Infantile AsthmaNCT02141893
Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
A study testing CALMA plus and CALMA in people with Infantile Asthma, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The aim of this group-randomized trial was to test the effectiveness of a new comprehensive program, which the investigators called CALMA -plus, in increasing controller medication use and reducing asthma symptoms. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Infantile Asthma
- What is being tested?
- CALMA plus and CALMA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Dec 2009to Jul 2013
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inclusion criteria required that the child have at least one claim with a diagnostic code for asthma or reactive airway disease (International Classification of Diseases (ICD 9) diagnostic code 493.xx) and in the last year period had either1) been hospitalized for asthma
- had at least 2 Emergency Department (ED) visits
- 3-5 ambulatory visits due to asthma
- utilized asthma medications from 2 of the following therapeutic categories: Anticholinergics, cromolyn, sympathomimetics, steroid inhalants, methylxanthines, leukotriene inhibitors, or corticosteroids.
Who cannot join
- currently participating in another asthma study
- no appropriate address for follow-up in the claims data.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Behavioral Sciences Research Institute
San Juan, PR, 00936
About this study
The aim of this group-randomized trial was to test the effectiveness of a new comprehensive program, which the investigators called CALMA -plus, in increasing controller medication use and reducing asthma symptoms. CALMA-plus involved the CALMA home-based family intervention, plus educational training of physicians and nurses, as well as screening for asthma in clinics serving Medicaid island Puerto Rican children with asthma. Because the provider training was expected to have an impact on the entire clinical setting where trained providers work, as well as the patients using that setting, the investigators randomized clinic groups rather than individual patients. The investigators compared the CALMA-Plus intervention to a CALMA-only group, which the investigators expected to obtain the same benefits as the investigators have previously documented.
Read the detailed description
Puerto Rico has high rates of pediatric asthma and morbidity associated in part with poor family asthma management and low rates of controller medication use. A previous study found a family management intervention called CALMA to be effective in reducing asthma symptoms and service utilization. However, CALMA was not effective in increasing the use of controller medications. CALMA- plus was developed to address this issue by adding to CALMA components of educational training of physicians and nurses, and screening for asthma in clinics serving Medicaid Puerto Rican children with persistent asthma. A total of 404 children in eight clinics were studied after forming four pairs of clinics and randomizing the clinics (1:1) to CALMA-only or CALMA-plus within each pair. After adjusting for clinic variation, the study failed to demonstrate that the CALMA-plus intervention was more efficacious than the CALMA- only intervention for increasing reported controller medication use or decreasing symptoms in children with persistent asthma. Both groups had lower rates of asthma symptoms and service utilization consistent with previous results of the CALMA-only intervention. Limitations of the study were small number of clinics available, comparison of the experimental intervention with an evidence based intervention, and limited exposure to some aspects of the intervention. More effective interventions may include aggressive case management, and providing the physician with more relevant information.
- Conditions
- Infantile Asthma
- Being tested
- CALMA plus, CALMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALMA plusBehavioural
Participants received a family education intervention (previously tested) known as CALMA plus physician education and organizational change of the clinics were addressed with a culturally tailored program developed by adapting content from several evidence-based provider training programs
CALMABehavioural
Family Education Intervention on management of pediatric asthma
| Study group | Role | What they receive |
|---|---|---|
| CALMA | Active comparator | Participants only received a family education intervention (previously tested) known as CALMA Receives: Behavioral: CALMA plus; Behavioral: CALMA |
| Calma plus | Experimental | Participants in Arm 2 received the CALMA family education intervention and physician education and organizational change of the clinics were addressed with a culturally tailored program developed by adapting content from several evidence-based provider training programs. Receives: Behavioral: CALMA plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up
Measured: Baseline, 12
Secondary outcomes (1)
Change in the Reduction of asthma symptomatology from baseline to 12 month follow-up
Measured: baseline, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infantile AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Glorisa Canino, University of Puerto Rico
- Investigators
- Glorisa Canino, PhD, Principal investigator, Medical Sciences Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141893
- Sponsor's protocol ID
- GC- 0160609-CALMA
- Other IDs
- P60MD00226
- Status last verified
- May 2014
- First submitted
- 12 May 2014
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Canino G, Shrout PE, Vila D, Ramirez R, Rand C. Effectiveness of a multi-level asthma intervention in increasing controller medication use: a randomized control trial. J Asthma. 2016;53(3):301-10. doi: 10.3109/02770903.2015.1057846. Epub 2016 Jan 19.
PubMed 26786240
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02141893
- Acronym / sponsor ID
- GC- 0160609-CALMA
- Conditions
- Infantile Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this group-randomized trial was to test the effectiveness of a new comprehensive program, which the investigators called CALMA -plus, in increasing controller medication use and reducing asthma symptoms. CALMA-plus involved the CALMA home-based family intervention, plus educational training of physicians and nurses, as well as screening for asthma in clinics serving Medicaid island Puerto Rican children with asthma. Because the provider training was expected to have an impact on the entire clinical setting where trained providers work, as well as the patients using that setting, the investigators randomized clinic groups rather than individual patients. The investigators compared the CALMA-Plus intervention to a CALMA-only group, which the investigators expected to obtain the same benefits as the investigators have previously documented.
Detailed description
Puerto Rico has high rates of pediatric asthma and morbidity associated in part with poor family asthma management and low rates of controller medication use. A previous study found a family management intervention called CALMA to be effective in reducing asthma symptoms and service utilization. However, CALMA was not effective in increasing the use of controller medications. CALMA- plus was developed to address this issue by adding to CALMA components of educational training of physicians and nurses, and screening for asthma in clinics serving Medicaid Puerto Rican children with persistent asthma. A total of 404 children in eight clinics were studied after forming four pairs of clinics and randomizing the clinics (1:1) to CALMA-only or CALMA-plus within each pair. After adjusting for clinic variation, the study failed to demonstrate that the CALMA-plus intervention was more efficacious than the CALMA- only intervention for increasing reported controller medication use or decreasing symptoms in children with persistent asthma. Both groups had lower rates of asthma symptoms and service utilization consistent with previous results of the CALMA-only intervention. Limitations of the study were small number of clinics available, comparison of the experimental intervention with an evidence based intervention, and limited exposure to some aspects of the intervention. More effective interventions may include aggressive case management, and providing the physician with more relevant information.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CALMA | Active comparator | Behavioral: CALMA plus, Behavioral: CALMAParticipants only received a family education intervention (previously tested) known as CALMA |
| Calma plus | Experimental | Behavioral: CALMA plusParticipants in Arm 2 received the CALMA family education intervention and physician education and organizational change of the clinics were addressed with a culturally tailored program developed by adapting content from several evidence-based provider training programs. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Inclusion criteria required that the child have at least one claim with a diagnostic code for asthma or reactive airway disease (International Classification of Diseases (ICD 9) diagnostic code 493.xx) and in the last year period had either1) been hospitalized for asthma
- had at least 2 Emergency Department (ED) visits
- 3-5 ambulatory visits due to asthma
- utilized asthma medications from 2 of the following therapeutic categories: Anticholinergics, cromolyn, sympathomimetics, steroid inhalants, methylxanthines, leukotriene inhibitors, or corticosteroids.
Key exclusion criteria (2 listed)
- currently participating in another asthma study
- no appropriate address for follow-up in the claims data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CALMA plusParticipants received a family education intervention (previously tested) known as CALMA plus physician education and organizational change of the clinics were addressed with a culturally tailored program developed by adapting content from several evidence-based provider training programs | Behavioural | CALMA, Calma plus |
| CALMAFamily Education Intervention on management of pediatric asthma | Behavioural | CALMA |
Primary outcome
Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up
Time frame: Baseline, 12
1 secondary outcome
Change in the Reduction of asthma symptomatology from baseline to 12 month follow-up
Time frame: baseline, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Derived from this study: PubMed 26786240Canino G, Shrout PE, Vila D, Ramirez R, Rand C. Effectiveness of a multi-level asthma intervention in increasing controller medication use: a randomized control trial. J Asthma. 2016;53(3):301-10. doi: 10.3109/02770903.2015.1057846. Epub 2016 Jan 19.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glorisa Canino, PhD principal investigator
Medical Sciences Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CALMA plus and CALMA in people with Infantile Asthma, run by University of Puerto Rico at 1 site in Puerto Rico.
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 2 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 20 May 2014. 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 Puerto Rico. 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 Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (time frame: Baseline, 12). 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 NCT02141893, which also lists 1 linked publication.
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 20 May 2014.