Effects of remote patient monitoring on chronic disease management

Not Applicable

Completed

• Conditions: Heart failure (HF), chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), uncontrolled hypertension, diabetes; Circulatory System

• Registration Number: ISRCTN41238563
• Lead Sponsor: niversity Health Network

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29162557 protocol 2021 Preprint results in https://doi.org/10.2196/31754 results in preprint (added 20/12/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-09
• Study Completion: 2020-11-01
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

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 patients 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:
1. Patients with HF as the primary chronic disease: with reduced ejection fraction (EF<0.40)
2. 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
3. Patients with CKD as the primary chronic disease: Grade 3-5 (eGFR < 60mL/1.73 m2)
4. 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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Health status: The SF-36 questionnaire will be administered at baseline, 1 month and 6 months<br> 2. Cost of healthcare assessed at 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<br>