- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03648203
Technology Enabled Asthma Management System (TEAMS) Pilot Study (TEAMS)
To evaluate feasibility, acceptability, safety, and preliminary efficacy of a novel patient-centered, technology-based intervention to improve asthma care in younger adult smartphone users.
The program, called TEAMS (Technology Enabled Asthma Management System), uses a combination of smartphone symptom monitoring, guideline-based medication protocols, nursing telemedicine home visits, and Electronic Medical Record (EMR) custom programming.
TEAMS is intended to augment primary asthma care as provided at the University of Rochester Medicine Clinic.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Uncontrolled asthma is a tremendous burden to individuals and society. Asthma is one of the most common chronic health conditions globally, affecting more than 8.2% of adults in the U.S. Of adults with asthma in the U.S., 63% have persistent disease, and less than half are well-controlled. Uncontrolled asthma is associated with bothersome symptoms, economic burden, lost work time, and poorer quality of life. Direct and indirect costs are estimated at 56 billion dollars annually, with over 1.8 million ED visits, 439,000 hospitalizations, and 3,400 deaths in 2010 alone. Asthma morbidity and mortality is preventable. Correct use of controller medication and effective self-management alleviates symptoms, prevents exacerbations, and minimizes long-term damage to lungs associated with pulmonary remodeling. For these reasons, the National Heart Lung & Blood Institute (NHLBI) Guidelines recommend that all individuals with persistent asthma should take daily controller medications and receive consistent self-management training.
Currently, less than half of adults with persistent asthma take controller medication, and most do not self-manage their asthma effectively. Patient, provider, and systems-level factors contribute to this pattern. Patients fail to report symptoms, take medications inconsistently, and have insufficient resources (knowledge, time, transportation, money) to manage their disease.Providers in turn may lack familiarity with current best-practice guidelines, follow alternate prescribing practices, or spend insufficient time educating patients. Translation of asthma management knowledge into practice-based solutions is urgently needed. Many asthma interventions have been implemented within investigator-controlled settings. Problematically, few have been evaluated within or translated into the context of real world practice, and thus hold little benefit for the greater patient population. Limited ability to translate interventions from the bench to clinical settings suggests a need to develop and test interventions within the context in which they are intended to function. Effective real-world intervention to improve asthma outcomes requires development of a multifaceted program targeting key factors at the patient, provider, and systems level.
These include:
- Patient tendency to ignore, forget, and not report symptoms;
- Patient non-adherence to prescribed medication;
- Patient lack of self-management skills and knowledge on how to self-manage effectively;
- Barriers to consistent follow-up (access to care, burdens of time and transportation);
- Provider non-adherence to National Guidelines for step-wise management of asthma; and
- Provider underestimation of symptoms, and lack of time to provide thorough asthma education.
Therefore, the purpose of this study is to test feasibility, acceptability, safety, and preliminary efficacy of comprehensive Technology Enabled Asthma Management System (TEAMS), which addresses these critical factors, in order to improve asthma management and outcomes in younger adults.
The specific aims of the study are:
Aim 1: To evaluate feasibility and acceptability of TEAMS. • Hypothesis A: TEAMS will be feasible for and acceptable to young adults and primary care providers for routine management of asthma, as measured by USE-Q survey data, frequency of symptom self-monitoring and at completion of least one virtual visit, and post-intervention qualitative interviews.
Aim 2: To evaluate safety and preliminary efficacy of TEAMS.
• Hypothesis B: TEAMS will be associated with improved asthma outcomes following intervention, as measured by primary outcomes of: (a) increased asthma control, pulmonary function, quality of life, and secondary outcomes of (b) decreased office visits for asthma exacerbations, asthma-related ED visits, and hospitalizations.
Aim 3: To optimize TEAMS intervention components based on quantitative survey data and qualitative interviews, including patient subject and clinic staff perspectives.
2. STUDY DESIGN
2.1. Overview TEAMS is a multi-level, theoretically-based intervention that capitalizes on patient-provider-nurse partnerships and use of technology to improve the quality and convenience of routine asthma care. TEAMS has Social Cognitive Theory underpinnings. It targets person level factors associated with asthma outcomes (individual knowledge, norms, attitudes, illness beliefs and self-efficacy), self-management behaviors (prevention, monitoring, management and communication of symptoms), and environmental factors (access to care, delivery of guideline-based care).
The overarching goal of TEAMS is to improve asthma outcomes by leveraging capabilities of existing technology (smartphone, telemedicine, electronic medical record). TEAMS will operate in conjunction with standard care in the Medicine Clinic.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
New York
-
Rochester, New York, Stany Zjednoczone, 14642
- University of Rochester
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
Patient Subjects:
- Target population, Age 18-40; Age criteria may be expanded to include adults older than 40 as needed to meet recruitment needs
- With a diagnosis of intermittent or persistent asthma;
- Possessing an active smartphone with data plan or WiFi access;
- Able to communicate in English.
- Able to perform study-related functions
- Able to give informed consent.
(All patient subjects will be counseled that telemedicine visits consume large amounts of data, and that use of Wifi is recommended. Patient subjects will be required to initial acknowledgement of this in the consent form. Currently however, many people have unlimited data plans, which may allow visits away from Wifi.)
Provider Subjects:
• Primary care provider to patient subjects enrolled in the study
Other Staff Subjects:
• Secretarial or Nursing staff at the clinic, having interaction with patient subjects or procedures.
Exclusion Criteria:
Patient Subjects:
- Diagnosis of confounding respiratory or cardiac diseases (e.g. cystic fibrosis, sarcoidosis, COPD, CHF, Hypertension);
- Pregnancy
Provider Subjects:
• None
Other Staff Subjects:
• None
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: TEAMS
Routine asthma care, as provided in the University of Rochester Medical Center Medicine Clinic, will be augmented by three intervention components over a six-month pilot period : (1) Patient subject smartphone asthma monitoring; (2) Nursing telemedicine follow up (virtual home visits); (3) EMR custom programming to guide nursing assessment and management.
|
See description of arm
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Acceptability of the TEAMS program for routine asthma management for patients as assessed by USE-Q at end of study
Ramy czasowe: 6 months
|
The USE-Q (Usability Satisfaction and Ease of Use Questionnaire) is a 7 point Likert type scale that consists of 21 positive statements which the user rates on a 7-point Likert scale, with 0= strongly disagree to 7=strongly agree.
|
6 months
|
|
Change in asthma control from baseline to end of study at 6 months
Ramy czasowe: 6 months
|
Clinician-rated asthma control will be measured using the Asthma Control Questionnaire (ACQ) by Juniper.
The instrument has 7 questions, each with a range of 0-6 with lower scores representing better asthma control.
Total ACQ score is the average of the 7 individual items.
A mean score of 0.75 (or less) on the ACQ has a positive predictive value of 0.85 for controlled asthma.
A mean score of 1.5 or higher has a positive predictive value of 0.88 for uncontrolled asthma.
Minimum important difference (MID) for the ACQ is a change score of 0.5.
|
6 months
|
|
Change in Forced Expiratory Volume over 1 second (FEV1) from baseline to end of study at 6 months
Ramy czasowe: 6 months
|
FEV1 will be measured using a digital peak flow meter with FEV1 capacity
|
6 months
|
|
Change in Asthma-related Quality of life from baseline to end of study at 6 months
Ramy czasowe: 6 months
|
Asthma-related quality of life will be measured using the Asthma Quality of Life Questionnaire (AQLQ(S)) by Juniper.
The AQLQ measures physical and emotional impact of disease.
There are 32 items with a range of 1-7 each, with higher scores representing better quality of life.
(7=no impairment; 4= moderate impairment; 1=maximum impairment).
The AQLQ consists of 4 domains.
Domain scores are computed by averaging the scores of individual items which range from 7 (no impairment) to 1 (maximal impairment).
The total AQLQ is computed by averaging the scores across all domains.
MID for change in AQLQ total score is 0.5 total, and 0.5 per domain.
|
6 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in frequency of acute healthcare utilization from baseline to end of study at 6 month
Ramy czasowe: 6 months
|
Counts (frequency) of asthma-related acute healthcare visits will be extracted from the electronic medical record (ED visits and hospitalizations related to asthma) and will be compared for the equivalent 6 months prior to intervention and the 6 months of intervention
|
6 months
|
|
(Qualitative) Participant experiences with and perceptions of TEAMS program
Ramy czasowe: 6 months
|
Assessment of participants experiences with and perceptions of the TEAMS program, as assessed by in-depth semi-structured qualitative interview (1:1).
|
6 months
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Tiffany Gommel, MS, CIM, CIP, University of Rochester
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SON2018-003
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Technology Enabled Asthma Management System
-
MicroPort Orthopedics Inc.ZakończonyBól stawu | Choroba zwyrodnieniowa stawów, biodro | Choroba zwyrodnieniowa stawu biodrowego | Choroba biodraStany Zjednoczone
-
Fudan UniversityJeszcze nie rekrutacjaKobieta z rakiem piersiChiny
-
Zhejiang Zylox Medical Device Co., Ltd.Jeszcze nie rekrutacjaRozwarstwienie aortyChiny
-
Indiana UniversityUniversity of Alabama at Birmingham; University of OttawaZakończonyPostępujące stwardnienie rozsianeStany Zjednoczone
-
Tongji HospitalRejestracja na zaproszenieTarczyca | Ultradźwięk | Wątroba | Nerka | Trzustka | Pęcherzyk żółciowy | Tętnica szyjna | ŚledzionaChiny
-
Dartmouth-Hitchcock Medical CenterPenn State UniversityRejestracja na zaproszenieWypadanie narządów miednicy mniejszejStany Zjednoczone
-
University of Southern DenmarkOdense University Hospital; University of Salford; Sygehus Lillebaelt; Region of... i inni współpracownicyZakończony
-
IRCCS San Raffaele RomaZakończonyUderzenie | Zaburzenia chodu, neurologiczneWłochy
-
Medtronic DiabetesZakończonyCukrzyca typu 1Stany Zjednoczone
-
Emory UniversityNational Football LeagueZakończony