AsthmaNCT01167855
Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children
A study testing Asthma Education Sessions, Asthma Health Assessment via Telemonitoring and Provider Treatment Prompt in people with Asthma and Quality of Life, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The overall goal of this proposal is to examine the efficacy of a school-based asthma telemedicine intervention in a predominately minority, low-income rural pediatric population. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Quality of Life, Children
- What is being tested?
- Asthma Education Sessions, Asthma Health Assessment via Telemonitoring and Provider Treatment Prompt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 823 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2011to 1 Feb 2017
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The investigators will recruit students (ages 7-14 years) with asthma who are currently enrolled in public school districts located in the Delta region of Arkansas.
- Eligibility of identified children will be determined by a brief telephone survey. The survey questions will determine if the child fulfills inclusion/exclusion criteria.
- Age ≥ 7 and ≤ 14 years.
- Use of asthma medications for acute relief of symptoms (rescue) or for control of symptoms (preventive) in the past 6 months. Children not on a controller who report using a rescue medication only for prevention of exercised-induced symptoms will not be eligible for the study.
- Physician-diagnosed asthma by parent/caregiver report. OR
- In the absence of a formal physician diagnosis, the caregiver must report symptoms consistent with at least mild persistent asthma. The investigators will use asthma screening criteria to ensure that participants meet eligibility requirements. Participants must establish a history of episodic airflow obstruction or airway hyperresponsiveness and meet National Heart Lung and Blood Institute (NHLBI) guidelines for persistent asthma. Mild persistent asthma will be defined as any 1 of the following during the prior 4 weeks (by caregiver report):
Show all 11Show fewer
- An average of > 2 days per week with asthma symptoms
- > 2 days per week with rescue medication use
- > 2 nights per month awakened with nighttime symptoms
- Minor limitation of activity
- ≥ 2 episodes of asthma during the past year that have required systemic corticosteroids
Who cannot join
- Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures.
- Significant co-morbid conditions (such as severe developmental delay) that could preclude participation in an education-based intervention.
- Inability to speak or understand English (child or parent).
- Children in foster care or other situations in which consent cannot be obtained from a guardian.
- Prior enrollment in the study.
- Families without access to a working telephone as all survey data will be collected via telephone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
About this study
The overall goal of this proposal is to examine the efficacy of a school-based asthma telemedicine intervention in a predominately minority, low-income rural pediatric population.
Read the detailed description
A total of 1110 subjects will be enrolled in this research study. Five hundred forty (540) subjects will be between the ages of 7-14 years. The remaining 540 subjects will be comprised of the primary caregiver of the participants. Thirty (30) school nurse/s providing care to the 270 intervention participants will also be enrolled in the study. To test our hypotheses, the investigators will conduct a cluster randomized trial with 540 children, ages 7-14 years and their parent/guardian(s), to address the following specific aims:
Specific Aim 1: Examine the efficacy of a school-based asthma telemedicine intervention in improving asthma-related health outcomes in an intervention group compared to children receiving usual care.
Specific Aim 2: Determine the effects of a school-based asthma telemedicine intervention on asthma self-management skills of intervention caregivers and participants compared to a usual care group. The investigators will compare changes in asthma self-efficacy, quality of life, and knowledge between groups.
Specific Aim 3: Determine the cost of the intervention in relation to health outcomes.
- Conditions
- Asthma, Quality of Life, Children
- Being tested
- Asthma Education Sessions, Asthma Health Assessment via Telemonitoring, Provider Treatment Prompt, School Absenteeism, Prescription Filling Profile
- Keywords
- Pediatric Asthma, Low-income, Arkansas Delta Region
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Education SessionsOther
Comprehensive asthma education sessions delivered via telemedicine.
Asthma Health Assessment via TelemonitoringOther
Each intervention participant will undergo assessment of asthma via school-based telemonitoring to measure lung function and provide a self-report of asthma symptoms.
Provider Treatment PromptOther
A treatment prompt will be mailed to the primary care provider at baseline and 3 months.
School AbsenteeismOther
Absenteeism before and after the intervention will be compared in the intervention group and also will be compared to absentee rates of the usual care group.
Prescription Filling ProfileOther
Study personnel will monitor participants' prescription profiles.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | * Telemedicine asthma education sessions
* Asthma health assessment via telemonitoring
* Provider treatment prompts
* School absenteeism
* Prescription filling profile Receives: Other: Asthma Education Sessions; Other: Asthma Health Assessment via Telemonitoring; Other: Provider Treatment Prompt; Other: School Absenteeism; Other: Prescription Filling Profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Free Days
Examine the efficacy of a school-based asthma telemedicine intervention.
Measured: The number of symptom-free days (SFD) during the prior 2 weeks assessed at the end of the intervention.
Secondary outcomes (1)
Secondary Clinical Outcomes
Secondary clinical outcomes will be measured at specific time points during the intervention.
Measured: Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study start25 May 2011
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
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.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara T. Perry, M.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167855
- Sponsor's protocol ID
- 112695
- Other IDs
- 1R01HL102388-01
- Status last verified
- May 2017
- First submitted
- 21 Jul 2010
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data.
Publications
Perry TT, Vargas PA, McCracken A, Jones SM. Underdiagnosed and uncontrolled asthma: findings in rural schoolchildren from the Delta region of Arkansas. Ann Allergy Asthma Immunol. 2008 Oct;101(4):375-81. doi: 10.1016/S1081-1206(10)60313-4.
PubMed 18939725Pesek R, PA V, Jones S, McCracken A, Perry TT. Pediatric asthma diagnosis and morbidity in urban and rural Arkansas. J Allergy Clin Immunol 2009;123:S210.
Vargas PA, Simpson PM, Gary Wheeler J, Goel R, Feild CR, Tilford JM, Jones SM. Characteristics of children with asthma who are enrolled in a Head Start program. J Allergy Clin Immunol. 2004 Sep;114(3):499-504. doi: 10.1016/j.jaci.2004.05.025.
PubMed 15356547Tilford JM. Cost-effectiveness analysis and emergency medical services for children: issues and applications. Ambul Pediatr. 2002 Jul-Aug;2(4 Suppl):330-6. doi: 10.1367/1539-4409(2002)0022.0.co;2.
PubMed 12135408Perry TT, Halterman JS, Brown RH, Luo C, Randle SM, Hunter CR, Rettiganti M. Results of an asthma education program delivered via telemedicine in rural schools. Ann Allergy Asthma Immunol. 2018 Apr;120(4):401-408. doi: 10.1016/j.anai.2018.02.013. Epub 2018 Feb 19.
PubMed 29471032
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children
- ClinicalTrials.gov ID
- NCT01167855
- Acronym / sponsor ID
- 112695
- Conditions
- Asthma, Quality of Life, Children
- Keywords
- Pediatric Asthma, Low-income, Arkansas Delta Region
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Arkansas
- Study start
- 25 May 2011 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 22 Jul 2010 (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 overall goal of this proposal is to examine the efficacy of a school-based asthma telemedicine intervention in a predominately minority, low-income rural pediatric population.
Detailed description
A total of 1110 subjects will be enrolled in this research study. Five hundred forty (540) subjects will be between the ages of 7-14 years. The remaining 540 subjects will be comprised of the primary caregiver of the participants. Thirty (30) school nurse/s providing care to the 270 intervention participants will also be enrolled in the study. To test our hypotheses, the investigators will conduct a cluster randomized trial with 540 children, ages 7-14 years and their parent/guardian(s), to address the following specific aims:
Specific Aim 1: Examine the efficacy of a school-based asthma telemedicine intervention in improving asthma-related health outcomes in an intervention group compared to children receiving usual care.
Specific Aim 2: Determine the effects of a school-based asthma telemedicine intervention on asthma self-management skills of intervention caregivers and participants compared to a usual care group. The investigators will compare changes in asthma self-efficacy, quality of life, and knowledge between groups.
Specific Aim 3: Determine the cost of the intervention in relation to health outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Asthma Education Sessions, Other: Asthma Health Assessment via Telemonitoring, Other: Provider Treatment Prompt, Other: School Absenteeism, Other: Prescription Filling Profile* Telemedicine asthma education sessions * Asthma health assessment via telemonitoring * Provider treatment prompts * School absenteeism * Prescription filling profile |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- The investigators will recruit students (ages 7-14 years) with asthma who are currently enrolled in public school districts located in the Delta region of Arkansas.
- Eligibility of identified children will be determined by a brief telephone survey. The survey questions will determine if the child fulfills inclusion/exclusion criteria.
- Age ≥ 7 and ≤ 14 years.
- Use of asthma medications for acute relief of symptoms (rescue) or for control of symptoms (preventive) in the past 6 months. Children not on a controller who report using a rescue medication only for prevention of exercised-induced symptoms will not be eligible for the study.
- Physician-diagnosed asthma by parent/caregiver report. OR
Key exclusion criteria (6 listed)
- Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures.
- Significant co-morbid conditions (such as severe developmental delay) that could preclude participation in an education-based intervention.
- Inability to speak or understand English (child or parent).
- Children in foster care or other situations in which consent cannot be obtained from a guardian.
- Prior enrollment in the study.
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 Education SessionsComprehensive asthma education sessions delivered via telemedicine. | Other | Intervention |
| Asthma Health Assessment via TelemonitoringEach intervention participant will undergo assessment of asthma via school-based telemonitoring to measure lung function and provide a self-report of asthma symptoms. | Other | Intervention |
| Provider Treatment PromptA treatment prompt will be mailed to the primary care provider at baseline and 3 months. | Other | Intervention |
| School AbsenteeismAbsenteeism before and after the intervention will be compared in the intervention group and also will be compared to absentee rates of the usual care group. | Other | Intervention |
| Prescription Filling ProfileStudy personnel will monitor participants' prescription profiles. | Other | Intervention |
Primary outcome
Symptom Free Days
Time frame: The number of symptom-free days (SFD) during the prior 2 weeks assessed at the end of the intervention.
Examine the efficacy of a school-based asthma telemedicine intervention.
1 secondary outcome
Secondary Clinical Outcomes
Time frame: Secondary outcomes will be measured during the intervention, at the end of the intervention and at 6-month follow-up.
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 16 May 2017.
- Background: PubMed 18939725Perry TT, Vargas PA, McCracken A, Jones SM. Underdiagnosed and uncontrolled asthma: findings in rural schoolchildren from the Delta region of Arkansas. Ann Allergy Asthma Immunol. 2008 Oct;101(4):375-81. doi: 10.1016/S1081-1206(10)60313-4.
- BackgroundPesek R, PA V, Jones S, McCracken A, Perry TT. Pediatric asthma diagnosis and morbidity in urban and rural Arkansas. J Allergy Clin Immunol 2009;123:S210.
- Background: PubMed 15356547Vargas PA, Simpson PM, Gary Wheeler J, Goel R, Feild CR, Tilford JM, Jones SM. Characteristics of children with asthma who are enrolled in a Head Start program. J Allergy Clin Immunol. 2004 Sep;114(3):499-504. doi: 10.1016/j.jaci.2004.05.025.
- Background: PubMed 12135408Tilford JM. Cost-effectiveness analysis and emergency medical services for children: issues and applications. Ambul Pediatr. 2002 Jul-Aug;2(4 Suppl):330-6. doi: 10.1367/1539-4409(2002)0022.0.co;2.
- Derived from this study: PubMed 29471032Perry TT, Halterman JS, Brown RH, Luo C, Randle SM, Hunter CR, Rettiganti M. Results of an asthma education program delivered via telemedicine in rural schools. Ann Allergy Asthma Immunol. 2018 Apr;120(4):401-408. doi: 10.1016/j.anai.2018.02.013. Epub 2018 Feb 19.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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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.
Tamara T. Perry, M.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Education Sessions, Asthma Health Assessment via Telemonitoring and Provider Treatment Prompt in people with Asthma and Quality of Life, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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 11 inclusion and 6 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 16 May 2017. 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 United States. 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?
Symptom Free Days (time frame: The number of symptom-free days (SFD) during the prior 2 weeks assessed at the end of the intervention.). 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 NCT01167855, 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 16 May 2017.