Trial Outcomes & Findings for Effects of Remote Patient Monitoring on Chronic Disease Management (NCT NCT03127852)

Last Updated: 2023-08-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

96 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2023-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	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	Control Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.
Overall Study STARTED	46	50
Overall Study COMPLETED	41	48
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Control Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.
Overall Study Withdrawal by Subject	4	1
Overall Study Death	1	1

Baseline Characteristics

Number analyzed reflects the number of participants who returned the baseline survey.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline, 6 months

Outcome measures

Outcome measures
Measure	Telemonitoring (Medly) n=24 Participants 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	Control n=25 Participants Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.
Quality of Life as Measured by SF-36 Physical Component	42.77 score on a scale Standard Deviation 8.58	42.39 score on a scale Standard Deviation 9.47
Quality of Life as Measured by SF-36 Mental Component	43.77 score on a scale Standard Deviation 12.28	48.31 score on a scale Standard Deviation 10.51

SECONDARY outcome

Timeframe: 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.

Number of hospitalizations, number of ED and clinic visits, and family physician visits.

Outcome measures

Outcome measures
Measure	Telemonitoring (Medly) n=28 Participants 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	Control n=23 Participants Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.
Self-reported Health Service Use Hospital (number of visits)	1.43 Visits Standard Deviation 4.11	0.35 Visits Standard Deviation 1.11
Self-reported Health Service Use ED visits	0.5 Visits Standard Deviation 1.33	0.22 Visits Standard Deviation 0.57
Self-reported Health Service Use Clinic visits	3.71 Visits Standard Deviation 2.85	2.95 Visits Standard Deviation 4.61
Self-reported Health Service Use Family physician visits	1.28 Visits Standard Deviation 1.62	1.85 Visits Standard Deviation 2.23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Telemonitoring (Medly) n=24 Participants 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	Control n=17 Participants Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.
Self-Care of Health Failure as Measured by the SCHFI Maintenance	79.83 score on a scale Standard Deviation 15.81	76.18 score on a scale Standard Deviation 17.48
Self-Care of Health Failure as Measured by the SCHFI Management	75.42 score on a scale Standard Deviation 19.83	69.53 score on a scale Standard Deviation 26.53
Self-Care of Health Failure as Measured by the SCHFI Confidence	71.83 score on a scale Standard Deviation 19.74	76.38 score on a scale Standard Deviation 19.86

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Telemonitoring (Medly) n=23 Participants 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	Control n=17 Participants Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.
Heart-failure Specific Quality of Life (MLHFQ) Total	35.88 score on a scale Standard Deviation 23.65	31.55 score on a scale Standard Deviation 29.45
Heart-failure Specific Quality of Life (MLHFQ) Physical	14.58 score on a scale Standard Deviation 10.9	19.05 score on a scale Standard Deviation 12.4
Heart-failure Specific Quality of Life (MLHFQ) Emotional	9 score on a scale Standard Deviation 7.45	9.33 score on a scale Standard Deviation 7.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Telemonitoring (Medly) n=24 Participants 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	Control n=23 Participants Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.
Anxiety and Depression as Measured by HADS Depression	5.51 score on a scale Standard Deviation 4.67	5.55 score on a scale Standard Deviation 4.2
Anxiety and Depression as Measured by HADS Anxiety	7.33 score on a scale Standard Deviation 5.07	5.97 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Telemonitoring (Medly) n=26 Participants 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	Control n=24 Participants Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.
Self-efficacy as Measured by the SEMCD6.	7.35 score on a scale Standard Deviation 1.57	6.75 score on a scale Standard Deviation 2.21

Adverse Events

Telemonitoring (Medly)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Patrick Ware

Centre for Global eHealth Innovation

Phone: 1 (416) 340 4800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Telemonitoring (Medly) n=46 Participants 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	Control n=50 Participants Standard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.	Total n=96 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 12.6 • n=46 Participants	55 years STANDARD_DEVIATION 14.3 • n=50 Participants	59 years STANDARD_DEVIATION 13.9 • n=96 Participants
Sex: Female, Male Female	9 Participants n=37 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	8 Participants n=34 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	17 Participants n=71 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Sex: Female, Male Male	28 Participants n=37 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	26 Participants n=34 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	54 Participants n=71 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Race/Ethnicity, Customized White	22 Participants n=34 Participants • Number analyzed reflects the number of participants who provided responses to this question.	24 Participants n=36 Participants • Number analyzed reflects the number of participants who provided responses to this question.	46 Participants n=70 Participants • Number analyzed reflects the number of participants who provided responses to this question.
Race/Ethnicity, Customized Black	2 Participants n=34 Participants • Number analyzed reflects the number of participants who provided responses to this question.	4 Participants n=36 Participants • Number analyzed reflects the number of participants who provided responses to this question.	6 Participants n=70 Participants • Number analyzed reflects the number of participants who provided responses to this question.
Race/Ethnicity, Customized Asian	3 Participants n=34 Participants • Number analyzed reflects the number of participants who provided responses to this question.	6 Participants n=36 Participants • Number analyzed reflects the number of participants who provided responses to this question.	9 Participants n=70 Participants • Number analyzed reflects the number of participants who provided responses to this question.
Race/Ethnicity, Customized Other	7 Participants n=34 Participants • Number analyzed reflects the number of participants who provided responses to this question.	2 Participants n=36 Participants • Number analyzed reflects the number of participants who provided responses to this question.	9 Participants n=70 Participants • Number analyzed reflects the number of participants who provided responses to this question.
Region of Enrollment Canada	46 participants n=46 Participants	50 participants n=50 Participants	96 participants n=96 Participants
Highest Education Achieved Less than high school	4 Participants n=34 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	1 Participants n=35 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	5 Participants n=69 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Highest Education Achieved High school	5 Participants n=34 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	4 Participants n=35 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	9 Participants n=69 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Highest Education Achieved Trade or technical training	5 Participants n=34 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	6 Participants n=35 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	11 Participants n=69 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Highest Education Achieved College or university	15 Participants n=34 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	19 Participants n=35 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	34 Participants n=69 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Highest Education Achieved Postgraduate	5 Participants n=34 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	5 Participants n=35 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	10 Participants n=69 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Comfort with Smartphone Not comfortable	1 Participants n=30 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	0 Participants n=47 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	1 Participants n=77 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Comfort with Smartphone Somewhat comfortable	8 Participants n=30 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	4 Participants n=47 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	12 Participants n=77 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Comfort with Smartphone Comfortable	8 Participants n=30 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	28 Participants n=47 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	36 Participants n=77 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Comfort with Smartphone Very comfortable	13 Participants n=30 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	15 Participants n=47 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	28 Participants n=77 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
SF-36 (Physical Component)	40.94 units on a scale STANDARD_DEVIATION 8.11 • n=24 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	41.55 units on a scale STANDARD_DEVIATION 8.86 • n=25 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	41.25 units on a scale STANDARD_DEVIATION 8.42 • n=49 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
SF-36 (Mental Component)	46.42 units on a scale STANDARD_DEVIATION 12.21 • n=24 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	46.96 units on a scale STANDARD_DEVIATION 11.21 • n=25 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	46.70 units on a scale STANDARD_DEVIATION 11.59 • n=49 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
HADS (Anxiety)	6.94 units on a scale STANDARD_DEVIATION 4.38 • n=24 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	6 units on a scale STANDARD_DEVIATION 4 • n=22 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	6.49 units on a scale STANDARD_DEVIATION 4.18 • n=46 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
HADS (Depression)	5.09 units on a scale STANDARD_DEVIATION 3.95 • n=23 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	5.21 units on a scale STANDARD_DEVIATION 3.85 • n=23 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	5.15 units on a scale STANDARD_DEVIATION 3.86 • n=46 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
SEMCD6	7.23 units on a scale STANDARD_DEVIATION 2.18 • n=26 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	7.08 units on a scale STANDARD_DEVIATION 2.55 • n=24 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	7.16 units on a scale STANDARD_DEVIATION 2.34 • n=50 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Hospital visits	4.29 Visits STANDARD_DEVIATION 10.56 • n=28 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	3.7 Visits STANDARD_DEVIATION 6.51 • n=23 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	4.02 Visits STANDARD_DEVIATION 8.89 • n=51 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
ED visits	1.29 Visits STANDARD_DEVIATION 4.65 • n=28 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	0.071 Visits STANDARD_DEVIATION 1.34 • n=23 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	0.74 Visits STANDARD_DEVIATION 3.58 • n=51 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Clinic visits	3.54 Visits STANDARD_DEVIATION 4.11 • n=20 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	4.19 Visits STANDARD_DEVIATION 6.01 • n=21 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	3.87 Visits STANDARD_DEVIATION 5.12 • n=41 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
Family physician visits	1.65 Visits STANDARD_DEVIATION 1.22 • n=25 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	2.48 Visits STANDARD_DEVIATION 3.72 • n=23 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	2.05 Visits STANDARD_DEVIATION 2.72 • n=48 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
SCHFI (Maintenance)	73.42 units on a scale STANDARD_DEVIATION 14.77 • n=24 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	73.64 units on a scale STANDARD_DEVIATION 15.75 • n=17 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	73.51 units on a scale STANDARD_DEVIATION 14.99 • n=41 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
SCHFI (Management)	71.75 units on a scale STANDARD_DEVIATION 15.64 • n=24 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	64.47 units on a scale STANDARD_DEVIATION 27.51 • n=17 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	68.73 units on a scale STANDARD_DEVIATION 21.37 • n=41 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
SCHFI (Confidence)	69.43 units on a scale STANDARD_DEVIATION 15.49 • n=24 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	69.94 units on a scale STANDARD_DEVIATION 25.09 • n=16 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	69.63 units on a scale STANDARD_DEVIATION 19.59 • n=40 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
MLHFQ (Total)	40.85 units on a scale STANDARD_DEVIATION 28.52 • n=23 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	42.81 units on a scale STANDARD_DEVIATION 26.15 • n=17 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	41.68 units on a scale STANDARD_DEVIATION 27.21 • n=40 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
MLHFQ (Physical)	19.13 units on a scale STANDARD_DEVIATION 11.01 • n=23 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	20.78 units on a scale STANDARD_DEVIATION 10.64 • n=17 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	19.83 units on a scale STANDARD_DEVIATION 10.75 • n=40 Participants • Number analyzed reflects the number of participants who returned the baseline survey.
MLHFQ (Emotional)	10.38 units on a scale STANDARD_DEVIATION 7.97 • n=22 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	11.38 units on a scale STANDARD_DEVIATION 7.08 • n=15 Participants • Number analyzed reflects the number of participants who returned the baseline survey.	10.79 units on a scale STANDARD_DEVIATION 7.54 • n=37 Participants • Number analyzed reflects the number of participants who returned the baseline survey.