Home Telemonitoring for Patients With Lung Cancer (HTPLC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by West Virginia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Georgia L. Narsavage, PhD, RN, West Virginia University
ClinicalTrials.gov Identifier:
NCT01670539
First received: August 9, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to learn more about using a home machine "Telemonitor" to find problems people with lung cancer may have after being discharged from the hospital and help them manage problems by contacting their healthcare provider.The study hypothesis is that patients with lung CA using short-term (14 days)home telemonitors, educated/coached by nurses on telemonitor data risks/implications for the first two weeks after hospital discharge, will be able to self-report their signs/ symptoms to the clinician resulting in decreased use of costly health care resources over 60 days.


Condition Intervention
Lung Cancer
Device: HomMed Telemonitor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: PILOT: Home Telemonitoring for Self-Management Education of Patients With Lung Ca

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Changes in telemonitor data from baseline to Time 3 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Changes in temperature, pulse rate, blood pressure, SpO2 and weight are measured by telemonitor daily over 14 days after hospital discharge


Secondary Outcome Measures:
  • Changes in telemonitor symptoms recorded from baseline to Time 3: dyspnea [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days.

  • Changes in telemonitor symptoms recorded from baseline to Time 3:functioning [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : general functioning activities, are collected daily via telemonitor for 14 days.

  • Changes in telemonitor symptoms recorded from baseline to Time 3: pain [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days.


Other Outcome Measures:
  • Changes in function and satisfaction from baseline to Time 5 [ Time Frame: 2 weeks, 1 month, 2 months ] [ Designated as safety issue: No ]
    Measures of functional status (PFSS-11), Quality of Life (QOL-5), and patient/family satisfaction (In-study form) are measured at baseline on hospital discharge, at 14 days, at one month and at two months.

  • Changes in nurse/physician contact, treatment changes, healthcare resource use [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Numbers of nurse/physician contact, treatment changes, and non-scheduled healthcare visits from study entry to 2 month end-point are described


Estimated Enrollment: 70
Study Start Date: June 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemonitor
In addition to routine care, the "HomMed Telemonitor" wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.
Device: HomMed Telemonitor
A "HomMed Telemonitor" wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses.
Other Names:
  • Honeywell HomMed Genesis™ DM Remote Patient Care Monitor
  • http://hommed.com/Products/Genesis_DM.asp
No Intervention: Routine care for patients with lungCa
Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670539

Contacts
Contact: Chuck Coole, BA 304-293-8050 ccoole@hsc.wvu.edu
Contact: Trisha Petitte, MSN 304-293-1084 tpetitte@hsc.wvu.edu

Locations
United States, West Virginia
WVU Mary Babb Randolph Cancer Center and Ruby Hospital Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Georgia L Narsavage, PhD, RN    304-293-6521    gnarsavage@hsc.wvu.edu   
Principal Investigator: Georgia L Narsavage, PhD, RN         
Principal Investigator: Yea-Jyh (Kathy) Chen, PhD, RN         
Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Georgia L Narsavage, PhD, MSN West Virginia University
  More Information

Publications:
Responsible Party: Georgia L. Narsavage, PhD, RN, Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT01670539     History of Changes
Other Study ID Numbers: H-22930, 1R15CA150999
Study First Received: August 9, 2012
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by West Virginia University:
Lung Cancer
Telemonitoring
Rural
Nursing

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014