Effects of remote patient monitoring on chronic disease management

• Register: ISRCTN
• Last refreshed on: 4 January 2022
• Main ID: ISRCTN41238563
• Date of registration: 09/08/2016
• Prospective Registration: Yes
• Primary sponsor: University Health Network
• Public title: Effects of remote patient monitoring on chronic disease management
• Scientific title: Randomized controlled trial of a mobile phone-based telemonitoring application for self-management and clinical decision support for patients with complex chronic conditions
• Date of first enrolment: 10/08/2016
• Target sample size: 146
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN41238563
• Study type: Interventional
• Study design: Multicentre randomized controlled trial (Other)
• Phase: Not Specified

Countries of recruitment

Canada

Contacts

• Name: Emily Seto

Key inclusion & exclusion 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 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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Patients will be randomized 1:1 into control and telemonitoring groups (73 in each group). The participants will be block randomized (blocks of 4) and stratified into groups according to their primary condition (HF, COPD, hypertension, and CKD). The HF group will further be stratified based on NYHA classification (NYHA class 2-3, NYHA class 4), and the hypertensive patients will be stratified to those with and those without diabetes.

To perform the randomization, the online computer generated randomization tool, Research Randomizer, will be used (www.randomizer.org). The study coordinator performing the recruitment will be blinded until the patient has consented to participate.

The telemonitoring technology will enable patients with complex chronic illnesses, including multiple chronic conditions, 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. Specifically, patients with HF will monitor daily weight and blood pressure/heart rate, CKD patients will monitor blood pressure, and HF, COPD, and CKD patients will monitor symptoms. Hypertension patients will monitor their blood pressure. Automated self-care instructions/messages that have been carefully developed with healthcare specialists 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 (i.e., in the specific specialty clinic). The clinicians will have all the relevant patient data sent to them

Primary Outcome(s)

1. Health status: The SF-36 questionnaire will be administered at baseline, 1 month and 6 months
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

Secondary Outcome(s)

All the following data (unless otherwise stated) will be collected through patient self-administered questionnaire and through the hospital EMR and a manual chart review of all participants’ clinical records. Timepoints for data collection are in parentheses.

All participants:
1. Combined hospitalization: Number of hospitalizations, days in hospital, number of ED and clinic visits, and medications will be determined through the hospital EMR and a manual chart review of all participants’ clinical records (baseline, 1 month, 6 months)
2. General quality of life: EQ-5D questionnaire (baseline, 6 months)
3. Mortality: assessed at 6 months

Condition-specific outcomes:

Heart failure:
1. Left ventricular ejection fraction (baseline, 6 months)
2. Brain natriuretic peptide (baseline, 6 months)
3. Self-care: Self-Care of Heart Failure Index (baseline, 1 month, 6 months)
4. Heart-failure specific quality of life as measured: Minnesota Living with Heart Failure Questionnaire (baseline, 1 month, 6 months)
5. Dyspnea: visual analogue scale (baseline, 6 months)
6. Blood work: creatinine, sodium, potassium, hemoglobin, urate (baseline, 6 months)
7. Prognosis: Seattle Health Failure Model (baseline, 6 months)

COPD:
1. Forced expiratory volume in one second (baseline, 6 months)
2. COPD-specific quality of life: COPD Assessment Test score (baseline, 6 months)
3. COPD-specific knowledge: Bristol COPD Knowledge Questionnaire (baseline, 6 months)
4. Self-efficacy at 6 months as measured by the COPD Self-Efficacy Scale (baseline, 6 months)
5. COPD severity: BODE Index (baseline, 6 months)

Chronic kidney disease
1. Estimated glomerular filtration rate (baseline, 6 months)
2. Blood pressure: automatic blood pressure monitor (baseline, 6 months)

Hypertension
1. Blood pressure: automatic blood pressure monitor (baseline, 6 months)

Diabetes
1. HgbA1c (baseline, 6 months)

Secondary ID(s)

15-9995-BE

Source(s) of Monetary Support

Canadian Institutes of Health Research

Ethics review

Status:
Approval date:
Contact:

University Health Network, 21/03/2016, ref: 15-9995-BE

Results

• Results available: Yes
• Date Completed: 01/11/2020