- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386256
Home Telerehabilitation for Deconditioned Older Adults
August 12, 2014 updated by: US Department of Veterans Affairs
Home Based Telerehabilitation for Deconditioned Older Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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West Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare System, West LA
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health Buddy outpatient
Received home telehealth monitoring by Health Buddy
|
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.
|
|
Experimental: Telephone outpatient
|
|
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Experimental: health buddy inpatient
|
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.
|
|
Experimental: telephone inpatient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise Adherence
Time Frame: at monthly intervals, for 3-months
|
An 11-week exercise adherence rate was calculated by dividing the total number of days that the participant reported exercising by 77 days and multiplying by 100.
This first calculation estimated the exercise adherence rate for the full intervention period regardless of participant dropout.
Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.
|
at monthly intervals, for 3-months
|
|
HB/Phone Adherence
Time Frame: Monthly over 3 months
|
An 11-week text messaging or phone adherence rate was calculated by dividing the number of response days via the HB or phone divided by 77 days and multiplied by 100.
This first calculation estimated the text messaging or phone adherence rate for the full intervention period regardless of participant dropout.
Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.
|
Monthly over 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nancy D. Harada, PhD MPA, VA Greater Los Angeles Healthcare System, West LA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
October 6, 2006
First Submitted That Met QC Criteria
October 10, 2006
First Posted (Estimate)
October 11, 2006
Study Record Updates
Last Update Posted (Estimate)
August 15, 2014
Last Update Submitted That Met QC Criteria
August 12, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E4204-R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.