NCT01128348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

1.9 years

First QC Date

May 20, 2010

Last Update Submit

March 19, 2013

Conditions

Asthma

Keywords

asthmaadherencequality of lifehealth literacyhealth disparities

Outcome Measures

Primary Outcomes (1)

  • adherence to prescribed inhaled corticosteroid regimen

    16 weeks

Secondary Outcomes (5)

  • change in FEV1

    16 weeks

  • asthma-related quality of life

    16 weeks

  • asthma control

    16 weeks

  • emergency department visits for asthma

    16 weeks

  • hospitalizations for asthma

    16 weeks

Study Arms (2)

patient advocate

EXPERIMENTAL

Patient advocate works with patient before, during, and after a visit to asthma doctor. Patient receives video of asthma education materials

Behavioral: patient advocate

asthma education

ACTIVE COMPARATOR

Patient receives video of asthma education materials

Behavioral: patient advocate

Interventions

patient advocateBEHAVIORAL

patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication

asthma educationpatient advocate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • significant other current pulmonary or cardiac disease
  • severe psychiatric problems making it impossible to understand or carryout the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • 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.

    PMID: 22788543BACKGROUND

  • 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.

    PMID: 20846085BACKGROUND

  • 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.

    PMID: 20855111BACKGROUND

  • 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.

    PMID: 21704360BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Andrea J Apter, MD, MSc, MA

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 21, 2010

Study Start

September 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 20, 2013

Record last verified: 2013-03

Locations

US(1)