Heart failure (HF), chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), uncontrolled hypertension, diabetes Circulatory System
Conditions
Interventions
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
Sponsors
University Health Network
Eligibility
Sex/Gender
All
Inclusion 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=140/90 mmHg auscultatory (manual measurement) or >=135/85 mmHg oscillometric (automated measurement). For diabetics: blood pressure >=130/80 mmHg
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 (ba | — |
Countries
Canada
Outcome results
None listed