A Patient Advocate and Literacy-Based Treatment of Asthma (HAP)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
patient advocate
Sponsored by

About this trial
This is an interventional health services research trial for Asthma focused on measuring asthma, adherence, quality of life, health literacy, health disparities
Eligibility Criteria
Inclusion Criteria:
- physician's diagnosis of asthma
- prescribed inhaled steroid
- moderate or severe asthma according to NHLBI Guidelines
- evidence of reversible airflow obstruction and improvement with bronchodilator
- Did not participate in the experimental arm (problem-solving) of WIN Study, HL073932
Exclusion Criteria:
- significant other current pulmonary or cardiac disease
- severe psychiatric problems making it impossible to understand or carryout the protocol
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patient advocate
asthma education
Arm Description
Patient advocate works with patient before, during, and after a visit to asthma doctor. Patient receives video of asthma education materials
Patient receives video of asthma education materials
Outcomes
Primary Outcome Measures
adherence to prescribed inhaled corticosteroid regimen
Secondary Outcome Measures
change in FEV1
asthma-related quality of life
asthma control
emergency department visits for asthma
hospitalizations for asthma
Full Information
NCT ID
NCT01128348
First Posted
May 20, 2010
Last Updated
March 19, 2013
Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01128348
Brief Title
A Patient Advocate and Literacy-Based Treatment of Asthma
Acronym
HAP
Official Title
A Patient Advocate and Literacy-Based Treatment of Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Half of US adults have no more than basic reading and numerical skills. A consequence is inadequate health literacy, which is associated with unsatisfactory patient-provider communication and poor health outcomes in chronic diseases, including asthma. We have adapted a patient navigator intervention to address asthma in high risk communities as a practical, immediate, and sustainable method of achieving effective health literacy in patients low health literacy. This intervention will lead to improved adherence and asthma control, attenuating health disparities so marked in asthma. It is compared for efficacy and cost-effectiveness with asthma education.
Detailed Description
This application addresses broad Challenge Area (05), Comparative Effectiveness Research, and Specific Challenge Topic 05-MD105, Health Literacy. Half of US adults have no more than basic reading and numerical skills; inadequate health literacy is a consequence. It is associated with unsatisfactory patient-provider communication and poor health outcomes in chronic diseases including asthma. We found low numeracy to be associated with prior ED visits and hospitalizations for asthma and determined that numerical skill may attenuate the association of minority status with lower asthma-related quality of life. We propose a Patient Advocate Intervention (PAI) as the most practical immediate but sustainable method of achieving effective health literacy (EHL) (understanding of asthma management and the practice/health system). Adapted from the Patient Navigator of Harold P. Freeman, MD and informed by focus groups of asthma patients, the PAI addresses low literacy, facilitating patient-provider communication surrounding self-management and navigation of the practice and health system to ensure medical recommendations can be accomplished. The PA is a nonprofessional with guidance from a social worker who will assist with and model preparations for a visit with the asthma doctor, attend the visit, and afterwards confirm understanding as well as facilitate scheduling, obtaining insurance coverage, and overcoming other barriers to carrying out medical advice. The primary outcome is electronically-monitored use of inhaled corticosteroids (ICS), the treatment of choice for all but the mildest asthma. ICS use is a marker of successful patient-provider communication. Other outcomes are asthma-related: hospitalizations, ED visits, change in FEV1, and asthma-related quality of life. We hypothesize that the PAI will improve these outcomes by promoting EHL.
We will enroll 84 adults with a high prevalence of low numerical skills who are approximately 67% black and 10% Latino with moderate or severe asthma to carry out the following Specific Aims. Specific Aim 1: refine and evaluate the feasibility of PAI and Specific Aim 2: conduct a randomized comparison of PAI with standard asthma education to obtain effect size estimates for ICS adherence and asthma-related outcomes for a future R01 confirmatory randomized trial of the final version of PAI. Exploratory analyses will assess EHL as a mediator, various moderators, and estimate the incremental costs of PAI. This novel project fills several research gaps. It 1) compares and tests an intervention addressing literacy to improve health, one that can easily be incorporated into practice to better patient self-management and preventive care, 2) is a potentially long-lasting intervention which will benefit all patients, especially those with low health literacy, and 3) will potentially improve prevention of asthma exacerbations, reducing the need for ED use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, adherence, quality of life, health literacy, health disparities
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient advocate
Arm Type
Experimental
Arm Description
Patient advocate works with patient before, during, and after a visit to asthma doctor.
Patient receives video of asthma education materials
Arm Title
asthma education
Arm Type
Active Comparator
Arm Description
Patient receives video of asthma education materials
Intervention Type
Behavioral
Intervention Name(s)
patient advocate
Intervention Description
patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication
Primary Outcome Measure Information:
Title
adherence to prescribed inhaled corticosteroid regimen
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
change in FEV1
Time Frame
16 weeks
Title
asthma-related quality of life
Time Frame
16 weeks
Title
asthma control
Time Frame
16 weeks
Title
emergency department visits for asthma
Time Frame
16 weeks
Title
hospitalizations for asthma
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
physician's diagnosis of asthma
prescribed inhaled steroid
moderate or severe asthma according to NHLBI Guidelines
evidence of reversible airflow obstruction and improvement with bronchodilator
Did not participate in the experimental arm (problem-solving) of WIN Study, HL073932
Exclusion Criteria:
significant other current pulmonary or cardiac disease
severe psychiatric problems making it impossible to understand or carryout the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea J Apter, MD, MSc, MA
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22788543
Citation
Black HL, Priolo C, Gonzalez R, Geer S, Adam B, Apter AJ. An analysis of contextual information relevant to medical care unexpectedly volunteered to researchers by asthma patients. J Asthma. 2012 Sep;49(7):731-7. doi: 10.3109/02770903.2012.699988. Epub 2012 Jul 13.
Results Reference
background
PubMed Identifier
20846085
Citation
Black HL, Priolo C, Akinyemi D, Gonzalez R, Jackson DS, Garcia L, George M, Apter AJ. Clearing clinical barriers: enhancing social support using a patient navigator for asthma care. J Asthma. 2010 Oct;47(8):913-9. doi: 10.3109/02770903.2010.506681.
Results Reference
background
PubMed Identifier
20855111
Citation
Krishnan JA, Schatz M, Apter AJ. A call for action: Comparative effectiveness research in asthma. J Allergy Clin Immunol. 2011 Jan;127(1):123-7. doi: 10.1016/j.jaci.2010.08.032. Epub 2010 Sep 19.
Results Reference
background
PubMed Identifier
21704360
Citation
Apter AJ, Wang X, Bogen DK, Rand CS, McElligott S, Polsky D, Gonzalez R, Priolo C, Adam B, Geer S, Ten Have T. Problem solving to improve adherence and asthma outcomes in urban adults with moderate or severe asthma: a randomized controlled trial. J Allergy Clin Immunol. 2011 Sep;128(3):516-23.e1-5. doi: 10.1016/j.jaci.2011.05.010. Epub 2011 Jun 25.
Results Reference
background
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A Patient Advocate and Literacy-Based Treatment of Asthma
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