Heart FailureTLCNCT02311114
Program Evaluation of Telehomecare: TeLeCare Study
An observational study of Heart Failure and Chronic Obstructive Pulmonary Disease, run by University of Toronto at 1 site in Canada.
Trial summary
This study will evaluate the Telehomecare (THC) Program offered to patients with heart failure or chronic obstructive pulmonary disease across the Central West, Toronto Central and North East Local Health Integration Networks in Ontario. 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
- What is being tested?
- In Depth interview, Observational fieldwork and Survey
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Sep 2018
- 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: Health care providers, technicians, administrators/decision makers and patients enrolled in 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 is 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
- Is receiving nursing services via CCAC
Show all 20Show fewer
- Frequent visits to primary care provider in the past year
- The patient or informal caregiver (if applicable) is an adult (over 18 yrs) able and willing to provide informed consent.
- The patient or informal caregiver (if applicable) is fluent in English
- The patient or informal caregiver is able and willing to operate the THC equipment
- The patient lives in a residential (private home or retirement home) setting with an active landline
- The patient or informal caregiver have agreed to be contacted for evaluation of this program when consenting to participate in the Telehomecare program.
- Health Care Provider
- Any health care provider who referred a patient to the telehomecare program
- Primary care providers of patients who are enrolled in the study
- Telehomecare nurses/physicians involved in the provision of care to patients enrolled in the telehomecare program
- For interviews and surveys telehomecare nurses/physicians must have 3 months experience with telehomecare
- Technician, Administrators and/or Decision Makers
- Technicians involved in the set-up of telehomecare equipment at patients' homes.
- Administrators and/or Decision Makers of the THC program as a larger network of care such as Healthcare Program Managers, key members of the LHIN, OTN etc.
Who cannot join
- Patient
- Less than 18 years of age
- Individuals without an established diagnosis of COPD or chronic HF
- Unable or unwilling to provide verbal informed consent
- Demonstrated non-adherence to the THC program
- The THC Clinician 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.
Show all 10Show fewer
- Inability or unwillingness to use THC equipment
- Do not have a regular caregiver to assist in the use of the equipment
- Health Care Provider, Technician, Administrators and/or Decision Makers
- Unable or unwilling to provide verbal informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Program Evaluation of Telehomecare for Patients With Heart Failure or Chronic Obstructive Pulmonary Disease: TeLeCare (TLC) Study
This study will evaluate the Telehomecare (THC) Program offered to patients with heart failure or chronic obstructive pulmonary disease across the Central West, Toronto Central and North East Local Health Integration Networks in Ontario. It will explore the opinions and experiences of patients, providers, technicians and administrators involved with THC Program in order to provide stakeholders with information about the processes and organizational factors impacting the program's adoption, the experiences of its participants, impact on patient outcomes, costs to the health-care system and who is benefiting the most from participating. These factors will be determined using semi-structured interviews, surveys, and observation of practices of everyone involved with THC. The study will also evaluate patient data to determine changes in patients' utilization of healthcare services.
Read the detailed description
The program evaluation will consist of three components that will employ two research methods, qualitative and quantitative.
Comparative Practice Study (Qualitative) This study will explore how factors related to the technology, patients, providers and organizational structures and processes influence the adoption and implementation of THC across selected sites (including micro-, meso- and macro-systems) in Ontario. Ethnographic study, in-depth semi-structured interviews and documentation collection and review will be employed to explore, among other factors, the behaviours, communication patterns, workflows and tasks of health care providers and their interaction with patients. Interviewees will be selected using purposive sampling.
Descriptive Study (Quantitative) The patterns of THC use will be evaluated by conducting a descriptive study based on the data routinely collected by the Ontario Telemedicine Newtrok that tracks all encounters (i.e. telephone calls, remote patient monitoring data transmission, face to face visits) between patients and THC providers. A randomly selected subset of THC participants/caregivers will also complete validated structured questionnaires at up to four time points during program, baseline, one, two, and three months after enrollment. These are the Quality of Life Profile Measure (SF12), Quality of Life Preference Measure (EQ5D), Telemedicine Perception Questionnaire (TMPQ), Stanford self-efficacy scale and Client Satisfaction Questionnaire (CSQ-8). The providers of THC will also be asked to complete questionnaires; physicians will be asked to complete Penn State Physician Telehomecare Survey, whereas the nurses will be asked to complete a Nurse Satisfaction Survey.
ICES Linkage Study (Quantitative) Primary collected research data will be linked to the Institute for Clinical Evaluative Sciences (ICES) administrative databases. Outcomes (i.e. hospitalizations, primary care visits) of patients receiving or have received Telehomecare, will be assessed for a period of 6 months prior to enrolment, during the program and for up to 6 months after discharge.
- Being tested
- In Depth interview, Observational fieldwork, Survey
- Keywords
- Program Evaluation, Telehomecare, Chronic Obstructive Pulmonary Disease, Heart Failure, LHINs, Local Health Integrative Network, OTN, Ontario Telemedicine Network
- 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.
In Depth interviewOther
In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.
Observational fieldworkOther
Observational fieldwork will conducted to observe everyday routine activities related to telehomecare. May last up to 1h per observation.
SurveyOther
Surveys with participants will be conducted using validated survey tools.
| Study group | Role | What they receive |
|---|---|---|
| Telehomecare patients | Observational fieldwork, in depth interviews and surveys up to 4 times will be conducted. Receives: Other: In Depth interview; Other: Observational fieldwork; Other: Survey | |
| Health care providers | In-Depth interviews, observational fieldwork and one time survey will be conducted. Receives: Other: In Depth interview; Other: Observational fieldwork; Other: Survey | |
| Telehomecare administrators | In depth interviews will be conducted Receives: Other: In Depth interview; Other: Observational fieldwork | |
| Telehomecare technicians | In-depth interviews, observational fieldwork will be conducted. Receives: Other: In Depth interview; Other: Observational fieldwork |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organizational Factors (Semi-structured interviews and general observation)
Those factors will be identified via qualitative research methods, hence no measurable units are applicable for them.
Semi-structured interviews and general observation of all types of participants will be done at different times/stages of program.
Measured: The data collection period will be approximately 3 months
Secondary outcomes (6)
Overall patterns of use (length of stay, drop out rates, nurse workload, etc.)
Participants' demographics, average length of stay within the program, drop out rates, nurses workload (number of patients per nurses), number of alerts per patients and per nurse.
Measured: Retrospectively using Ontario Telemedicine Network database, for all participants who were enrolled in the Telehomecare program. The data collection period will be approximately 3 months
Telemedicine perception (Telemedicine perception questionnaire (TMPQ))
Measured via Telemedicine perception questionnaire (TMPQ)
Measured: Prospectively at baseline, and at month 1, 2, 3 follow-up
Health services utilization (hospitalization, LOS, ED visits, etc.)
Number of hospitalizations, length of stay, ED visits, primary care visits, cost related to health services utilization. Will be done through linkage with ICES database
Measured: Retrospectively, six months before, during and after the Telehomecare program. Will be collected for the patients who completed the Telehomecare by the 28 Feb 2014.
Quality of life
Measured via EQ-5D and SF-12 questionnaires
Measured: Prospectively at baseline, and at month 1, 2, 3 follow-up
Client satisfaction (satisfaction questionnaire (CSQ-8)
Measured via client satisfaction questionnaire (CSQ-8)
Measured: Prospectively at baseline, and at month 1, 2, 3 follow-up
Chronic disease management (Stanford Chronic Disease Self-Management 33-item scale)
Measured via Stanford Chronic Disease Self-Management 33-item scale
Measured: Prospectively at baseline, and at month 1, 2, 3 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionSep 2018 (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
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Murray Krahn, University of Toronto
- Investigators
- Murray Krahn, MD,MSc, Principal investigator, THETA CollaborativeValeria Rac, MD, PhD, Principal investigator, THETA Collaborative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311114
- Sponsor's protocol ID
- 30158
- Acronym
- TLC
- Status last verified
- Mar 2018
- First submitted
- 27 Jun 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program Evaluation of Telehomecare for Patients With Heart Failure or Chronic Obstructive Pulmonary Disease: TeLeCare (TLC) Study
- ClinicalTrials.gov ID
- NCT02311114
- Acronym / sponsor ID
- TLC / 30158
- Keywords
- Program Evaluation, Telehomecare, Chronic Obstructive Pulmonary Disease, Heart Failure, LHINs, Local Health Integrative Network, OTN, Ontario Telemedicine Network
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 8 Dec 2014 (estimated)
- 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.
This study will evaluate the Telehomecare (THC) Program offered to patients with heart failure or chronic obstructive pulmonary disease across the Central West, Toronto Central and North East Local Health Integration Networks in Ontario. It will explore the opinions and experiences of patients, providers, technicians and administrators involved with THC Program in order to provide stakeholders with information about the processes and organizational factors impacting the program's adoption, the experiences of its participants, impact on patient outcomes, costs to the health-care system and who is benefiting the most from participating. These factors will be determined using semi-structured interviews, surveys, and observation of practices of everyone involved with THC. The study will also evaluate patient data to determine changes in patients' utilization of healthcare services.
Detailed description
The program evaluation will consist of three components that will employ two research methods, qualitative and quantitative.
Comparative Practice Study (Qualitative) This study will explore how factors related to the technology, patients, providers and organizational structures and processes influence the adoption and implementation of THC across selected sites (including micro-, meso- and macro-systems) in Ontario. Ethnographic study, in-depth semi-structured interviews and documentation collection and review will be employed to explore, among other factors, the behaviours, communication patterns, workflows and tasks of health care providers and their interaction with patients. Interviewees will be selected using purposive sampling.
Descriptive Study (Quantitative) The patterns of THC use will be evaluated by conducting a descriptive study based on the data routinely collected by the Ontario Telemedicine Newtrok that tracks all encounters (i.e. telephone calls, remote patient monitoring data transmission, face to face visits) between patients and THC providers. A randomly selected subset of THC participants/caregivers will also complete validated structured questionnaires at up to four time points during program, baseline, one, two, and three months after enrollment. These are the Quality of Life Profile Measure (SF12), Quality of Life Preference Measure (EQ5D), Telemedicine Perception Questionnaire (TMPQ), Stanford self-efficacy scale and Client Satisfaction Questionnaire (CSQ-8). The providers of THC will also be asked to complete questionnaires; physicians will be asked to complete Penn State Physician Telehomecare Survey, whereas the nurses will be asked to complete a Nurse Satisfaction Survey.
ICES Linkage Study (Quantitative) Primary collected research data will be linked to the Institute for Clinical Evaluative Sciences (ICES) administrative databases. Outcomes (i.e. hospitalizations, primary care visits) of patients receiving or have received Telehomecare, will be assessed for a period of 6 months prior to enrolment, during the program and for up to 6 months after discharge.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telehomecare patients | – | Other: In Depth interview, Other: Observational fieldwork, Other: SurveyObservational fieldwork, in depth interviews and surveys up to 4 times will be conducted. |
| Health care providers | – | Other: In Depth interview, Other: Observational fieldwork, Other: SurveyIn-Depth interviews, observational fieldwork and one time survey will be conducted. |
| Telehomecare administrators | – | Other: In Depth interview, Other: Observational fieldworkIn depth interviews will be conducted |
| Telehomecare technicians | – | Other: In Depth interview, Other: Observational fieldworkIn-depth interviews, observational fieldwork will be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health care providers, technicians, administrators/decision makers and patients enrolled in the Telehomecare Program.
Key inclusion criteria (20 listed)
- Patient
- The patient has a documented diagnosis of HF or COPD (with or without co-morbid conditions)
- The patient is 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
Key exclusion criteria (10 listed)
- Patient
- Less than 18 years of age
- Individuals without an established diagnosis of COPD or chronic 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In Depth interviewIn Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program. | Other | Health care providers, Telehomecare administrators, Telehomecare patients, Telehomecare technicians |
| Observational fieldworkObservational fieldwork will conducted to observe everyday routine activities related to telehomecare. May last up to 1h per observation. | Other | Health care providers, Telehomecare administrators, Telehomecare patients, Telehomecare technicians |
| SurveySurveys with participants will be conducted using validated survey tools. | Other | Health care providers, Telehomecare patients |
Primary outcome
Organizational Factors (Semi-structured interviews and general observation)
Time frame: The data collection period will be approximately 3 months
Those factors will be identified via qualitative research methods, hence no measurable units are applicable for them. Semi-structured interviews and general observation of all types of participants will be done at different times/stages of program.
6 secondary outcomes
Overall patterns of use (length of stay, drop out rates, nurse workload, etc.)
Time frame: Retrospectively using Ontario Telemedicine Network database, for all participants who were enrolled in the Telehomecare program. The data collection period will be approximately 3 months
Telemedicine perception (Telemedicine perception questionnaire (TMPQ))
Time frame: Prospectively at baseline, and at month 1, 2, 3 follow-up
Health services utilization (hospitalization, LOS, ED visits, etc.)
Time frame: Retrospectively, six months before, during and after the Telehomecare program. Will be collected for the patients who completed the Telehomecare by the 28 Feb 2014.
Quality of life
Time frame: Prospectively at baseline, and at month 1, 2, 3 follow-up
Client satisfaction (satisfaction questionnaire (CSQ-8)
Time frame: Prospectively at baseline, and at month 1, 2, 3 follow-up
Chronic disease management (Stanford Chronic Disease Self-Management 33-item scale)
Time frame: Prospectively at baseline, and at month 1, 2, 3 follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
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.
Murray Krahn, MD,MSc principal investigator
THETA Collaborative
Valeria Rac, MD, PhD principal investigator
THETA Collaborative
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 20 inclusion and 10 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 22 Mar 2018. 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?
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?
Organizational Factors (Semi-structured interviews and general observation) (time frame: The data collection period will be approximately 3 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 22 Mar 2018.