Supporting Asthma Management Behaviors in Aging Adults
SAMBA
Clinic-based vs. Home-based Support to Improve Care and Outcomes for Older Asthmatics
2 other identifiers
interventional
406
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Jan 2015
Typical duration for not_applicable asthma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2014
CompletedFirst Posted
Study publicly available on registry
December 12, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2018
CompletedResults Posted
Study results publicly available
October 6, 2021
CompletedOctober 6, 2021
September 1, 2021
3.1 years
December 10, 2014
December 10, 2018
September 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Asthma Control Test (ACT)
The Asthma Control Test™ is a quick test for people with asthma 12 years and older. The ACT is a 5 items, with 4-week recall (on symptoms and daily functioning) patient self-administered tool for identifying those with poorly controlled asthma. Each items is scored on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled), The total scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. It provides a numerical score to help assess asthma control at 12 months compared to baseline.
baseline, 3 months, 6 months, and 12 months
Secondary Outcomes (4)
Mini Asthma Quality of Life Questionnaire (AQLQ)
baseline, 3 months, 6 months, and 12 months
Change in Percent of Patients With >=1 Emergency Dept Visits
12 months
Medication Adherence Rating Scale (MARS)
baseline, 3 months, 6 months, and 12 months
Number of Participants With Correct MDI Technique
baseline and 12 months
Study Arms (3)
Clinic-based care coordination
EXPERIMENTALThe 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.
Home-based care coordination
ACTIVE COMPARATORThe 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.
Usual care
NO INTERVENTIONClinician-centric strategy and EMR-based clinician decision support
Interventions
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.
Eligibility Criteria
You may qualify if:
- ages ≤60 years
- physician diagnosis of asthma
- English- or Spanish-speaking
You may not qualify if:
- physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or other chronic lung condition
- ≤15 pack-years
- enrollment in another asthma self-management program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The Institute for Family Health
New York, New York, 10003, United States
Mount Sinai-St. Luke's Roosevelt Hospital Center
New York, New York, 10025, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Publications (2)
Federman AD, Thanik E, O'Conor R, Arora A, Wolf MS, Wisnivesky JP. Patient characteristics associated with improvements in asthma control and reduction in emergency department visits for older adults with asthma. J Asthma. 2021 Nov;58(11):1528-1535. doi: 10.1080/02770903.2020.1805753. Epub 2020 Aug 19.
PMID: 32812836DERIVEDFederman 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 Aug 1;179(8):1113-1121. doi: 10.1001/jamainternmed.2019.1201.
PMID: 31180474DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Alex Federman
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Federman, MD,MPH
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2014
First Posted
December 12, 2014
Study Start
January 1, 2015
Primary Completion
February 2, 2018
Study Completion
February 2, 2018
Last Updated
October 6, 2021
Results First Posted
October 6, 2021
Record last verified: 2021-09