Personal Health Libraries for Formerly Incarcerated Individuals

NCT ID: NCT05441306

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-02-28

Brief Summary

This is a randomized pilot study to test the acceptance and use of PerHL among formerly incarcerated individuals

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.

Conditions

Personal Health Information; Incarcerated Individuals

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Personal Health Library (PerHL) + MyChart

Intervention Type: DEVICE

Participants randomized to the PerHL arm will have access to PerHL + the standard of care patient portal (Epic®MyChart).

Control - MyChart

Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart).

Group Type: ACTIVE_COMPARATOR

Epic®MyChart

Intervention Type: DEVICE

Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart).

Interventions

Personal Health Library (PerHL) + MyChart

Participants randomized to the PerHL arm will have access to PerHL + the standard of care patient portal (Epic®MyChart).

Intervention Type: DEVICE

Epic®MyChart

Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Library of Medicine (NLM)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Wang, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Central Contacts

Kimberly Vasquez, MPH

Role: CONTACT

kimberly.vasquez@yale.edu

2123630809

Facility Contacts

Marisol Foumakoye, MA

Role: primary

marisol.credle@yale.edu

203-627-4050

Other Identifiers

1R01LM013477-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000028862

Identifier Type: -

Identifier Source: org_study_id