CommunicationNCT04212117
CALS Patient Activated Learning System (PALS)
A study testing The Patient Activated Learning System (PALS) and WebMD in people with Communication and Trust, run by Cornell University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication, Trust, Health Knowledge, Attitudes, Practice
- What is being tested?
- The Patient Activated Learning System (PALS) and WebMD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 1 Nov 2023
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Communication, Trust, Health Knowledge, Attitudes, Practice
- Being tested
- The Patient Activated Learning System (PALS), WebMD
- Medical subject headings
- Communication, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Patient Activated Learning System (PALS)Other
Randomization into PALS arm.
WebMDOther
Randomization into WebMD arm.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Educational Platform, PALS | Other | The Patient Activated Learning System is a free, health education platform written bu trusted MDs. Receives: Other: The Patient Activated Learning System (PALS) |
| Arm 2 - WebMD | Other | WebMD is a widely used educational platform for health information. Receives: Other: WebMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
as measured by assessment questions on the nutrition information provided
Measured: Day 1, Immediately after reading article
Trust in eHealth
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
Measured: Day 1, Immediately after reading article
E-health usability
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
Measured: Day 1, Immediately after reading article
Physician trust
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
Measured: Day 1, Immediately after reading article
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start18 Feb 2020
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Lewis, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212117
- Sponsor's protocol ID
- 19-08020714
- Status last verified
- Feb 2024
- First submitted
- 23 Dec 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Digital Patient Activated Learning System Increase Racial Minority Engagement With Health Information? A Multi-Site Pilot Examination in New York State
- ClinicalTrials.gov ID
- NCT04212117
- Acronym / sponsor ID
- 19-08020714
- Conditions
- Communication, Trust, Health Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Educational Platform, PALS | Other | Other: The Patient Activated Learning System (PALS)The Patient Activated Learning System is a free, health education platform written bu trusted MDs. |
| Arm 2 - WebMD | Other | Other: WebMDWebMD is a widely used educational platform for health information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient ≥ 18 years of age.
- Self-reported hypertension diagnosis.
- English speaking
- Passing the cognition screener
- Able to read in English
Key exclusion criteria (6 listed)
- Non-English speakers
- Not having self-identified as having hypertension
- Inability to read in English
- Being younger than 18
- Not passing the screener
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Patient Activated Learning System (PALS)Randomization into PALS arm. | Other | Arm 1 - Educational Platform, PALS |
| WebMDRandomization into WebMD arm. | Other | Arm 2 - WebMD |
Primary outcome
Knowledge
Time frame: Day 1, Immediately after reading article
as measured by assessment questions on the nutrition information provided
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Lewis, PhD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Patient Activated Learning System (PALS) and WebMD in people with Communication and Trust, run by 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 6 inclusion and 6 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 13 Feb 2024. 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 (time frame: Day 1, Immediately after reading article). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.