Study Stopped
SARS-CoV2 pandemic
Health Literacy Activation RCT Among the COPD Patients and Designated Support Dyad
A Randomized Controlled Trial of Health Literacy Activation Among the Chronic Obstructive Pulmonary Disease Patients and Designated Support Dyad
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
October 26, 2018
CompletedStudy Start
First participant enrolled
June 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2020
CompletedSeptember 10, 2020
September 1, 2020
11 months
October 23, 2018
September 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
3 months
Secondary Outcomes (2)
Medication adherence
3 months
Healthcare utilization
3 months
Study Arms (2)
Control
NO INTERVENTIONThis group will receive the standard of care for this condition.
Intervention
EXPERIMENTALThis group will receive additional education along with their designated health support person prior to hospital discharge. This intervention does not include drugs/or devices.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Dyads unable to participate in the education session
- Patients discharged to a skilled nursing facility or rehabilitation facility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, 19141, United States
Related Publications (1)
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.
PMID: 35514131DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Audrey Djibo, PhD
Albert Einstein Healthcare Network
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
- Scientist, Interim Chair of the Research Division, Department of Medicine
Study Record Dates
First Submitted
October 23, 2018
First Posted
October 26, 2018
Study Start
June 15, 2019
Primary Completion
April 26, 2020
Study Completion
April 26, 2020
Last Updated
September 10, 2020
Record last verified: 2020-09