Personal Health Libraries for Formerly Incarcerated Individuals

April 30, 2026 updated by: Yale University
This is a randomized pilot study to test the acceptance and use of PerHL among formerly incarcerated individuals

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eligible participants will be enrolled after providing informed consent .Participants will then complete a baseline assessment. After the interview, eligible participants will be randomly assigned to the intervention or control group. The research assistant (RA) will be blinded to the randomization allocation until after the consent process. For the purposes of this study, permuted block randomization with random block sizes of 2, 4 and 6 will be used.

Intervention: Those randomized to the intervention arm will have access to PerHL. The intervention group will watch a demonstration by the RA and will practice using PerHL for 10-15 minutes, i.e. taking a picture of a document and uploading to PerHL, entering specific information, voice recording an appointment reminder. The RA will be responsible for providing technical support and assist with the need for initial support, e.g. phone-call or text-based support. At baseline, participants will be asked to provide a list of every organization they visited that may have health and health-related social information on them and receive consent to request their information to be sent to the participant and the study team on their behalf.

Control: Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart). The RA will give them an informational pamphlet outlining key features of the patient portal and guide them through the steps for signing up for a MyChart account, assist them to sign up, add the standard patient portal MyChart app to their phone, and provide them with the MyChart technical support hotline.

Study Procedures: During the intervention phase, all participants will meet with the RA at baseline, 1- and 3 months. During the study, each participant will be asked to provide at least 5 verified locators who are likely to have knowledge of their whereabouts throughout follow-up. Each participant will be provided with $50 payment to participants for each completion of surveys at baseline, 1, 3 months. In addition, participants will be given $10 each month to travel to a location with free wireless so their information can be uploaded to the cloud and a list of available locations. In total, each participant will receive $180 for participation.

For the 1- and 3-month follow-up period, the RA will ask participants to bring information collected and uploaded in PerHL and additional information that is important to the participant but was not uploaded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine
        • Contact:
        • Principal Investigator:
          • Karen Wang, MD, MHS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years or older
  • English-speaking
  • have at least one chronic condition
  • engaged in primary care in the community
  • have been released from a correctional facility in the past year.

Exclusion Criteria:

  • visual impairments
  • cognitive impairments
  • language barriers
  • planned relocation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control - MyChart
Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart).
Device: Epic®MyChart
Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart).
Experimental: Access to Personal Health Library (PerHL) + MyChart
Participants randomized to the PerHL arm will have access to PerHL and the standard of care patient portal (Epic®MyChart).
Device: Personal Health Library (PerHL) + MyChart
Participants randomized to the PerHL arm will have access to PerHL + the standard of care patient portal (Epic®MyChart).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptance - Intention to use
Time Frame: 1 month post enrollment
Assess intention to use the app developed for the project. Intention to use will be assessed by a survey conducted in person. This survey item is in development.
1 month post enrollment
Acceptance - Intention to use
Time Frame: 3 month post enrollment
Assess intention to use the app developed for the project. Intention to use will be assessed by a survey conducted in person. This survey item is in development.
3 month post enrollment
Use of Personal health information technology
Time Frame: 1 month post enrollment
Assess the number of times the personal health information app was accessed each week and the duration of time on the system per week. This will be assessed using tracking functionality built into the app.
1 month post enrollment
Use of Personal health information technology
Time Frame: 3 month post enrollment
Assess the number of times the personal health information app was accessed each week and the duration of time on the system per week. This will be assessed using tracking functionality built into the app.
3 month post enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived ease of use for the app
Time Frame: 1 month post enrollment
Assess how easy it was for the participant to use the app. Perceived ease of use will be assessed by self-report survey. This survey item is in development.
1 month post enrollment
Perceived ease of use for the app
Time Frame: 3 month post enrollment
Assess how easy it was for the participant to use the app. Perceived ease of use will be assessed by self-report survey. This survey item is in development.
3 month post enrollment
Perceived usefulness of the app
Time Frame: 1 month post enrollment
Assess how useful the participant found app to be. Perceived usefulness will be assessed by self-report survey. This survey item is in development.
1 month post enrollment
Perceived usefulness of the app
Time Frame: 3 month post enrollment
Assess how useful the participant found app to be. Perceived usefulness will be assessed by self-report survey. This survey item is in development.
3 month post enrollment
Attitude towards use of technology
Time Frame: 1 month post enrollment
Assess the participant's attitude towards using technology. Attitude towards technology will be assessed by self-report survey. This survey item is in development.
1 month post enrollment
Attitude towards use of technology
Time Frame: 3 month post enrollment
Assess the participant's attitude towards using technology. Attitude towards technology will be assessed by self-report survey. This survey item is in development.
3 month post enrollment
Completeness of data
Time Frame: 1 month post enrollment
Assess the proportion of health system data sources received by study team and/or patient (#organizational data received/ #organizational requests made), assess type of data received (# of medication list received/ requested or # of allergies received/requests made) to determine completeness of data.
1 month post enrollment
Completeness of data
Time Frame: 3 month post enrollment
Assess the proportion of health system data sources received by study team and/or patient (#organizational data received/ #organizational requests made), assess type of data received (# of medication list received/ requested or # of allergies received/requests made) to determine completeness of data.
3 month post enrollment
General self-efficacy
Time Frame: 1 month post enrollment
Assess participant self-efficacy. Self-efficacy will be assessed by self-report survey. This survey item is in development.
1 month post enrollment
General self-efficacy
Time Frame: 3 month post enrollment
Assess participant self-efficacy. Self-efficacy will be assessed by self-report survey. This survey item is in development.
3 month post enrollment
Medication adherence
Time Frame: 1 month post enrollment
Medication Adherence will be measured by personal health information technology use (MyChart) at Yale New Haven Hospital, medication adherence (as measured by ninety-day medication refill).
1 month post enrollment
Medication adherence
Time Frame: 3 month post enrollment
Medication Adherence will be measured by personal health information technology use (MyChart) at Yale New Haven Hospital, medication adherence (as measured by ninety-day medication refill).
3 month post enrollment
Engagement in primary care
Time Frame: 1 month post enrollment
Engagement in primary care will be measured by personal health information technology use (MyChart) at Yale New Haven Hospital, engagement in primary care (as measured by appointments made) via MyChart systems.
1 month post enrollment
Engagement in primary care
Time Frame: 3 month post enrollment
Engagement in primary care will be measured by personal health information technology use (MyChart) at Yale New Haven Hospital, engagement in primary care (as measured by appointments made) via MyChart systems.
3 month post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Library of Medicine (NLM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen Wang, MD, MHS, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000028862
  • 1R01LM013477-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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