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Health Literacy Activation RCT Among the COPD Patients and Designated Support Dyad

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03721315
Recruitment Status : Terminated (SARS-CoV2 pandemic)
First Posted : October 26, 2018
Last Update Posted : September 10, 2020
Information provided by (Responsible Party):
Audrey Djibo, Albert Einstein Healthcare Network

Brief Summary:
This study investigates whether increasing health literacy among COPD patients and their designated health coach during a hospital admission caused by symptoms exacerbation will lead to better health outcomes including increased health quality, and lower healthcare utilization.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Behavioral: Intervention Not Applicable

Detailed Description:

Until recently, contemporary methods to chronic disease management have failed to consistently tailor approaches among patients with low health literacy. They have produced mixed results in terms of successful interventions to address the needs of these populations. Low health literacy is especially common in medically underserved communities, including in North Philadelphia. This is reflected in the predominantly low-income and racial/ethnic minority population of the patients at this medical center. Management of chronic conditions such as COPD is complex. Patients with low health literacy find it especially challenging to self-navigate disease management. However, there is a lack of information on approaches to improve health outcomes among COPD patients with low health literacy.

The long-term goal is to develop and evaluate a model of interventions to improve healthcare outcomes for socially disadvantaged populations. The objective is to pilot a randomized controlled trial that evaluates the effects of an intervention that provides enhanced education and material support, on adherence to care, among patients admitted for COPD-related issues and their home support dyad.

The central hypothesis is that: compared to the standard educational intervention delivered by a registered nurse, the addition of an enhanced intervention (enhanced education, problem-solving skills and facilitative support) and the inclusion of a patient-designated support pair will result in greater adherence care and improves quality of life, especially among patients with low health literacy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial of Health Literacy Activation Among the Chronic Obstructive Pulmonary Disease Patients and Designated Support Dyad
Actual Study Start Date : June 15, 2019
Actual Primary Completion Date : April 26, 2020
Actual Study Completion Date : April 26, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
This group will receive the standard of care for this condition.
Experimental: Intervention
This group will receive additional education along with their designated health support person prior to hospital discharge. This intervention does not include drugs/or devices.
Behavioral: Intervention

The health literacy enhancement will comprise of the following:

  • Practical day to day information to help manage the disease
  • Benefits of medication and adherence
  • Tips to improve managing shortness of breath
  • Proper use of inhalers (if applicable)
  • Managing daily activities

Primary Outcome Measures :
  1. Change in Respiratory Specific Health Related Quality of life (HRQoL) [ Time Frame: 3 months ]
    Change in Respiratory Specific Health Related Quality of life (HRQoL) based on questionnaire responses at baseline and 3 months follow-up

Secondary Outcome Measures :
  1. Medication adherence [ Time Frame: 3 months ]
    Medication adherence measured by the number of prescription refills

  2. Healthcare utilization [ Time Frame: 3 months ]
    Healthcare utilization measured by the number of ER visits, and 30 day readmissions

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients will be 55 years old and above
  • A history of hospital admissions for COPD related issues
  • Able to designate a support person that can help them manage their condition
  • Discharged home

Exclusion Criteria:

  • Dyads unable to participate in the education session
  • Patients discharged to a skilled nursing facility or rehabilitation facility.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03721315

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United States, Pennsylvania
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
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Principal Investigator: Audrey Djibo, PhD Albert Einstein Healthcare Network
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Responsible Party: Audrey Djibo, Scientist, Interim Chair of the Research Division, Department of Medicine, Albert Einstein Healthcare Network Identifier: NCT03721315    
Other Study ID Numbers: 2019-19
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No