An Evaluation of Home-Based Telemedicine Services

Diabetes Clinical Trial

Official title:

An Evaluation of Home-Based Telemedicine Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105846
• Other study ID #: TEL 20-015
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2005
• Last updated: April 6, 2015
• Est. completion date: June 2004

Study information

• Verified date: February 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.

Description:

Background:

Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.

Objectives:

The primary objectives were to determine if tele-home health care patients, compared with patients receiving usual home care, have:1) higher levels of health related quality of life and home care satisfaction; 2) fewer inpatient admissions, hospital stays, and outpatient and emergency room visits; and 3) higher levels of home care access, in terms of the total number of contacts between HBPC nurses and patients.

Methods:

Patients were randomly assigned to the intervention or to the control group. Video tele-health units were installed in patient homes for the intervention group, and control group patients received usual home care services. Baseline and six month follow up surveys included questions on perceived health related quality of life and home care satisfaction. T-tests were used to compare intervention and control group members in terms of six month changes in health related quality of life and satisfaction with home care. Multivariate analyses were used to assess group differences in six month health care service use, with prior service use and survival included as covariates.

Status:

The study is completed, with a final enrollment of 37 patients. Three study manuscrip[ts have been completed (two published and one under review).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients must be enrolled in the home care program at the Indianapolis VAMC and have at least: (a) 6 outpatient visits, one hospitalization, or 2 or more emergency room visits in the last twelve months, (b) a care plan specifying two or more skilled nursing visits per month, (c) an expected need for future home care visits for at least one month.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Diabetes
• Heart Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Home care telemedicine

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hopp F, Woodbridge P, Subramanian U, Copeland L, Smith D, Lowery J. Outcomes associated with a home care telehealth intervention. Telemed J E Health. 2006 Jun;12(3):297-307. — View Citation

Hopp F, Woodbridge P, Subramanian U, Copeland L, Smith D. Home telehealth's role in diabetes case management. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2005 Apr 1; 11:220.

Subramanian U, Hopp F, Lowery J, Woodbridge P, Smith D. Research in home-care telemedicine: challenges in patient recruitment. Telemed J E Health. 2004 Summer;10(2):155-61. — View Citation