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Supporting Asthma Management Behaviors in Aging Adults (SAMBA)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supporting Asthma Management Behaviors in Aging Adults (SAMBA)
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring asthma, high-risk, adult, elderly, care coordination, community health worker, electronic medical record

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Institute for Family Health
  • Mount Sinai-St. Luke's Roosevelt Hospital Center
  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Clinic-based care coordination

Home-based care coordination

Usual care

Arm Description

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.

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.

Clinician-centric strategy and EMR-based clinician decision support

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mini Asthma Quality of Life Questionnaire (AQLQ)
The mini AQLQ is a 15-item self-administered questionnaire, each question scored on a 7-point scale, from 1 (all of the time) to 7 (none of the time) for the first 11 questions, and 1 (totally limited) to 7 (not at all limited) for the last 4 question , with total scale as an average from 1 to 7, with higher score indicating better quality of life or less impairment.
Change in Percent of Patients With >=1 Emergency Dept Visits
Percent of patients with one or more acute asthma-related Emergency Department visits at 12 months compared to baseline for participants in Home-based care coordination and Clinic-based care coordination.
Medication Adherence Rating Scale (MARS)
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. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood), with higher score indicating higher likelihood of medication adherence
Number of Participants With Correct MDI Technique
Number of participants demonstrating MDI technique, correctly completed steps at 12 months as compared to baseline

Full Information

First Posted
December 10, 2014
Last Updated
September 9, 2021
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02316223
Brief Title
Supporting Asthma Management Behaviors in Aging Adults
Acronym
SAMBA
Official Title
Clinic-based vs. Home-based Support to Improve Care and Outcomes for Older Asthmatics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2, 2018 (Actual)
Study Completion Date
February 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, high-risk, adult, elderly, care coordination, community health worker, electronic medical record

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinic-based care coordination
Arm Type
Experimental
Arm Description
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.
Arm Title
Home-based care coordination
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Clinician-centric strategy and EMR-based clinician decision support
Intervention Type
Behavioral
Intervention Name(s)
Supporting Asthma Management Behaviors in Aging Adults (SAMBA)
Other Intervention Name(s)
SAMBA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Asthma Control Test (ACT)
Description
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.
Time Frame
baseline, 3 months, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
Mini Asthma Quality of Life Questionnaire (AQLQ)
Description
The mini AQLQ is a 15-item self-administered questionnaire, each question scored on a 7-point scale, from 1 (all of the time) to 7 (none of the time) for the first 11 questions, and 1 (totally limited) to 7 (not at all limited) for the last 4 question , with total scale as an average from 1 to 7, with higher score indicating better quality of life or less impairment.
Time Frame
baseline, 3 months, 6 months, and 12 months
Title
Change in Percent of Patients With >=1 Emergency Dept Visits
Description
Percent of patients with one or more acute asthma-related Emergency Department visits at 12 months compared to baseline for participants in Home-based care coordination and Clinic-based care coordination.
Time Frame
12 months
Title
Medication Adherence Rating Scale (MARS)
Description
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. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood), with higher score indicating higher likelihood of medication adherence
Time Frame
baseline, 3 months, 6 months, and 12 months
Title
Number of Participants With Correct MDI Technique
Description
Number of participants demonstrating MDI technique, correctly completed steps at 12 months as compared to baseline
Time Frame
baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Federman, MD,MPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Institute for Family Health
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai-St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32812836
Citation
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.
Results Reference
derived
PubMed Identifier
31180474
Citation
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 Aug 1;179(8):1113-1121. doi: 10.1001/jamainternmed.2019.1201.
Results Reference
derived

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Supporting Asthma Management Behaviors in Aging Adults

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