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AsthmaAIRENCT03986177

Asthma Implementation Research Trial

A study testing Self-management Intervention Package in people with Asthma and Asthma in Children, run by Johns Hopkins University at 1 site in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Asthma is the most common chronic disease among children worldwide, with 80% of asthma related deaths occurring in low- and middle-income countries (LMICs), such as Peru. While evidence-based guidelines exist for asthma treatment and management, adherence to guideline-based practices is low in high-income country… Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Asthma, Asthma in Children
What is being tested?
Self-management Intervention Package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 sitePeru
Study dates
3 Jun 2019to 30 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Currently living in Lima, Peru
  • 5-17 years of age
  • Has a physician diagnosis of asthma
  • Has attended the emergency room or urgent care for asthma, or has been hospitalized for asthma at least once in the previous 12 months

Who cannot join

  • Family plans to move out of the study community within the next 12 months
  • Co-occurring chronic respiratory or cardiovascular disorders other than asthma
  • Active tuberculosis or are currently taking tuberculosis medications
  • Diagnosis of HIV/AIDS

Trial locations and contacts

1 site in 1 country.

Peru1 site

  • Hospital Nacional Cayetano Heredia

    Lima

Other trials in Peru

About this study

Official title: Implementation of a Community Intervention to Improve Asthma Self-Management Practices in Peru

Asthma is the most common chronic disease among children worldwide, with 80% of asthma related deaths occurring in low- and middle-income countries (LMICs), such as Peru. While evidence-based guidelines exist for asthma treatment and management, adherence to guideline-based practices is low in high-income country (HIC) and LMIC settings alike. There a clear need for effective, locally-tailored solutions to address the asthma treatment gap in low-income communities in LMICs, such as Peru. This study aims to develop and test a locally-adapted intervention package to improve adoption of self-management practices and utilization of preventive health services for asthma among children in Lima. There is a paucity of research regarding the development and testing of interventions to improve asthma self-management in LMIC settings, which experience unique or exacerbated barriers to receiving evidence-based care. To the investigators' knowledge, no studies have systematically developed and evaluated an asthma management program in Peru. Therefore, the long-term goal of this study is to disseminate locally appropriate asthma management strategies to reduce asthma-related emergency department visits and improve service utilization in LMIC settings. For the current study, the investigators will carry out a randomized controlled trial to test the effectiveness of the intervention package in a group of 110 children with asthma who will be randomized to the intervention (55 children) or no intervention (55 children) arm. Participants in the intervention group will receive case management from a designated nurse manager, who will provide ongoing educational, social, and self-management support during monthly follow-up home visits and text-message based communication. Participants will be followed up every month for data collection over a six-month period. Throughout the follow-up period, the investigators will collect data on asthma control, healthcare utilization, medication adherence, quality of life of children with asthma and the children's caregivers, caregiver mental health, fidelity to the intervention, and acceptability and feasibility. Ultimately, this study will inform the scientific community about effective strategies and treatment programs for asthma in low-income settings.

Being tested
Self-management Intervention Package
Keywords
Implementation Science, Global Health, Peru
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-management Intervention PackageBehavioural

    Children will receive basic asthma education, based on the National Heart, Lung, and Blood Institute "A Breath of Life" asthma education program. Children/caregivers in the intervention arm will also be assigned a designated nurse case manager who will provide home visits and be available via text message and phone-based support throughout follow-up. Intervention components:

    • Interactive education and support on use of an asthma action plan
    • Locally adapted patient-provider communication tool
    • Child-oriented educational materials in comic book format
    • Modeling and hands-on practice of inhaler technique (written instructions, in person, video)
    • Education regarding environmental trigger abatement
    • Patient navigation, home visits, and goal setting support from nurse manager
Study groups in NCT03986177
Study groupRoleWhat they receive
InterventionExperimentalThe intervention arm will receive a multi-faceted self-management intervention package.
Receives: Behavioral: Self-management Intervention Package
Enhanced careNo interventionThe control arm will receive usual care plus basic asthma education from a trained nurse educator.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Asthma Control as assessed by Childhood Asthma Control Test (cACT) Score

    cACT (5-11 years of age) will be administered at baseline and monthly during the follow-up period. The cACT is scored by summing the scores for all items. Overall scores ranges from 0 to 27. Lower scores indicate poorer asthma control and higher scores indicate better asthma control. Scores 19 and below suggest impaired asthma control.

    Measured: Baseline, then monthly up to 6 months

  2. Change in Asthma Control as assessed by Asthma Control Test (ACT) Score

    ACT (12-17 years of age) will be administered at baseline and monthly during the follow-up period. The ACT is scored by summing the scores for all items. Overall score ranges from 5 to 25. Lower scores indicate poorer asthma control and higher scores indicate better asthma control. Scores 19 and below suggest impaired asthma control.

    Measured: Baseline, then monthly up to 6 months

  3. Number of participants with at least one asthma-related ED or urgent care visit during the six-month follow-up period

    Number with asthma-related emergency department (ED) or urgent care visits will be used to assess healthcare utilization.

    Measured: 6 months

Secondary outcomes (8)

  1. Change in Adherence to Refills and Medications Scale-7 (ARMS-7) score

    ARMS-7 will administered at baseline and monthly during the follow-up period. Score is calculated by summing the scores for all items. Overall score ranges between 7 and 28. Lower scores indicate better adherence.

    Measured: Baseline, then monthly up to 6 months

  2. Medication adherence as assessed by Dose counter-measured medication use

    Number of puffs used divided by the number of puffs indicated to be used over monthly follow-up period.

    Measured: 6 months

  3. Quality of life as assessed by Pediatric Asthma Quality of Life Questionnaire (PAQLQ)-Mini

    Measures disease-specific quality of life in children and adolescents with asthma. The PAQLQ-mini has 13 items, each scored on a 7-point Likert scale with "1" indicating severe impairment and "7" indicating no impairment. Score is calculated by taking the average of scores for each item. Higher scores indicate better quality of life. Range: [1 to 7].

    Measured: 6 months

  4. Quality of life in caregivers of children and adolescents with asthma as assessed by Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

    Measures quality of life in caregivers of children and adolescents with asthma. The PACQLQ has 13 items, each scored on a 7-point Likert scale with "1" indicating severe impairment and "7" indicating no impairment. Score is calculated by taking the average of scores for each item. Higher scores indicate better quality of life. Range: [1 to 7].

    Measured: 6 months

  5. Depression as assessed by Patient Health Questionnaire-9 (PHQ-9)

    Measures depressive symptoms. Will be administered to caregivers of children and adolescents with asthma. The PHQ-9 has nine items, each scored on a Likert scale from 0 to 3. Higher scores indicate more evidence of depressive disorder of greater severity of disorder. Scores are calculated by summing the scores for all items. Range: [0 to 27].

    Measured: 6 months

  6. Number of participants with asthma-related hospitalizations

    Count of participants (children) with at least one asthma-related hospitalization during six-month follow-up period.

    Measured: 6 months

  7. Number of participants with all-cause emergency department (ED) or urgent care visits

    Count of participants with at least one all-cause ED or urgent care visit during the six-month follow-up period.

    Measured: 6 months

  8. Number of participants who attend two or more outpatient appointments with healthcare provider for asthma.

    Count of participants who attend two or more outpatient appointments with healthcare provider for asthma over six-month follow-up period.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2019
  2. Study start3 Jun 2019
  3. Primary completion30 Mar 2020
  4. Study completion30 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03986177
Sponsor's protocol ID
IRB00170462
Acronym
AIRE
Status last verified
May 2020
First submitted
11 Jun 2019
Last updated
29 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zevallos-Morales A, Romani-Huacani E, Psoter KJ, Flores-Flores O, Reif D, Siddharthan T, Portell M, Anguera MT, Underhill LJ, Pollard SL. Effectiveness and implementation of a multi-faceted intervention to facilitate adoption of asthma self-management practices in Peruvian children and adolescents: a hybrid type 2 individually randomized controlled trial. Front Public Health. 2026 Jan 13;13:1710746. doi: 10.3389/fpubh.2025.1710746. eCollection 2025.

    PubMed 41607915

  • Romani ED, Siddharthan T, Lovaton N, Alvitez-Luna CC, Flores-Flores O, Pollard SL. Implementation of an intervention to improve the adoption of asthma self-management practices in Peru: Asthma Implementation Research (AIRE) randomized trial study protocol. Trials. 2020 May 4;21(1):377. doi: 10.1186/s13063-020-4207-5.

    PubMed 32366314

Questions about this trial

What is this clinical trial studying?

A study testing Self-management Intervention Package in people with Asthma and Asthma in Children, run by Johns Hopkins University at 1 site in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Asthma Control as assessed by Childhood Asthma Control Test (cACT) Score (time frame: Baseline, then monthly up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03986177, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.

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