Asthma Implementation Research Trial
- Conditions
- AsthmaAsthma in Children
- Interventions
- Behavioral: Self-management Intervention Package
- Registration Number
- NCT03986177
- Lead Sponsor
- Johns Hopkins University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Self-management Intervention Package The intervention arm will receive a multi-faceted self-management intervention package.
- Primary Outcome Measures
Name Time Method Change in Asthma Control as assessed by Asthma Control Test (ACT) Score 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 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 6 months Number with asthma-related emergency department (ED) or urgent care visits will be used to assess healthcare utilization.
- Secondary Outcome Measures
Name Time Method Quality of life as assessed by Pediatric Asthma Quality of Life Questionnaire (PAQLQ)-Mini 6 months 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: \[1 to 7\].
Number of participants with asthma-related hospitalizations 6 months Count of participants (children) with at least one asthma-related hospitalization during six-month follow-up period.
Number of participants with all-cause emergency department (ED) or urgent care visits 6 months Count of participants with at least one all-cause ED or urgent care visit during the six-month follow-up period.
Change in Adherence to Refills and Medications Scale-7 (ARMS-7) score Baseline, then monthly up to 6 months 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.
Medication adherence as assessed by Dose counter-measured medication use 6 months Number of puffs used divided by the number of puffs indicated to be used over monthly follow-up period.
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 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: \[1 to 7\].
Depression as assessed by Patient Health Questionnaire-9 (PHQ-9) 6 months 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: \[0 to 27\].
Number of participants who attend two or more outpatient appointments with healthcare provider for asthma. 6 months Count of participants who attend two or more outpatient appointments with healthcare provider for asthma over six-month follow-up period.
Trial Locations
- Locations (1)
Hospital Nacional Cayetano Heredia
🇵🇪Lima, Peru