PsoriasisNCT04633616
Tailored Patient-Provider Communication (TPPC): Evaluating the Impact of TPPC in Dermatology Patients
A study testing Tailored Patient-Provider Communication and Non-Tailored Patient-Provider Communication in people with Psoriasis and Atopic Dermatitis, run by University of Southern California at 1 site in United States.
Trial summary
The impact of tailored patient-provider communication to improve clinical trial recruitment, patient knowledge, and patient engagement will be studied. Tailored patient-provider communication refers to the individualization of patient-provider communication using patients' preferred methods of communication. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Atopic Dermatitis, Acne
- What is being tested?
- Tailored Patient-Provider Communication and Non-Tailored Patient-Provider Communication
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 19 Jan 2022
- 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
- Provide signed and dated informed consent form
- Speak English or Spanish
- Male or female, at least 18 years of age
- Have an active, physician-diagnosed dermatological condition
- Have access to an electronic device that is capable of capturing images with a minimum resolution of 1024x768 pixels
- Have access to at least one form of social messaging (e-mail, SMS, WhatsApp, or Facebook) which can connect online
Who cannot join
- Does not have an active dermatological condition at the beginning of the study
- Does not live in southern California
- Unable to fulfill the required tasks of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Patient-Provider Communication (TPPC): A Pragmatic Single-Blinded Trial Evaluating the Impact of TPPC in Dermatology Patients Compared to Standard Patient-Provider Communication.
The impact of tailored patient-provider communication to improve clinical trial recruitment, patient knowledge, and patient engagement will be studied. Tailored patient-provider communication refers to the individualization of patient-provider communication using patients' preferred methods of communication. This involves the utilization of social messaging such as e-mail or text and/or social media platforms. These communication methods purport to and meet individual patient needs whilst ensuring that information is received and in a format that is familiar to each patient. The primary outcomes of the proposed research is to evaluate the impact of tailored patient-provider communication on patient response rates (speed and number), clinical trial recruitment rates, patient knowledge, and patient engagement.
Read the detailed description
This is a 3-month, pragmatic, single-blinded randomized controlled trial evaluating the impact of tailored patient-provider communication on patient engagement and clinical outcomes of adult dermatology patients compared to non-tailored patient-provider communication. The pragmatic trial will compare patient engagement and clinical outcomes between the two models. The rationale for proposing a pragmatic trial is to test whether tailored patient-provider communication works in real life. This design allows for a large spectrum of everyday clinical settings in order to maximize applicability and generalizability. The pragmatic approaches are especially pronounced along the inclusive eligibility criteria, experimental intervention flexibility, and primary outcome being highly relevant to patients and providers alike.
The investigators will recruit from approximately 32,310 adult patients from target populations, southern California to enroll 134 participants in the study. In addition to recruiting from the general population, the investigators will place a specific emphasis on recruiting patients living in rural and underserved communities; the investigators will also recruit from a full range of dermatological diseases.
Patient recruitment and enrollment will begin the first month of year one and continue through the fourth month of year one. The expected duration of this pragmatic, single-blinded randomized controlled equivalency trial for each participant will be a maximum of 3 months, including an initial baseline visit. No additional follow-up visits beyond this are expected for this research study.
Patients will be randomized to receive patient education via tailored or non-tailored patient-provider communication. The study team will know which form of communication each patient will receive while study participants will not know the different types of communication being studied. Patients randomized to either study population groups can be assessed remotely or in-person at the screening/baseline visit. At month 3, all patients will take high-quality photographs of their skin and submit these pictures to our dermatologist online. Any additional in-person or remote visits will be determined by providers and patients just as they would occur in the real-world. Primary and secondary outcomes will be monitored at months 0, 1.5, and 3.
- Conditions
- Psoriasis, Atopic Dermatitis, Acne
- Being tested
- Tailored Patient-Provider Communication, Non-Tailored Patient-Provider Communication
- Medical subject headings
- Psoriasis, Dermatitis, Atopic, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Patient-Provider CommunicationOther
Every 1.5 months, patients randomized to the tailored patient-provider communication model will receive weblinks directing patients to disease-specific educational videos and associated questionnaires. Communication will be tailored as the mode of weblink delivery will be customized to patient preference. Patients can choose messages to be delivered via e-mail, SMS, WhatsApp, or Facebook. For example, if one patient determines SMS messaging as their preferred communication mode, then this patient will receive a weblink via SMS directing the patient to customized educational videos and questionnaires. Weblinks delivered via tailored patient-provider communication will be enabled by Wecudos.
Non-Tailored Patient-Provider CommunicationOther
Every 1.5 months, patients randomized to the non-tailored patient-provider communication model will receive weblinks directing patients to disease-specific educational videos and associated questionnaires. Communication will be non-tailored such that patients will not be able to choose their preferred mode of communication and will receive hardcopy. Patients will receive hardcopy on how to access psoriasis education. Weblinks delivered via non-tailored patient-provider communication will be enabled by Wecudos.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Delivery of Education | Experimental | Communication will be tailored as the mode of weblink delivery will be customized to patient preference. Receives: Other: Tailored Patient-Provider Communication |
| Non-tailored Delivery of Education | Placebo comparator | Communication will be non-tailored such that patients will not be able to choose their preferred mode of communication and will receive hardcopy. Receives: Other: Non-Tailored Patient-Provider Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Response Rates
Patient response rate will determine the first step of patient engagement and assesses a patients willingness to 'interact' with the weblink delivered. Patient response rates will be measured by click rates. Click rates will be calculated using the proportions of patients in both study populations who choose to click on the weblinks delivered throughout the study, regardless of whether or not questionnaires are completed. The time elapsed from when the weblink is sent and when the weblink is clicked will also be recorded.
Measured: 3 months
Secondary outcomes (3)
Patient Activation
Measured by the proportion of patients achieving patient activation level 3 or 4 on the Patient Activation Measure 13-item measurement (PAM-13). The PAM-13 score is a validated scale consisting of 13 questions that will determine patient 'activation', or 'empowerment' of a patient to participate in their healthcare. The higher the score, the higher the activation level. Patients in level 1 may still believe their nurse or doctor will "fix" them. Patients in level 2 may understand they must be involved in their healthcare but lack the knowledge and confidence to take care of their conditions. Patients in level 3 are beginning to gain confidence to take on self-management behaviors and need to experience small successes to build a sense of self-efficacy and increase activation. Patients in level 4 have the confidence and skills to manage their health but may need help with maintaining their progress during stressful times.
Measured: 3 months
Patient Experience
Measured by the proportion of patients who report 'good' or 'very good' on the Armstrong Viewer Assessment (AVA). The AVA is a validated scale that will be used to determine patient experience with the educational materials viewed. Patients will be asked to complete this single question questionnaire after watching each educational video. This will ask how each participant felt about the video using a 5-point Likert scales between 0-4, where 0=very poor, 1=poor, 2=fair, 3=good, and 4=very good.
Measured: 3 months
Patient Drop-out Rate
Patient drop-out rate will determine the proportion of patients who 'accept' the delivered weblinks.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start16 Nov 2020
- Primary completion19 Oct 2021
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tailored patient-provider communication versus non-tailored patient-provider communication on patient recruitment to clinical trials and patient engagement.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Psoriasis Foundation
- Responsible party
- Principal investigator, April Armstrong, University of Southern California
- Investigators
- April Armstrong, MD, MPH, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633616
- Sponsor's protocol ID
- APP-18-03588
- Status last verified
- Dec 2022
- First submitted
- 6 Nov 2020
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subject confidentiality is strictly held in trust by the investigators, study staff, and the sponsor(s) and their agents. The study protocol, documentation, data, and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any unauthorized third party without prior written approval of the sponsor. The study monitor or other authorized representatives of the sponsor may inspect all study documents and records required to be maintained by the investigator, including but not limited to, medical records (office, clinic, or hospital) for the study subjects. The clinical study site will permit access to such records.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Patient-Provider Communication (TPPC): A Pragmatic Single-Blinded Trial Evaluating the Impact of TPPC in Dermatology Patients Compared to Standard Patient-Provider Communication.
- ClinicalTrials.gov ID
- NCT04633616
- Acronym / sponsor ID
- APP-18-03588
- Conditions
- Psoriasis, Atopic Dermatitis, Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Psoriasis Foundation
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 18 Nov 2020 (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 impact of tailored patient-provider communication to improve clinical trial recruitment, patient knowledge, and patient engagement will be studied. Tailored patient-provider communication refers to the individualization of patient-provider communication using patients' preferred methods of communication. This involves the utilization of social messaging such as e-mail or text and/or social media platforms. These communication methods purport to and meet individual patient needs whilst ensuring that information is received and in a format that is familiar to each patient. The primary outcomes of the proposed research is to evaluate the impact of tailored patient-provider communication on patient response rates (speed and number), clinical trial recruitment rates, patient knowledge, and patient engagement.
Detailed description
This is a 3-month, pragmatic, single-blinded randomized controlled trial evaluating the impact of tailored patient-provider communication on patient engagement and clinical outcomes of adult dermatology patients compared to non-tailored patient-provider communication. The pragmatic trial will compare patient engagement and clinical outcomes between the two models. The rationale for proposing a pragmatic trial is to test whether tailored patient-provider communication works in real life. This design allows for a large spectrum of everyday clinical settings in order to maximize applicability and generalizability. The pragmatic approaches are especially pronounced along the inclusive eligibility criteria, experimental intervention flexibility, and primary outcome being highly relevant to patients and providers alike.
The investigators will recruit from approximately 32,310 adult patients from target populations, southern California to enroll 134 participants in the study. In addition to recruiting from the general population, the investigators will place a specific emphasis on recruiting patients living in rural and underserved communities; the investigators will also recruit from a full range of dermatological diseases.
Patient recruitment and enrollment will begin the first month of year one and continue through the fourth month of year one. The expected duration of this pragmatic, single-blinded randomized controlled equivalency trial for each participant will be a maximum of 3 months, including an initial baseline visit. No additional follow-up visits beyond this are expected for this research study.
Patients will be randomized to receive patient education via tailored or non-tailored patient-provider communication. The study team will know which form of communication each patient will receive while study participants will not know the different types of communication being studied. Patients randomized to either study population groups can be assessed remotely or in-person at the screening/baseline visit. At month 3, all patients will take high-quality photographs of their skin and submit these pictures to our dermatologist online. Any additional in-person or remote visits will be determined by providers and patients just as they would occur in the real-world. Primary and secondary outcomes will be monitored at months 0, 1.5, and 3.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Tailored patient-provider communication versus non-tailored patient-provider communication on patient recruitment to clinical trials and patient engagement.
| Arm | Type | Receives |
|---|---|---|
| Tailored Delivery of Education | Experimental | Other: Tailored Patient-Provider CommunicationCommunication will be tailored as the mode of weblink delivery will be customized to patient preference. |
| Non-tailored Delivery of Education | Placebo comparator | Other: Non-Tailored Patient-Provider CommunicationCommunication will be non-tailored such that patients will not be able to choose their preferred mode of communication and will receive hardcopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide signed and dated informed consent form
- Speak English or Spanish
- Male or female, at least 18 years of age
- Have an active, physician-diagnosed dermatological condition
- Have access to an electronic device that is capable of capturing images with a minimum resolution of 1024x768 pixels
Key exclusion criteria (3 listed)
- Does not have an active dermatological condition at the beginning of the study
- Does not live in southern California
- Unable to fulfill the required tasks of the study
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 |
|---|---|---|
| Tailored Patient-Provider CommunicationEvery 1.5 months, patients randomized to the tailored patient-provider communication model will receive weblinks directing patients to disease-specific educational videos and associated questionnaires. Communication will be tailored as the mode of weblink delivery will be customized to patient preference. Patients can choose messages to be delivered via e-mail, SMS, WhatsApp, or Facebook. For example, if one patient determines SMS messaging as their preferred communication mode, then this patient will receive a weblink via SMS directing the patient to customized educational videos and questionnaires. Weblinks delivered via tailored patient-provider communication will be enabled by Wecudos. | Other | Tailored Delivery of Education |
| Non-Tailored Patient-Provider CommunicationEvery 1.5 months, patients randomized to the non-tailored patient-provider communication model will receive weblinks directing patients to disease-specific educational videos and associated questionnaires. Communication will be non-tailored such that patients will not be able to choose their preferred mode of communication and will receive hardcopy. Patients will receive hardcopy on how to access psoriasis education. Weblinks delivered via non-tailored patient-provider communication will be enabled by Wecudos. | Other | Non-tailored Delivery of Education |
Primary outcome
Patient Response Rates
Time frame: 3 months
Patient response rate will determine the first step of patient engagement and assesses a patients willingness to 'interact' with the weblink delivered. Patient response rates will be measured by click rates. Click rates will be calculated using the proportions of patients in both study populations who choose to click on the weblinks delivered throughout the study, regardless of whether or not questionnaires are completed. The time elapsed from when the weblink is sent and when the weblink is clicked will also be recorded.
3 secondary outcomes
Patient Activation
Time frame: 3 months
Patient Experience
Time frame: 3 months
Patient Drop-out Rate
Time frame: 3 months
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 15 Dec 2022.
- Individual participant dataSharing planned: No. Subject confidentiality is strictly held in trust by the investigators, study staff, and the sponsor(s) and their agents. The study protocol, documentation, data, and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any unauthorized third party without prior written approval of the sponsor. The study monitor or other authorized representatives of the sponsor may inspect all study documents and records required to be maintained by the investigator, including but not limited to, medical records (office, clinic, or hospital) for the study subjects. The clinical study site will permit access to such records.
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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.
April Armstrong, MD, MPH principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Patient-Provider Communication and Non-Tailored Patient-Provider Communication in people with Psoriasis and Atopic Dermatitis, run by University of Southern California 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 3 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 15 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
Patient Response Rates (time frame: 3 months). 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 15 Dec 2022.