Effects of Remote Patient Monitoring on Chronic Disease Management

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127852
• Other study ID #: 15-9995
• Status: Completed
• Phase: N/A
• Start date: August 23, 2016
• Est. completion date: December 15, 2020

Study information

• Verified date: March 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 15, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Obstructive Pulmonary Disease
• Diabetes
• Heart Failure
• Kidney Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Renal Insufficiency, Chronic
• Uncontrolled Hypertension

Intervention

Device:
• Medly

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Self-reported Health Service Use	Number of hospitalizations, number of ED and clinic visits, and family physician visits.	Baseline, 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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