Back to resultsEffects of Remote Patient Monitoring on Chronic Disease Management
Primary Purpose
Heart Failure, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Medly
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
All participants:
- Adults (age 18 years or older)
- 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)
- Patient or their caregiver speaks and reads English adequately to provide informed consent and understand the text prompts in the application.
- 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:
- Patients on mechanical circulatory support
- Patients on the heart transplant list
- Terminal diagnosis with life expectancy < 1 year
- Dementia or uncontrolled psychiatric illness
- Resident of a long term care facility
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telemonitoring (Medly)
Control
Arm Description
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.
Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Self-reported Health Service Use
Number of hospitalizations, number of ED and clinic visits, and family physician visits.
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.
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.
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.
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.
Full Information
NCT ID
NCT03127852
First Posted
August 9, 2016
Last Updated
October 17, 2022
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03127852
Brief Title
Effects of Remote Patient Monitoring on Chronic Disease Management
Official Title
Randomized Controlled Trial of a Mobile Phone-based Telemonitoring Application for Self-management and Clinical Decision Support for Patients With Complex Chronic Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 23, 2016 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease, Uncontrolled Hypertension, Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemonitoring (Medly)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.
Intervention Type
Device
Intervention Name(s)
Medly
Primary Outcome Measure Information:
Title
Quality of Life as Measured by SF-36
Description
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
Secondary Outcome Measure Information:
Title
Self-reported Health Service Use
Description
Number of hospitalizations, number of ED and clinic visits, and family physician visits.
Time Frame
Baseline, 6 months
Title
Self-Care of Health Failure as Measured by the SCHFI
Description
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
Title
Heart-failure Specific Quality of Life (MLHFQ)
Description
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
Title
Anxiety and Depression as Measured by HADS
Description
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
Title
Self-efficacy as Measured by the SEMCD6.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All participants:
Adults (age 18 years or older)
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)
Patient or their caregiver speaks and reads English adequately to provide informed consent and understand the text prompts in the application.
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:
Patients on mechanical circulatory support
Patients on the heart transplant list
Terminal diagnosis with life expectancy < 1 year
Dementia or uncontrolled psychiatric illness
Resident of a long term care facility
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35080502
Citation
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.
Results Reference
derived
PubMed Identifier
29162557
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Remote Patient Monitoring on Chronic Disease Management
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