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NCT Number: NCT05441306

Personal Health Libraries for Formerly Incarcerated Individuals

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location contact

Karen Wang, MD, MHS

PRINCIPAL_INVESTIGATOR

Marisol Foumakoye, MA

CONTACT

[email protected]

203-627-4050

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personal Health Library (PerHL) + MyChart

Device

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

Epic®MyChart

Device

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

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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).

  13. 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.

  14. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Vasquez, MPH

CONTACT

[email protected]

2123630809

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Library of Medicine (NLM)

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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