Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R15CA150999 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitor | Experimental | 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. |
|
| Routine care for patients with lungCa | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HomMed Telemonitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Telemonitor Data From Baseline: Temperature | Changes in temperature measured by telemonitor daily over 14 days after hospital discharge | 14 days |
| Changes in Telemonitor Data From Baseline: Pulse Rate | Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge | 14 days |
| Changes in Telemonitor Data From Baseline: Blood Pressure | Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge | 14 days |
| Changes in Telemonitor Data From Baseline: SpO2 | Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge | 14 days |
| Changes in Telemonitor Data From Baseline: Weight | Changes in weight measured by telemonitor daily over 14 days after hospital discharge | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea | Numeric rating for dyspnea, from 0 to 10 with a lower number being a decrease in dysnea. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days. | 14 days |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Georgia L Narsavage, PhD, MSN | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Mary Babb Randolph Cancer Center and Ruby Hospital | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20957666 | Background | 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. | |
| 12764721 | Background | Narsavage G, Romeo E. Education and support needs of younger and older cancer survivors. Appl Nurs Res. 2003 May;16(2):103-9. doi: 10.1016/s0897-1897(03)00008-9. |
Not provided
Not provided
Two visits were needed in hospital to explain study prior to requesting consent in order to address literacy and provide opportunity for family member to be present. Time 1 data were collected at time of consent and then patients were assigned to groups prior to discharge.
Subjects were enrolled from West Virginia University Ruby Memorial Hospital (WVUH) and the Mary Babb Randolph Cancer Center (MBRCC) at WVUH. The study subject recruitment began in April, 2011 and terminated at the end of December 2012.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
PI has left the institution and a report about the results was found, but the information within the report is not always broken down between the arms.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telemonitor and Routine Care for Patients With lungCa | PI left the institution and demographic information was not broken down into arms. 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. 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). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Telemonitor Data From Baseline: Temperature | Changes in temperature measured by telemonitor daily over 14 days after hospital discharge | Results information was not available broken down by arm. | Posted | Mean | Full Range | Degrees Fahrenheit | 14 days |
|
Not provided
The PI left the institution and a small results document has been found, the documents does not contain adverse events information. All efforts were to made to retrieve adverse events information, but were unsuccessful.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Georgia L Narsavage | West Virginia University | 304-293-6729 | gnarsavage@hsc.wvu.edu |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Changes in Telemonitor Symptoms Recorded From Baseline: Functioning |
Pulmonary Functional Status Scale (PFSS-11) , scoring from 0 to 10 with increasing scores indicating an improvement in functioning. 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. |
| 14 days |
| Changes in Telemonitor Symptoms Recorded From Baseline: Pain | Numeric rating for pain (0 to 10 scale) with a lower number indicating less pain. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days. | 14 days |
| 11111516 | Background | 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. doi: 10.3928/0098-9134-20000501-08. |
| years |
|
| Sex: Female, Male | All efforts have been made to contact the PI, but the only available information is a small results document. The results information found was not always broken down by arm and the gender and race information provided include information from a 10 person sub-study. It cannot be determined which participants were from the sub-study, so information related to gender and race for this specific study cannot be determined. | All efforts have been made to contact the PI, but the only available information is a small results document. The results information found was not always broken down by arm and the gender and race information provided include information from a 10 person sub-study. It cannot be determined which participants were from the sub-study, so information related to gender and race for this specific study cannot be determined. | Count of Participants | Participants |
|
| Race (NIH/OMB) | All efforts have been made to contact the PI, but the only available information is a small results document. The results information found was not always broken down by arm and the gender and race information provided include information from a 10 person sub-study. It cannot be determined which participants were from the sub-study, so information related to gender and race for this specific study cannot be determined. | Count of Participants | Participants |
|
|
|
| Primary | Changes in Telemonitor Data From Baseline: Pulse Rate | Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge | Results information was not available broken down by arm | Posted | Mean | Full Range | beats per minutes (bpm) | 14 days |
|
|
|
| Primary | Changes in Telemonitor Data From Baseline: Blood Pressure | Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge | Results information was not available broken down by arm | Posted | Mean | Full Range | mmHg | 14 days |
|
|
|
| Primary | Changes in Telemonitor Data From Baseline: SpO2 | Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge | Results information was not available broken down by arm. | Posted | Mean | Full Range | percentage of oxygen | 14 days |
|
|
|
| Primary | Changes in Telemonitor Data From Baseline: Weight | Changes in weight measured by telemonitor daily over 14 days after hospital discharge | Results information was not available broken down by arm. | Posted | Mean | Full Range | pounds | 14 days |
|
|
|
| Secondary | Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea | Numeric rating for dyspnea, from 0 to 10 with a lower number being a decrease in dysnea. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days. | Posted | Mean | Inter-Quartile Range | score on a scale | 14 days |
|
|
|
| Secondary | Changes in Telemonitor Symptoms Recorded From Baseline: Functioning | Pulmonary Functional Status Scale (PFSS-11) , scoring from 0 to 10 with increasing scores indicating an improvement in functioning. 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. | Posted | Mean | Inter-Quartile Range | score on a scale | 14 days |
|
|
|
| Secondary | Changes in Telemonitor Symptoms Recorded From Baseline: Pain | Numeric rating for pain (0 to 10 scale) with a lower number indicating less pain. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days. | Posted | Mean | Inter-Quartile Range | score on a scale | 14 days |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |