NCT00300261

Brief Summary

We are testing the use of telehealth technology that includes self monitoring of blood pressure, weight, blood sugar, and oxygen levels for patients with heart failure who are receiving home care. We are interested to learn if using the equipment results in improved self care and decreased incidence of rehospitalization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P50-P75 for phase_3 heart-failure

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_3 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 2, 2015

Status Verified

March 1, 2010

Enrollment Period

4.8 years

First QC Date

March 6, 2006

Last Update Submit

November 30, 2015

Conditions

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • To learn if using telehealth technology equipment results in improved self care and decreased incidence of rehospitalization.

    60, 120 and 180 days from baseline.

Study Arms (2)

1

NO INTERVENTION

receives home care

2

EXPERIMENTAL

receives telehealth monitoring in addition to home care

Behavioral: Telehealth monitoring

Interventions

Experimental group receives telehealth monitoring equipment in their homes for the duration of home care. Equipment includes blood pressure cuff, scale, and pulse oximeter, or glucometer as needed. Two home care nurses provide video visits with subjects on the days when the home care nurse does not visit. Patients use the equipment daily and the results are downloaded to the nurse's computer at the home care agency where they are checked daily. The nurse acts on any abnormal readings by calling the patient, the home care nurse, or the physician.

2

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of heart failure, English speaking; mentally competent, weigh less than 450 pounds, have a telephone in their home; have Medicare insurance; are able to see, hear, place a cuff on their arm, and stand on a scale to weigh themselves, receiving home care from Penn Care at Home.

You may not qualify if:

  • cognitive impairment, weight \> 450 pounds, receiving disease management or on a heart transplant waiting list, receiving home care from a non- participating agency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Kathryn H Bowles, PhD,RN

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
van Ameringen Professor in Nursing Excellence

Study Record Dates

First Submitted

March 6, 2006

First Posted

March 8, 2006

Study Start

September 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

December 2, 2015

Record last verified: 2010-03

Locations