Palliative Care Health Literacy Education and QOL Compared to Usual Care

NCT06089499 | Unknown

• 1 other identifier: IRB#2096893-AA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot randomized controlled trial is to compare health literacy (HL) and quality of life (QOL) among older adults with chronic obstructive pulmonary disease (COPD) who completed a series of standardized palliative care (PC) educational video learning modules to usual care (US). The main question\[s\] it aims to answer are: Between Groups:

• What effect does completing a series of standardized PC education video learning modules have on HL among older adults with COPD treated in the emergency department (ED) compared to usual care?
• What effect does completing a series of standardized PC education video learning modules have on QOL among older adults with COPD treated in the ED compared to usual care? Within Groups:
• What is the change from baseline to study completion for older adults with COPD who receive the educational intervention series of PC learning modules on HL?
• What is the change from baseline to study completion for older adults with COPD who receive the educational intervention series of PC learning modules on QOL?
• What is the change from baseline to study completion for older adults with COPD who receive UC on HL?
• What is the change from baseline to study completion for older adults with COPD who receive UC on QOL? All participants will complete a baseline and study completion health literacy questionnaire (HLQ) and Medical Outcomes Study: Short Form 36 survey. The treatment group will view one standardized learning module per week for four weeks provided by Get Palliative Care and log their weekly completion in REDCap. The control group will receive usual COPD care. Researchers will compare the treatment group receiving weekly palliative care education to usual care to see if HL and QOL change.

Conditions

COPD

Keywords

Health Literacy QOL Palliative Care COPD; Emergency Medicine Older Adults

Outcome Measures

Primary Outcomes (2)

• Health Literacy Questionaire

  The HLQ has been validated for sample participants 65 years and older. The prose of the tool includes numeracy and comprehension. There are nine scales of multidimensional constructs of health and each scale is reliable and generates key information about an individual's perceived health literacy abilities, and their experiences. It was designed to be sensitive to change, identifying small differences between populations, and changes over time. The first five scales comprise items that ask the respondents to indicate their level of agreement on one of four response options (strongly disagree to strongly agree). The remaining scales (6-9) represent scales of self-reported capability and items within these scales are scored on one of five response options (cannot do; very difficult; quite difficult; quite easy; very easy).

  Baseline and immediately after the intervention, through study completion up to 12 weeks

• Medical Outcomes Study-Short Form 36

  The Medical Outcomes Study Short Form-36 (SF-36) survey measures eight health concepts including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy/fatigue levels, emotional well-being, social functioning, and vitality to measure quality of life. The SF-36 survey uses a 5-point Likert scale ranging from one which is equivalent to poorer (or poor) health to five which is equivalent to excellent health. Lower scores represent poorer quality of life.

  Baseline and immediately after the intervention, through study completion up to 12 weeks

Study Arms (2)

Get Palliative Care: four educational learning module videos

EXPERIMENTAL

Get Palliative Care educational learning module videos available online in the public domain. A Webinar: How to Manage Shortness of Breath and Improve Your Quality of Life (2019) presented by Tara Liberman, DO reviews how to live with COPD, where and when palliative care can be implemented, what alternatives to treatment may look like, and final provides a summary of the benefits of palliative care. Each learning module is approximately five to seven minutes in length. The four learning modules are accessible at https://youtu.be/\_\_phRXS4jZs?si=TivFch6cFE6roXDZ. After completing the weekly learning module, the participant will log their viewing in REDCap via a link provided to the participant by the email provided at the time of enrollment.

Behavioral: Get Palliative Care: four educational learning module videos

Usual Care

NO INTERVENTION

Usual care for COPD includes oxygen therapy, steroid therapy, chest radiography, nebulized bronchodilators, and antimicrobial therapy.

Interventions

Get Palliative Care: four educational learning module videos BEHAVIORAL

Organizational Sponsored public domain educational videos

Get Palliative Care: four educational learning module videos

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• COPD diagnosis
• English speaking
• Access to technology and Internet/online services

You may not qualify if:

• Enrolled in hospice care
• Cancer diagnosis stage IV or greater

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

Study Sites (1)

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sue Lasiter, PhD

  University of Missouri, Kansas City

  STUDY CHAIR

Central Study Contacts

Kelly Counts, PhD (c)

CONTACT

618-444-9595; kdb7x9@umsystem.edu

Sue Lasiter, PhD

CONTACT

816-235-6766; lasiterr@umkc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Recruitment will take place for 30 days, and the study duration will be 30 days from the time of enrollment. A 1:1 randomization will be used to assign participants to the treatment or control group. The goal of 15 participants in each arm of the pilot study.

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 18, 2023
• Study Start: November 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: March 31, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (1)