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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring (Medly) | Experimental | 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. |
|
| Control | No Intervention | Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medly | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Health Service Use | Number of hospitalizations, number of ED and clinic visits, and family physician visits. | Baseline, 6 months |
| Self-Care of Health Failure as Measured by the SCHFI |
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Inclusion Criteria:
All participants:
Primary chronic disease-specific criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35080502 | Derived | Ware P, Shah A, Ross HJ, Logan AG, Segal P, Cafazzo JA, Szacun-Shimizu K, Resnick M, Vattaparambil T, Seto E. Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study. J Med Internet Res. 2022 Jan 26;24(1):e31754. doi: 10.2196/31754. | |
| 29162557 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control | Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Early termination of recruitment before reaching the target sample size because (1) the HF telemonitoring program became standard of care; (2) recruitment challenges observed for patients with DM because of the rapid emergence and growing use of continuous and flash glucose monitors; and (3) the COVID-19 pandemic led to a pause of nonessential research activities and a significant shift toward virtual care, which fundamentally altered the control group after the research pause was lifted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick Ware | Centre for Global eHealth Innovation | 1 (416) 340 4800 | 4765 | Patrick.Ware@uhn.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2019 | Mar 3, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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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 |
| 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 |
| 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 |
| 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 |
| Seto E, Ware P, Logan AG, Cafazzo JA, Chapman KR, Segal P, Ross HJ. Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2017 Nov 21;6(11):e229. doi: 10.2196/resprot.8367. |
| BG001 | Control | Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Number analyzed reflects the number of participants who returned the baseline survey. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number analyzed reflects the number of participants who provided responses to this question. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Highest Education Achieved | Number analyzed reflects the number of participants who returned the baseline survey. | Count of Participants | Participants |
|
| Comfort with Smartphone | Number analyzed reflects the number of participants who returned the baseline survey. | Count of Participants | Participants |
|
| SF-36 (Physical Component) | 36-Item Short Form Survey (SF-36) measures health-related quality of life. It consists of 2 component summary measures: physical and mental health. The Physical Component Summary (PCS) measure is derived from domain scales of Physical Functioning (10 items), Role-Physical (4 items), Bodily Pain (2 items), and General Health (5 items). Component summary measure scores range from 0 to 100 with higher scores indicating better outcomes. Norm-based scoring was used so that scores for each component summary measure has a mean of 50 (standardized to the US population) and standard deviation of 10. | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| SF-36 (Mental Component) | 36-Item Short Form Survey (SF-36) measures health-related quality of life and consists of 2 component summary measures: physical and mental health. The Mental Component Summary (MCS) measure is derived from domain scales of: Vitality (4 items), Social Functioning (2 items), Role-emotional (3 items), and Mental Health (5 items). Component summary measure scores range from 0 to 100 with higher scores indicating better outcomes. Norm-based scoring was used so that scores for each component summary measure has a mean of 50 (standardized to the US population) and standard deviation of 10. | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| HADS (Anxiety) | Hospital Anxiety and Depression Scale (HADS) has two sub-scales for anxiety and depression. Scores for items in the anxiety sub-scale are summed to produce an anxiety score (HADS-A). The anxiety sub-scale has scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| HADS (Depression) | Hospital Anxiety and Depression Scale (HADS) has two sub-scales for anxiety and depression. Scores for items in the depression sub-scale are summed to produce a depression score (HADS-D). The depression sub-scale has scores ranging from 0 to 21, with higher scores indicating higher levels of depression. | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| SEMCD6 | Each item on the Self-Efficacy for Managing Chronic Disease 6-Item scale (SEMCD6) 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. | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| Hospital visits | Self-reported number of hospital visits | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | Visits |
|
| ED visits | Self-reported emergency department visits | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | Visits |
|
| Clinic visits | Self-reported clinic visits | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | Visits |
|
| Family physician visits | Self-reported family physician visits | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | Visits |
|
| SCHFI (Maintenance) | Self-Care of Heart Failure Index (SCHFI) has three scales: maintenance, management, confidence. The self-care maintenance subscale includes 10 items asking how often patients check their heart failure symptoms and treatment adherence. The score is standardized to a 0- to 100-point range with each scale score standardized to a 0 to 100 range with 0 indicating the worst and 100 indicating the best performance for each scale score. | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| SCHFI (Management) | Self-Care of Heart Failure Index (SCHFI) has three scales: maintenance, management, confidence. The self-care management sub-scale includes 6 items if patients report any heart failure symptoms in the past month. Then based on the responses on how quick they recognize it as a symptom of heart failure and remedies they tried. The score is standardized to a 0- to 100-point range with each scale score standardized to a 0 to 100 range with 0 indicating the worst and 100 indicating the best performance for each scale score. | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| SCHFI (Confidence) | Self-Care of Heart Failure Index (SCHFI) has three scales: maintenance, management, confidence. The self-care confidence subscale includes 6 items asking how confident that they can keep themselves free of symptoms, follow treatment advice, recognize changes in their health and etc. The score is standardized to a 0- to 100-point range with each scale score standardized to a 0 to 100 range with 0 indicating the worst and 100 indicating the best performance for each scale score. | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| MLHFQ (Total) | Minnesota Living with Heart Failure Questionnaire (MLHFQ) provides a total score which ranges from 0-105. A lower total score is indicative of better quality of life. | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| MLHFQ (Physical) | Minnesota Living with Heart Failure Questionnaire (MLHFQ) provides a total score, as well as scores for two dimensions, physical and emotional. The sum of points of the physical dimension sub-scale (8 items) ranges from 0-40 and a lower physical score is indicative of better quality of life. | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| MLHFQ (Emotional) | Minnesota Living with Heart Failure Questionnaire (MLHFQ) provides a total score, as well as scores for two dimensions, physical and emotional. The sum of points of the emotional dimension sub-scale (5 items) ranges from 0-25 and a lower emotional score is indicative of better quality of life. | Number analyzed reflects the number of participants who returned the baseline survey. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control | Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months. |
|
|
|
| Secondary | Self-reported Health Service Use | Number of hospitalizations, number of ED and clinic visits, and family physician visits. | 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. | Posted | Mean | Standard Deviation | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months |
|
|
|
|
| 1 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Control | Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months. | 1 | 50 | 0 | 50 | 0 | 50 |
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| D012140 |
| Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Trade or technical training |
|
| College or university |
|
| Postgraduate |
|
| Comfortable |
|
| Very comfortable |
|
| ED visits |
|
|
| Clinic visits |
|
|
| Family physician visits |
|
|
| .12 |
| Superiority |
| Poststudy between-group comparison of self-reported number of clinic visits. | t-test, 2 sided | .39 | Superiority |
| Poststudy between-group comparison of self-reported number of family physician visits. | t-test, 2 sided | .28 | Superiority |
| Management |
|
|
| Confidence |
|
|
| .67 |
| Superiority |
| Poststudy between-group comparison of SCHFI confidence sub-scale. | t-test, 2 sided | .92 | Superiority |
| Physical |
|
|
| Emotional |
|
|
| .43 |
| Superiority |
| Poststudy between-group comparison of MLHFQ emotional domain score. | t-test, 2 sided | .64 | Superiority |
| .77 |
| Superiority |