Emily Seto, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

The SMaRT Study is for adults over 18 who have recently been discharged from certain hospitals in Canada and have at least one chronic condition like heart failure, COPD, high blood pressure, diabetes, or depression. Participants need to be able to use the telemonitoring app and devices (like a weight scale) and speak English or have someone who can communicate for them.

Inclusion Criteria

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)

I have a chronic condition like heart failure or diabetes that could improve with 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.)

Exclusion Criteria

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

Timeline for a Trial Participant

Design and Development

Design and development of the SMaRT Clinic model and telemonitoring system

2 years

Implementation and Effectiveness Evaluation

Implementation of the SMaRT Clinics and evaluation of their effectiveness through various research activities

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Telemonitoring

Trial Overview This study tests the SMaRT Clinic model which uses nurse-led care coordinated through telemonitoring to manage patients with multiple chronic conditions after they leave the hospital. It aims to improve self-care education and clinical coordination across patient care teams.

How Is the Trial Designed?

Group I: Telemonitoring (Medly MCC) Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Markham Stouffville Hospital

Collaborator

Trials

4

Recruited

2,500+

Health Sciences North

Collaborator

Trials

6

Recruited

1,100+

William Osler Health System

Collaborator

Trials

11

Recruited

36,100+

Women's College Hospital

Collaborator

Trials

108

Recruited

43,700+

Published Research Related to This Trial

In a randomized clinical trial involving 316 elderly heart failure patients, supplementing nurse case management with Internet-connected telemonitoring did not significantly reduce hospitalizations, emergency department visits, or mortality compared to case management alone.

Despite the lack of difference in the primary outcomes, participants in the telemonitoring group had 42% fewer inpatient days during the intervention compared to the previous year, highlighting the potential benefits of case management in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring with case management for seniors with heart failure. Wade, MJ., Desai, AS., Spettell, CM., et al.[2022]

Telemonitoring allows older patients to record and send vital signs like blood pressure and pulse to nurses remotely, helping to identify health issues early and potentially prevent hospital admissions.

This method of care is generally well-received by patients and has shown promise in improving clinical outcomes, but nurses need to be trained to effectively use telemonitoring to maximize its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of telemonitoring in caring for older people with long-term conditions. Barrett, D.[2016]

Nurse-led telephone counseling significantly improved health behaviors and self-care for hypertension in low-income older adults, with a medium effect size (Cohen's d = 1.16) after 8 weeks.

The intervention also led to a reduction in systolic blood pressure (Cohen's d = -0.61), suggesting that personalized support can enhance health outcomes in disadvantaged populations using telemonitoring systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone Support and Telemonitoring for Low-Income Older Adults. Jeong, S., Choi, H., Gwon, SH., et al.[2018]

Health care practitioners view remote patient monitoring (RPM) as a feasible and beneficial tool for continuous patient care, enhancing self-care, communication, and education, based on insights from 2351 practitioners across 13 studies.

Despite its advantages, practitioners also highlighted challenges such as increased workload, patient anxiety, data accuracy issues, and privacy concerns, indicating that while RPM is promising, careful consideration of these drawbacks is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits and Challenges of Remote Patient Monitoring as Perceived by Health Care Practitioners: A Systematic Review. Serrano, LP., Maita, KC., Avila, FR., et al.[2023]

Patients using home telehealth self-monitoring with remote care nurse support reported high satisfaction, noting improved health awareness and motivation to change health behaviors.

The study identified barriers such as equipment malfunctions and connectivity issues, but overall, the telehealth model was effective in empowering patients and enhancing their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home telehealth: facilitators, barriers, and impact of nurse support among high-risk dialysis patients. Minatodani, DE., Chao, PJ., Berman, SJ.[2019]

Telemonitoring, which involves remotely tracking patients' vital signs, has the potential to significantly reduce hospital admissions for heart failure patients and alleviate pressure on healthcare systems like the NHS.

This innovative approach not only aims to enhance patients' quality of life and clinical outcomes but also highlights the crucial role of nurses in managing alerts and responding to patient needs in telemonitoring systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of telemonitoring in the care of patients with heart failure. Atkin, P., Barrett, D.[2016]

A study involving 43 patients and 9 telehomecare nurses found that there was little correlation between patients' perceptions of nurses' communication and their actual integration of health information into daily self-care practices.

However, nurses perceived a strong relationship between their communication with patients and the patients' integration of health information, suggesting that nurses may overestimate patients' understanding and use of telemonitored data, highlighting the need for clearer education and communication strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehomecare communication and self-care in chronic conditions: moving toward a shared understanding. Shea, K., Chamoff, B.[2022]

Telemonitoring for chronic disease management, such as for Type 2 diabetes and cardiovascular disease, is generally viewed positively by patients, who appreciate the convenience and reassurance it provides compared to traditional clinic visits.

Barriers to effective telemonitoring include generational differences and challenges with technology, highlighting the need for further research to improve technology usability and maintain long-term patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of telemonitoring in patient self-management of chronic disease: a qualitative meta-synthesis. Creber, A., Leo, DG., Buckley, BJR., et al.[2023]

The study analyzed 2,336 nursing actions taken in a telemonitoring program for 68 and 65 patients with diabetes and hypertension, highlighting the importance of remote support in managing chronic illnesses.

Common issues addressed included lifestyle changes and communication with primary care providers, indicating that telemonitoring can effectively facilitate patient education and care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing interventions in a telemonitoring program. Wakefield, BJ., Scherubel, M., Ray, A., et al.[2021]

A nurse-led telemonitoring program for asthma patients, involving 55 participants over 12 months, demonstrated feasibility and reliability, with high patient satisfaction and a low dropout rate.

Despite some technical issues, most patients (at least 75%) provided valid peak expiratory flow (PEF) tests, indicating good compliance, although the average number of tests recorded was slightly below the required amount.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process evaluation of a nurse-led telemonitoring programme for patients with asthma. Willems, DC., Joore, MA., Hendriks, JJ., et al.[2007]

A home monitoring and care coordination program for veterans with diabetes significantly reduced all-cause mortality over four years, with 19% deaths in the intervention group compared to 26% in the control group.

The intervention group experienced longer survival times (mean of 1348 days) and a hazard ratio of 0.7 indicates a 30% reduction in the risk of death, suggesting that daily telemonitoring by care coordinators is effective in managing diabetes and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality risk for diabetes patients in a care coordination, home-telehealth programme. Chumbler, NR., Chuang, HC., Wu, SS., et al.[2009]

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