Technology Enabled Asthma Management System (TEAMS) Pilot Study (TEAMS)
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|ClinicalTrials.gov Identifier: NCT03648203|
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : February 15, 2019
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|
|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|
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
- 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.
- 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.
- 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
- 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.
- 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
- (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).
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
|Contact: Jennifer Mammen, PhD NP-Cemail@example.com|
|Contact: Kimberly J Arcoleo, PhD, MPHfirstname.lastname@example.org|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Marc Berliant, MD 585-275-7424 email@example.com|
|Contact: Kimberly Arcoleo, PhD, MPH 585-273-5645 firstname.lastname@example.org|
|Principal Investigator: Jennifer Mammen, PhD, NP-C|
|Sub-Investigator: Kimberly Arcoleo, PhD, MPH|
|Sub-Investigator: Marc Berliant, MD|
|Study Director:||Tiffany Gommel, MS, CIM, CIP||University of Rochester|