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Technology Enabled Asthma Management System (TEAMS) Pilot Study (TEAMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648203
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
University of Rhode Island
Information provided by (Responsible Party):
Jennifer Mammen, University of Rochester

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Asthma Behavioral: Technology Enabled Asthma Management System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is using a single arm, single site, pre-post assessment interventional design, with no control group. Because this is a pilot study, all subjects will receive the intervention.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Technology Enabled Asthma Management System (TEAMS) Pilot Study
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 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.
Behavioral: Technology Enabled Asthma Management System
See description of arm
Other Name: TEAMS




Primary Outcome Measures :
  1. Acceptability of the TEAMS program for routine asthma management for patients as assessed by USE-Q at end of study [ Time Frame: 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.

  2. Change in asthma control from baseline to end of study at 6 months [ Time Frame: 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.

  3. Change in Forced Expiratory Volume over 1 second (FEV1) from baseline to end of study at 6 months [ Time Frame: 6 months ]
    FEV1 will be measured using a digital peak flow meter with FEV1 capacity

  4. Change in Asthma-related Quality of life from baseline to end of study at 6 months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in frequency of acute healthcare utilization from baseline to end of study at 6 month [ Time Frame: 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

  2. (Qualitative) Participant experiences with and perceptions of TEAMS program [ Time Frame: 6 months ]
    Assessment of participants experiences with and perceptions of the TEAMS program, as assessed by in-depth semi-structured qualitative interview (1:1).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648203


Contacts
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Contact: Jennifer Mammen, PhD NP-C 585-489-2236 jennifer_mammen@urmc.rochester.edu
Contact: Kimberly J Arcoleo, PhD, MPH 585-273-5645 kimberly_arcoleo@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Marc Berliant, MD    585-275-7424    marc_berliant@urmc.rochester.edu   
Contact: Kimberly Arcoleo, PhD, MPH    585-273-5645    kimberly_arcoleo@urmc.rochester.edu   
Principal Investigator: Jennifer Mammen, PhD, NP-C         
Sub-Investigator: Kimberly Arcoleo, PhD, MPH         
Sub-Investigator: Marc Berliant, MD         
Sponsors and Collaborators
University of Rochester
University of Rhode Island
Investigators
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Study Director: Tiffany Gommel, MS, CIM, CIP University of Rochester

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Responsible Party: Jennifer Mammen, Clinical Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03648203    
Other Study ID Numbers: SON2018-003
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Mammen, University of Rochester:
asthma
quality of life
self-care
healthcare utilization
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases