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

NCT ID: NCT03721315

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-15

Study Completion Date

2020-04-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COPD Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

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Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albert Einstein Healthcare Network

OTHER

Sponsor Role lead

Responsible Party

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Audrey Djibo

Scientist, Interim Chair of the Research Division, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Audrey Djibo, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Healthcare Network

Locations

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Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.

Reference Type DERIVED
PMID: 35514131 (View on PubMed)

Other Identifiers

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2019-19

Identifier Type: -

Identifier Source: org_study_id

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