NCT03648203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

July 31, 2018

Last Update Submit

March 17, 2020

Conditions

Asthma

Keywords

asthmaquality of lifeself-carehealthcare utilization

Outcome Measures

Primary Outcomes (4)

  • Acceptability of the TEAMS program for routine asthma management for patients as assessed by USE-Q at end of study

    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

    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

    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

    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

Secondary Outcomes (2)

  • Change in frequency of acute healthcare utilization from baseline to end of study at 6 month

    6 months

  • (Qualitative) Participant experiences with and perceptions of TEAMS program

    6 months

Study Arms (1)

TEAMS

EXPERIMENTAL

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

Interventions

Technology Enabled Asthma Management SystemBEHAVIORAL

See description of arm

Also known as: TEAMS
TEAMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Mammen JR, Java JJ, Halterman J, Berliant MN, Crowley A, Frey SM, Reznik M, Feldman JM, Schoonmaker JD, Arcoleo K. Development and preliminary results of an Electronic Medical Record (EMR)-integrated smartphone telemedicine program to deliver asthma care remotely. J Telemed Telecare. 2021 May;27(4):217-230. doi: 10.1177/1357633X19870025. Epub 2019 Aug 22.

    PMID: 31438761DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Tiffany Gommel, MS, CIM, CIP

    University of Rochester

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 27, 2018

Study Start

February 15, 2018

Primary Completion

February 5, 2020

Study Completion

March 17, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)