ASMAS for Asthma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rhode Island Hospital, Providence, RIAsthmaASMAS - Behavioral
Eligibility
11 - 14
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a novel intervention - ASMAS - which is specifically designed to help Latino middle school children with asthma manage their condition. The intervention will be delivered by trained high school students who also have asthma, and the trial will take place in Providence, RI and San Juan, PR.

Treatment Effectiveness

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

Month 8
Change in asthma Action plan/Inhaler availability
Change in asthma control
Change in asthma related school absence ratio
Change in asthma self-management
Change in child asthma knowledge
Change in child asthma self-efficacy
Change in lung function
Change in symptom free days

Trial Safety

Trial Design

3 Treatment Groups

Asthma education plus child health
1 of 3
No Treatment Control
1 of 3
ASMAS
1 of 3

Active Control

Experimental Treatment

432 Total Participants · 3 Treatment Groups

Primary Treatment: ASMAS · No Placebo Group · N/A

ASMAS
Behavioral
Experimental Group · 1 Intervention: ASMAS · Intervention Types: Behavioral
Asthma education plus child health
Behavioral
ActiveComparator Group · 1 Intervention: Asthma education plus child health · Intervention Types: Behavioral
No Treatment ControlNoIntervention Group · 1 Intervention: No Treatment Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor
241 Previous Clinical Trials
58,773 Total Patients Enrolled
9 Trials studying Asthma
2,652 Patients Enrolled for Asthma
University of Puerto RicoOTHER
49 Previous Clinical Trials
16,530 Total Patients Enrolled
1 Trials studying Asthma
404 Patients Enrolled for Asthma
Glorisa Canino, PhDPrincipal InvestigatorUniversity of Puerto Rico
4 Previous Clinical Trials
742 Total Patients Enrolled
1 Trials studying Asthma
404 Patients Enrolled for Asthma
Daphne Koinis-Mitchell, PhDPrincipal InvestigatorRhode Island Hospital
4 Previous Clinical Trials
393 Total Patients Enrolled
3 Trials studying Asthma
303 Patients Enrolled for Asthma
Maria T Coutinho, PhDStudy DirectorRhode Island Hospital
1 Previous Clinical Trials
90 Total Patients Enrolled

Eligibility Criteria

Age 11 - 14 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Children who have had asthma symptoms in the last 4 weeks will not be eligible to participate.
You must have persistent asthma, which means you need to take medicine to control your asthma OR you have had asthma symptoms during the day more than twice a week or have woken up at night at least 3-4 times a month because of asthma, or use short-acting beta-agonist at least twice a week or have limitations in your activities or have used oral steroids at least twice a year in the past four weeks.

Frequently Asked Questions

Does this clinical trial allow those over forty to participate?

"The study's parameters require that those wishing to participate are between 11 and 14 years old. Subsequently, this yields 119 trials suitable for minors and 199 applicable clinical studies for seniors." - Anonymous Online Contributor

Unverified Answer

Are enrollees being accepted at this time for the trial?

"This trial is still in the process of enrolling participants based on information from clinicaltrials.gov. It was initially posted on April 1st 2019 and edited for the last time October 21st 2020." - Anonymous Online Contributor

Unverified Answer

How many individuals are currently enrolled in this trial?

"Yes, according to the clinicaltrials.gov records, this medical investigation is actively seeking participants. It was first posted on April 1st 2019 and most recently updated October 21th 2020, looking for 432 people over a single site." - Anonymous Online Contributor

Unverified Answer

What is the primary goal of this research endeavor?

"The primary endpoint of this investigation, which will be monitored at baseline, after the intervention as well as 4, 8 and 12 months post-treatment is a change in symptom free days. Secondary objectives include an alteration in asthma self-management (via validated and reliable assessments for both child and caregiver), availability of rescue inhaler at school with an accompanying action plan according to reports from school nurses, plus modifications in child asthma self-efficacy based on scores registered using the Children's Asthma Self-Efficacy Scale (Cronbach alpha .87; Bursch et al., 1999). This tool comprises 14 items graded between 1" - Anonymous Online Contributor

Unverified Answer

Is it possible for me to become involved in this research trial?

"Participants between the ages of 11 and 14 with a diagnosis of asthma are eligible for this trial, which aims to recruit 432 people in total." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.