AsthmaNCT00005711
Intervention for Hispanic Children With Asthma
A study testing Asthma self-management education in people with Asthma and Lung Diseases, run by The University of Texas Health Science Center at San Antonio.
Trial summary
To design, implement, and evaluate an intervention program for Hispanic children with asthma which included both a physician education and a patient/family education component. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Asthma, Lung Diseases
- What is being tested?
- Asthma self-management education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Aug 1990to Jul 2009
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Physician diagnosis of asthma; moderate severity (1997 criteria), ie. >= 2 ED visits or 1 hospitalization in past year or prescribed daily asthma medication.
About this study
To design, implement, and evaluate an intervention program for Hispanic children with asthma which included both a physician education and a patient/family education component.
Read the detailed description
BACKGROUND:
Although asthma affects 6-10 percent of children aged 6-16 years, the prevalence of asthma in Hispanic groups and the degree of resulting morbidity were unknown in 1990. The study sought to answer the following questions: 1) Would a physician education intervention result in improved medical management for Hispanic children with asthma who were cared for within the context of an outpatient clinic? 2) Would a focused educational intervention for Hispanic children with asthma and their families result in decreased morbidity and improved quality of life? If effective, the physician education and patient education programs could serve as models for the implementation of similar programs in outpatient clinic settings which serve Hispanic children with asthma.
The study was part of a demonstration and education initiative "Interventions for Control of Asthma Among Black and Hispanic Children" which was released by the NHLBI in June 1989.
DESIGN NARRATIVE:
Prior to enrollment of patients, all physicians participated in an intervention which included the following elements: a brief seminar about medical management for children with asthma, introduction of protocols in low chart format (algorithms), use of a standardized progress note from for children with asthma, a series of computer-based simulations and individualized feedback to physicians. The effectiveness of the physician education component in changing physician behavior was measured by pre- /post-test, chart audit, and performance on computer-based simulations.
One hundred sixty (160) Hispanic children with asthma, aged 6-15 years who were cared for in a pediatric residents' continuity clinic were enrolled for study. A research associate interviewed parents and children separately using standardized questionnaires to obtain information about 1) health beliefs, 2) reported health behavior, 3) knowledge and attitudes about asthma, 4) functional morbidity, 5) acculturation, and 6) socio-demographic factors. A research nurse performed spirometry on each subject. Additional information was obtained by review of medical records and school attendance records. Patients were then randomized into treatment and control groups. Treatment group patients and their families participated in the patient education intervention. The intervention consisted of a series of four videotapes and written materials which focused on major aspects of self-management for children with asthma. Patients and families received the four modules at one month intervals. Selected modules were reviewed with the research nurse at appointed visits approximately six, 9, and 12 months following enrollment. Follow-up data were obtained by interview, medical record review, and spirometry at six, 12, 18, and 24 months following enrollment.
Intervention and control group children were compared for morbidity (the number of emergency room visits, hospitalizations, school days missed) and quality of life (impact on family and functional status), after controlling for confounding variables. Secondary data analysis examined the effect of the intervention on knowledge, reported health behaviors, and post-intervention spirometry.
- Conditions
- Asthma, Lung Diseases
- Being tested
- Asthma self-management education
- Medical subject headings
- Asthma, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma self-management educationBehavioural
Treatment group children and their families participated in the patient education program which consisted of four separate one-hour sessions. The topics were: symptoms of asthma, causes of asthma ("triggers"), medications, and peak flow. A bilingual nurse educator working one-on-one with the child and family members delivered these four sessions. The four sessions were delivered over a six week period. Culturally sensitive educational materials include both print (flip charts, take-home brochures) and videotape materials. The videotapes feature children from the clinic and highlight how they successfully manage their asthma. All materials are available in both English and Spanish.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Control group children received routine medical care by their primary care providers as well as study visits every 6 months. At each study visit, following assessment of technique for using peak flow and metered dose inhalers, errors were corrected and children/families were coached on correct technique. |
| Asthma self-management education | Experimental | Treatment group children and their families participated in the patient education program which consisted of four separate one-hour sessions. The topics were: symptoms of asthma, causes of asthma ("triggers"), medications, and peak flow. A bilingual nurse educator working one-on-one with the child and family members delivered these four sessions. The four sessions were delivered over a six week period. Culturally sensitive educational materials include both print (flip charts, take-home brochures) and videotape materials. The videotapes feature children from the clinic and highlight how they successfully manage their asthma. All materials are available in both English and Spanish. Receives: Behavioral: Asthma self-management education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care utilization
ED visits; hospitalizations
Measured: Enrollment, 12 months, 24 months
Secondary outcomes (5)
School absenteeism
Number of school days misses per year
Measured: Enrollment, 12 months, 24 months
Lung function (FEV1 % predicted)
FEV1 % predicted
Measured: Enrollment, 6, 12, 18, 24 months
Quality of life: Impact on Family
Impact on Family scores
Measured: Enrollment, 6, 12, 18, 24 months
Quality of life: functional status
functional impairment (FSII scores)
Measured: Enrollment, 6, 12, 18, 24 months
Self-management
self-reported self-management behaviors
Measured: Enrollment, 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startAug 1990
- Primary completionJul 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005711
- Sponsor's protocol ID
- 4920
- Other IDs
- R01HL045297, HSC19900128H
- Status last verified
- May 2016
- First submitted
- 25 May 2000
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hendricson WD, Wood PR, Hidalgo HA, Ramirez AG, Kromer ME, Selva M, Parcel G. Implementation of individualized patient education for Hispanic children with asthma. Patient Educ Couns. 1996 Nov;29(2):155-65. doi: 10.1016/0738-3991(96)00861-0.
PubMed 9006232Hendricson WD, Wood PR, Hidalgo HA, Kromer ME, Parcel GS, Ramirez AG. Implementation of a physician education intervention. The Childhood Asthma Project. Arch Pediatr Adolesc Med. 1994 Jun;148(6):595-601. doi: 10.1001/archpedi.1994.02170060049008.
PubMed 8193683Kromer ME, Prihoda TJ, Hidalgo HA, Wood PR. Assessing quality of life in Mexican-American children with asthma: impact-on-family and functional status. J Pediatr Psychol. 2000 Sep;25(6):415-26. doi: 10.1093/jpepsy/25.6.415.
PubMed 10980046Hidalgo H, Prihoda T, Arfken C, Evans D, Hanson J, Lapidus J, Malveaux F, Mellins R, Murphy S, Ramos C, Rand C, Strunk R, Sussman L, Thompson L, Wood P. Impact of home smoke exposure on black and hispanic children with asthma: a multi-center study. 1996. p. A420. (Am J Respir Crit Care Med; vol. 153).
Wood PR, Hidalgo HA, Prihoda TJ, Kromer ME, Hendricson WD, Ramirez AG, Marinez YM. Asthma in hispanic children: a controlled study of the impact of patient education on morbidity. 1996. p. A276. (Am J Respir Crit Care Med; vol. 153).
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Hispanic Children With Asthma
- ClinicalTrials.gov ID
- NCT00005711
- Acronym / sponsor ID
- 4920
- Conditions
- Asthma, Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1990
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 May 2000 (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.
To design, implement, and evaluate an intervention program for Hispanic children with asthma which included both a physician education and a patient/family education component.
Detailed description
BACKGROUND:
Although asthma affects 6-10 percent of children aged 6-16 years, the prevalence of asthma in Hispanic groups and the degree of resulting morbidity were unknown in 1990. The study sought to answer the following questions: 1) Would a physician education intervention result in improved medical management for Hispanic children with asthma who were cared for within the context of an outpatient clinic? 2) Would a focused educational intervention for Hispanic children with asthma and their families result in decreased morbidity and improved quality of life? If effective, the physician education and patient education programs could serve as models for the implementation of similar programs in outpatient clinic settings which serve Hispanic children with asthma.
The study was part of a demonstration and education initiative "Interventions for Control of Asthma Among Black and Hispanic Children" which was released by the NHLBI in June 1989.
DESIGN NARRATIVE:
Prior to enrollment of patients, all physicians participated in an intervention which included the following elements: a brief seminar about medical management for children with asthma, introduction of protocols in low chart format (algorithms), use of a standardized progress note from for children with asthma, a series of computer-based simulations and individualized feedback to physicians. The effectiveness of the physician education component in changing physician behavior was measured by pre- /post-test, chart audit, and performance on computer-based simulations.
One hundred sixty (160) Hispanic children with asthma, aged 6-15 years who were cared for in a pediatric residents' continuity clinic were enrolled for study. A research associate interviewed parents and children separately using standardized questionnaires to obtain information about 1) health beliefs, 2) reported health behavior, 3) knowledge and attitudes about asthma, 4) functional morbidity, 5) acculturation, and 6) socio-demographic factors. A research nurse performed spirometry on each subject. Additional information was obtained by review of medical records and school attendance records. Patients were then randomized into treatment and control groups. Treatment group patients and their families participated in the patient education intervention. The intervention consisted of a series of four videotapes and written materials which focused on major aspects of self-management for children with asthma. Patients and families received the four modules at one month intervals. Selected modules were reviewed with the research nurse at appointed visits approximately six, 9, and 12 months following enrollment. Follow-up data were obtained by interview, medical record review, and spirometry at six, 12, 18, and 24 months following enrollment.
Intervention and control group children were compared for morbidity (the number of emergency room visits, hospitalizations, school days missed) and quality of life (impact on family and functional status), after controlling for confounding variables. Secondary data analysis examined the effect of the intervention on knowledge, reported health behaviors, and post-intervention spirometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Control group children received routine medical care by their primary care providers as well as study visits every 6 months. At each study visit, following assessment of technique for using peak flow and metered dose inhalers, errors were corrected and children/families were coached on correct technique. |
| Asthma self-management education | Experimental | Behavioral: Asthma self-management educationTreatment group children and their families participated in the patient education program which consisted of four separate one-hour sessions. The topics were: symptoms of asthma, causes of asthma ("triggers"), medications, and peak flow. A bilingual nurse educator working one-on-one with the child and family members delivered these four sessions. The four sessions were delivered over a six week period. Culturally sensitive educational materials include both print (flip charts, take-home brochures) and videotape materials. The videotapes feature children from the clinic and highlight how they successfully manage their asthma. All materials are available in both English and Spanish. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Asthma self-management educationTreatment group children and their families participated in the patient education program which consisted of four separate one-hour sessions. The topics were: symptoms of asthma, causes of asthma ("triggers"), medications, and peak flow. A bilingual nurse educator working one-on-one with the child and family members delivered these four sessions. The four sessions were delivered over a six week period. Culturally sensitive educational materials include both print (flip charts, take-home brochures) and videotape materials. The videotapes feature children from the clinic and highlight how they successfully manage their asthma. All materials are available in both English and Spanish. | Behavioural | Asthma self-management education |
Primary outcome
Health care utilization
Time frame: Enrollment, 12 months, 24 months
ED visits; hospitalizations
5 secondary outcomes
School absenteeism
Time frame: Enrollment, 12 months, 24 months
Lung function (FEV1 % predicted)
Time frame: Enrollment, 6, 12, 18, 24 months
Quality of life: Impact on Family
Time frame: Enrollment, 6, 12, 18, 24 months
Quality of life: functional status
Time frame: Enrollment, 6, 12, 18, 24 months
Self-management
Time frame: Enrollment, 6, 12, 18, 24 months
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 10 May 2016.
- Results publication: PubMed 9006232Hendricson WD, Wood PR, Hidalgo HA, Ramirez AG, Kromer ME, Selva M, Parcel G. Implementation of individualized patient education for Hispanic children with asthma. Patient Educ Couns. 1996 Nov;29(2):155-65. doi: 10.1016/0738-3991(96)00861-0.
- Results publication: PubMed 8193683Hendricson WD, Wood PR, Hidalgo HA, Kromer ME, Parcel GS, Ramirez AG. Implementation of a physician education intervention. The Childhood Asthma Project. Arch Pediatr Adolesc Med. 1994 Jun;148(6):595-601. doi: 10.1001/archpedi.1994.02170060049008.
- Results publication: PubMed 10980046Kromer ME, Prihoda TJ, Hidalgo HA, Wood PR. Assessing quality of life in Mexican-American children with asthma: impact-on-family and functional status. J Pediatr Psychol. 2000 Sep;25(6):415-26. doi: 10.1093/jpepsy/25.6.415.
- Results publicationHidalgo H, Prihoda T, Arfken C, Evans D, Hanson J, Lapidus J, Malveaux F, Mellins R, Murphy S, Ramos C, Rand C, Strunk R, Sussman L, Thompson L, Wood P. Impact of home smoke exposure on black and hispanic children with asthma: a multi-center study. 1996. p. A420. (Am J Respir Crit Care Med; vol. 153).
- Results publicationWood PR, Hidalgo HA, Prihoda TJ, Kromer ME, Hendricson WD, Ramirez AG, Marinez YM. Asthma in hispanic children: a controlled study of the impact of patient education on morbidity. 1996. p. A276. (Am J Respir Crit Care Med; vol. 153).
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma self-management education in people with Asthma and Lung Diseases, run by The University of Texas Health Science Center at San Antonio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Health care utilization (time frame: Enrollment, 12 months, 24 months). 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 NCT00005711, which also lists 5 linked publications.
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 10 May 2016.