Effects of Remote Patient Monitoring on Chronic Disease Management

Overview

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.

Full Title of Study: “Randomized Controlled Trial of a Mobile Phone-based Telemonitoring Application for Self-management and Clinical Decision Support for Patients With Complex Chronic Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 23, 2018

Detailed Description

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. Patients with complex chronic conditions will be provided with a mobile phone and commercial home medical devices, such as a blood pressure monitor and weight scale. The measurements from the medical devices will be automatically sent to the mobile phone, and from there to a data server at the hospital for analysis and storage. Both clinicians and patients will be able to access these data and will be sent alerts by the system if the measurements are outside of the normal range. The system will be evaluated through interviews and comparing outcomes between the intervention and control groups.

Interventions

  • Device: Medly

Arms, Groups and Cohorts

  • Experimental: Telemonitoring (Medly)
    • The telemonitoring technology will enable patients with complex chronic illnesses, to take clinically relevant physiological measurements with wireless home medical devices and to answer symptom questions on the mobile phone. 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.
  • No Intervention: Control
    • Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Quality of life as measures by SF-36
    • Time Frame: Baseline, 1 month, 6 months
    • Change in Quality of life as measures by SF-36
  • Change Cost of healthcare
    • Time Frame: Baseline, 1 month, 6 months
    • The cost of the intervention will be tracked, including for equipment costs and human resources for clinical support, technical support, and program management. Standard cost values for a day in-hospital, ED visit, etc. will be used to estimate net cost savings or expenditures.

Secondary Measures

  • Change in combined hospitalizations
    • Time Frame: Baseline, 1month, 6 months
    • Number of hospitalizations, days in hospital, number of ED and clinic visits, and medications will be determined through the hospital EMR and a manual chart review of all participants’ clinical records.
  • Change in left ventricular ejection fraction
    • Time Frame: Baseline, 6 months
    • Left ventricular ejection fraction as measures by echocardiogram
  • Change in brain natriuretic peptide
    • Time Frame: Baseline, 6 months
    • Change in brain natriuretic peptide blood levels measured in pg/mL
  • Change in self-care of health failure
    • Time Frame: Baseline, 1 month, 6 months
    • Change in self-care of health failure as measured by the Self-Care of Heart Failure Index
  • Change in Heart-failure specific quality of life
    • Time Frame: Baseline, 1 month, 6 months
    • Change in Heart-failure specific quality of life as measured by the Minnesota Living with Heart Failure Questionnaire
  • Change in dyspnea
    • Time Frame: Baseline, 1 month, 6 months
    • Change in dyspnea as measured using a visual analogue scale
  • Change in heart failure blood work
    • Time Frame: Baseline, 6 months
    • Change in blood concentration of the following: creatinine (u/mol/L), sodium (mmol/L), potassium(mmol/L), hemoglobin, urate(umol/L)
  • Change in heart failure prognosis
    • Time Frame: Baseline, 6 months
    • Change in heart failure prognosis as determined by the Seattle Health Failure Model
  • Change in forced expiratory volume in one second
    • Time Frame: Baseline, 6 months
    • Change in forced expiratory volume in one second
  • Change in COPD-specific quality of life
    • Time Frame: Baseline, 6 months
    • Change in COPD-specific quality of life as measured by the COPD Assessment Test
  • Change in COPD-specific knowledge
    • Time Frame: Baseline, 6 months
    • Change in COPD-specific knowledge as measured by the Bristol COPD Knowledge Questionnaire
  • Change in COPD self-efficacy
    • Time Frame: Baseline, 6 months
    • Change in COPD self-efficacy as measured by the COPD Self-Efficacy Scale
  • Change in COPD severity
    • Time Frame: Baseline, 6 months
    • Change in COPD severity as measured by the BODE Index
  • Change estimated glomerular filtration rate
    • Time Frame: Baseline, 6 months
    • Change estimated glomerular filtration rate
  • Change blood pressure
    • Time Frame: Baseline, 6 months
    • Change blood pressure
  • Change in HgbA1c
    • Time Frame: Baseline, 6 months
    • Change in HgbA1c

Participating in This Clinical Trial

Inclusion Criteria

All participants:

1. Adults (age 18 years or older)

2. 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)

3. Patient or their caregiver speaks and reads English adequately to provide informed consent and understand the text prompts in the application.

4. 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<0.40)
  • Patients with COPD as the primary chronic disease: Spirometrically confirmed diagnosis of COPD of GOLD Stage II or higher (defined as post-bronchodilator FEV1 < 80% predicted and FEV1/FVC ratio < 70%); smoking history of ≥ 20 pack-years or homozygous alpha-1 antitrypsin deficiency; and prescribed an action plan for the early self-treatment of acute exacerbations
  • Patients with CKD as the primary chronic disease: Grade 3-5 (eGFR < 60mL/1.73 m2)
  • Patients with uncontrolled hypertension as the primary chronic disease: For non-diabetics: blood pressure >=140/90 mmHg auscultatory (manual measurement) or >=135/85 mmHg oscillometric (automated measurement). For diabetics: blood pressure >=130/80 mmHg

Exclusion Criteria

1. Patients on mechanical circulatory support

2. Patients on the heart transplant list

3. Terminal diagnosis with life expectancy < 1 year

4. Dementia or uncontrolled psychiatric illness

5. Resident of a long term care facility

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Emily Seto, PhD, 416-669-9295, emily.seto@utoronto.ca

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