Home Telemonitoring for Patients With Lung Cancer (HTPLC)

• ClinicalTrials.gov Identifier: NCT01670539
• Recruitment Status: Unknown
• First Posted: August 22, 2012
• Last Update Posted: August 22, 2012
• Sponsor: West Virginia University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Georgia L. Narsavage, PhD, RN, West Virginia University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Lung Cancer	Device: HomMed Telemonitor	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: PILOT: Home Telemonitoring for Self-Management Education of Patients With Lung Ca
• Study Start Date: June 2010
• Estimated Primary Completion Date: December 2012
• Estimated Study Completion Date: May 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Changes in telemonitor data from baseline to Time 3 [ Time Frame: 14 days ]
   Changes in temperature, pulse rate, blood pressure, SpO2 and weight are measured by telemonitor daily over 14 days after hospital discharge

Secondary Outcome Measures :

1. Changes in telemonitor symptoms recorded from baseline to Time 3: dyspnea [ Time Frame: 14 days ]
   Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days.
2. Changes in telemonitor symptoms recorded from baseline to Time 3:functioning [ Time Frame: 14 days ]
   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.
3. Changes in telemonitor symptoms recorded from baseline to Time 3: pain [ Time Frame: 14 days ]
   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:

1. Changes in function and satisfaction from baseline to Time 5 [ Time Frame: 2 weeks, 1 month, 2 months ]
   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.
2. Changes in nurse/physician contact, treatment changes, healthcare resource use [ Time Frame: 2 months ]
   Numbers of nurse/physician contact, treatment changes, and non-scheduled healthcare visits from study entry to 2 month end-point are described

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Georgia L Narsavage, PhD, MSN; West Virginia University

More Information

Publications:

Chen YJ, Narsavage GL, Culp SL, Weaver TE. The development and psychometric analysis of the short-form Pulmonary Functional Status Scale (PFSS-11). Res Nurs Health. 2010 Dec;33(6):477-85. doi: 10.1002/nur.20403. Epub 2010 Oct 18.

Narsavage G, Romeo E. Education and support needs of younger and older cancer survivors. Appl Nurs Res. 2003 May;16(2):103-9.

Narsavage GL, Naylor MD. Factors associated with referral of elderly individuals with cardiac and pulmonary disorders for home care services following hospital discharge. J Gerontol Nurs. 2000 May;26(5):14-20.

• Responsible Party: Georgia L. Narsavage, PhD, RN, Professor, West Virginia University
• ClinicalTrials.gov Identifier: NCT01670539
• Other Study ID Numbers: H-22930; 1R15CA150999 ( U.S. NIH Grant/Contract )
• First Posted: August 22, 2012
• Last Update Posted: August 22, 2012
• Last Verified: August 2012

Keywords provided by Georgia L. Narsavage, PhD, RN, 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; Triamcinolone; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs