Home Telerehabilitation for Deconditioned Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00386256
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition: Osteoarthritis
Interventions: Device: Health Buddy, Home telehealth technology
Other: Telephone counseling

  Participant Flow

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
No text entered.

Reporting Groups
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 16   15   4   3   38 
[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 
[Units: Years]
Mean (Standard Deviation)
 69.9  (7.9)   65  (6.1)   78  (4.7)   76  (7.5)   72.2  (6.6) 
[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

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

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

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

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

Responsible Party: VA Office of Research and Development Identifier: NCT00386256     History of Changes
Obsolete Identifiers: NCT00929149
Other Study ID Numbers: E4204-R
First Submitted: October 6, 2006
First Posted: October 11, 2006
Results First Submitted: September 11, 2013
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014