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Trial record 1 of 1 for:    NCT02316223
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Supporting Asthma Management Behaviors in Aging Adults (SAMBA)

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ClinicalTrials.gov Identifier: NCT02316223
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE December 10, 2014
First Posted Date  ICMJE December 12, 2014
Last Update Posted Date February 5, 2018
Study Start Date  ICMJE January 2015
Actual Primary Completion Date February 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
Change in Asthma Control Test (ACT) [ Time Frame: baseline and 12 months ]
The ASTHMA CONTROL TEST™ is a quick test for people with asthma 12 years and older. It provides a numerical score to help assess asthma control at 12 months compared to baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
  • Mini Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: baseline and 12 months ]
  • Resource Utilization [ Time Frame: baseline and 12 months ]
    Acute asthma-related ED visits and hospitalizations will be assessed by self-report using select items from the CDC-BRFSS 2012 Asthma Call-Back Survey and through the SPARCS dataset at 12 months compared to baseline.
  • Medication Adherence [ Time Frame: baseline and 12 months ]
    Adherence to ICS and leukotriene receptor antagonists will be assessed with the MARS, a 10-item self-reported measure of adherence to inhaler medications at 12 months compared to baseline.
  • Airway Obstruction [ Time Frame: baseline and 12 months ]
    Change in FEV1 using spirometry at 12 months as compared to baseline.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supporting Asthma Management Behaviors in Aging Adults
Official Title  ICMJE Clinic-based vs. Home-based Support to Improve Care and Outcomes for Older Asthmatics
Brief Summary A 3-arm, patient-randomized trial among Latino and African-American older adults with poorly-controlled asthma will be conducted to compare the effectiveness of clinic-based vs. home-based asthma care coordination / self-management support (CC/SMS) vs. usual care.
Detailed Description

Older asthmatics experience worse outcomes than younger adults, especially if they identify as Latino or African-American. Several factors contribute to worse outcomes in these populations including frailty, cognitive impairment, managing multiple chronic diseases and multiple daily medications, low health literacy and English proficiency, high healthcare costs, and misunderstandings about asthma. To our knowledge, there are no programs designed to help older asthmatics manage their illness. In order to address these factors two emerging patient-centered strategies, clinic- and home-based care coordination and self-management support led by an Asthma Care Coach (ACC) and a community health worker (CHW), respectively, will be tested. These strategies will be combined a clinician-centered strategy, use of electronic medical record (EMR)-based asthma decision support that guides medication prescribing, basic counseling, and provision of asthma action plans.

Specific aims are:

  1. To compare the effectiveness of (1) ACC/clinic- or (2) CHW/home-based asthma care coordination and self-management support with (3) no care coordination/self-management support (usual care) for improving asthma-related outcomes;
  2. To identify subsets of individuals who have greater benefit from home-based care coordination and self-management support compared to clinic-based support.

A 3-arm, randomized trial will be conducted among 450 adult asthmatics ages 60 and older at primary care practices in East and Central Harlem and the South Bronx. All patients, regardless of assignment, will receive care from primary care providers (PCP) with access to the EMR-based asthma decision support. Patients in the ACC and CHW arms will be assessed for barriers to asthma control and will receive support specifically tailored to the identified barriers, including those arising from physical, mental, social/economic, or cognitive issues. Program participation will be 12 months, during which the ACCs and CHWs will also work with the patients' PCPs to optimize care. The study team will engage stakeholders (patients and caregivers, clinicians, community-based organizations, others) to develop and prepare study materials and protocols. In addition to studying patient outcomes, the process of implementing these models of care will be evaluated and documented.

Patients in the ACC and CHW arms will have similar asthma outcomes (asthma control, quality of life, use of urgent care, appointment keeping, medication adherence, use of asthma actions plans). Compared to usual care, patients in the ACC and CHW arms will perform better on these outcomes. Patients with more severe asthma and those at greater risk of missed clinic appointments because of physical or cognitive impairment and psychosocial issues (e.g., substance abuse, mental illness) will be more likely to benefit from the CHW/home-based intervention.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Asthma
Intervention  ICMJE Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)
The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). All interventions, including usual care, will include EMR-based asthma self-management and decision support tools for clinicians in all practice sites. The ACC and CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months. Outcomes will be measured through interviews, EMR chart abstractions, and from the Statewide Planning and Research Cooperative System (SPARCS) dataset to identify all ED visits and hospitalizations to any New York State facility.
Other Name: SAMBA
Study Arms  ICMJE
  • Experimental: Clinic-based care coordination
    The ACC and CHW programs for asthma CC/SMS will have the same objectives and provide the same general services at the office/clinic. The ACC and CHW programs were developed from existing, successfully operating programs at the participating sites, and in the East Harlem and South Bronx communities.
    Intervention: Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)
  • Active Comparator: Home-based care coordination
    The ACC and CHW programs for asthma CC/SMS will have the same objectives and provide the same general services at participant's home. The ACC and CHW programs were developed from existing, successfully operating programs at the participating sites, and in the East Harlem and South Bronx communities.
    Intervention: Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)
  • No Intervention: Usual care
    Clinician-centric strategy and EMR-based clinician decision support
Publications * Federman AD, O'Conor R, Mindlis I, Hoy-Rosas J, Hauser D, Lurio J, Shroff N, Lopez R, Erblich J, Wolf MS, Wisnivesky JP. Effect of a Self-management Support Intervention on Asthma Outcomes in Older Adults: The SAMBA Study Randomized Clinical Trial. JAMA Intern Med. 2019 Jun 10. doi: 10.1001/jamainternmed.2019.1201. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2017)
406
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2014)
450
Actual Study Completion Date  ICMJE February 2, 2018
Actual Primary Completion Date February 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ages ≤60 years
  • physician diagnosis of asthma
  • English- or Spanish-speaking

Exclusion Criteria:

  • physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or other chronic lung condition
  • ≤15 pack-years
  • enrollment in another asthma self-management program
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02316223
Other Study ID Numbers  ICMJE GCO 13-1401
AS-1307-05584 ( Other Identifier: Patient-Centered Outcomes Research Institute (PCORI) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alex Federman, MD,MPH Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP