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

A Randomized Controlled Trial of Health Literacy Activation Among the Chronic Obstructive Pulmonary Disease Patients and Designated Support Dyad

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03721315
Enrollment
6
Registered
2018-10-26
Start date
2019-06-15
Completion date
2020-04-26
Last updated
2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

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.

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.

Interventions

BEHAVIORALIntervention

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

Sponsors

Albert Einstein Healthcare Network
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Respiratory Specific Health Related Quality of life (HRQoL)3 monthsChange in Respiratory Specific Health Related Quality of life (HRQoL) based on questionnaire responses at baseline and 3 months follow-up

Secondary

MeasureTime frameDescription
Medication adherence3 monthsMedication adherence measured by the number of prescription refills
Healthcare utilization3 monthsHealthcare utilization measured by the number of ER visits, and 30 day readmissions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026