NCT02311114

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

June 27, 2014

Last Update Submit

March 21, 2018

Conditions

Keywords

Program EvaluationTelehomecareChronic Obstructive Pulmonary DiseaseHeart FailureLHINsLocal Health Integrative NetworkOTNOntario Telemedicine Network

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.)

    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))

    Prospectively at baseline, and at month 1, 2, 3 follow-up

  • Health services utilization (hospitalization, LOS, ED visits, etc.)

    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

    Prospectively at baseline, and at month 1, 2, 3 follow-up

  • Client satisfaction (satisfaction questionnaire (CSQ-8)

    Prospectively at baseline, and at month 1, 2, 3 follow-up

  • +1 more secondary outcomes

Study Arms (4)

Telehomecare patients

Observational fieldwork, in depth interviews and surveys up to 4 times will be conducted.

Other: In Depth interviewOther: Observational fieldworkOther: Survey

Health care providers

In-Depth interviews, observational fieldwork and one time survey will be conducted.

Other: In Depth interviewOther: Observational fieldworkOther: Survey

Telehomecare administrators

In depth interviews will be conducted

Other: In Depth interviewOther: Observational fieldwork

Telehomecare technicians

In-depth interviews, observational fieldwork will be conducted.

Other: In Depth interviewOther: Observational fieldwork

Interventions

In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.

Health care providersTelehomecare administratorsTelehomecare patientsTelehomecare technicians

Observational fieldwork will conducted to observe everyday routine activities related to telehomecare. May last up to 1h per observation.

Health care providersTelehomecare administratorsTelehomecare patientsTelehomecare technicians
SurveyOTHER

Surveys with participants will be conducted using validated survey tools.

Health care providersTelehomecare patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health care providers, technicians, administrators/decision makers and patients enrolled in the Telehomecare Program.

You may qualify if:

  • 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
  • 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
  • +5 more criteria

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Canada

Location

MeSH Terms

Conditions

Heart FailurePulmonary Disease, Chronic Obstructive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Murray Krahn, MD,MSc

    THETA Collaborative

    PRINCIPAL INVESTIGATOR
  • Valeria Rac, MD, PhD

    THETA Collaborative

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD MSc

Study Record Dates

First Submitted

June 27, 2014

First Posted

December 8, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

September 1, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations