Testing the Effects of Telehealth Monitoring on Rehospitalization and Self Care for Heart Failure Patients in Home Care - Full Text View

Sponsored by:	National Institute of Nursing Research (NINR)
Information provided by:	National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:	NCT00300261

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Behavioral: Control Group Behavioral: Experimental Group	Phase III

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Investigator), Active Control, Single Group Assignment
Official Title:	Promoting Self Care Using Telehomecare: Impact on Outcomes

Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:

To learn if using telehealth technology equipment results in improved self care and decreased incidence of rehospitalization. [ Time Frame: 60, 120 and 180 days from baseline. ] [ Designated as safety issue: No ]

Estimated Enrollment:	216
Study Start Date:	September 2005
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Behavioral: Control Group Control group receives traditional episodes of Medicare or Medicare/Managed Care home care.
2: Experimental	Behavioral: Experimental Group 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.

Arms

Assigned Interventions

1: Active Comparator

Behavioral: Control Group

Control group receives traditional episodes of Medicare or Medicare/Managed Care home care.

2: Experimental

Behavioral: Experimental Group

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.

Detailed Description:

Despite telehomecare's potential to enhance patients' self-care in a cost-effective manner, few studies have evaluated its efficacy. Reported studies were conducted prior to the introduction of Medicare's prospective payment system for home care and evaluated the use of telehomecare in addition to traditional home visits. None examined patients' involvement in decision-making regarding the use of such technology in meeting their health care needs. Available data suggest that telehomecare may improve self-care and enhance outcomes for elders with heart failure but major gaps in knowledge exist regarding the clinical and cost effectiveness of this technology when decisions regarding its use are negotiated with patients and when it substitutes for traditional nurse visits under the recently introduced changes in the financing of home health care.

Patient and cost outcomes will include: self-care, health care resource utilization, health status, quality of life, satisfaction, access to care and cost effectiveness. Data analysis will consist of a variety of statistical tests, and estimates of treatment costs. Findings will help guide optimal use of telehomecare in promoting self-care in the growing population of chronically ill elders whose conditions are characterized by high morbidity, complex therapies and poor quality and cost outcomes.

Subjects will be enrolled from the acute care setting and will be randomized to receive home care with or without telehealth monitoring. Baseline and follow-up interviews will be conducted at admission, 60, 120 and 180 days.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300261

Contacts

Contact: Kathryn H Bowles, PhD,RN

215-898-0323

bowles@nursing.upenn.edu

Locations

United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kathryn H Bowles, PhD,RN 215-898-0323 bowles@nursing.upenn.edu
Principal Investigator: Kathryn H Bowles, PhD,RN

Sponsors and Collaborators

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:

Kathryn H Bowles, PhD,RN

University of Pennsylvania

More Information

Responsible Party:	University of Pennsylvania, School of Nursing ( Kathryn H. Bowles, PhD, RN )
Study ID Numbers:	10003907
Study First Received:	March 6, 2006
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00300261
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):

Heart Failure

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009