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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT00300261

Collaborator

National Institute of Nursing Research (NINR) (NIH)

216

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Behavioral: Telehealth monitoring	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Official Title:

Promoting Self Care Using Telehomecare: Impact on Outcomes

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 receives home care
Experimental: 2 receives telehealth monitoring in addition to home care	Behavioral: Telehealth monitoring 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.

Arm

Intervention/Treatment

No Intervention: 1

receives home care

Experimental: 2

receives telehealth monitoring in addition to home care

Behavioral: Telehealth monitoring

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.

Outcome Measures

Primary Outcome Measures

To learn if using telehealth technology equipment results in improved self care and decreased incidence of rehospitalization. [60, 120 and 180 days from baseline.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania
National Institute of Nursing Research (NINR)

Investigators

Principal Investigator: Kathryn H Bowles, PhD,RN, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kathryn Bowles, van Ameringen Professor in Nursing Excellence, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT00300261

Other Study ID Numbers:

10003907
R01NR008923

First Posted:

Mar 8, 2006

Last Update Posted:

Dec 2, 2015

Last Verified:

Mar 1, 2010

Keywords provided by Kathryn Bowles, van Ameringen Professor in Nursing Excellence, University of Pennsylvania

Heart Failure

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Dec 2, 2015