Effects of Remote Patient Monitoring on Chronic Disease Management

NCT03127852 | Completed Results

• 1 other identifier: 15-9995
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Self-reported Health Service Use

  Baseline, 6 months

• Self-Care of Health Failure as Measured by the SCHFI

  Baseline, 6 months

• Heart-failure Specific Quality of Life (MLHFQ)

  Baseline, 6 months

• Anxiety and Depression as Measured by HADS

  Baseline, 6 months

• Self-efficacy as Measured by the SEMCD6.

  Baseline, 6 months

Study Arms (2)

Telemonitoring (Medly)

EXPERIMENTAL

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

Control

NO INTERVENTION

Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.

Interventions

Medly DEVICE

Telemonitoring (Medly)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\<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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, Canada

Location

Related Publications (2)

• 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.

  PMID: 35080502 DERIVED

• 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.

  PMID: 29162557 DERIVED

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Renal Insufficiency, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Early termination of recruitment before reaching the target sample size because (1) the HF telemonitoring program became standard of care; (2) recruitment challenges observed for patients with DM because of the rapid emergence and growing use of continuous and flash glucose monitors; and (3) the COVID-19 pandemic led to a pause of nonessential research activities and a significant shift toward virtual care, which fundamentally altered the control group after the research pause was lifted.

Results Point of Contact

• Title: Dr. Patrick Ware
• Organization: Centre for Global eHealth Innovation

Patrick.Ware@uhn.ca

1 (416) 340 4800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: April 25, 2017
• Study Start: August 23, 2016
• Primary Completion: June 20, 2020
• Study Completion: December 15, 2020
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)