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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL136945-01A1 | U.S. NIH Grant/Contract | View source | |
| 3R01HL136945-01A1S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Nemours Children's Health System | OTHER |
| American Lung Association | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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) (also known as Digital Adherence Monitoring [DAM]). 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTM-EAM | Experimental | Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM] |
|
| EAM only | Active Comparator | Electronic Adherence Self-Management [EAM] only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication Therapy Management (MTM) Video Telehealthcare | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of ICS Inhaler Adherent Days | Proportion of daily adherence over the follow-up period recorded using the digital sensor on the ICS inhaler (adherence outcome) Daily ICS adherence was calculated as a proportion of sensor-recorded inhalations to the number expected based on prescribed daily dose. For primary analyses, an adherent day was defined as completion of at least 75% of prescribed inhalations, with adherence capped at 100%. The time frame of 12 months includes a run-in period prior to randomization. | Up to 12 months |
| Percent Cumulative Incidence Severe Exacerbation | Percent cumulative incidence of first asthma severe exacerbation (efficacy outcome). Percent cumulative incidence of first severe asthma exacerbation was defined as a worsening of asthma requiring: (1) use of systemic corticosteroids for at least three days, (2) an emergency department visit requiring systemic corticosteroid treatment, (3) hospitalization due to asthma, or (4) death from any cause. Exacerbations were identified using biweekly My Asthma surveys, in which participants reported health-care use, medication changes, and impacts on work or school. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| University of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33105234 | Derived | Blake KV. Telemedicine and adherence monitoring in children with asthma. Curr Opin Pulm Med. 2021 Jan;27(1):37-44. doi: 10.1097/MCP.0000000000000739. |
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375 participants enrolled into the study. 54 declined to participate. 321 participants were randomized to MTM-EAM (n=166) or EAM (n=155). 162 randomized into MTM-EAM contributed adherence outcomes data and 164 contributed to the efficacy outcomes. 149 randomized into EAM contributed adherence outcomes and 155 to the efficacy outcomes.
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| ID | Title | Description |
|---|---|---|
| FG000 | MTM-EAM | Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM] 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 Electronic Adherence Self-Management (EAM): Participants will have a sensor which monitors their adherence to medication use |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2023 |
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Randomized, parallel, superiority trial with two intervention groups
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| Electronic Adherence Self-Management (EAM) | Behavioral | Participants will have a sensor which monitors their adherence to medication use |
|
| Tucson |
| Arizona |
| 85724 |
| United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | United States |
| Nemours Children's Specialty Care | Jacksonville | Florida | 32207 | United States |
| University of Florida College of Medicine | Jacksonville | Florida | 32209 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60608 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Hospitals | Chicago | Illinois | 60637 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66103 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-5360 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10029 | United States |
| Mount Sinai National Jewish Health Respiratory Institute; Icahn School of Medicine | New York | New York | 10029 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Vermont Lung Center at The University of Vermont | Colchester | Vermont | 05466 | United States |
| Pacific Northwest Airways - VA Puget Sound Healthcare System | Seattle | Washington | 98108 | United States |
| FG001 | EAM Only | Electronic Adherence Self-Management [EAM] only Electronic Adherence Self-Management (EAM): Participants will have a sensor which monitors their adherence to medication use |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MTM-EAM | Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM] 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 Electronic Adherence Self-Management (EAM): Participants will have a sensor which monitors their adherence to medication use |
| BG001 | EAM Only | Electronic Adherence Self-Management [EAM] only Electronic Adherence Self-Management (EAM): Participants will have a sensor which monitors their adherence to medication use |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Participants with controller inhalations prescribed per day | The number of participants with baseline prescription data for the controller inhalations | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of ICS Inhaler Adherent Days | Proportion of daily adherence over the follow-up period recorded using the digital sensor on the ICS inhaler (adherence outcome) Daily ICS adherence was calculated as a proportion of sensor-recorded inhalations to the number expected based on prescribed daily dose. For primary analyses, an adherent day was defined as completion of at least 75% of prescribed inhalations, with adherence capped at 100%. The time frame of 12 months includes a run-in period prior to randomization. | Participants with data collected | Posted | Mean | 95% Confidence Interval | Proportion of adherent days | Up to 12 months |
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|
| |||||||||||||||||||||||||||||||||||
| Primary | Percent Cumulative Incidence Severe Exacerbation | Percent cumulative incidence of first asthma severe exacerbation (efficacy outcome). Percent cumulative incidence of first severe asthma exacerbation was defined as a worsening of asthma requiring: (1) use of systemic corticosteroids for at least three days, (2) an emergency department visit requiring systemic corticosteroid treatment, (3) hospitalization due to asthma, or (4) death from any cause. Exacerbations were identified using biweekly My Asthma surveys, in which participants reported health-care use, medication changes, and impacts on work or school. | Only 319 MATCH participants (164 MTM vs. 155 EAM) had exacerbation follow-up data. | Posted | Number | 95% Confidence Interval | Percent cumulative incidence | Up to 12 months |
|
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Enrollment until end of follow-up, up to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MTM-EAM | Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM] | 0 | 166 | 6 | 166 | 83 | 166 |
| EG001 | EAM Only | Electronic Adherence Self-Management [EAM] only | 0 | 155 | 14 | 155 | 77 | 155 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Difficulty breathing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Surgery | General disorders | Non-systematic Assessment |
| ||
| COVID | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Altered mental status | Psychiatric disorders | Non-systematic Assessment |
| ||
| Lupus flareup | Immune system disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Medical issue | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Blake, Pharm D | Department of Biomedical Research, Nemours Children's Health | 904-697-3806 | kathryn.blake@nemours.org |
| Mar 4, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form | Oct 20, 2021 | Mar 4, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Assent Form | Oct 20, 2021 | Mar 4, 2026 | ICF_002.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D054539 | Medication Therapy Management |
| C099588 | myotubularin |
| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Black |
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| Asian |
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| Other single races |
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| More than one race |
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| Unknown |
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| 2 inhalations |
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| 4 inhalations |
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| Greater than 4 inhalations |
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| Months 2 to 5 Adherence |
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| Months 5 to 11 Adherence |
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