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Clinical Trials/NCT03986177
NCT03986177
Completed
Not Applicable

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

Johns Hopkins University1 site in 1 country110 target enrollmentJune 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Johns Hopkins University
Enrollment
110
Locations
1
Primary Endpoint
Change in Asthma Control as assessed by Asthma Control Test (ACT) Score
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 3, 2019
End Date
March 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline, then monthly up to 6 months

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.

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

Time Frame: Baseline, then monthly up to 6 months

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.

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

Time Frame: 6 months

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

Secondary Outcomes

  • Quality of life as assessed by Pediatric Asthma Quality of Life Questionnaire (PAQLQ)-Mini(6 months)
  • Change in Adherence to Refills and Medications Scale-7 (ARMS-7) score(Baseline, then monthly up to 6 months)
  • Medication adherence as assessed by Dose counter-measured medication use(6 months)
  • Quality of life in caregivers of children and adolescents with asthma as assessed by Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)(6 months)
  • Depression as assessed by Patient Health Questionnaire-9 (PHQ-9)(6 months)
  • Number of participants with asthma-related hospitalizations(6 months)
  • Number of participants with all-cause emergency department (ED) or urgent care visits(6 months)
  • Number of participants who attend two or more outpatient appointments with healthcare provider for asthma.(6 months)

Study Sites (1)

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