NCT00386256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

August 15, 2014

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

1.6 years

First QC Date

October 6, 2006

Results QC Date

September 11, 2013

Last Update Submit

August 12, 2014

Conditions

Keywords

telehealthtelerehabilitationdeconditioningexercise

Outcome Measures

Primary Outcomes (2)

  • Exercise Adherence

    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

    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

Study Arms (4)

Health Buddy outpatient

EXPERIMENTAL

Received home telehealth monitoring by Health Buddy

Device: Health Buddy, Home telehealth technology

Telephone outpatient

EXPERIMENTAL
Other: Telephone counseling

health buddy inpatient

EXPERIMENTAL
Device: Health Buddy, Home telehealth technology

telephone inpatient

EXPERIMENTAL
Other: Telephone counseling

Interventions

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.

Health Buddy outpatienthealth buddy inpatient
Telephone outpatienttelephone inpatient

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

Related Publications (1)

  • 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. doi: 10.1682/jrrd.2009.09.0149.

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Nancy Harada, PhD
Organization
VA Greater Los Angeles Healthcare System

Study Officials

  • Nancy D. Harada, PhD MPA

    VA Greater Los Angeles Healthcare System, West LA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2006

First Posted

October 11, 2006

Study Start

October 1, 2006

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

August 15, 2014

Results First Posted

August 15, 2014

Record last verified: 2014-08

Locations