N/A N=96 Randomized Health Services Research

Effects of Remote Patient Monitoring on Chronic Disease Management

Heart Failure · Chronic Obstructive Pulmonary Disease · Chronic Kidney Disease · Uncontrolled Hypertension · Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT03127852 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Quality of Life as Measured by SF-36 — 42.77; 42.39; 43.77; 48.31 score on a scale — p=.48

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Medly (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Health Network, Toronto
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Quality of Life as Measured by SF-36	42.77; 42.39; 43.77; 48.31	.48
SECONDARY Self-reported Health Service Use	1.43; 0.35; 0.5; 0.22; 3.71; 2.95	.02 sig
SECONDARY Self-Care of Health Failure as Measured by the SCHFI	79.83; 76.18; 75.42; 69.53; 71.83; 76.38	.74
SECONDARY Heart-failure Specific Quality of Life (MLHFQ)	35.88; 31.55; 14.58; 19.05; 9; 9.33	.67
SECONDARY Anxiety and Depression as Measured by HADS	7.33; 5.97; 5.51; 5.55	.06
SECONDARY Self-efficacy as Measured by the SEMCD6.	7.35; 6.75	.13

Summary

Remote patient monitoring is a potential component for the management of chronic conditions that may provide reliable and real-time physiological measurements for clinical decision support, alerting, and patient self-management. The purpose of this study is to evaluate an UHN-built remote monitoring system for patients with complex chronic conditions called Medly.

Eligibility Criteria

Inclusion Criteria

All participants:

Adults (age 18 years or older)
Diagnosed with HF, COPD, CKD, and/or uncontrolled hypertension (individuals with diabetes who require blood glucose monitoring will be included as a co-morbidity only if patient's have at least one of the above four chronic illnesses, and will be in the form of self-care support only)
Patient or their caregiver speaks and reads English adequately to provide informed consent and understand the text prompts in the application.
Ability to comply with using the telemonitoring system (e.g, able to stand on the weight scale, able to answer symptom questions, etc.).

Primary chronic disease-specific criteria:

Patients with HF as the primary chronic disease: with reduced ejection fraction (EF =140/90 mmHg auscultatory (manual measurement) or >=135/85 mmHg oscillometric (automated measurement). For diabetics: blood pressure >=130/80 mmHg

Exclusion Criteria

Patients on mechanical circulatory support
Patients on the heart transplant list
Terminal diagnosis with life expectancy < 1 year
Dementia or uncontrolled psychiatric illness
Resident of a long term care facility

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03127852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.