Home Telerehabilitation for Deconditioned Older Adults

This study has been completed.

Sponsor:

Information provided by:

Department of Veterans Affairs

ClinicalTrials.gov Identifier:

NCT00386256

First received: October 6, 2006

Last updated: February 10, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2006

Last Updated Date

February 10, 2009

Start Date ^ICMJE

October 2006

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Six-Minute Walk Test [ Time Frame: at monthly intervals, for 3-months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

SF-8 Health Survey,
Timed Get Up and Go Test,IADL Index,motor subscale of the FIM,
SF-8 Health Survey,grip strength,and patient satisfaction—all
at the end of 3 months.
Determine changes from baseline for the following
outcome measures: Timed Get Up and Go Test,
IADL Index,
motor subscale of the FIM,
grip strength, and
patient satisfaction
—all at the end of 3 months.

Change History

Complete list of historical versions of study NCT00386256 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Home Telerehabilitation for Deconditioned Older Adults

Official Title ^ICMJE

Home Based Telerehabilitation for Deconditioned Older Adults

Brief Summary

The purpose of this study is to develop a home exercise program for patients 60 years of age and over who are deconditioned following their discharge from the hospital, or recruited from GLA outpatient clinics. The program will be designed to monitor and improve patients' exercise behavior through the use of home technology, such as text messaging monitors.

Detailed Description

The aim of this study is to develop and determine the feasibility of implementing a home exercise and functional status monitoring telerehabilitation program, known as TEL-REHAB, for older adults 60 years of age and over who are deconditioned following their discharge from the inpatient setting, or recruited from GLA outpatient clinics. Deconditioning is a modifiable risk factor for preventing institutionalization of frail elderly patients who would otherwise be able to live independently. Home exercise programs are an effective intervention to reduce the risk, but patient compliance with home exercise programs, and assessments of patients during home exercise programs, are barriers to achieving maximal benefits. Face-to-face visits with physical medicine professionals are an effective means to perform these functions, but are problematic because of professional time impacts and patient transportation problems. A TEL-REHAB program will empower these patients to take responsibility for their own health by providing ongoing communication with a healthcare provider. In this way, telerehabilitation may assist older adults to remain independent in their homes as long as possible.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Telemedicine

Intervention ^ICMJE

Device: Health Buddy(R), Home telehealth technology

Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.

Study Arm (s)

feasibility study

Intervention: Device: Health Buddy(R), Home telehealth technology

Publications *

Harada ND, Dhanani S, Elrod M, Hahn T, Kleinman L, Fang M. Feasibility study of home telerehabilitation for physically inactive veterans. J Rehabil Res Dev. 2010;47(5):465-75.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

acute decline in functional status while hospitalized as reported by the patient
physically inactive outpatients (exercise less than 30 min/day, 3 d/wk)
ability to hear and communicate via telephone
ability to read a video or text monitor
ability to manually operate the technology
have a working telephone and power source
willingness to use the TEL-REHAB technology

Exclusion Criteria:

does not speak English
poor cognition as determined by the Mini-Cog
non-ambulatory
had a stroke, myocardial infarction, hip fracture, or total hip or knee replacement within the prior 6 months

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00386256

Other Study ID Numbers ^ICMJE

E4204R

Has Data Monitoring Committee

Responsible Party

Harada, Nancy - Principal Investigator, Department of Veterans Affairs

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nancy D. Harada, PhD MPA

VA Greater Los Angeles Healthcare System, West LA

Information Provided By

Department of Veterans Affairs

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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