Clinical trial NCT03721315: Health Literacy Activation RCT Among the COPD Patients and Designated Support Dyad
Official title: A Randomized Controlled Trial of Health Literacy Activation Among the Chronic Obstructive Pulmonary Disease Patients and Designated Support Dyad
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD Exacerbation
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 6
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Respiratory Specific Health Related Quality of life (HRQoL)
timeFrame: 3 months
Secondary outcomes:
measure: Medication adherence
timeFrame: 3 months
measure: Healthcare utilization
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Einstein Medical Center Philadelphia
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Audrey Djibo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.