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The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03907410
Recruitment Status : Active, not recruiting
First Posted : April 9, 2019
Last Update Posted : April 13, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
Improving adherence to inhaled corticosteroids (ICS) medication in urban minority pediatric populations is a clinical and population health priority. Financial incentives have been shown as a compelling method to engage a high-risk asthma population in regular ICS use, but whether and how adherence can be maintained and lead to sustained high adherence trajectories is unknown.

Condition or disease Intervention/treatment Phase
Medication Adherence Asthma in Children Other: Nominal Financial Incentives Other: Daily Adherence Reminders/Adherence Performance Feedback Not Applicable

Detailed Description:

Investigators propose to enroll 125 children and their parents in a six-month intervention with a six month follow-up period. Children will be ages 5-12, and must be hospitalized or recently hospitalized for asthma at Children's Hospital of Philadelphia (CHOP).

The study intervention will include daily automated medication reminders (either via text message or push reminder), an app to track daily medication use, and nominal incentives to promote daily controller use. Inhaled controller medication adherence and rescue medication use will be measured using electronic monitors affixed to the inhalers. Factors associated with differential adherence will be assessed using surveys administered during enrollment, the experiment interval (months 1 through 3), the observation interval (months 4 through 6), and study completion (months 12-13). Efficacy outcomes will include change in parent-reported asthma control and mean adherence to ICS between study arms during the experiment interval, as well as the observation interval.

Patients will be considered enrolled when they fulfill the requirements of the Run-in period (sensor data uploaded to research platform AND text message receipt confirmed by caregiver) and are subsequently randomized.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Arm 1: Incentives, plus reminders & feedback (IRF)

There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).

During the "Experiment" period (Months 1-3), Arm 1 will receive the IRF intervention.

During the "Observation" period (Months 4-6), all the arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.

Other: Nominal Financial Incentives
The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.

Other: Daily Adherence Reminders/Adherence Performance Feedback
Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.

Active Comparator: Arm 2: Reminders & feedback ONLY

There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).

During the "Experiment" period (Months 1-3), Arm 2 will receive ONLY reminders and feedback, without nominal financial incentives.

During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.

Other: Daily Adherence Reminders/Adherence Performance Feedback
Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.

No Intervention: Arm 3 (Control)

There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).

During the "Experiment" period (Months 1-3), Arm 3 will not receive any component of the IRF intervention.

During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.




Primary Outcome Measures :
  1. Adherence to ICS regime [ Time Frame: 6 months ]
    Calculated as the mean daily proportion of prescribed doses taken by study month. Days that reflect >1 will be truncated to 1.


Secondary Outcome Measures :
  1. Adherence trajectory [ Time Frame: 6 months ]
    Calculate group-based modeling of adherence patterns

  2. Changes in Child Asthma Control Tool (cACT) score [ Time Frame: 12 months ]
    Assess the cACT score at multiple time points and evaluate the changes in score from first study visit to the second, third, fourth, and fifth study visits. The Child Asthma Control Tool (cACT) score ranges from 0 (poor control) to 27 (complete control). The greater the value, the higher the control. The larger the difference (larger magnitude) of the value in the differences between the scores, the greater the improvement in controlling the child's asthma diagnosis.

  3. Number of asthma-related emergency room visits and hospitalizations [ Time Frame: 12 months ]
    Calculate and compare the number of asthma-related emergency room visits and hospitalizations between study arms.

  4. Healthcare costs of utilization [ Time Frame: 12 months ]
    Calculate the costs associated with emergency room and hospital utilization between study arms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females age 5 to 12 years and their parent or legal guardian.
  • Caregiver has an app enabled cellular phone (i.e., smartphone)
  • Prescribed inhaled corticosteroid or corticosteroid/long acting beta agonist combination for daily use
  • At least 2 hospitalizations OR one hospitalization AND at least one emergency department (ED) visit for asthma in the preceding year
  • Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

  • Subjects prescribed a controller medication to which the electronic device cannot affix
  • Subjects in which the mobile app is not compatible with their smartphone model
  • Subjects with major developmental delays or disabilities
  • Subjects with comorbid chronic diagnoses that influence their asthma management such as cystic fibrosis, bronchopulmonary dysplasia, or cyanotic heart disease
  • Families with active Department of Human Services (DHS) involvement
  • Non-English speaking families
  • Parents/guardians or subjects whose medical team recommends against approaching for enrollment in a research 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): NCT03907410


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Chen Kenyon, MD Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03907410    
Other Study ID Numbers: 18-015434
1K23HL136842-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
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
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