Condition category
Circulatory System
Date applied
11/11/2018
Date assigned
21/01/2019
Last edited
21/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Heart failure is a chronic illness that happens when the heart is unable to pump well enough to properly support the body’s needs. Many people with heart failure run the risk of getting hospitalized frequently and are at high risk for death. This study aims to explore the impact of a mobile phone-based home monitoring system that allows participants to record their weight, blood pressure, heart rate, and symptoms. The home monitoring system provides patients with self-care instructions and their healthcare providers are alerted when it appears that the patient’s health is getting worse. This study aims to determine the impact of the home monitoring system on self-care, quality of life, and other health outcomes.

Who can participate?
Participants must be 18 years of age or older. There are no gender restrictions. Participants must be able to read and understand English (or have a caregiver that can assist them) in order to complete the study questionnaires and be able to follow the instructions on Medly. Participants must have heart failure and have been hospitalized for 48 hours or more within 2 weeks of beginning the study.

What does the study involve?
Standard care for a person with heart failure that has recently been hospitalized is to receive self-care instructions from their healthcare provider regarding dietary restrictions, exercise, symptom management and an explanation of how to appropriately take their medications. Both groups in the study will receive this standard care. The intervention group will also receive a blood pressure cuff, scale and smartphone with the Medly app pre-loaded onto it. Participants in the intervention group will use the Medly app and equipment to record their weight, blood pressure, heart rate and symptoms every morning. Once complete, the app will provide a self-care message depending on their measurements, and their clinician will be alerted if necessary. Their heart failure clinicians will also be able to see these measurements to keep track of their health status in between clinic visits.

Participants in both groups will be asked to complete a baseline questionnaire within 24 hours of being enrolled in the study and then one at the end of the study (after 3 months of being enrolled). Participants may be asked to take part in an interview that can be done over the phone. When contacted, participants can always decline the interview. Questions will be similar to those asked in the questionnaire but with more detail.

What are the possible benefits and risks of participating?
Participants may or may not experience benefits from the study. The only known risk is that some participants may feel uncomfortable or have anxiety about taking their measurements every morning. Participants are welcome to discuss this with their healthcare team and are also able to withdraw from the study at any time. It is believed that this discomfort would not persist if they withdraw from the study.

Where is the study run from?
The study will run at 3 sites: Sunnybrook Health Sciences Centre, Michael Garron Hospital and Mt. Sinai Hospital. There will be approx. 48 participants recruited from each site. The co-Principal Investigator is located at University Health Network which is where all the data will be stored on a secure server, with paper data being stored in double-locked drawers for access only by the study team.

When is the study starting and how long is it expected to run for?
The approximate start date for participant recruitment is Nov. 16th/2018. Each participant will be in the study for 3 months (unless they choose to withdraw from the study). As we will be recruiting participants from 3 different sites, the overall study is expected to last about 9 months from Nov. 16th/2018.

Who is funding the study?
This study is funded by Ted Rogers Centre for Heart Research and the Sunnybrook AFP Innovation Fund.

Who is the main contact?
The main contact for this study will be Dr. Emily Seto, the co-Principal Investigator along with Dr. Stephanie Poon. She can be reached at Emily.Seto@utoronto.ca.

Trial website

Contact information

Type

Public

Primary contact

Miss Alana Tibbles

ORCID ID

Contact details

190 Elizabeth St.
Toronto
M5G 2C4
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT03358303

Protocol/serial number

17-5887

Study information

Scientific title

Medly-AID: Effect of a mobile phone-based telemonitoring program on the outcome of heart failure patients After an Incidence of acute Decompensation

Acronym

Medly-AID

Study hypothesis

If heart failure patients use the telemonitoring system after discharge from hospital, then they will perform better self-care and have improved health outcomes including quality of life.

Ethics approval

University Health Network Research Ethics Board (approval number 17-5887): 15/01/2018
Sunnybrook Health Sciences Centre Research Ethics Board (approval number 143-2017): 13/09/2017

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Heart failure

Intervention

Every patient at each site will be randomized to either the intervention or control group. For each participating site, block randomization will be used with random block sizes of 2, 4, or 6. The study coordinator will be blinded to which group the patient will be assigned until he/she has consented to participate in the study. The control group will receive standard of care, while the patients in the intervention arm will receive standard of care plus the telemonitoring.

Control Group: Standard of care of HF patients being discharged from hospital include receiving discharge instructions for self-care at home (ie. dietary restrictions, symptoms), prescription for home medications and a follow-up appointment with a primary care provider or specialized hospital clinic (internal medicine, heart function).

Intervention Group: In addition to the standard of care mentioned above, on discharge from hospital, each patient in the intervention group will receive a Medly kit that includes a smart phone with a limited data plan, a Bluetooth-enabled weight scale, and a blood pressure cuff.

Each participant will be in the study for a total of 3 months. They will be asked to complete their questionnaires at baseline (within 24h of joining the study) and again at the 3-month end point. Patients in the Medly group will return their equipment at this point as well. Bloodwork and any heart failure-related hospitalizations during this 3-month period will also be recorded for data analysis.

Intervention type

Device

Phase

Drug names

Primary outcome measure

1. Self-care of heart failure, as measured with the Self-Care of Heart Failure Index (SCHFI) will be measured at baseline and 3 months.
2. Quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and EuroQol (EQ5D) at baseline and 3 months.
3. Heart failure classification (NYHA class) will be measured using clinical notes at baseline and 3 months.
4. Brain natriuretic peptide (BNP) levels will be measured at baseline and 3 months.
5. Compliance with Medly utilization will be measured using the Medly database at 3 months.

Secondary outcome measures

1. 30-day HF re-admission rate will be measured using clinical notes at 3 months.
2. Length of hospital stay will be measured using clinical notes at 3 months.
3. Number of visits to the emergency department (ED) will be measured using the discharge summary at baseline and 3 months.
4. Creatinine levels will be measured at baseline and 3 months.
5. Sodium levels will be measured at baseline and 3 months.
6. Potassium levels will be measured at baseline and 3 months.

Overall trial start date

01/01/2017

Overall trial end date

15/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Hospitalization for decompensated heart failure (HF) for >48 h
3. Speaks and reads English adequately to provide informed consent and understand the text prompts in the application
4. Ability to comply with using Medly (for example, able to stand on the weight scale, able to answer symptom questions, etc.)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Dementia
2. Resident of long-term care facility
3. Will require inpatient rehabilitation after discharge
4. Participating in another clinical trial

Recruitment start date

16/11/2018

Recruitment end date

15/11/2019

Locations

Countries of recruitment

Canada

Trial participating centre

Sunnybrook Health Sciences Centre
2075 Bayview Ave
Toronto
M4N 3M5
Canada

Trial participating centre

The Mount Sinai Hospital
1 Gustave L. Levy Place
New York
10029-6574
United States of America

Trial participating centre

Michael Garron Hospital
825 Coxwell Ave, East York
Toronto
M4C 3E7
Canada

Sponsor information

Organisation

University Health Network

Sponsor details

200 Elizabeth St
Toronto
M5G 2C4
Canada
(416) 860-0420
tgriadmin@uhnresearch.ca

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

AHSC AFP Innovation Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ted Rogers Centre for Heart Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement: The datasets generated during and/or analysed during the current study are not expected to be made available because data contains personal health information that would require consent from patients to be used for other research, as well as appropriate research ethics board approval.

Intention to publish date

01/07/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes