- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04212117
CALS Patient Activated Learning System (PALS)
February 9, 2024 updated by: Cornell University
Can the Digital Patient Activated Learning System Increase Racial Minority Engagement With Health Information? A Multi-Site Pilot Examination in New York State
The overall goal in this line of inquiry is to test whether the Patient Activated Learning System (PALS) is effective in reducing disparities in access to reliable, easily understood health information, and whether this increased understanding has downstream consequences such as increases in trust in the medical system and self-management behaviors.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Participants will view, in randomized order, PALS or WebMD content on hypertension and on high cholesterol.
This study will test knowledge uptake across topics as well as attitudes toward and trust in the information and information providers.
Study Type
Interventional
Enrollment (Actual)
232
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Cornell Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patient ≥ 18 years of age.
- Self-reported hypertension diagnosis.
- English speaking
- Passing the cognition screener
- Able to read in English
- Patient at designated recruitment clinics
Exclusion Criteria:
- Non-English speakers
- Not having self-identified as having hypertension
- Inability to read in English
- Being younger than 18
- Not passing the screener
- Not being a patient on the participating clinics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Arm 1 - Educational Platform, PALS
The Patient Activated Learning System is a free, health education platform written bu trusted MDs.
|
Randomization into PALS arm.
|
|
Other: Arm 2 - WebMD
WebMD is a widely used educational platform for health information.
|
Randomization into WebMD arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge
Time Frame: Day 1, Immediately after reading article
|
as measured by assessment questions on the nutrition information provided
|
Day 1, Immediately after reading article
|
|
Trust in eHealth
Time Frame: Day 1, Immediately after reading article
|
as measured by e-Health Impact Questionnaire by Kelly et al. on a 5-point likert scale where one is strongly disagree and 5 is strongly agree
|
Day 1, Immediately after reading article
|
|
E-health usability
Time Frame: Day 1, Immediately after reading article
|
as measured by e-Health Impact Questionnaire scale by Harris et al. on a 5-point likert scale where one is strongly disagree and 5 is strongly agree
|
Day 1, Immediately after reading article
|
|
Physician trust
Time Frame: Day 1, Immediately after reading article
|
as measured by assessment questions from Wake Forest Physician Trust Scale on a 5-point likert scale where one is strongly disagree and 5 is strongly agree
|
Day 1, Immediately after reading article
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Lewis, PhD, Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2020
Primary Completion (Actual)
November 1, 2023
Study Completion (Actual)
November 1, 2023
Study Registration Dates
First Submitted
December 23, 2019
First Submitted That Met QC Criteria
December 24, 2019
First Posted (Actual)
December 26, 2019
Study Record Updates
Last Update Posted (Estimated)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 9, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 19-08020714
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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