AsthmaNCT01169883
Coping Peer Intervention for Adherence
A study testing Coping Peer Support, Doctor Asthma Messages and Coping Peer Asthma Messages in people with Asthma, run by Rush University Medical Center at 1 site in United States.
Trial summary
Inner-city African American and Hispanic adolescents suffer from disproportionately high rates of emergency room visits and hospitalizations for acute exacerbations of asthma. This study proposes the use of a coping peer support intervention, enhanced by a technology-based platform that infuses peer support throughout… Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Asthma
- What is being tested?
- Coping Peer Support, Doctor Asthma Messages and Coping Peer Asthma Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2012
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Self-identify as African American or Hispanic
- 11-16 years of age
- Have persistent asthma
- Be on a prescription daily inhaled steroid medication for asthma
Who cannot join
- Candidate refusal
- Presence of other co-morbidities that could interfere with study participation
- greater than 47% adherence to daily inhaled steroid medication as measured at baseline using the Doser CT
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Inner-city African American and Hispanic adolescents suffer from disproportionately high rates of emergency room visits and hospitalizations for acute exacerbations of asthma. This study proposes the use of a coping peer support intervention, enhanced by a technology-based platform that infuses peer support throughout adolescents' daily routines, to increase adherence to daily controller medications and ultimately reduce asthma exacerbation risk in this important population subgroup.
Read the detailed description
High rates of asthma morbidity and mortality among inner-city African American and Hispanic adolescents demand urgent intervention. To address this disparity, the investigators have designed a culturally sensitive intervention aimed at improving adherence to daily controller medications for asthma, and ultimately reduce asthma exacerbation risk, that fits easily into adolescents' chaotic lifestyles.
The proposed study is a behavioral randomized controlled trial that tests if a coping peer intervention can increase adherence to asthma controller medications among urban African American and Hispanic adolescents 11 to 16 years of age. To ensure the project's success, the principal investigator has assembled a multi-disciplinary team of researchers, including behavioral and social science experts. The Specific Aims propose to: (1) evaluate the impact of a 10-week coping peer support intervention on adherence and knowledge, compared to an attention control; (2) evaluate the ability of a 10-week coping peer support intervention to achieve sustained post-treatment improvements in adherence and knowledge, compared to an attention control; and (3) to develop estimates needed for the design of a subsequent R01 behavioral controlled trial testing the efficacy of this intervention to decrease risk of asthma exacerbations. The study's primary outcome is adherence to daily asthma controller medications, measured using an objective electronic monitor. Study participants will be randomized to receive equal asthma supervision and music tracks plus either: (1) group support, coping peer group problem solving, and peer delivered asthma messages (intervention group); or (2) study team developed and recorded asthma health messages (attention control group) between music tracks, on a portable MP3 player. The group support and coping peer group problem solving consists of: putting subjects together in a small group to discuss barriers to adherence and ways to overcome these barriers; then having group members record messages to each other about overcoming barriers that will be played on their MP3 player, between music tracks, during the course of their daily routines. This effectively brings the coping peer support from the group into the course of the adolescents' day-to-day lives. The investigators hypothesize that it is the ability of the MP3 player to facilitate ongoing peer support that will be the basis for improved adherence. The long term goal is to apply the data from this research to submit an R01 grant application to conduct a behavioral randomized trial evaluating the effectiveness of this coping peer intervention to improve adherence, and ultimately reduce asthma exacerbations, in urban African American and Hispanic adolescents with asthma.
- Conditions
- Asthma
- Being tested
- Coping Peer Support, Doctor Asthma Messages, Coping Peer Asthma Messages, Asthma Supervision, Music Tracks
- Keywords
- adherence, asthma, pediatrics, behavioral intervention, inner city
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Peer SupportBehavioural
The Coping Peer Support is delivered at weekly group meetings over the 10 week active treatment phase. The Coping Peer Support consists of: group support, coping peer group problem solving, and development and recording of Coping Peer Asthma Messages. More specifically, a social worker facilitates a peer group discussion of barriers to taking their daily inhaled steroids, and ways to overcome these barriers. The social worker also facilitates peer recording of messages by the participants encouraging each other to take their daily inhaled steroid medication.
Doctor Asthma MessagesBehavioural
The attention control group will receive Doctor Asthma Messages delivered during the 10 week active treatment phase. The content and number of these messages will be equivalent to those received by the intervention group. These messages are developed and recorded by an Allergist/Immunologist. The participants in the attention control group will listen to these Doctor Asthma Messages, between their favorite music tracks on their MP3 player, as they go about their day-to-day activities.
Coping Peer Asthma MessagesBehavioural
The Coping Peer Asthma Messages developed and recorded by study participants for each other at the weekly coping peer group meetings will be placed on intervention group participants' MP3 players. These Coping Peer Asthma Messages will be played on their MP3 players, between their favorite music tracks, during the course of their daily routines. This infuses the coping peer support from the coping peer group meetings into the adolescents' daily routines.
Asthma SupervisionBehavioural
A member of the study team meets individually with each participant at baseline to teach proper use of a peak flow meter and spacer.
Music TracksBehavioural
Participants receive an MP3 player (iPod Shuffle) in the baseline period. Participants receives clean, radio-edited music tracks of their choice in the baseline period and 10 week active treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control Group | Active comparator | 1) Doctor Asthma Messages delivered over a 10 week time period; 2) Asthma Supervision; and 3) Music Tracks. Receives: Behavioral: Doctor Asthma Messages; Behavioral: Asthma Supervision; Behavioral: Music Tracks |
| Intervention Group | Experimental | 1) Coping Peer Support delivered over a 10 week time period; 2) Coping Peer Asthma Messages delivered over a 10 week time period; 3) Asthma Supervision; and 4) Music Tracks. Receives: Behavioral: Coping Peer Support; Behavioral: Coping Peer Asthma Messages; Behavioral: Asthma Supervision; Behavioral: Music Tracks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively measured adherence to inhaled corticosteroids using an electronic dose counter, (Doser CT; Meditrac, Inc., Hudson, MA)
Adherence is measured as the average of daily adherence to prescribed inhaled corticosteroid medication dose over 14 days at both baseline and at 10 weeks. The average rate of adherence in the intervention group at 10-weeks will be compared to that in the attention control group, adjusting for baseline levels, using a hierarchical linear model since participants are clustered into groups.
Measured: 10 weeks
Secondary outcomes (1)
Asthma Knowledge assessed using the ZAP Asthma Knowledge Instrument
The average score on the ZAP Asthma Knowledge Instrument in the intervention group at 10-weeks will be compared to that in the attention control group, adjusting for baseline levels, using a hierarchical linear model since participants are clustered into groups.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012
- Study completionJun 2012
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.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle Mosnaim, Rush University Medical Center
- Investigators
- Giselle S Mosnaim, MD, MS, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169883
- Sponsor's protocol ID
- 09111001
- Other IDs
- 1R21HL098812-01A1
- Status last verified
- Oct 2012
- First submitted
- 23 Jul 2010
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping Peer Intervention for Adherence
- ClinicalTrials.gov ID
- NCT01169883
- Acronym / sponsor ID
- 09111001
- Conditions
- Asthma
- Keywords
- adherence, asthma, pediatrics, behavioral intervention, inner city
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 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.
Inner-city African American and Hispanic adolescents suffer from disproportionately high rates of emergency room visits and hospitalizations for acute exacerbations of asthma. This study proposes the use of a coping peer support intervention, enhanced by a technology-based platform that infuses peer support throughout adolescents' daily routines, to increase adherence to daily controller medications and ultimately reduce asthma exacerbation risk in this important population subgroup.
Detailed description
High rates of asthma morbidity and mortality among inner-city African American and Hispanic adolescents demand urgent intervention. To address this disparity, the investigators have designed a culturally sensitive intervention aimed at improving adherence to daily controller medications for asthma, and ultimately reduce asthma exacerbation risk, that fits easily into adolescents' chaotic lifestyles.
The proposed study is a behavioral randomized controlled trial that tests if a coping peer intervention can increase adherence to asthma controller medications among urban African American and Hispanic adolescents 11 to 16 years of age. To ensure the project's success, the principal investigator has assembled a multi-disciplinary team of researchers, including behavioral and social science experts. The Specific Aims propose to: (1) evaluate the impact of a 10-week coping peer support intervention on adherence and knowledge, compared to an attention control; (2) evaluate the ability of a 10-week coping peer support intervention to achieve sustained post-treatment improvements in adherence and knowledge, compared to an attention control; and (3) to develop estimates needed for the design of a subsequent R01 behavioral controlled trial testing the efficacy of this intervention to decrease risk of asthma exacerbations. The study's primary outcome is adherence to daily asthma controller medications, measured using an objective electronic monitor. Study participants will be randomized to receive equal asthma supervision and music tracks plus either: (1) group support, coping peer group problem solving, and peer delivered asthma messages (intervention group); or (2) study team developed and recorded asthma health messages (attention control group) between music tracks, on a portable MP3 player. The group support and coping peer group problem solving consists of: putting subjects together in a small group to discuss barriers to adherence and ways to overcome these barriers; then having group members record messages to each other about overcoming barriers that will be played on their MP3 player, between music tracks, during the course of their daily routines. This effectively brings the coping peer support from the group into the course of the adolescents' day-to-day lives. The investigators hypothesize that it is the ability of the MP3 player to facilitate ongoing peer support that will be the basis for improved adherence. The long term goal is to apply the data from this research to submit an R01 grant application to conduct a behavioral randomized trial evaluating the effectiveness of this coping peer intervention to improve adherence, and ultimately reduce asthma exacerbations, in urban African American and Hispanic adolescents with asthma.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control Group | Active comparator | Behavioral: Doctor Asthma Messages, Behavioral: Asthma Supervision, Behavioral: Music Tracks1) Doctor Asthma Messages delivered over a 10 week time period; 2) Asthma Supervision; and 3) Music Tracks. |
| Intervention Group | Experimental | Behavioral: Coping Peer Support, Behavioral: Coping Peer Asthma Messages, Behavioral: Asthma Supervision, Behavioral: Music Tracks1) Coping Peer Support delivered over a 10 week time period; 2) Coping Peer Asthma Messages delivered over a 10 week time period; 3) Asthma Supervision; and 4) Music Tracks. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Self-identify as African American or Hispanic
- 11-16 years of age
- Have persistent asthma
- Be on a prescription daily inhaled steroid medication for asthma
Key exclusion criteria (3 listed)
- Candidate refusal
- Presence of other co-morbidities that could interfere with study participation
- greater than 47% adherence to daily inhaled steroid medication as measured at baseline using the Doser CT
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 |
|---|---|---|
| Coping Peer SupportThe Coping Peer Support is delivered at weekly group meetings over the 10 week active treatment phase. The Coping Peer Support consists of: group support, coping peer group problem solving, and development and recording of Coping Peer Asthma Messages. More specifically, a social worker facilitates a peer group discussion of barriers to taking their daily inhaled steroids, and ways to overcome these barriers. The social worker also facilitates peer recording of messages by the participants encouraging each other to take their daily inhaled steroid medication. | Behavioural | Intervention Group |
| Doctor Asthma MessagesThe attention control group will receive Doctor Asthma Messages delivered during the 10 week active treatment phase. The content and number of these messages will be equivalent to those received by the intervention group. These messages are developed and recorded by an Allergist/Immunologist. The participants in the attention control group will listen to these Doctor Asthma Messages, between their favorite music tracks on their MP3 player, as they go about their day-to-day activities. | Behavioural | Attention Control Group |
| Coping Peer Asthma MessagesThe Coping Peer Asthma Messages developed and recorded by study participants for each other at the weekly coping peer group meetings will be placed on intervention group participants' MP3 players. These Coping Peer Asthma Messages will be played on their MP3 players, between their favorite music tracks, during the course of their daily routines. This infuses the coping peer support from the coping peer group meetings into the adolescents' daily routines. | Behavioural | Intervention Group |
| Asthma SupervisionA member of the study team meets individually with each participant at baseline to teach proper use of a peak flow meter and spacer. | Behavioural | Attention Control Group, Intervention Group |
| Music TracksParticipants receive an MP3 player (iPod Shuffle) in the baseline period. Participants receives clean, radio-edited music tracks of their choice in the baseline period and 10 week active treatment period. | Behavioural | Attention Control Group, Intervention Group |
Primary outcome
Objectively measured adherence to inhaled corticosteroids using an electronic dose counter, (Doser CT; Meditrac, Inc., Hudson, MA)
Time frame: 10 weeks
Adherence is measured as the average of daily adherence to prescribed inhaled corticosteroid medication dose over 14 days at both baseline and at 10 weeks. The average rate of adherence in the intervention group at 10-weeks will be compared to that in the attention control group, adjusting for baseline levels, using a hierarchical linear model since participants are clustered into groups.
1 secondary outcome
Asthma Knowledge assessed using the ZAP Asthma Knowledge Instrument
Time frame: 10 weeks
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 25 Oct 2012.
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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.
Giselle S Mosnaim, MD, MS principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Peer Support, Doctor Asthma Messages and Coping Peer Asthma Messages in people with Asthma, run by Rush University Medical Center 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 4 inclusion and 3 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 25 Oct 2012. 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?
Objectively measured adherence to inhaled corticosteroids using an electronic dose counter, (Doser CT; Meditrac, Inc., Hudson, MA) (time frame: 10 weeks). 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 25 Oct 2012.