Trial record 2 of 352 for:
match | asthma
Medication Adherence With Telehealthcare Medication Therapy Management (MATCH)
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| ClinicalTrials.gov Identifier: NCT03978936 |
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Recruitment Status :
Recruiting
First Posted : June 7, 2019
Last Update Posted : August 25, 2022
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Sponsor:
Johns Hopkins University
Collaborators:
Nemours Children's Health System
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University
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Brief Summary:
Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH) is a multi-center, randomized parallel group study targeted to an at-risk population of Adolescents and Young Adults (AYA) with uncontrolled asthma who have poor adherence with prescribed Inhaled corticosteroid (ICS) therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uncontrolled Asthma Young Adults | Behavioral: Medication Therapy Management (MTM) Video Telehealthcare Behavioral: Electronic Adherence Self-Management (EAM) | Not Applicable |
The study evaluates a Medication Therapy Management (MTM) video telehealthcare intervention to address poor medication adherence. In addition, it employs a novel method to track and provide feedback to participants on adherence by using Propeller Sensors. 300 adolescents and young adults will be randomized to Medication Therapy Management (MTM) video telehealthcare plus electronic adherence self-management [MTM EAM] or electronic adherence self-management alone (EAM). Due to the hierarchal design of the trial, two primary outcomes to be tested in a sequential manner are specified, adherence and time to first asthma exacerbation.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, parallel, superiority trial with two intervention groups |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma |
| Actual Study Start Date : | November 18, 2019 |
| Estimated Primary Completion Date : | January 31, 2024 |
| Estimated Study Completion Date : | June 30, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: MTM-EAM
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM]
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Behavioral: Medication Therapy Management (MTM) Video Telehealthcare
MTM is an individualized approach to "optimize medication use for improved patient outcomes" and is designed to "empower patients to take an active role in managing patients' medications" thus, providing a favorable strategy for addressing adherence issues. Five core elements define MTM: complete medication therapy review (CMR), creation of a personal medication list (PML), development of a medication action plan (MAP), intervention and/or referral for drug therapy problems, and documentation and follow-up Behavioral: Electronic Adherence Self-Management (EAM) Participants will have a sensor which monitors their adherence to medication use |
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Active Comparator: EAM only
Electronic Adherence Self-Management [EAM] only
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Behavioral: Electronic Adherence Self-Management (EAM)
Participants will have a sensor which monitors their adherence to medication use |
Primary Outcome Measures :
- Time (days) to first exacerbation event [ Time Frame: 12 months ]Time to first asthma exacerbation is the time to first exacerbation event defined as a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, or asthma-specific emergency department visit with treatment with systemic corticosteroids, or asthma-specific hospitalization, or death (all cause and asthma exacerbation). 104. These data will be collected by self-report in the "My Asthma" bi-weekly assessment questionnaire, and verified by the study site coordinator with the participant's provider.
- Proportion of adherent days as assessed by Propeller sensors [ Time Frame: 12 months ]Adherence will be measured using data collected from Propeller sensors. Adherence for each day is calculated as the number of inhalations taken divided by the expected number of doses. A day will be defined as adherent if the participant completes 80% or more of the prescribed inhalations. The primary outcome will be the proportion of adherent days over the course of follow-up, i.e. from the randomization visit to the 1-year visit.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years to 35 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 12 through 35 years
- Speaks English or Spanish
- Physician diagnosed asthma (without any other co-morbid pulmonary disease)
- Prescribed ICS treatment for at least 3 months prior to screening
- Adherence to Refills and Medication Scale (ARMS) 7-item questionnaire score of >8 (low or moderate adherence)
- Current use of albuterol metered dose inhaler (MDI) for rescue: ProAir, Ventolin, albuterol sulfate (from Prasco or Teva)
- Uncontrolled asthma:
- Symptomatic asthma defined as 3 of the following in the past 4 weeks:
- Daytime symptoms of asthma more than twice per week
- Any night awakening due to asthma
- Rescue inhaler use for symptoms more than twice per week
- Any activity limitation due to asthma; OR
- Asthma Control Test score ≤19
- Has iPhone or Android smart phone with Short Message Service (SMS)
- Has access to reliable WiFi service and a device with capability for telemedicine study visits
- Ability to understand and willingness to sign consent documents
- Evidence of Propeller sensor connection in the 4-week run-in period
Exclusion Criteria:
- Use of an investigational treatment in the previous 30 days.
- Previous enrollment in MATCH Structured Interviews ( Aim 1)
- Currently enrolled in an intervention trial
- Currently uses an ICS not compatible with the Propeller sensor
- Inability to comply with study procedures, including:
- Inability or unwillingness to provide informed consent (or assent in the case of a minor).
- Inability to perform study measurements.
- inability to be contacted by phone via calls and /or text messaging
- Not willing to have video chat
- Any condition(s) in the opinion of the physician that puts the participant at risk from participating in the study
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): NCT03978936
Contacts
| Contact: Heather Hazucha, MPH | 410-502-0585 | hhazuch1@jhu.edu |
Locations
Show 22 study locations
Sponsors and Collaborators
Johns Hopkins University
Nemours Children's Health System
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Kathryn Blake, Pharm.D | Nemours Children's Specialty Care | |
| Principal Investigator: | Robert Wise, MD | Johns Hopkins School of Medicine | |
| Principal Investigator: | Janet Holbrook, PhD | Johns Hopkins Bloomberg School of Public Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT03978936 |
| Other Study ID Numbers: |
IRB00197194 1R01HL136945-01A1 ( U.S. NIH Grant/Contract ) 3R01HL136945-01A1S1 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 7, 2019 Key Record Dates |
| Last Update Posted: | August 25, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Johns Hopkins University:
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Bronchial Diseases Respiratory Tract Diseases Lung Diseases Obstructive Lung Diseases |
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 |