H. Pylori InfectionNCT03340454
Patient-Centered Cancer Prevention In Chinese Americans
A study testing Test-and-treat EHR-CHW intervention in people with H. Pylori Infection, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will assess the efficacy, adoption, and impact of an integrated intervention to improve adherence to recommended stomach cancer prevention guidelines (H. pylori test-and-treat) for at-risk Chinese Americans in NYC. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- Test-and-treat EHR-CHW intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self identifies as Chinese American
- is an outpatient aged 21 years and older (adult)
- plans to continue to live in the region during the next 12 months;
- is willing to be randomized to either treatment or control groups
- has a confirmed diagnosis of H. pylori infection by at least one of the following methods: C-urea breath test, histology, rapid urease test or bacterial culture, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test.
Who cannot join
- advanced chronic disease that would not allow the patient to complete follow-up or attend visits;
- allergy to any of the study drugs;
- pregnancy or currently breastfeeding
- taking antibiotics or bismuth salts within 2 weeks before the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This study will assess the efficacy, adoption, and impact of an integrated intervention to improve adherence to recommended stomach cancer prevention guidelines (H. pylori test-and-treat) for at-risk Chinese Americans in NYC. The integrated multifaceted theory-based intervention involves: 1) a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; and 2) a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. Using a 2-arm randomized controlled trial (RCT) design, > 144 Chinese American patients across NYC safety net hospital endoscopy clinics and primary health centers will participate.
- Conditions
- H. Pylori Infection
- Being tested
- Test-and-treat EHR-CHW intervention, Usual care of EHR-only intervention
- Keywords
- H. pylori, H. pylori infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test-and-treat EHR-CHW interventionOther
a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies
Usual care of EHR-only interventionOther
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.
| Study group | Role | What they receive |
|---|---|---|
| Health systems-level intervention | Active comparator | using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; Receives: Other: Test-and-treat EHR-CHW intervention |
| CHW-led patient navigation program | Active comparator | a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability Receives: Other: Usual care of EHR-only intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Eradication of H. Pylori (ITT)
Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR. Includes positive results for those with self-reported or missing results.
Measured: Up to Month 3-Post Treatment
Secondary outcomes (7)
Number of Participants With Eradication of H. Pylori (Clinically Confirmed)
Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR.
Measured: Up to Month 3-Post Treatment
Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months
Participants completed the Ottawa Decision Self-Efficacy Scale, which assessed participants' confidence in making an informed choice, at baseline and 6-month follow-up. The scale consists of 11 questions on a 5-point Likert scale from 0 (not at all confident) to 4 (very confident). The raw score is the sum of responses. The raw score is converted to a standardized total score that ranges from 0 to 100; higher total scores indicate greater decision self-efficacy.
Measured: Baseline, Month 6
Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6
Participants completed the MARS-5 self-assessment of medication adherence at baseline and 6-month follow-up. One item assessed unintentional non-adherence, while four items assessed intentional non-adherence. Participants indicated how often each statement applied to them in the past month on a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never), resulting in a total score ranging from 5 to 25. Adherence is defined as a score of 25.
Measured: Baseline, Month 6
Change in Stomach Cancer Knowledge Between Baseline and 6-months
Participants were asked about associations with the risk of getting stomach cancer (alcohol, spicy food, stress, family history, h. pylori infection, smoking, salty food, being physically inactive, pickled food, food high in sugar). True or false was chosen. Variables were recoded to correct (1) and incorrect (0), and summed for a final score (0-10, 10=highest knowledge)
Measured: Baseline, Month 6
Change in H. Pylori Knowledge Between Baseline and 6-months
Participants were asked about associations with h. pylori (blood, untreated/contaminated water, rats, mosquitoes, contaminated food, vomit, poor sanitation). True or false was chosen. Variables were recoded to correct (1) and incorrect (0), and summed for a final score (0-7, 7=highest knowledge)
Measured: Baseline, Month 6
Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months
Participants completed the PROMIS Global Physical Health Scale, which assessed participants' physical health, at baseline and 6-month follow-up. Four questions assessed global physical health. Three questions were administered using five-category response scales, and one item used a response scale of 0-10 that was recoded to five categories. Responses are recoded into t-scores, which rescales the raw sum score into a standardized score from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the concept being measured.
Measured: Baseline, Month 6
Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months
Participants completed the PROMIS Global Mental Health Scale, which assessed participants' mental health, at baseline and 6-month follow-up. Four questions assessed global mental health, and all were administered using five-category response scales. Responses are recoded into t-scores, which rescales the raw sum score into a standardized score from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the concept being measured.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start15 Aug 2018
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for H. Pylori InfectionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Simona Kwon, DrPH,MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340454
- Sponsor's protocol ID
- 17-01446
- Other IDs
- 2U54MD000538
- Status last verified
- Jul 2024
- First submitted
- 6 Nov 2017
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Cancer Prevention In Chinese Americans
- ClinicalTrials.gov ID
- NCT03340454
- Acronym / sponsor ID
- 17-01446
- Conditions
- H. Pylori Infection
- Keywords
- H. pylori, H. pylori infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy, adoption, and impact of an integrated intervention to improve adherence to recommended stomach cancer prevention guidelines (H. pylori test-and-treat) for at-risk Chinese Americans in NYC. The integrated multifaceted theory-based intervention involves: 1) a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; and 2) a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. Using a 2-arm randomized controlled trial (RCT) design, > 144 Chinese American patients across NYC safety net hospital endoscopy clinics and primary health centers will participate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health systems-level intervention | Active comparator | Other: Test-and-treat EHR-CHW interventionusing electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; |
| CHW-led patient navigation program | Active comparator | Other: Usual care of EHR-only interventiona community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self identifies as Chinese American
- is an outpatient aged 21 years and older (adult)
- plans to continue to live in the region during the next 12 months;
- is willing to be randomized to either treatment or control groups
- has a confirmed diagnosis of H. pylori infection by at least one of the following methods: C-urea breath test, histology, rapid urease test or bacterial culture, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test.
Key exclusion criteria (4 listed)
- advanced chronic disease that would not allow the patient to complete follow-up or attend visits;
- allergy to any of the study drugs;
- pregnancy or currently breastfeeding
- taking antibiotics or bismuth salts within 2 weeks before 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 |
|---|---|---|
| Test-and-treat EHR-CHW interventiona health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies | Other | Health systems-level intervention |
| Usual care of EHR-only interventiona community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. | Other | CHW-led patient navigation program |
Primary outcome
Number of Participants With Eradication of H. Pylori (ITT)
Time frame: Up to Month 3-Post Treatment
Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR. Includes positive results for those with self-reported or missing results.
7 secondary outcomes
Number of Participants With Eradication of H. Pylori (Clinically Confirmed)
Time frame: Up to Month 3-Post Treatment
Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months
Time frame: Baseline, Month 6
Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6
Time frame: Baseline, Month 6
Change in Stomach Cancer Knowledge Between Baseline and 6-months
Time frame: Baseline, Month 6
Change in H. Pylori Knowledge Between Baseline and 6-months
Time frame: Baseline, Month 6
Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months
Time frame: Baseline, Month 6
Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months
Time frame: Baseline, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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HELICOBACTER PYLORI INFECTIONS
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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.
Simona Kwon, DrPH,MPH principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test-and-treat EHR-CHW intervention in people with H. Pylori Infection, run by NYU Langone Health 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 3 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Eradication of H. Pylori (ITT) (time frame: Up to Month 3-Post Treatment). 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 Jul 2024.