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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00300261
First received: March 6, 2006
Last updated: March 9, 2010
Last verified: March 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: Promoting Self Care Using Telehomecare: Impact on Outcomes

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

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
Active Comparator: 1 Behavioral: Control Group
Control group receives traditional episodes of Medicare or Medicare/Managed Care home care.
Experimental: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Kathryn H Bowles, PhD,RN University of Pennsylvania
  More Information

No publications provided

Responsible Party: Kathryn H. Bowles, PhD, RN, University of Pennsylvania, School of Nursing
ClinicalTrials.gov Identifier: NCT00300261     History of Changes
Other Study ID Numbers: 10003907, R01NR008923
Study First Received: March 6, 2006
Last Updated: March 9, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014