Home Telerehabilitation for Deconditioned Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00386256
First received: October 6, 2006
Last updated: August 12, 2014
Last verified: August 2014
Results First Received: September 11, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Osteoarthritis
Interventions: Device: Health Buddy, Home telehealth technology
Other: Telephone counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from both the inpatient and outpatient settings of a large urban academic VA hospital. Potential participants were recruited through referrals from physicians, case managers, and social workers, participant recruitment fairs, and flyers posted around the hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None.

Reporting Groups
  Description
Health Buddy Outpatient 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.
Telephone Outpatient No text entered.
Health Buddy Inpatient No text entered.
Telephone Inpatient No text entered.

Participant Flow:   Overall Study
    Health Buddy Outpatient     Telephone Outpatient     Health Buddy Inpatient     Telephone Inpatient  
STARTED     16     15     4     3  
COMPLETED     16     15     4     3  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Health Buddy Outpatient Received Health Buddy, recruited from outpatient setting
Telephone Outpatient Received telephone counseling, recruited from outpatient setting
Health Buddy Inpatient Received Health Buddy, recruited from inpatient setting
Telephone Inpatient Received telephone counseling, recruited from inpatient setting
Total Total of all reporting groups

Baseline Measures
    Health Buddy Outpatient     Telephone Outpatient     Health Buddy Inpatient     Telephone Inpatient     Total  
Number of Participants  
[units: participants]
  16     15     4     3     38  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     1     1     0     0     2  
>=65 years     15     14     4     3     36  
Age  
[units: years]
Mean ± Standard Deviation
  69.9  ± 7.9     65  ± 6.1     78  ± 4.7     76  ± 7.5     72.2  ± 6.6  
Gender  
[units: participants]
         
Female     0     0     0     0     0  
Male     16     15     4     3     38  
Region of Enrollment  
[units: participants]
         
United States     16     15     4     3     38  



  Outcome Measures
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1.  Primary:   Exercise Adherence   [ Time Frame: at monthly intervals, for 3-months ]

2.  Primary:   HB/Phone Adherence   [ Time Frame: Monthly over 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Intervention was developed on a male Veteran population, direct comparisons between groups were formed based on the participant’s preference, exercise adherence was based on participants’ self reports, small convenience sample.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nancy Harada, PhD
Organization: VA Greater Los Angeles Healthcare System
phone: 310-268-3632
e-mail: Nancy.Harada@va.gov


No publications provided by Department of Veterans Affairs

Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00386256     History of Changes
Obsolete Identifiers: NCT00929149
Other Study ID Numbers: E4204-R
Study First Received: October 6, 2006
Results First Received: September 11, 2013
Last Updated: August 12, 2014
Health Authority: United States: Federal Government