NCT03156634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

March 15, 2017

Last Update Submit

April 22, 2019

Conditions

Keywords

Patient educationInternet

Outcome Measures

Primary Outcomes (1)

  • Knowledge acquisition

    Subjects will be asked questions about the materials they viewed.

    Immediate

Secondary Outcomes (3)

  • Recall

    1 week

  • User experience

    Immediate

  • Decision making

    Immediate

Study Arms (2)

PALS

EXPERIMENTAL

Participants will view materials about the antihypertensive, chlorthalidone on the Patient Activated Learning System (PALS).

Other: PALS

WedMD

ACTIVE COMPARATOR

Participants will view materials about the antihypertensive, chlorthalidone on WebMD.

Other: WebMD

Interventions

PALSOTHER

PALS is a web based patient education system that uses text and audiovisual formats to deliver patient education materials.

PALS
WebMDOTHER

WebMD is an internet based health information source.

WedMD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Internal Medicine Associates

New York, New York, 10021, United States

Location

Related Publications (1)

  • Carmel AS, Cornelius-Schecter A, Frankel B, Jannat-Khah D, Sinha S, Pelzman F, Safford MM. Evaluation of the Patient Activated Learning System (PALS) to improve knowledge acquisition, retention, and medication decision making among hypertensive adults: Results of a pilot randomized controlled trial. Patient Educ Couns. 2019 Aug;102(8):1467-1474. doi: 10.1016/j.pec.2019.03.001. Epub 2019 Mar 4.

Study Officials

  • Amanda S Carmel, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician will be masked to the group assignment.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be randomized to view materials via one of to systems (Patient Activated Learning System or WebMD)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2017

First Posted

May 17, 2017

Study Start

April 15, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations