- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01670539
Home Telemonitoring for Patients With Lung Cancer (HTPLC)
23. september 2022 opdateret af: West Virginia University
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.
Studieoversigt
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
47
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26506
- WVU Mary Babb Randolph Cancer Center and Ruby Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
Andre navne:
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Changes in Telemonitor Data From Baseline: Temperature
Tidsramme: 14 days
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Changes in temperature measured by telemonitor daily over 14 days after hospital discharge
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14 days
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Changes in Telemonitor Data From Baseline: Pulse Rate
Tidsramme: 14 days
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Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge
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14 days
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Changes in Telemonitor Data From Baseline: Blood Pressure
Tidsramme: 14 days
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Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge
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14 days
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Changes in Telemonitor Data From Baseline: SpO2
Tidsramme: 14 days
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Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge
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14 days
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Changes in Telemonitor Data From Baseline: Weight
Tidsramme: 14 days
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Changes in weight measured by telemonitor daily over 14 days after hospital discharge
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14 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea
Tidsramme: 14 days
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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.
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14 days
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Changes in Telemonitor Symptoms Recorded From Baseline: Functioning
Tidsramme: 14 days
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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.
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14 days
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Changes in Telemonitor Symptoms Recorded From Baseline: Pain
Tidsramme: 14 days
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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.
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14 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Georgia L Narsavage, PhD, MSN, West Virginia University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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. doi: 10.1016/s0897-1897(03)00008-9.
- 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. doi: 10.3928/0098-9134-20000501-08.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2011
Primær færdiggørelse (Faktiske)
1. december 2012
Studieafslutning (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først indsendt
9. august 2012
Først indsendt, der opfyldte QC-kriterier
21. august 2012
Først opslået (Skøn)
22. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. oktober 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. september 2022
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-22930
- 1R15CA150999 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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