Lung CancerHTPLCNCT01670539
Home Telemonitoring for Patients With Lung Cancer
A study testing HomMed Telemonitor in people with Lung Cancer, run by West Virginia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- HomMed Telemonitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- are not discharged to home settings
- are discharged to hospice
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
WVU Mary Babb Randolph Cancer Center and Ruby Hospital
Morgantown, West Virginia, 26506
About this study
Official title: PILOT: Home Telemonitoring for Self-Management Education of Patients With Lung Ca
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.
Read the 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
- Conditions
- Lung Cancer
- Being tested
- HomMed Telemonitor
- Keywords
- Lung Cancer, Telemonitoring, Rural, Nursing
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomMed TelemonitorDevice
Also called Honeywell HomMed Genesis™ DM Remote Patient Care Monitor, http://hommed.com/Products/Genesis_DM.asp
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HomMed Telemonitor |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Telemonitor Data From Baseline: Temperature
Changes in temperature measured by telemonitor daily over 14 days after hospital discharge
Measured: 14 days
Changes in Telemonitor Data From Baseline: Pulse Rate
Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge
Measured: 14 days
Changes in Telemonitor Data From Baseline: Blood Pressure
Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge
Measured: 14 days
Changes in Telemonitor Data From Baseline: SpO2
Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge
Measured: 14 days
Changes in Telemonitor Data From Baseline: Weight
Changes in weight measured by telemonitor daily over 14 days after hospital discharge
Measured: 14 days
Secondary outcomes (3)
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.
Measured: 14 days
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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Georgia L Narsavage, PhD, MSN, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670539
- Sponsor's protocol ID
- H-22930
- Other IDs
- 1R15CA150999
- Acronym
- HTPLC
- Status last verified
- Dec 2021
- First submitted
- 9 Aug 2012
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 20957666Narsavage 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.
PubMed 12764721Narsavage 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.
PubMed 11111516
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT: Home Telemonitoring for Self-Management Education of Patients With Lung Ca
- ClinicalTrials.gov ID
- NCT01670539
- Acronym / sponsor ID
- HTPLC / H-22930
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Telemonitoring, Rural, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2011 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Posted 20 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitor | Experimental | Device: HomMed TelemonitorIn 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. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- are not discharged to home settings
- are discharged to hospice
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HomMed TelemonitorAlso: Honeywell HomMed Genesis™ DM Remote Patient Care Monitor, http://hommed.com/Products/Genesis_DM.aspA "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. | Device | Telemonitor |
Primary outcome
Changes in Telemonitor Data From Baseline: Temperature
Time frame: 14 days
Changes in temperature measured by telemonitor daily over 14 days after hospital discharge
Changes in Telemonitor Data From Baseline: Pulse Rate
Time frame: 14 days
Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge
Changes in Telemonitor Data From Baseline: Blood Pressure
Time frame: 14 days
Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge
Changes in Telemonitor Data From Baseline: SpO2
Time frame: 14 days
Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge
Changes in Telemonitor Data From Baseline: Weight
Time frame: 14 days
Changes in weight measured by telemonitor daily over 14 days after hospital discharge
3 secondary outcomes
Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea
Time frame: 14 days
Changes in Telemonitor Symptoms Recorded From Baseline: Functioning
Time frame: 14 days
Changes in Telemonitor Symptoms Recorded From Baseline: Pain
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20957666Chen 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.
- Background: PubMed 12764721Narsavage 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.
- Background: PubMed 11111516Narsavage 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgia L Narsavage, PhD, MSN principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HomMed Telemonitor in people with Lung Cancer, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Telemonitor Data From Baseline: Temperature (time frame: 14 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01670539, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.