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Patient EducationNCT03156634

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

A study testing PALS and WebMD in people with Patient Education, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Patient Education
What is being tested?
PALS and WebMD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteUnited States
Study dates
15 Apr 2017to 31 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Weill Cornell Internal Medicine Associates

    New York, New York, 10021

Other trials in United States

About this study

Official title: The Impact of the Patient Activated Learning System (PALS) on Knowledge Acquisition, Recall, and Decision Making About Antihypertensive Medication: A Pilot Study

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.

Read the detailed description

Primary research question:

1)Do hypertensive participants who learn about hypertension medication with PALS (intervention) have higher immediate and 1 week knowledge assessment scores than participants randomized to learn the same information via WebMD (control)? The investigators hypothesize that participants in the PALS group will have higher immediate and one week assessment scores.

Secondary research questions:

  1. Do participants in the PALS group feel more informed to make hypothetical decisions about taking medications compared to participants in the WebMD group? The investigators hypothesize that participants in the PALS group will be more likely to indicate that they have sufficient information to make hypothetical decisions about taking medications than participants in the WebMD group.
  2. Do participants in the PALS group rate it higher on user experience measures such as trust, usefulness, comprehensibility, and adequacy of the information, attractiveness of the site, and level of engagement, than those in the WebMD group? The investigators hypothesize ratings on these measures will be higher in the PALS group compared to the WebMD group.
  3. Which questions about antihypertensives do participants consider most important and are the 5 most highly rated questions more likely to be addressed on PALS vs. WebMD? The investigators hypothesize that PALS will address more questions that participants rate as important compared to WebMD.

Participants with hypertension, who have been prescribed any antihypertensive medicine except chlorthalidone will be recruited from the Weill Cornell Internal Medicine Associates (WCIMA) practice. Potentially eligible participants who have an upcoming appointment at WCIMA will be identified via a review of the electronic medical record. In cases where the participant's eligibility is unclear, Research Assistants (RA's) will contact the participant's Primary Medical Doctor (PMD) to confirm eligibility. Potentially eligible participants will be contacted via the telephone to assess their interest in participating and to schedule a study visit for those interested. Verbal consent will be obtained either on the phone or at the study visit. Potentially eligible participants may also be recruited from the waiting room at WCIMA if the RA's were unable to contact them by phone prior to their WCIMA visit.

Eligible participants who agree to participate will be randomized to view information about the antihypertensive, chlorthalidone, via the PALS or WebMD. The study procedures will be identical for both the PALS and WebMD groups.

Chlorthalidone was chosen because, despite its efficacy, it is not prescribed as often as other antihypertensives. This will allow the investigators to select a sample of participants who are less likely to have baseline knowledge of the information we are testing.

To assess knowledge acquisition and recall, participants will be shown up to 10 pre-specified webpages within their site of randomization that contain information that answers up to 10 discrete questions about chlorthalidone. Participants will answer up to 10 corresponding assessment questions immediately after viewing the information. The knowledge score will be the percentage of correct responses. The RA's will evaluate knowledge retention by asking the same assessment questions over the phone one week later. User experience, trust, and participant decision-making will be assessed through a survey and through a short semi structured interview. The investigators will also collect information on health literacy via the REALM-SF health literacy questionnaire as well as demographic information including age, level of education, race/ethnicity, prior Internet use, and access to the Internet.

To assess question prioritization/availability on PALS/WebMD, the investigators will show participants a list of up to 40 questions and ask them to chose those most important to them. The investigators will search for the answers to the highest prioritized questions to determine availability on PALS/WebMD.

Surveys and knowledge scores will be administered via Qualtrics. Participants will be compensated with a $25 ClinCard after completing the study visit.

Being tested
PALS, WebMD
Keywords
Patient education, Internet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PALSOther

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

  • WebMDOther

    WebMD is an internet based health information source.

Study groups in NCT03156634
Study groupRoleWhat they receive
PALSExperimentalParticipants will view materials about the antihypertensive, chlorthalidone on the Patient Activated Learning System (PALS).
Receives: Other: PALS
WedMDActive comparatorParticipants will view materials about the antihypertensive, chlorthalidone on WebMD.
Receives: Other: WebMD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knowledge acquisition

    Subjects will be asked questions about the materials they viewed.

    Measured: Immediate

Secondary outcomes (3)
  1. Recall

    Subjects will be asked questions about the materials they viewed.

    Measured: 1 week

  2. User experience

    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.

    Measured: Immediate

  3. Decision making

    Participants will be asked if they have sufficient information to make hypothetical decisions about taking chlorthalidone.

    Measured: Immediate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2017
  2. Study start15 Apr 2017
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to view materials via one of to systems (Patient Activated Learning System or WebMD)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03156634
Sponsor's protocol ID
1610017672
Status last verified
Apr 2019
First submitted
15 Mar 2017
Last updated
23 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30928344

Questions about this trial

What is this clinical trial studying?

A study testing PALS and WebMD in people with Patient Education, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge acquisition (time frame: Immediate). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03156634, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.

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