Health Literacy Activation RCT Among the COPD Patients and Designated Support Dyad
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|ClinicalTrials.gov Identifier: NCT03721315|
Recruitment Status : Enrolling by invitation
First Posted : October 26, 2018
Last Update Posted : July 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD Exacerbation||Behavioral: Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized Controlled Trial of Health Literacy Activation Among the Chronic Obstructive Pulmonary Disease Patients and Designated Support Dyad|
|Actual Study Start Date :||June 15, 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||January 2020|
No Intervention: Control
This group will receive the standard of care for this condition.
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.
The health literacy enhancement will comprise of the following:
- 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
- Medication adherence [ Time Frame: 3 months ]Medication adherence measured by the number of prescription refills
- Healthcare utilization [ Time Frame: 3 months ]Healthcare utilization measured by the number of ER visits, and 30 day readmissions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721315
|United States, Pennsylvania|
|Einstein Medical Center Philadelphia|
|Philadelphia, Pennsylvania, United States, 19141|
|Principal Investigator:||Audrey Djibo, PhD||Albert Einstein Healthcare Network|