AsthmaHCWABTNCT03489655
Helping Chicago's Westside Adults Breathe and Thrive
A study testing Maintenance Phase Intervention in people with Asthma, run by Sinai Health System at 1 site in United States.
Trial summary
Adults with asthma living in Chicago's West and Southwest side who completed the home-based Community Health Worker (CHW) intervention called Helping Chicago's Westside Adults Breathe and Thrive (HCWABT I) after October 2015 were eligible to participate in a randomized control trial called HCWABT II, which will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Maintenance Phase Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Resident of targeted Southwest or Westside communities of Chicago
- Diagnosed with asthma by a health care provider
- Has poorly controlled asthma, meeting one of the following criteria: Hospitalized for asthma within 12 months preceding enrollment; Visited an ED for asthma within 12 months preceding enrollment; Symptoms of persistent asthma - has been prescribed an inhaled corticosteroid in the last year, has asthma symptoms > 2 days/week over past 2 months, has nighttime symptoms 3-4 times/month or more, or Short acting beta2-agonist use for symptom control >2 days/week; or Has poorly controlled asthma per the Asthma Control Test (i.e., ACT score < 19)
- Has completed the HCWABT Active Intervention
Who cannot join
- Participated in another comprehensive asthma program within the past year
- Plans to move out of Chicago within the study period
- Has a diagnosis of Chronic Heart Failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helping Chicago's Westside Adults Breathe and Thrive: Long Term Effectiveness of a Healthy Homes Approach to Improving Respiratory Health
Adults with asthma living in Chicago's West and Southwest side who completed the home-based Community Health Worker (CHW) intervention called Helping Chicago's Westside Adults Breathe and Thrive (HCWABT I) after October 2015 were eligible to participate in a randomized control trial called HCWABT II, which will evaluate the long-term impact of the intervention on their asthma control, asthma severity, healthcare use, and asthma-related quality of life. Participants are randomly assigned to an intervention arm, where they continue to receive occasional (monthly or bimonthly) contact from the CHW who served them during HCWABT I. or a control arm, where they no longer receive contact from the CHW. Members of both groups receive monthly data collection calls from a Research Assistant. We hypothesize that participants in the control arm will experience sustained improvements in asthma outcomes as compared to their pre-HCWABT I levels and that participants in the CHW intervention arm will continue to improve in asthma control severity, quality of life, and healthcare use.
Read the detailed description
Participants who enroll into HCWABT II will be randomized into one of two study arms: MPI or MPC. In order to randomly choose which arm participants will be enrolled into, the RA will select an envelope prior to the 12-Month visit that will tell them which arm to consent the participant into. A total of 68 envelopes will read MPI and 68 envelopes will read MPC. If a participant declines the maintenance phase, that envelope will be recycled for a future drawing.
All data will be stored in a password-protected database on Sinai's secure server. Data will be de-identified, except for one data collection tool, the Personal Data Sheet, which will contain the participant's personal information along with their study ID. This information will be kept in a separate password protected database. All data will be archived. Paper files will be saved for a minimum of seven years in a secure locked facility. Electronic data will be saved indefinitely, but will always remain password protected and stored on a secure server hosted by Sinai's Information Systems Department. De-identified data will be available to researchers who wish to use it through a data agreement approved by both institutions. Findings will be widely disseminated. The dissemination plan is discussed in Rating Factor 5.
Baseline characteristics will be compared between participants who complete the entire intervention and follow-up period, and those who are either lost to follow-up or dropout, to assess the effect of selection bias. Dropout and completion rates will be reported. Screening-to-enrollment ratios will be calculated from screening data. Frequencies, means and medians, as appropriate, will be calculated for each outcome variable at baseline and over the follow-up period associated with that outcome. The effect of the 12-month AI will be evaluated using pre-posttest methods with each participant serving as his/her own historical control. Participants enrolled in Maintenance RCT will be both evaluated against their own historical data as well as the data of the other arm of the study. A cost effectiveness analysis will also be conducted using process measures, including staff time, materials, referrals and time spent on various intervention activities in order to calculate program-specific costs. Non-parametric tests will be used to assess whether changes between baseline and follow-up are statistically significant. In cases where the degree of difference is important, such as when comparing differences in outcomes between the two study arms, the Wilcoxon Signed-Rank test will be used. Frequencies across time will be assessed via the McNemar Test for Proportions. All statistical tests will be two-sided, with a significance level of 0.05.
Goals and milestones will be rigorously evaluated each quarter and adjustments made if/when we are behind our target. As one example, we expect to enroll 25 new participants, or 25% of our total goal, into the AI every quarter of the first year. If, for some reason, we are only able to recruit 10% of the total participants after the first quarter, we will adjust our methods of recruitment, send out an additional mailing to Housing Choice Voucher residents and pursue real-time monitoring of eligible patients in our health system to ensure that we are reaching all adults who need our program. If after those efforts we've only met 30% of our recruitment goal after the second quarter, we may propose a limited expansion in our targeted area, but we do not foresee this being an issue.
- Conditions
- Asthma
- Being tested
- Maintenance Phase Intervention
- Keywords
- Healthy Homes, Asthma, Community Health Worker
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance Phase InterventionBehavioural
The CHW will utilize motivational interviewing techniques over phone calls to reinforce all asthma education provided in the AI phase, including asthma basics, triggers and reduction strategies, purpose of medications, and steps for proper medication use. The CHW will identify barriers the participant is facing in management of their asthma and set goals to overcome them. The CHW will encourage regular visits with the Primary Care Physician and assist with referrals for other medical and social services, as needed. CHWs will check-in with participants via phone, monthly for the first 6 months and bi-monthly in the remaining 6 months Participants will receive bi-monthly data collection follow-up phone calls by a Research Assistant.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Phase Intervention | Experimental | Participants receive a phone-based Community Health Worker (CHW) intervention in addition to bi-monthly data collection calls with a research assistant. Receives: Behavioral: Maintenance Phase Intervention |
| Maintenance Phase Control | No intervention | Participants receive no further interventions, but have bi-monthly data collection calls with a research assistant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Department Visits
Number of visits to an emergency department in prior 12 months
Measured: 12 months
Daytime asthma symptom frequency
Average frequency of daytime asthma symptoms over the past 12 months
Measured: 12 months
Asthma-related quality of life score
Score on asthma-related quality of life questionnaire
Measured: 12 months
Secondary outcomes (3)
Asthma Control Test score
Score on Asthma Control Test
Measured: 12 months
Activity-limited days
Number of self-reported activity-limited days
Measured: 12 months
Access to medical care
Self-reported access to primary care physician, insurance coverage, and medications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Nov 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinai Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Margellos-Anast, MPH, Principal investigator, Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489655
- Sponsor's protocol ID
- ILHHU0029-15
- Other IDs
- ILHHU0029-15
- Acronym
- HCWABT
- Status last verified
- Mar 2018
- First submitted
- 29 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Chicago's Westside Adults Breathe and Thrive: Long Term Effectiveness of a Healthy Homes Approach to Improving Respiratory Health
- ClinicalTrials.gov ID
- NCT03489655
- Acronym / sponsor ID
- HCWABT / ILHHU0029-15
- Conditions
- Asthma
- Keywords
- Healthy Homes, Asthma, Community Health Worker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Sinai Health SystemUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Apr 2018 (actual)
- 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.
Adults with asthma living in Chicago's West and Southwest side who completed the home-based Community Health Worker (CHW) intervention called Helping Chicago's Westside Adults Breathe and Thrive (HCWABT I) after October 2015 were eligible to participate in a randomized control trial called HCWABT II, which will evaluate the long-term impact of the intervention on their asthma control, asthma severity, healthcare use, and asthma-related quality of life. Participants are randomly assigned to an intervention arm, where they continue to receive occasional (monthly or bimonthly) contact from the CHW who served them during HCWABT I. or a control arm, where they no longer receive contact from the CHW. Members of both groups receive monthly data collection calls from a Research Assistant. We hypothesize that participants in the control arm will experience sustained improvements in asthma outcomes as compared to their pre-HCWABT I levels and that participants in the CHW intervention arm will continue to improve in asthma control severity, quality of life, and healthcare use.
Detailed description
Participants who enroll into HCWABT II will be randomized into one of two study arms: MPI or MPC. In order to randomly choose which arm participants will be enrolled into, the RA will select an envelope prior to the 12-Month visit that will tell them which arm to consent the participant into. A total of 68 envelopes will read MPI and 68 envelopes will read MPC. If a participant declines the maintenance phase, that envelope will be recycled for a future drawing.
All data will be stored in a password-protected database on Sinai's secure server. Data will be de-identified, except for one data collection tool, the Personal Data Sheet, which will contain the participant's personal information along with their study ID. This information will be kept in a separate password protected database. All data will be archived. Paper files will be saved for a minimum of seven years in a secure locked facility. Electronic data will be saved indefinitely, but will always remain password protected and stored on a secure server hosted by Sinai's Information Systems Department. De-identified data will be available to researchers who wish to use it through a data agreement approved by both institutions. Findings will be widely disseminated. The dissemination plan is discussed in Rating Factor 5.
Baseline characteristics will be compared between participants who complete the entire intervention and follow-up period, and those who are either lost to follow-up or dropout, to assess the effect of selection bias. Dropout and completion rates will be reported. Screening-to-enrollment ratios will be calculated from screening data. Frequencies, means and medians, as appropriate, will be calculated for each outcome variable at baseline and over the follow-up period associated with that outcome. The effect of the 12-month AI will be evaluated using pre-posttest methods with each participant serving as his/her own historical control. Participants enrolled in Maintenance RCT will be both evaluated against their own historical data as well as the data of the other arm of the study. A cost effectiveness analysis will also be conducted using process measures, including staff time, materials, referrals and time spent on various intervention activities in order to calculate program-specific costs. Non-parametric tests will be used to assess whether changes between baseline and follow-up are statistically significant. In cases where the degree of difference is important, such as when comparing differences in outcomes between the two study arms, the Wilcoxon Signed-Rank test will be used. Frequencies across time will be assessed via the McNemar Test for Proportions. All statistical tests will be two-sided, with a significance level of 0.05.
Goals and milestones will be rigorously evaluated each quarter and adjustments made if/when we are behind our target. As one example, we expect to enroll 25 new participants, or 25% of our total goal, into the AI every quarter of the first year. If, for some reason, we are only able to recruit 10% of the total participants after the first quarter, we will adjust our methods of recruitment, send out an additional mailing to Housing Choice Voucher residents and pursue real-time monitoring of eligible patients in our health system to ensure that we are reaching all adults who need our program. If after those efforts we've only met 30% of our recruitment goal after the second quarter, we may propose a limited expansion in our targeted area, but we do not foresee this being an issue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance Phase Intervention | Experimental | Behavioral: Maintenance Phase InterventionParticipants receive a phone-based Community Health Worker (CHW) intervention in addition to bi-monthly data collection calls with a research assistant. |
| Maintenance Phase Control | No intervention | –Participants receive no further interventions, but have bi-monthly data collection calls with a research assistant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Resident of targeted Southwest or Westside communities of Chicago
- Diagnosed with asthma by a health care provider
- Has poorly controlled asthma, meeting one of the following criteria: Hospitalized for asthma within 12 months preceding enrollment; Visited an ED for asthma within 12 months preceding enrollment; Symptoms of persistent asthma - has been prescribed an inhaled corticosteroid in the last year, has asthma symptoms > 2 days/week over past 2 months, has nighttime symptoms 3-4 times/month or more, or Short acting beta2-agonist use for symptom control >2 days/week; or Has poorly controlled asthma per the Asthma Control Test (i.e., ACT score < 19)
- Has completed the HCWABT Active Intervention
Key exclusion criteria (3 listed)
- Participated in another comprehensive asthma program within the past year
- Plans to move out of Chicago within the study period
- Has a diagnosis of Chronic Heart Failure
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 |
|---|---|---|
| Maintenance Phase InterventionThe CHW will utilize motivational interviewing techniques over phone calls to reinforce all asthma education provided in the AI phase, including asthma basics, triggers and reduction strategies, purpose of medications, and steps for proper medication use. The CHW will identify barriers the participant is facing in management of their asthma and set goals to overcome them. The CHW will encourage regular visits with the Primary Care Physician and assist with referrals for other medical and social services, as needed. CHWs will check-in with participants via phone, monthly for the first 6 months and bi-monthly in the remaining 6 months Participants will receive bi-monthly data collection follow-up phone calls by a Research Assistant. | Behavioural | Maintenance Phase Intervention |
Primary outcome
Number of Emergency Department Visits
Time frame: 12 months
Number of visits to an emergency department in prior 12 months
Daytime asthma symptom frequency
Time frame: 12 months
Average frequency of daytime asthma symptoms over the past 12 months
Asthma-related quality of life score
Time frame: 12 months
Score on asthma-related quality of life questionnaire
3 secondary outcomes
Asthma Control Test score
Time frame: 12 months
Activity-limited days
Time frame: 12 months
Access to medical care
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- 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.
Helen Margellos-Anast, MPH principal investigator
Sinai Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maintenance Phase Intervention in people with Asthma, run by Sinai Health System 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 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: status not confirmed, as of the sponsor's last update on 5 Apr 2018. 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?
Results are not available in the source record.
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?
Number of Emergency Department Visits (time frame: 12 months). The study lists 3 primary outcomes in all. 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 5 Apr 2018.