COPDPACEDNCT06089499
Palliative Care Health Literacy Education and QOL Compared to Usual Care
A study testing Get Palliative Care: four educational learning module videos in people with COPD, run by University of Missouri, Kansas City at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Get Palliative Care: four educational learning module videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age or older
- COPD diagnosis
- English speaking
- Access to technology and Internet/online services
Who cannot join
- Enrolled in hospice care
- Cancer diagnosis stage IV or greater
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Kelly Counts, PhD (c), 618-444-9595, kdb7x9@umsystem.edu
About this study
Official title: The PACED Study: A Randomized Controlled Pilot Study of Palliative Care Education Compared to Usual Care on Health Literacy and Quality of Life Among Older Adults With Chronic Obstructive Pulmonary Disease
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:
Read more
- 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.
Read the detailed description
Purpose: The purpose of this study is to conduct a pilot randomized controlled trial (RCT) 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. Problem: Older adults aged 65 years and older with COPD are living longer, reported one in four have low HL, overall poorer health, and often seek emergency department (ED) care for the relief of symptoms impacting their QOL. Significance: The incidence of aging, the risk for chronic disease development like COPD with unpredictable disease trajectories, increased end-of-life healthcare costs, and limited HL have resulted in poor QOL. Limited research has been conducted on HL related to PC in the ED. Innovation: The pilot RCT will be a unique contribution to critical care nursing research by demonstrating the importance HL has on PC while improving overall QOL for older adult COPD patients seeking care in the ED. A 2030 Healthy People initiative is to decrease ED visits for COPD. Theory: The Expanded Chronic Care Model incorporates PC constructs focusing on older adults at risk for poor health outcomes while adding emphasis on digital constructs and educational training programs. Design: The study design is pilot RCT comparing QOL and HL among older adults with COPD treated in the ED who complete a series of standardized PC educational learning modules compared to usual care (UC). Setting: The study will be conducted at Missouri Baptist Medical Center, a community-based geriatric-designated ED in Saint Louis, Missouri. Sample: A convenience sample of older adults aged 65 or older with a diagnosis of COPD who seek care in the ED is the target population. This is a pilot study and, therefore, will have no statistical power with the overall goal of enrolling 30 participants. Intervention: All consenting participants will complete a baseline and study completion HL questionnaire (HLQ) and QOL 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. Procedure: Informed consent will be obtained from participants who meet inclusion criteria and volunteer to participate in the study. 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 intervention or control group. Instrument: The Medical Outcomes Study Short Form-36 QOL survey and HLQ will measure the outcome variables at baseline and study completion. Analysis Plan: Demographic data using descriptive statistics will be calculated. Trends of the mean scores from baseline to study completion among groups and between groups will be conducted. REDCap will securely store all study-related data.
- Conditions
- COPD
- Being tested
- Get Palliative Care: four educational learning module videos
- Keywords
- Health Literacy QOL Palliative Care COPD, Emergency Medicine Older Adults
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Get Palliative Care: four educational learning module videosBehavioural
Organizational Sponsored public domain educational videos
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline and immediately after the intervention, through study completion up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Counts, University of Missouri, Kansas City
- Investigators
- Sue Lasiter, PhD, Study chair, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089499
- Sponsor's protocol ID
- IRB#2096893-AA
- Acronym
- PACED
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PACED Study: A Randomized Controlled Pilot Study of Palliative Care Education Compared to Usual Care on Health Literacy and Quality of Life Among Older Adults With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06089499
- Acronym / sponsor ID
- PACED / IRB#2096893-AA
- Conditions
- COPD
- Keywords
- Health Literacy QOL Palliative Care COPD, Emergency Medicine Older Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose: The purpose of this study is to conduct a pilot randomized controlled trial (RCT) 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. Problem: Older adults aged 65 years and older with COPD are living longer, reported one in four have low HL, overall poorer health, and often seek emergency department (ED) care for the relief of symptoms impacting their QOL. Significance: The incidence of aging, the risk for chronic disease development like COPD with unpredictable disease trajectories, increased end-of-life healthcare costs, and limited HL have resulted in poor QOL. Limited research has been conducted on HL related to PC in the ED. Innovation: The pilot RCT will be a unique contribution to critical care nursing research by demonstrating the importance HL has on PC while improving overall QOL for older adult COPD patients seeking care in the ED. A 2030 Healthy People initiative is to decrease ED visits for COPD. Theory: The Expanded Chronic Care Model incorporates PC constructs focusing on older adults at risk for poor health outcomes while adding emphasis on digital constructs and educational training programs. Design: The study design is pilot RCT comparing QOL and HL among older adults with COPD treated in the ED who complete a series of standardized PC educational learning modules compared to usual care (UC). Setting: The study will be conducted at Missouri Baptist Medical Center, a community-based geriatric-designated ED in Saint Louis, Missouri. Sample: A convenience sample of older adults aged 65 or older with a diagnosis of COPD who seek care in the ED is the target population. This is a pilot study and, therefore, will have no statistical power with the overall goal of enrolling 30 participants. Intervention: All consenting participants will complete a baseline and study completion HL questionnaire (HLQ) and QOL 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. Procedure: Informed consent will be obtained from participants who meet inclusion criteria and volunteer to participate in the study. 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 intervention or control group. Instrument: The Medical Outcomes Study Short Form-36 QOL survey and HLQ will measure the outcome variables at baseline and study completion. Analysis Plan: Demographic data using descriptive statistics will be calculated. Trends of the mean scores from baseline to study completion among groups and between groups will be conducted. REDCap will securely store all study-related data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Get Palliative Care: four educational learning module videos | Experimental | Behavioral: Get Palliative Care: four educational learning module videosGet 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. |
| Usual Care | No intervention | –Usual care for COPD includes oxygen therapy, steroid therapy, chest radiography, nebulized bronchodilators, and antimicrobial therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years of age or older
- COPD diagnosis
- English speaking
- Access to technology and Internet/online services
Key exclusion criteria (2 listed)
- Enrolled in hospice care
- Cancer diagnosis stage IV or greater
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Get Palliative Care: four educational learning module videosOrganizational Sponsored public domain educational videos | Behavioural | Get Palliative Care: four educational learning module videos |
Primary outcome
Health Literacy Questionaire
Time frame: Baseline and immediately after the intervention, through study completion up to 12 weeks
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).
Medical Outcomes Study-Short Form 36
Time frame: Baseline and immediately after the intervention, through study completion up to 12 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Lasiter, PhD study chair
University of Missouri, Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Get Palliative Care: four educational learning module videos in people with COPD, run by University of Missouri, Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Counts, PhD (c) (618-444-9595, kdb7x9@umsystem.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Literacy Questionaire (time frame: Baseline and immediately after the intervention, through study completion up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.