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A Pilot Study of the Impact of the Patient Activated Learning System (PALS) on Knowledge Acquisition, Recall, and Decision Making

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03156634
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
This is a randomized pilot study comparing the impact of the Patient Activated Learning System (PALS) on knowledge acquisition, recall, and decision making about antihypertensive medication compared to an established online health information system (WebMD). We will also compare the two systems with regard to user experience measures such as understandability and trust.

Condition or disease Intervention/treatment Phase
Patient Education Other: PALS Other: WebMD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to view materials via one of to systems (Patient Activated Learning System or WebMD)
Masking: Single (Outcomes Assessor)
Masking Description: The statistician will be masked to the group assignment.
Primary Purpose: Health Services Research
Official Title: The Impact of the Patient Activated Learning System (PALS) on Knowledge Acquisition, Recall, and Decision Making About Antihypertensive Medication: A Pilot Study
Actual Study Start Date : April 15, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: PALS
Participants will view materials about the antihypertensive, chlorthalidone on the Patient Activated Learning System (PALS).
Other: PALS
PALS is a web based patient education system that uses text and audiovisual formats to deliver patient education materials.

Active Comparator: WedMD
Participants will view materials about the antihypertensive, chlorthalidone on WebMD.
Other: WebMD
WebMD is an internet based health information source.




Primary Outcome Measures :
  1. Knowledge acquisition [ Time Frame: Immediate ]
    Subjects will be asked questions about the materials they viewed.


Secondary Outcome Measures :
  1. Recall [ Time Frame: 1 week ]
    Subjects will be asked questions about the materials they viewed.

  2. User experience [ Time Frame: Immediate ]
    Participants will be asked about user experience including trust, usefulness, comprehensibility, and adequacy of the information, attractiveness of the site, and level of engagement of materials.

  3. Decision making [ Time Frame: Immediate ]
    Participants will be asked if they have sufficient information to make hypothetical decisions about taking chlorthalidone.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Weill Cornell Internal Medicine Associates (WCIMA) patients with hypertension who have been prescribed any antihypertensive medicine except chlorthalidone.
  • Patients who meet the criteria above and are English speaking and without cognitive impairment or other medical condition that would impair or preclude their ability to participate (such as a serious medical condition).

Exclusion Criteria:

  • WCIMA patients without hypertension
  • WCIMA patients with hypertension who have not been prescribed antihypertensive medicine
  • Patients who are non-English speaking
  • Patients with cognitive impairment or other medical condition that would impair or preclude their ability to participate (such as a serious medical condition).

Information from the National Library of Medicine

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): NCT03156634


Locations
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United States, New York
Weill Cornell Internal Medicine Associates
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Amanda S Carmel, MD Weill Medical College of Cornell University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03156634    
Other Study ID Numbers: 1610017672
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Patient education
Internet