Heart FailureTHRIVENCT03212001
TeleHomecaRe InterVention Evaluation Study
An observational study of Heart Failure and Chronic Obstructive Pulmonary Disease, run by University of Toronto at 1 site in Canada.
Trial summary
The goal of this study is to evaluate the overall impact of Telehomecare on COPD and HF patients and system level outcomes using a comparison group of patients that did not participate in the program (for up to 18 months). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Chronic Obstructive Pulmonary Disease
- How many people
- 5,400 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This community based study will be conducted across 8 Local Health Integration Networks (LHINs) in Ontario: Toronto Central, North East, Central West, Erie St Claire, Central, North Simcoe Muskoka, North West and South West LHINs. The study population will include COPD and HF patients that currently or previously participated in Telehomecare program. The study population will also include informal caregivers and healthcare providers involved in and/or caring for a patient enrolled in the program as well as administrators /decision makers involved with the Telehomecare program.
Who may be able to join
- Patient:
- The patient has a documented diagnosis of HF or COPD (with or without co-morbid conditions);
- The patient has been classified as a 'heavy user' of the health care system, characterized by any of the following:
- A minimum of one hospitalization for a respiratory or cardiac complaint in the past six months;
- A minimum of two emergency department/urgent care center visits for a respiratory or cardiac complaint in the past six months;
- Currently receiving nursing services via CCAC;
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- Frequent visits to primary care provider in the past year;
- Patient/informal caregiver (if applicable) is an adult (over 18 years), able and willing to provide informed consent;
- Patient/informal caregiver (if applicable) is fluent in English;
- Patient/informal caregiver is able and willing to operate the Telehomecare equipment; and
- Patient lives in a residential (private home or retirement home) setting with an active landline.
- In addition to the program eligibility criteria, the following criteria for the intervention evaluation study apply to recruitment of patients:
- Patient must have a documented consent for participating in Telehomecare
- Patients enrolled in the Telehomecare program must have agreed to share their contact and health information for evaluative purposes
- Patients must provide informed consent before participating in observations, interviews, and surveys as part of the program evaluation study
- Healthcare Provider
- A healthcare provider that has:
- Referred a patient that has been previously enrolled in the Telehomecare program, and/or;
- Provided primary care to a patient enrolled in the evaluation study
- Previously or currently participated in delivering Telehomecare as a provider or care administrator; o For observations, interviews, and surveys: nurses/physicians must have at least 2 months experience in providing care using Telehomecare
- Technicians, Administrators, and/or Decision Makers
- The following are eligible for inclusion in the study:
- Technicians involved in the set-up of Telehomecare equipment in the patient home.
- Administrators and/or decision makers of the Telehomecare program as a larger network of care such as Healthcare Program Managers, key members of the LHINs, OTN etc.
Who cannot join
- Patient
- Less than 18 years of age;
- Individuals without an established diagnosis of COPD or HF
- Unable or unwilling to provide verbal informed consent
- Demonstrated non-adherence to the THC program:
- o The Telehomecare Nurse works with each patient on a case-by-case review to assess willingness to partner in their own care, and if the number of missed consultation appointments and reasons for demonstrate overall non-adherence with the program;
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- Inability or unwillingness to use Telehomecare equipment, and/or;
- Do not have a regular caregiver to assist in the use of the equipment (if assistance is required)
- Healthcare Provider
- Is not a practicing healthcare provider in any of the said LHINs
- Technicians, Administrators and/or Decision Makers
- Unable or unwilling to provide verbal informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Valeria Rac, MD, PhD, 416-634-8799, valeria.rac@theta.utoronto.ca
Nida Shahid, 416-634-8804 ext. Shahid, nida.shahid@theta.utoronto.ca
About this study
Official title: TeleHomecaRe InterVention Evaluation (THRIVE) Study
The goal of this study is to evaluate the overall impact of Telehomecare on COPD and HF patients and system level outcomes using a comparison group of patients that did not participate in the program (for up to 18 months). This evaluation study will explore costs, participants' experiences, perceptions, and patterns of use related to Telehomecare. The study will include eight Local Health Integration Networks (LHINs) across Ontario, Canada.
Read the detailed description
The key question to answer is how different models of Telehomecare enabled self-management impacts patient outcomes, experiences and system costs across Ontario. The evaluation study will also attempt to answer questions on who is benefitting the most from the program and the quantifiable benefits a patient would experience from participating.
The intervention evaluation study will use a mixed-methods design comprising of four components (sub-studies), using both qualitative and quantitative research methods: (1) Comparative Effectiveness Study that evaluates patient-level clinical outcomes (e.g. hospitalization, ED visits) using administrative data in comparison with usual care; (2) Economic Evaluation Study that will evaluate costs associated with the program and patient level outcomes as well as cost-effectiveness of the program in comparison with 'usual care'; (3) Evaluation study of Telehomecare use that will evaluate the patterns of program use and perceived quality of life, disease management, satisfaction and caregiver strain; and (4) Adoption study that will use ethnographic fieldwork, semi-structured interviews (during and after program participation) and review of documentary sources to gain understanding of program adoption.
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Telehomecare patients (matched cohort study) | COPD and HF patients in Telehomecare program (followed up to 18 months) | |
| Usual-care patients (matched cohort study) | COPD and HF patients in 'usual care' (followed up to 18 months) | |
| Telehomecare patients (observations, interviews and surveys) | 1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare. 2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess patient experience with Telehomecare program. 3. Surveys conducted up to four times using validated survey tools. | |
| Informal caregiver (observations, interviews and surveys) | 1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare. 2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess caregiver experience with Telehomecare program. 3. Surveys conducted up to four times using validated survey tools. | |
| Healthcare providers (observations, interviews and surveys) | 1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare. 2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess provider experience with Telehomecare program. | |
| Administrators and Decision Makers (observations, interviews) | 1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare. 2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess administrator/decision-maker experience with Telehomecare program. | |
| Technician (observation, interviews) | 1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare. 2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess technician experience with Telehomecare program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease specific hospitalization and ED visits
Comparison of disease specific hospitalization and ED visits between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
Measured: 18 months
Secondary outcomes (7)
Number of all-cause hospitalization/ED visits
Comparison of the number of all-cause hospitalization/ED visits between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
Measured: 18 months
Number of visits to primary care physicians
Comparison of the number of visits to primary care physicians between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
Measured: 18 months
Number of visits to specialists
Comparison of the number of visits to specialists between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
Measured: 18 months
Number of visits to in-home health professionals
Comparison of the number of visits to in-home health professionals between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
Measured: 18 months
Number of admissions to long-term care facilities
Comparison of the number of admissions to long-term care facilities between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
Measured: 18 months
Length of stay in hospital
Comparison of length-of-stay in hospital between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
Measured: 18 months
Medication use
Comparison of medication use between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startJul 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Dr. Valeria Rac, University of Toronto
- Investigators
- Valeria Rac, MD, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212001
- Sponsor's protocol ID
- 16-5136
- Acronym
- THRIVE
- Status last verified
- Apr 2019
- First submitted
- 27 Mar 2017
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeleHomecaRe InterVention Evaluation (THRIVE) Study
- ClinicalTrials.gov ID
- NCT03212001
- Acronym / sponsor ID
- THRIVE / 16-5136
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Jul 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the overall impact of Telehomecare on COPD and HF patients and system level outcomes using a comparison group of patients that did not participate in the program (for up to 18 months). This evaluation study will explore costs, participants' experiences, perceptions, and patterns of use related to Telehomecare. The study will include eight Local Health Integration Networks (LHINs) across Ontario, Canada.
Detailed description
The key question to answer is how different models of Telehomecare enabled self-management impacts patient outcomes, experiences and system costs across Ontario. The evaluation study will also attempt to answer questions on who is benefitting the most from the program and the quantifiable benefits a patient would experience from participating.
The intervention evaluation study will use a mixed-methods design comprising of four components (sub-studies), using both qualitative and quantitative research methods: (1) Comparative Effectiveness Study that evaluates patient-level clinical outcomes (e.g. hospitalization, ED visits) using administrative data in comparison with usual care; (2) Economic Evaluation Study that will evaluate costs associated with the program and patient level outcomes as well as cost-effectiveness of the program in comparison with 'usual care'; (3) Evaluation study of Telehomecare use that will evaluate the patterns of program use and perceived quality of life, disease management, satisfaction and caregiver strain; and (4) Adoption study that will use ethnographic fieldwork, semi-structured interviews (during and after program participation) and review of documentary sources to gain understanding of program adoption.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Telehomecare patients (matched cohort study) | – | –COPD and HF patients in Telehomecare program (followed up to 18 months) |
| Usual-care patients (matched cohort study) | – | –COPD and HF patients in 'usual care' (followed up to 18 months) |
| Telehomecare patients (observations, interviews and surveys) | – | –1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare. 2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess patient experience with Telehomecare program. 3. Surveys conducted up to four times using validated survey tools. |
| Informal caregiver (observations, interviews and surveys) | – | –1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare. 2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess caregiver experience with Telehomecare program. 3. Surveys conducted up to four times using validated survey tools. |
| Healthcare providers (observations, interviews and surveys) | – | –1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare. 2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess provider experience with Telehomecare program. |
| Administrators and Decision Makers (observations, interviews) | – | –1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare. 2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess administrator/decision-maker experience with Telehomecare program. |
| Technician (observation, interviews) | – | –1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare. 2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess technician experience with Telehomecare program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This community based study will be conducted across 8 Local Health Integration Networks (LHINs) in Ontario: Toronto Central, North East, Central West, Erie St Claire, Central, North Simcoe Muskoka, North West and South West LHINs. The study population will include COPD and HF patients that currently or previously participated in Telehomecare program. The study population will also include informal caregivers and healthcare providers involved in and/or caring for a patient enrolled in the program as well as administrators /decision makers involved with the Telehomecare program.
Key inclusion criteria (24 listed)
- The patient has a documented diagnosis of HF or COPD (with or without co-morbid conditions);
- The patient has been classified as a 'heavy user' of the health care system, characterized by any of the following:
- Patient/informal caregiver (if applicable) is an adult (over 18 years), able and willing to provide informed consent;
- Patient/informal caregiver (if applicable) is fluent in English;
- Patient/informal caregiver is able and willing to operate the Telehomecare equipment; and
Key exclusion criteria (12 listed)
- Patient
- Less than 18 years of age;
- Individuals without an established diagnosis of COPD or HF
- Unable or unwilling to provide verbal informed consent
- Demonstrated non-adherence to the THC program:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease specific hospitalization and ED visits
Time frame: 18 months
Comparison of disease specific hospitalization and ED visits between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
7 secondary outcomes
Number of all-cause hospitalization/ED visits
Time frame: 18 months
Number of visits to primary care physicians
Time frame: 18 months
Number of visits to specialists
Time frame: 18 months
Number of visits to in-home health professionals
Time frame: 18 months
Number of admissions to long-term care facilities
Time frame: 18 months
Length of stay in hospital
Time frame: 18 months
Medication use
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeria Rac, MD, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Chronic Obstructive Pulmonary Disease, run by University of 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 24 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valeria Rac, MD, PhD (416-634-8799, valeria.rac@theta.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease specific hospitalization and ED visits (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2019.