AsthmaDHAMPNCT02860390
Denver Health Asthma Management Program
A study testing Denver Health Asthma Management Program and Person of Support in people with Asthma, run by Denver Health and Hospital Authority.
Trial summary
This is a Comparison Effectiveness Research (CER) study in a population of 13 to 40 year-old individuals with persistent asthma comparing differing levels of texting interventions with each other and with a usual care group. Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- Asthma
- What is being tested?
- Denver Health Asthma Management Program and Person of Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 15 Aug 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 13 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject and significant other as applicable must have phone or other device capable of receiving text messages
- Ages 13 to 19 with persistent asthma per Denver Health electronic health record and/or HEDIS (modified) criteria for asthma
- Ages 20 to 40 with HEDIS (modified) criteria for persistent asthma
- Hospital-based utilization for asthma (i.e. persistent asthma)
- Denver Health Primary Care Provider visits within last 3 years
- Ability to read English or Spanish.
Who cannot join
- complex and special health care needs pediatric patients
- pregnant/expectant mothers
- incarcerated individuals
- Non-English and non-Spanish speakers
- Chronic Obstructive Pulmonary Disease/COPD or other non-asthma pulmonary diagnoses (e.g. pulmonary function testing inconsistent with asthma and/or negative methacholine challenge testing/lack of reversibility with β-agonist, diagnostic errors despite inclusion in the Asthma Registry)
- Patients who by input of the primary care provider are less likely to participate in an interactive asthma text messaging trial (e.g. intellectual delay, mental health issues)
About this study
This is a Comparison Effectiveness Research (CER) study in a population of 13 to 40 year-old individuals with persistent asthma comparing differing levels of texting interventions with each other and with a usual care group. The two texting interventions include 1) texting only the individual with asthma and 2) texting the individual with asthma and an important person in that individual's life such as a parent or spouse. These two texting groups will be compared to a group receiving usual asthma care at Denver Health.
Read the detailed description
This is Phase 2 of a two-phase pilot project to build and study a texting program for patients at Denver Health who have persistent asthma. The overall goal of the program is to provide educational support for asthma care between clinic visits and to survey for evidence of poorly controlled asthma, which would prompt clinic recall. Phase 1 used a focus group/interview methodology to inform Phase 2 and allow Phase 2 to be more patient-centered. Based on results of focus groups/interviews, the investigators will conduct a three-arm trial among 13- to 19-year-olds and a two-arm trial among 20- to 40-year-olds. For the 13- to 19-year-old group, a 'usual care' group will be compared to two intervention groups: 1) a subject group receiving text messages about asthma care and 2) a group of subjects and their 'significant other', such as a parent, who will also receive the text messages. Overall, Phase 1 findings suggested the 20- to 40-year-old group was more reluctant to involve a significant other and therefore for this group a 'usual care' arm will be compared to an arm where only the patient receives the text messages, but not a significant other. Other features built into Phase 2 upon recommendation from the focus group/interview phase include a midpoint survey and tailoring the amount of texting a patient receives based on the level of asthma control elicited by administration of the validated tool, the Asthma Control Test (ACT).
- Conditions
- Asthma
- Being tested
- Denver Health Asthma Management Program, Person of Support
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denver Health Asthma Management ProgramOther
text message (SMS) support including educational, motivational, and resource content.
Person of SupportOther
Subjects in the adolescent cohort will designate a support person (e.g. parent) to receive messages from the Denver Health Asthma Management Program
| Study group | Role | What they receive |
|---|---|---|
| Adolescent - Control | No intervention | Usual care arm of subjects aged 13-19 years old |
| Adolescent - SMS | Experimental | Subjects aged 13-19 years and receiving Denver Health Asthma Management Program (text messaging intervention) Receives: Other: Denver Health Asthma Management Program |
| Adolescent - SMS plus support person | Experimental | Subjects aged 13-19 years, Denver Health Asthma Management Program (text messaging intervention) sent to subjects and subjects' chosen Person of Support. Receives: Other: Denver Health Asthma Management Program; Other: Person of Support |
| Adult - Control | No intervention | Usual care arm of subjects aged 20-40 years old. |
| Adult - SMS | Experimental | Subjects aged 20-40 years and receiving Denver Health Asthma Management Program (text messaging intervention). Receives: Other: Denver Health Asthma Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Asthma Control Test Score
Measured: Six months
Secondary outcomes (6)
Asthma-related utilization - Emergent Care
Emergent care
Measured: Six months
Asthma-related utilization - Urgent Care
Urgent Care
Measured: Six months
Asthma-related utilization - Hospitalization
Hospitalizations
Measured: Six months
Quality of Life
as measured by the Juniper Asthma Quality of Life Questionnaire(s) and PHQ-4
Measured: Six months
Medication Adherence
as measured by the Asthma Medication Ratio
Measured: Six months
Pre/Post Comparison of Asthma Control Test score
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startMay 2016
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
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
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860390
- Sponsor's protocol ID
- 15-0308 (Anderson)
- Acronym
- DHAMP
- Status last verified
- Oct 2017
- First submitted
- 3 Aug 2016
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denver Health Asthma Management Program
- ClinicalTrials.gov ID
- NCT02860390
- Acronym / sponsor ID
- DHAMP / 15-0308 (Anderson)
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- May 2016
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 9 Aug 2016 (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.
This is a Comparison Effectiveness Research (CER) study in a population of 13 to 40 year-old individuals with persistent asthma comparing differing levels of texting interventions with each other and with a usual care group. The two texting interventions include 1) texting only the individual with asthma and 2) texting the individual with asthma and an important person in that individual's life such as a parent or spouse. These two texting groups will be compared to a group receiving usual asthma care at Denver Health.
Detailed description
This is Phase 2 of a two-phase pilot project to build and study a texting program for patients at Denver Health who have persistent asthma. The overall goal of the program is to provide educational support for asthma care between clinic visits and to survey for evidence of poorly controlled asthma, which would prompt clinic recall. Phase 1 used a focus group/interview methodology to inform Phase 2 and allow Phase 2 to be more patient-centered. Based on results of focus groups/interviews, the investigators will conduct a three-arm trial among 13- to 19-year-olds and a two-arm trial among 20- to 40-year-olds. For the 13- to 19-year-old group, a 'usual care' group will be compared to two intervention groups: 1) a subject group receiving text messages about asthma care and 2) a group of subjects and their 'significant other', such as a parent, who will also receive the text messages. Overall, Phase 1 findings suggested the 20- to 40-year-old group was more reluctant to involve a significant other and therefore for this group a 'usual care' arm will be compared to an arm where only the patient receives the text messages, but not a significant other. Other features built into Phase 2 upon recommendation from the focus group/interview phase include a midpoint survey and tailoring the amount of texting a patient receives based on the level of asthma control elicited by administration of the validated tool, the Asthma Control Test (ACT).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Adolescent - Control | No intervention | –Usual care arm of subjects aged 13-19 years old |
| Adolescent - SMS | Experimental | Other: Denver Health Asthma Management ProgramSubjects aged 13-19 years and receiving Denver Health Asthma Management Program (text messaging intervention) |
| Adolescent - SMS plus support person | Experimental | Other: Denver Health Asthma Management Program, Other: Person of SupportSubjects aged 13-19 years, Denver Health Asthma Management Program (text messaging intervention) sent to subjects and subjects' chosen Person of Support. |
| Adult - Control | No intervention | –Usual care arm of subjects aged 20-40 years old. |
| Adult - SMS | Experimental | Other: Denver Health Asthma Management ProgramSubjects aged 20-40 years and receiving Denver Health Asthma Management Program (text messaging intervention). |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Subject and significant other as applicable must have phone or other device capable of receiving text messages
- Ages 13 to 19 with persistent asthma per Denver Health electronic health record and/or HEDIS (modified) criteria for asthma
- Ages 20 to 40 with HEDIS (modified) criteria for persistent asthma
- Hospital-based utilization for asthma (i.e. persistent asthma)
- Denver Health Primary Care Provider visits within last 3 years
Key exclusion criteria (6 listed)
- complex and special health care needs pediatric patients
- pregnant/expectant mothers
- incarcerated individuals
- Non-English and non-Spanish speakers
- Chronic Obstructive Pulmonary Disease/COPD or other non-asthma pulmonary diagnoses (e.g. pulmonary function testing inconsistent with asthma and/or negative methacholine challenge testing/lack of reversibility with β-agonist, diagnostic errors despite inclusion in the Asthma Registry)
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 |
|---|---|---|
| Denver Health Asthma Management Programtext message (SMS) support including educational, motivational, and resource content. | Other | Adolescent - SMS, Adolescent - SMS plus support person, Adult - SMS |
| Person of SupportSubjects in the adolescent cohort will designate a support person (e.g. parent) to receive messages from the Denver Health Asthma Management Program | Other | Adolescent - SMS plus support person |
Primary outcome
Mean Asthma Control Test Score
Time frame: Six months
6 secondary outcomes
Asthma-related utilization - Emergent Care
Time frame: Six months
Asthma-related utilization - Urgent Care
Time frame: Six months
Asthma-related utilization - Hospitalization
Time frame: Six months
Quality of Life
Time frame: Six months
Medication Adherence
Time frame: Six months
Pre/Post Comparison of Asthma Control Test score
Time frame: Six 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 3 Oct 2017.
- 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 Denver Health Asthma Management Program and Person of Support in people with Asthma, run by Denver Health and Hospital Authority.
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 6 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 3 Oct 2017. 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?
Mean Asthma Control Test Score (time frame: Six months). 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 3 Oct 2017.