- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01670539
Home Telemonitoring for Patients With Lung Cancer (HTPLC)
23 septembre 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Interventionnel
Inscription (Réel)
47
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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West Virginia
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Morgantown, West Virginia, États-Unis, 26506
- WVU Mary Babb Randolph Cancer Center and Ruby Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
45 ans à 90 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Aucune 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Telemonitor Data From Baseline: Temperature
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Georgia L Narsavage, PhD, MSN, West Virginia University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2011
Achèvement primaire (Réel)
1 décembre 2012
Achèvement de l'étude (Réel)
1 juin 2013
Dates d'inscription aux études
Première soumission
9 août 2012
Première soumission répondant aux critères de contrôle qualité
21 août 2012
Première publication (Estimation)
22 août 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 octobre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 septembre 2022
Dernière vérification
1 décembre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Tumeurs pulmonaires
- Effets physiologiques des médicaments
- Agents anti-inflammatoires
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Triamcinolone
Autres numéros d'identification d'étude
- H-22930
- 1R15CA150999 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .