A Patient Advocate and Literacy-Based Treatment of Asthma (HAP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrea Apter, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01128348
First received: May 20, 2010
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Asthma
Behavioral: patient advocate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Patient Advocate and Literacy-Based Treatment of Asthma

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • adherence to prescribed inhaled corticosteroid regimen [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in FEV1 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • asthma-related quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • asthma control [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • emergency department visits for asthma [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • hospitalizations for asthma [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patient advocate

Patient advocate works with patient before, during, and after a visit to asthma doctor.

Patient receives video of asthma education materials

Behavioral: patient advocate
patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication
Active Comparator: asthma education
Patient receives video of asthma education materials
Behavioral: patient advocate
patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128348

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Andrea J Apter, MD, MSc, MA University of Pennsylvania
  More Information

Publications:
Responsible Party: Andrea Apter, Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01128348     History of Changes
Other Study ID Numbers: 700, RC1HL099612
Study First Received: May 20, 2010
Last Updated: March 19, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
asthma
adherence
quality of life
health literacy
health disparities

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014