Chronic Kidney Disease, Chronic Obstructive Pulmonary Disease, Diabetes, Heart Failure, Uncontrolled Hypertension
Conditions
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.
Interventions
DEVICEMedly
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Measured by SF-36 | Baseline, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Health Service Use | Baseline, 6 months | Number of hospitalizations, number of ED and clinic visits, and family physician visits. |
| Self-Care of Health Failure as Measured by the SCHFI | Baseline, 6 months | 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. |
| Heart-failure Specific Quality of Life (MLHFQ) | Baseline, 6 months | 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. |
| Anxiety and Depression as Measured by HADS | Baseline, 6 months | 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. |
| Self-efficacy as Measured by the SEMCD6. | Baseline, 6 months | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telemonitoring (Medly) The telemonitoring technology will enable patients with complex chronic illnesses, 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. Automated self-care instructions/messages 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. The clinicians will have all the relevant patient data sent to them and will be able to access (through a secure web portal) to view historical and trending data for their patients.
Medly | 46 |
| Control Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months. | 50 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Telemonitoring (Medly) | Control | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 12.6 | 55 years STANDARD_DEVIATION 14.3 | 59 years STANDARD_DEVIATION 13.9 |
| Clinic visits | 3.54 Visits STANDARD_DEVIATION 4.11 | 4.19 Visits STANDARD_DEVIATION 6.01 | 3.87 Visits STANDARD_DEVIATION 5.12 |
| Comfort with Smartphone Comfortable | 8 Participants | 28 Participants | 36 Participants |
| Comfort with Smartphone Not comfortable | 1 Participants | 0 Participants | 1 Participants |
| Comfort with Smartphone Somewhat comfortable | 8 Participants | 4 Participants | 12 Participants |
| Comfort with Smartphone Very comfortable | 13 Participants | 15 Participants | 28 Participants |
| ED visits | 1.29 Visits STANDARD_DEVIATION 4.65 | 0.071 Visits STANDARD_DEVIATION 1.34 | 0.74 Visits STANDARD_DEVIATION 3.58 |
| Family physician visits | 1.65 Visits STANDARD_DEVIATION 1.22 | 2.48 Visits STANDARD_DEVIATION 3.72 | 2.05 Visits STANDARD_DEVIATION 2.72 |
| HADS (Anxiety) | 6.94 units on a scale STANDARD_DEVIATION 4.38 | 6 units on a scale STANDARD_DEVIATION 4 | 6.49 units on a scale STANDARD_DEVIATION 4.18 |
| HADS (Depression) | 5.09 units on a scale STANDARD_DEVIATION 3.95 | 5.21 units on a scale STANDARD_DEVIATION 3.85 | 5.15 units on a scale STANDARD_DEVIATION 3.86 |
| Highest Education Achieved College or university | 15 Participants | 19 Participants | 34 Participants |
| Highest Education Achieved High school | 5 Participants | 4 Participants | 9 Participants |
| Highest Education Achieved Less than high school | 4 Participants | 1 Participants | 5 Participants |
| Highest Education Achieved Postgraduate | 5 Participants | 5 Participants | 10 Participants |
| Highest Education Achieved Trade or technical training | 5 Participants | 6 Participants | 11 Participants |
| Hospital visits | 4.29 Visits STANDARD_DEVIATION 10.56 | 3.7 Visits STANDARD_DEVIATION 6.51 | 4.02 Visits STANDARD_DEVIATION 8.89 |
| MLHFQ (Emotional) | 10.38 units on a scale STANDARD_DEVIATION 7.97 | 11.38 units on a scale STANDARD_DEVIATION 7.08 | 10.79 units on a scale STANDARD_DEVIATION 7.54 |
| MLHFQ (Physical) | 19.13 units on a scale STANDARD_DEVIATION 11.01 | 20.78 units on a scale STANDARD_DEVIATION 10.64 | 19.83 units on a scale STANDARD_DEVIATION 10.75 |
| MLHFQ (Total) | 40.85 units on a scale STANDARD_DEVIATION 28.52 | 42.81 units on a scale STANDARD_DEVIATION 26.15 | 41.68 units on a scale STANDARD_DEVIATION 27.21 |
| Race/Ethnicity, Customized Asian | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 24 Participants | 46 Participants |
| Region of Enrollment Canada | 46 participants | 50 participants | 96 participants |
| SCHFI (Confidence) | 69.43 units on a scale STANDARD_DEVIATION 15.49 | 69.94 units on a scale STANDARD_DEVIATION 25.09 | 69.63 units on a scale STANDARD_DEVIATION 19.59 |
| SCHFI (Maintenance) | 73.42 units on a scale STANDARD_DEVIATION 14.77 | 73.64 units on a scale STANDARD_DEVIATION 15.75 | 73.51 units on a scale STANDARD_DEVIATION 14.99 |
| SCHFI (Management) | 71.75 units on a scale STANDARD_DEVIATION 15.64 | 64.47 units on a scale STANDARD_DEVIATION 27.51 | 68.73 units on a scale STANDARD_DEVIATION 21.37 |
| SEMCD6 | 7.23 units on a scale STANDARD_DEVIATION 2.18 | 7.08 units on a scale STANDARD_DEVIATION 2.55 | 7.16 units on a scale STANDARD_DEVIATION 2.34 |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 28 Participants | 26 Participants | 54 Participants |
| SF-36 (Mental Component) | 46.42 units on a scale STANDARD_DEVIATION 12.21 | 46.96 units on a scale STANDARD_DEVIATION 11.21 | 46.70 units on a scale STANDARD_DEVIATION 11.59 |
| SF-36 (Physical Component) | 40.94 units on a scale STANDARD_DEVIATION 8.11 | 41.55 units on a scale STANDARD_DEVIATION 8.86 | 41.25 units on a scale STANDARD_DEVIATION 8.42 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 46 | 1 / 50 |
| other Total, other adverse events | 0 / 46 | 0 / 50 |
| serious Total, serious adverse events | 0 / 46 | 0 / 50 |
Outcome results
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.
Time frame: Baseline, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telemonitoring (Medly) | Quality of Life as Measured by SF-36 | Physical Component | 42.77 score on a scale | Standard Deviation 8.58 |
| Telemonitoring (Medly) | Quality of Life as Measured by SF-36 | Mental Component | 43.77 score on a scale | Standard Deviation 12.28 |
| Control | Quality of Life as Measured by SF-36 | Physical Component | 42.39 score on a scale | Standard Deviation 9.47 |
| Control | Quality of Life as Measured by SF-36 | Mental Component | 48.31 score on a scale | Standard Deviation 10.51 |
Comparison: Poststudy between-group comparison of SF-36 physical component summary score.p-value: 0.48t-test, 2 sided
Comparison: Poststudy between-group comparison of SF-36 mental component summary score.p-value: 0.73t-test, 2 sided
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.
Time frame: Baseline, 6 months
Population: Number of participants analyzed reflects those who completed the follow-up survey. Shifting priorities at the onset of the COVID-19 pandemic affected the collection of poststudy data, as patients followed for hypertension and diabetes mellitus ended their enrollment during the first wave of the pandemic, which led to a higher rate of incomplete questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telemonitoring (Medly) | Anxiety and Depression as Measured by HADS | Anxiety | 7.33 score on a scale | Standard Deviation 5.07 |
| Telemonitoring (Medly) | Anxiety and Depression as Measured by HADS | Depression | 5.51 score on a scale | Standard Deviation 4.67 |
| Control | Anxiety and Depression as Measured by HADS | Anxiety | 5.97 score on a scale | Standard Deviation 3.5 |
| Control | Anxiety and Depression as Measured by HADS | Depression | 5.55 score on a scale | Standard Deviation 4.2 |
Comparison: Poststudy between-group comparison of HADS anxiety sub-scale.p-value: 0.06t-test, 2 sided
Comparison: Poststudy between-group comparison of HADS depression sub-scale.p-value: 0.77t-test, 2 sided
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.
Time frame: Baseline, 6 months
Population: Number of participants analyzed reflects those who completed the follow-up survey. Shifting priorities at the onset of the COVID-19 pandemic affected the collection of poststudy data, as patients followed for hypertension and diabetes mellitus ended their enrollment during the first wave of the pandemic, which led to a higher rate of incomplete questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telemonitoring (Medly) | Heart-failure Specific Quality of Life (MLHFQ) | Emotional | 9 score on a scale | Standard Deviation 7.45 |
| Telemonitoring (Medly) | Heart-failure Specific Quality of Life (MLHFQ) | Total | 35.88 score on a scale | Standard Deviation 23.65 |
| Telemonitoring (Medly) | Heart-failure Specific Quality of Life (MLHFQ) | Physical | 14.58 score on a scale | Standard Deviation 10.9 |
| Control | Heart-failure Specific Quality of Life (MLHFQ) | Physical | 19.05 score on a scale | Standard Deviation 12.4 |
| Control | Heart-failure Specific Quality of Life (MLHFQ) | Emotional | 9.33 score on a scale | Standard Deviation 7.1 |
| Control | Heart-failure Specific Quality of Life (MLHFQ) | Total | 31.55 score on a scale | Standard Deviation 29.45 |
Comparison: Poststudy between-group comparison of MLHFQ total score.p-value: 0.67t-test, 2 sided
Comparison: Poststudy between-group comparison of MLHFQ physical domain score.p-value: 0.43t-test, 2 sided
Comparison: Poststudy between-group comparison of MLHFQ emotional domain score.p-value: 0.64t-test, 2 sided
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.
Time frame: Baseline, 6 months
Population: Number of participants analyzed reflects those who completed the follow-up survey. Shifting priorities at the onset of the COVID-19 pandemic affected the collection of poststudy data, as patients followed for hypertension and diabetes mellitus ended their enrollment during the first wave of the pandemic, which led to a higher rate of incomplete questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telemonitoring (Medly) | Self-Care of Health Failure as Measured by the SCHFI | Maintenance | 79.83 score on a scale | Standard Deviation 15.81 |
| Telemonitoring (Medly) | Self-Care of Health Failure as Measured by the SCHFI | Management | 75.42 score on a scale | Standard Deviation 19.83 |
| Telemonitoring (Medly) | Self-Care of Health Failure as Measured by the SCHFI | Confidence | 71.83 score on a scale | Standard Deviation 19.74 |
| Control | Self-Care of Health Failure as Measured by the SCHFI | Maintenance | 76.18 score on a scale | Standard Deviation 17.48 |
| Control | Self-Care of Health Failure as Measured by the SCHFI | Management | 69.53 score on a scale | Standard Deviation 26.53 |
| Control | Self-Care of Health Failure as Measured by the SCHFI | Confidence | 76.38 score on a scale | Standard Deviation 19.86 |
Comparison: Poststudy between-group comparison of SCHFI maintenance sub-scale.p-value: 0.74t-test, 2 sided
Comparison: Poststudy between-group comparison of SCHFI management sub-scale.p-value: 0.67t-test, 2 sided
Comparison: Poststudy between-group comparison of SCHFI confidence sub-scale.p-value: 0.92t-test, 2 sided
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.
Time frame: Baseline, 6 months
Population: Number of participants analyzed reflects those who completed the follow-up survey. Shifting priorities at the onset of the COVID-19 pandemic affected the collection of poststudy data, as patients followed for hypertension and diabetes mellitus ended their enrollment during the first wave of the pandemic, which led to a higher rate of incomplete questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemonitoring (Medly) | Self-efficacy as Measured by the SEMCD6. | 7.35 score on a scale | Standard Deviation 1.57 |
| Control | Self-efficacy as Measured by the SEMCD6. | 6.75 score on a scale | Standard Deviation 2.21 |
Comparison: Poststudy between-group comparison of SEMCD6.p-value: 0.13t-test, 2 sided
Secondary
Self-reported Health Service Use
Number of hospitalizations, number of ED and clinic visits, and family physician visits.
Time frame: Baseline, 6 months
Population: Number of participants analyzed reflects those who completed the follow-up survey. Shifting priorities at the onset of the COVID-19 pandemic affected the collection of poststudy data, as patients followed for hypertension and diabetes mellitus ended their enrollment during the first wave of the pandemic, which led to a higher rate of incomplete questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telemonitoring (Medly) | Self-reported Health Service Use | Hospital (number of visits) | 1.43 Visits | Standard Deviation 4.11 |
| Telemonitoring (Medly) | Self-reported Health Service Use | ED visits | 0.5 Visits | Standard Deviation 1.33 |
| Telemonitoring (Medly) | Self-reported Health Service Use | Clinic visits | 3.71 Visits | Standard Deviation 2.85 |
| Telemonitoring (Medly) | Self-reported Health Service Use | Family physician visits | 1.28 Visits | Standard Deviation 1.62 |
| Control | Self-reported Health Service Use | Family physician visits | 1.85 Visits | Standard Deviation 2.23 |
| Control | Self-reported Health Service Use | Hospital (number of visits) | 0.35 Visits | Standard Deviation 1.11 |
| Control | Self-reported Health Service Use | Clinic visits | 2.95 Visits | Standard Deviation 4.61 |
| Control | Self-reported Health Service Use | ED visits | 0.22 Visits | Standard Deviation 0.57 |
Comparison: Poststudy between-group comparison of self-reported number of hospital visits.p-value: 0.02t-test, 2 sided
Comparison: Poststudy between-group comparison of self-reported emergency department visits.p-value: 0.12t-test, 2 sided
Comparison: Poststudy between-group comparison of self-reported number of clinic visits.p-value: 0.39t-test, 2 sided
Comparison: Poststudy between-group comparison of self-reported number of family physician visits.p-value: 0.28t-test, 2 sided