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

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03721315
• Other study ID #: 2019-19
• Status: Terminated
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: April 26, 2020

Study information

• Verified date: September 2020
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 26, 2020
• Est. primary completion date: April 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

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

Locations

Country	Name	City	State
United States	Einstein Medical Center Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Respiratory Specific Health Related Quality of life (HRQoL)	Change in Respiratory Specific Health Related Quality of life (HRQoL) based on questionnaire responses at baseline and 3 months follow-up	3 months
Secondary	Medication adherence	Medication adherence measured by the number of prescription refills	3 months
Secondary	Healthcare utilization	Healthcare utilization measured by the number of ER visits, and 30 day readmissions	3 months