COPD ExacerbationNCT03721315
Health Literacy Activation RCT Among the COPD Patients and Designated Support Dyad
A study testing Intervention in people with COPD Exacerbation, run by Albert Einstein Healthcare Network at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2019to 26 Apr 2020
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dyads unable to participate in the education session
- Patients discharged to a skilled nursing facility or rehabilitation facility.
Trial locations and contacts
1 site in 1 country.
United States1 site
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, 19141
About this study
Official title: A Randomized Controlled Trial of Health Literacy Activation Among the Chronic Obstructive Pulmonary Disease Patients and Designated Support Dyad
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.
Read the 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.
- Conditions
- COPD Exacerbation
- Being tested
- Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will receive the standard of care for this condition. |
| Intervention | Experimental | 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. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (2)
Medication adherence
Medication adherence measured by the number of prescription refills
Measured: 3 months
Healthcare utilization
Healthcare utilization measured by the number of ER visits, and 30 day readmissions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start15 Jun 2019
- Primary completion26 Apr 2020
- Study completion26 Apr 2020
Why it stopped: SARS-CoV2 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies 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
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrey Djibo, Albert Einstein Healthcare Network
- Investigators
- Audrey Djibo, PhD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721315
- Sponsor's protocol ID
- 2019-19
- Status last verified
- Sep 2020
- First submitted
- 23 Oct 2018
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35514131
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Health Literacy Activation Among the Chronic Obstructive Pulmonary Disease Patients and Designated Support Dyad
- ClinicalTrials.gov ID
- NCT03721315
- Acronym / sponsor ID
- 2019-19
- Conditions
- COPD Exacerbation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SARS-CoV2 pandemic
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 26 Apr 2020 (actual)
- Study completion
- 26 Apr 2020 (actual)
- First posted
- 26 Oct 2018 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will receive the standard of care for this condition. |
| Intervention | Experimental | Behavioral: InterventionThis group will receive additional education along with their designated health support person prior to hospital discharge. This intervention does not include drugs/or devices. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Dyads unable to participate in the education session
- Patients discharged to a skilled nursing facility or rehabilitation facility.
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 |
|---|---|---|
| InterventionThe 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 | Behavioural | Intervention |
Primary outcome
Change in Respiratory Specific Health Related Quality of life (HRQoL)
Time frame: 3 months
Change in Respiratory Specific Health Related Quality of life (HRQoL) based on questionnaire responses at baseline and 3 months follow-up
2 secondary outcomes
Medication adherence
Time frame: 3 months
Healthcare utilization
Time frame: 3 months
Results and safety
The study was stopped early (reason given: SARS-CoV2 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Derived from this study: PubMed 35514131Cross 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.
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FreeDom: Innovative Strategy for the Management of COPD Exacerbations
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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.
Audrey Djibo, PhD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with COPD Exacerbation, run by Albert Einstein Healthcare Network 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: stopped early, as of the sponsor's last update on 10 Sep 2020. 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?
The study was stopped early (reason given: SARS-CoV2 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Respiratory Specific Health Related Quality of life (HRQoL) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03721315, which also lists 1 linked publication.
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 10 Sep 2020.