Clinical trial NCT03127852: Effects of Remote Patient Monitoring on Chronic Disease Management
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease
Chronic Kidney Disease
Uncontrolled Hypertension
Diabetes
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life as Measured by SF-36
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Self-reported Health Service Use
timeFrame: Baseline, 6 months
measure: Self-Care of Health Failure as Measured by the SCHFI
timeFrame: Baseline, 6 months
measure: Heart-failure Specific Quality of Life (MLHFQ)
timeFrame: Baseline, 6 months
measure: Anxiety and Depression as Measured by HADS
timeFrame: Baseline, 6 months
measure: Self-efficacy as Measured by the SEMCD6.
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
citation: 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.
citation: 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.