Home Telemonitoring for Patients With Lung Cancer (HTPLC)
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|ClinicalTrials.gov Identifier: NCT01670539|
Recruitment Status : Unknown
Verified August 2012 by Georgia L. Narsavage, PhD, RN, West Virginia University.
Recruitment status was: Recruiting
First Posted : August 22, 2012
Last Update Posted : August 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Device: HomMed Telemonitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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|
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.
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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670539
|Contact: Chuck Coole, BAfirstname.lastname@example.org|
|Contact: Trisha Petitte, MSNemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Georgia L Narsavage, PhD, RN|
|Principal Investigator: Yea-Jyh (Kathy) Chen, PhD, RN|
|Principal Investigator:||Georgia L Narsavage, PhD, MSN||West Virginia University|