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Heart FailureNCT03127852

Effects of Remote Patient Monitoring on Chronic Disease Management

A study testing Medly in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Medly
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteCanada
Study dates
23 Aug 2016to 15 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network

    Toronto, Ontario

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Medly
Medical subject headings
Heart Failure, Pulmonary Disease, Chronic Obstructive, Renal Insufficiency, Chronic, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MedlyDevice

Study groups in NCT03127852
Study groupRoleWhat they receive
Telemonitoring (Medly)ExperimentalThe 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.
Receives: Device: Medly
ControlNo interventionStandard of care: Patients are followed in a specialty care clinic treating their primary conditions. Patients typically have scheduled appointments every six months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 6 months

Secondary outcomes (5)

  1. Self-reported Health Service Use

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

    Measured: Baseline, 6 months

  2. 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.

    Measured: Baseline, 6 months

  3. 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.

    Measured: Baseline, 6 months

  4. 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.

    Measured: Baseline, 6 months

  5. 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.

    Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study start23 Aug 2016
  3. Primary completion20 Jun 2020
  4. Study completion15 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03127852
Sponsor's protocol ID
15-9995
Status last verified
Mar 2022
First submitted
9 Aug 2016
Last updated
21 Aug 2023
Individual data sharing
No

Publications

  • 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.

    PubMed 35080502

  • 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.

    PubMed 29162557

Questions about this trial

What is this clinical trial studying?

A study testing Medly in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life as Measured by SF-36 (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03127852, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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