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Home Telerehabilitation for Deconditioned Older Adults

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ClinicalTrials.gov Identifier: NCT00386256
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Health Buddy, Home telehealth technology Other: Telephone counseling Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Home Based Telerehabilitation for Deconditioned Older Adults
Study Start Date : October 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Health Buddy outpatient
Received home telehealth monitoring by Health Buddy
 Device: Health Buddy, 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.
Experimental: Telephone outpatient Other: Telephone counseling
Experimental: health buddy inpatient Device: Health Buddy, 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.
Experimental: telephone inpatient Other: Telephone counseling


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386256


Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Nancy D. Harada, PhD MPA VA Greater Los Angeles Healthcare System, West LA
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00386256     History of Changes
Obsolete Identifiers: NCT00929149
Other Study ID Numbers: E4204-R
First Posted: October 11, 2006    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014
Last Verified: August 2014

Keywords provided by VA Office of Research and Development:
telehealth
telerehabilitation
deconditioning
exercise

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases