- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01670539
Home Telemonitoring for Patients With Lung Cancer (HTPLC)
23. September 2022 aktualisiert von: 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.
Studienübersicht
Detaillierte Beschreibung
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
Studientyp
Interventionell
Einschreibung (Tatsächlich)
47
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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West Virginia
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Morgantown, West Virginia, Vereinigte Staaten, 26506
- WVU Mary Babb Randolph Cancer Center and Ruby Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
45 Jahre bis 90 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
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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.
Andere Namen:
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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes in Telemonitor Data From Baseline: Temperature
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Georgia L Narsavage, PhD, MSN, West Virginia University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. April 2011
Primärer Abschluss (Tatsächlich)
1. Dezember 2012
Studienabschluss (Tatsächlich)
1. Juni 2013
Studienanmeldedaten
Zuerst eingereicht
9. August 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. August 2012
Zuerst gepostet (Schätzen)
22. August 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Oktober 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
23. September 2022
Zuletzt verifiziert
1. Dezember 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H-22930
- 1R15CA150999 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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