AsthmaPEPACNCT00832923
Improving Asthma Care Through Parental Empowerment
A study testing PEPAC in people with Asthma, run by Children's National Research Institute at 1 site in United States.
Trial summary
The overall aim of this study will be to perform a prospective randomized clinical trial of an enhanced version of the IMPACT DC intervention involving short-term case management to facilitate PCP follow-up appointments and to provide education for parents about how to communicate more effectively with their… Read more about this study
- Who is it for?
- Ages 12 months to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- PEPAC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2011
- 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 12 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ages between 12 months and 12 years, inclusive
- prior physician diagnosed asthma
- ability of the parent to identify a specific PCP for their child
- public insurance covering the child
- parent/guardian available for interview
Who cannot join
- significant medical co-morbidities
- enrollment in another asthma research intervention study
- unavailability for telephone follow-up
- primary language of the caregiver other than English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Improving Asthma Care Through Parental Empowerment: Effect on Healthcare Utilization and Parent Self-Efficacy
The overall aim of this study will be to perform a prospective randomized clinical trial of an enhanced version of the IMPACT DC intervention involving short-term case management to facilitate PCP follow-up appointments and to provide education for parents about how to communicate more effectively with their children's PCPs as a means (1) to improve the rate of utilization of primary care services for ongoing asthma care and (2) to enhance the self-efficacy of parents in their interactions with their children's provider regarding the child's asthma care needs in 150 parents of high risk children referred within the IMPACT DC Asthma Clinic.
Read the detailed description
Asthma is the most common chronic disease of childhood, and it disproportionately affects urban, minority, and disadvantaged children. When implemented correctly, existing evidence-based guidelines from the National Heart, Lung, and Blood Institute (NHLBI) improve pediatric asthma care and outcomes. One key component of these guidelines is the importance of longitudinal care as part of a partnership among patient, parents, and a healthcare provider. Such a partnership depends on effective communication of healthcare status by parents to providers. Improving the communication skills of inner-city parents may improve their ability to obtain more effective longitudinal asthma care within their primary care homes and thereby to improve their child's asthma health outcomes. IMPACT DC ("Improving Pediatric Asthma Care in the District of Columbia") is a locally validated emergency department (ED) based intervention that improves multiple measures of asthma care and outcomes through an intensive short-term program of asthma education, medical care, and care coordination. In spite of these successes, achieving increased subsequent contact and partnership with primary care providers (PCPs) for asthma care after the intervention has not been successful. Therefore, for the current study, we propose to assess the effectiveness of an enhanced version of the existing IMPACT DC intervention consisting of short-term case management by trained asthma educators.
- Conditions
- Asthma
- Being tested
- PEPAC
- Keywords
- parental empowerment, parent self-efficacy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPACBehavioural
The proposed enhancement of the IMPACT DC intervention will consist of three key components: (1) an enhanced IMPACT DC Asthma Clinic visit; (2) short-term case management to increase the rate of primary care follow-up visits in the first month after the IMPACT DC Asthma Clinic visit; and (3) training in an "asthma care toolkit" to improve communication around asthma care with the child's primary care provider.
| Study group | Role | What they receive |
|---|---|---|
| Routine IMPACT DC care | No intervention | Participants receive standard asthma education as routine for IMPACT DC |
| Enhanced care PEPAC Intervention | Experimental | Not described Receives: Behavioral: PEPAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of Primary Care Provider
Measured: 2 months & 6 months after visit
Secondary outcomes (1)
Parental Self-efficacy in communicating about Asthma care with child's primary care provider
Measured: 2 months & 6 months after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen J. Teach, MD, MPH, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832923
- Sponsor's protocol ID
- RAC #207
- Acronym
- PEPAC
- Status last verified
- Sep 2014
- First submitted
- 29 Jan 2009
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Asthma Care Through Parental Empowerment: Effect on Healthcare Utilization and Parent Self-Efficacy
- ClinicalTrials.gov ID
- NCT00832923
- Acronym / sponsor ID
- PEPAC / RAC #207
- Conditions
- Asthma
- Keywords
- parental empowerment, parent self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jan 2009 (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 aim of this study will be to perform a prospective randomized clinical trial of an enhanced version of the IMPACT DC intervention involving short-term case management to facilitate PCP follow-up appointments and to provide education for parents about how to communicate more effectively with their children's PCPs as a means (1) to improve the rate of utilization of primary care services for ongoing asthma care and (2) to enhance the self-efficacy of parents in their interactions with their children's provider regarding the child's asthma care needs in 150 parents of high risk children referred within the IMPACT DC Asthma Clinic.
Detailed description
Asthma is the most common chronic disease of childhood, and it disproportionately affects urban, minority, and disadvantaged children. When implemented correctly, existing evidence-based guidelines from the National Heart, Lung, and Blood Institute (NHLBI) improve pediatric asthma care and outcomes. One key component of these guidelines is the importance of longitudinal care as part of a partnership among patient, parents, and a healthcare provider. Such a partnership depends on effective communication of healthcare status by parents to providers. Improving the communication skills of inner-city parents may improve their ability to obtain more effective longitudinal asthma care within their primary care homes and thereby to improve their child's asthma health outcomes. IMPACT DC ("Improving Pediatric Asthma Care in the District of Columbia") is a locally validated emergency department (ED) based intervention that improves multiple measures of asthma care and outcomes through an intensive short-term program of asthma education, medical care, and care coordination. In spite of these successes, achieving increased subsequent contact and partnership with primary care providers (PCPs) for asthma care after the intervention has not been successful. Therefore, for the current study, we propose to assess the effectiveness of an enhanced version of the existing IMPACT DC intervention consisting of short-term case management by trained asthma educators.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine IMPACT DC care | No intervention | –Participants receive standard asthma education as routine for IMPACT DC |
| Enhanced care PEPAC Intervention | Experimental | Behavioral: PEPAC |
Who may qualify
- Ages
- 12 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ages between 12 months and 12 years, inclusive
- prior physician diagnosed asthma
- ability of the parent to identify a specific PCP for their child
- public insurance covering the child
- parent/guardian available for interview
Key exclusion criteria (4 listed)
- significant medical co-morbidities
- enrollment in another asthma research intervention study
- unavailability for telephone follow-up
- primary language of the caregiver other than English
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 |
|---|---|---|
| PEPACThe proposed enhancement of the IMPACT DC intervention will consist of three key components: (1) an enhanced IMPACT DC Asthma Clinic visit; (2) short-term case management to increase the rate of primary care follow-up visits in the first month after the IMPACT DC Asthma Clinic visit; and (3) training in an "asthma care toolkit" to improve communication around asthma care with the child's primary care provider. | Behavioural | Enhanced care PEPAC Intervention |
Primary outcome
Utilization of Primary Care Provider
Time frame: 2 months & 6 months after visit
1 secondary outcome
Parental Self-efficacy in communicating about Asthma care with child's primary care provider
Time frame: 2 months & 6 months after visit
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 12 Sep 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEPAC in people with Asthma, run by Children's National 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 5 inclusion and 4 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 12 Sep 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 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?
Utilization of Primary Care Provider (time frame: 2 months & 6 months after visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2014.