NCT04633616

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

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

November 6, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2022

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

November 6, 2020

Last Update Submit

December 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (3)

  • Patient Activation

    3 months

  • Patient Experience

    3 months

  • Patient Drop-out Rate

    3 months

Other Outcomes (2)

  • Potential clinical trial recruitment rate

    3 months

  • Patient Knowledge

    3 months

Study Arms (2)

Tailored Delivery of Education

EXPERIMENTAL

Communication will be tailored as the mode of weblink delivery will be customized to patient preference.

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.

Other: Non-Tailored Patient-Provider Communication

Interventions

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.

Tailored Delivery of Education

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.

Non-tailored Delivery of Education

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

PsoriasisDermatitis, AtopicAcne Vulgaris

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesAcneiform EruptionsSebaceous Gland Diseases

Study Officials

  • April Armstrong, MD, MPH

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
Single-blinded
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Tailored patient-provider communication versus non-tailored patient-provider communication on patient recruitment to clinical trials and patient engagement.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor/Professor

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 18, 2020

Study Start

November 16, 2020

Primary Completion

October 19, 2021

Study Completion

January 19, 2022

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

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.

Locations