NCT00247000

Brief Summary

To demonstrate the safety, feasibility, quality of life, primary caregiver satisfaction, and cost effectiveness of integrated Home Telehealth care versus standard care in a heart failure clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
2 years until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 31, 2022

Status Verified

February 1, 2006

Enrollment Period

1.9 years

First QC Date

October 30, 2005

Last Update Submit

October 26, 2022

Conditions

Heart Failure

Keywords

Cardiovascular DiseasesHeart DiseaseHeart Failure,CongestiveHealth OutcomesDisease ManagementTelehomecareHome Telehealth

Outcome Measures

Primary Outcomes (1)

  • A composite of total all-cause hospitalizations and total mortality at one year.

    1 year

Secondary Outcomes (11)

  • Heart failure morbidity and mortality

    1 year

  • Cardiovascular hospitalization

    1 year

  • Total number days in hospital

    1 year

  • Total outpatient physician visits

    1 year

  • Number of non-scheduled health visits outside the home

    1 year

  • +6 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Home teleheatlh for heart failure management

Device: Routine Care in a HF clinic vs Home Telehealth Care for HF

2

ACTIVE COMPARATOR

Usual care for the management of Heart Failure

Device: Routine Care in a HF clinic vs Home Telehealth Care for HF

Interventions

Routine Care in a HF clinic vs Home Telehealth Care for HFDEVICE
12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subject's ≥ 18 years of age with a diagnosis of Heart Failure
  • Subject must reside in either the Province of Nova Scotia or New Brunswick
  • Subject has been hospitalized for heart failure during the past two years or has a known history of heart failure for a minimum of two years.
  • Subject must have a dedicated working telephone line in their primary place of residence.
  • Subject must have a grounded electrical power supply in their primary place of residence.
  • Primary care physician provides their agreement to participate in STARTEL

You may not qualify if:

  • Inability to understand the English or French language or understand the study and provide informed consent.
  • Absence of a suitable area to conduct the home telehealth visit in the patient's place of residence.
  • Physical impairment, which would prohibit the successful completion of a home telehealth visit, including attachment of the peripheral equipment (BP cuff, ability to stand on a scale, etc).
  • In cases 1 \& 3 only: a live in caregiver whose presence may overcome these limitations may allow the patient to be included in the study, however, only the patient's next of kin or duly appointed guardian (with documentation and with patient assent) may provide informed consent to participate).
  • Subject has a planned cardiac procedure such as open-heart surgery or percutaneous coronary intervention (PCI) within the next 6 months.
  • Subject has had cardiac surgery, percutaneous coronary intervention or a diagnosis of acute myocardial infarction within 1 month before randomization).
  • Condition where existing routine follow up occurs more than once weekly (i.e. hemodialysis, cancer treatment including: chemotherapy/radiation treatment). .
  • Patient is institutionalized (includes chronic care facility)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Brunswick Heart Centre, Atlantic Health Sciences Corporation

Saint John, New Brunswick, B2L 4L2, Canada

Location

MeSH Terms

Conditions

Heart FailureCardiovascular DiseasesHeart Diseases

Study Officials

  • Jonathan G Howlett, M.D.,FRCPC

    Capital District Health Authority, QEII Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2005

First Posted

November 1, 2005

Study Start

November 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2012

Last Updated

October 31, 2022

Record last verified: 2006-02

Locations

CA(1)