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PILOT: Home Telemonitoring for Self-Management Education of Patients With Lung Ca


N/A
45 Years
90 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

PILOT: Home Telemonitoring for Self-Management Education of Patients With Lung Ca


All patients in the study will receive usual care after hospital discharge. This study also
involves an interview and review of your medical records, and uses the "telemonitor" machine
to measure your temperature, pulse, oxygen level,weight and blood pressure. The telemonitor
will also ask you to press YES or NO buttons in response to questions on your symptoms such
as difficulty breathing. Research nurses will come to your home 3 times and it will take
about 30 minutes for each visit for the nurse to record the information using the
telemonitor. You will also be asked to fill out a survey about your ability to do activities
and your health status. This will take approximately another 30 minutes. You may or may not
receive the small telemonitor (about as big as a large book) for 14 days after discharge to
provide additional information to the researchers. If you receive the monitor for the full
14 days, you or someone you ask us to train will be taught to use the monitor every morning
to collect information on how you will "talk" to you to tell you to put a blood pressure
cuff on your arm and an oxygen measurer on your finger. You will step on a scale to take
your weight and you will use a forehead sensor to take your temperature. The blood pressure,
weight, temperature, your pulse, and your oxygen level will be recorded by the monitor. It
will then ask you at least 10 questions and you will push a yes or no button indicating how
much difficulty you are having with your daily activities and shortness of breath. The
monitor will then connect to your telephone line using a no-charge "800" number and transmit
the information to the researchers. If you do not have a phone, a special antenna will be
connected to the monitor to transmit the information wirelessly. The nurse will call you
every day for the 14 days when you have the monitor. If you do not receive the monitor for
the full 14 days, you will still have the monitor used by the nurse when you are visited at
least 3 times at home to gather information on how you are doing after hospital discharge.
These home monitor visits will be within 2 days after discharge, 2 weeks after discharge,
and 2 months after discharge. The main difference is that the monitor will not be left in
your home but will be brought by the nurse on each visit. You will also receive a phone call
to ask you questions about the study at 1 month after discharge. If you do not have a phone,
you will receive another home visit. Whether or not you get the monitor for the full 14 days
will be determined randomly by computer before the nurse visits you at home the first time.
are doing. The monitor will turn on each day at the same time; the monitor


Inclusion Criteria:



(1) patients admitted to the hospital for lung CA as a primary or secondary diagnosis; (2)
at least 45 years of age and up to 90 years old; (3) stable mental status and ability to
speak (but not necessarily read) the primary language of the region (English).

Exclusion Criteria:

1. are not discharged to home settings

2. are discharged to hospice

3. display a verbalized inability to understand or answer the questionnaires, (4) are
disqualified at the discretion of the treating physician, and/or (4) live beyond a 75
mile radius of the hospital.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Changes in telemonitor data from baseline to Time 3

Outcome Description:

Changes in temperature, pulse rate, blood pressure, SpO2 and weight are measured by telemonitor daily over 14 days after hospital discharge

Outcome Time Frame:

14 days

Safety Issue:

Yes

Principal Investigator

Georgia L Narsavage, PhD, MSN

Investigator Role:

Principal Investigator

Investigator Affiliation:

West Virginia University

Authority:

United States: Institutional Review Board

Study ID:

H-22930

NCT ID:

NCT01670539

Start Date:

June 2010

Completion Date:

May 2013

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Telemonitoring
  • Rural
  • Nursing
  • Lung Neoplasms

Name

Location

WVU Mary Babb Randolph Cancer Center and Ruby Hospital Morgantown, West Virginia  26506