Asthma Implementation Research Trial

Asthma Clinical Trial

— AIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986177
• Other study ID #: IRB00170462
• Status: Completed
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Behavioral:
• Self-management Intervention Package
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

Locations

Country	Name	City	State
Peru	Hospital Nacional Cayetano Heredia	Lima

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	American Thoracic Society, Asociación Benéfica Prisma, Hospital Nacional Cayetano Heredia

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, then monthly up to 6 months
Primary	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.	Baseline, then monthly up to 6 months
Primary	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.	6 months
Secondary	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.	Baseline, then monthly up to 6 months
Secondary	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.	6 months
Secondary	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].	6 months
Secondary	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].	6 months
Secondary	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].	6 months
Secondary	Number of participants with asthma-related hospitalizations	Count of participants (children) with at least one asthma-related hospitalization during six-month follow-up period.	6 months
Secondary	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.	6 months
Secondary	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.	6 months