Effects of Remote Patient Monitoring on Chronic Disease Management

Randomized Controlled Trial of a Mobile Phone-based Telemonitoring Application for Self-management and Clinical Decision Support for Patients With Complex Chronic Conditions

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Diabetes; Chronic Obstructive Pulmonary Disease; Chronic Kidney Disease; Uncontrolled Hypertension
• Intervention / Treatment: Device: Medly

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Medly
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life as Measured by SF-36	Change in Quality of life as measured by the Short Form (36) Health Survey. The SF-36 assesses participants' overall quality of life in eight domains 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 contribute to the physical component summary (PCS) score, and items 5-8 contribute to the mental component summary (MCS) score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement.	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Health Service Use	Number of hospitalizations, number of ED and clinic visits, and family physician visits.	Baseline, 6 months
Self-Care of Health Failure as Measured by the SCHFI	Self-care of health failure as measured by the Self-Care of Heart Failure Index (SCHFI). The SCFHI has three scales: maintenance, management, confidence with each scale score is standardized to a 0 to 100 range with 0 indicating the worst and 100 indicating the best performance for each scale score.	Baseline, 6 months
Heart-failure Specific Quality of Life (MLHFQ)	Heart-failure specific quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The MLHFQ provides a total score (score range 0-105), as well as scores for two dimensions, physical (score range 0-40) and emotional (score range 0-25). A lower total score is indicative of better quality of life.	Baseline, 6 months
Anxiety and Depression as Measured by HADS	Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS). The HADS has two sub-scales for anxiety and depression. Each sub-scale has scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety/depression.	Baseline, 6 months
Self-efficacy as Measured by the SEMCD6.	Self-efficacy as measured by the Self-Efficacy for Managing Chronic Disease 6-Item scale (SEMCD6). Each item on the scale is rated from 1 (not at all confident) to 10 (totally confident). The final score for the scale is the mean of the six items with higher scores indicating higher self-efficacy.	Baseline, 6 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Publications and helpful links

General Publications

• Ware P, Shah A, Ross HJ, Logan AG, Segal P, Cafazzo JA, Szacun-Shimizu K, Resnick M, Vattaparambil T, Seto E. Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study. J Med Internet Res. 2022 Jan 26;24(1):e31754. doi: 10.2196/31754.
• Seto E, Ware P, Logan AG, Cafazzo JA, Chapman KR, Segal P, Ross HJ. Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2017 Nov 21;6(11):e229. doi: 10.2196/resprot.8367.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2016
• Primary Completion (Actual): June 20, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 15-9995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO