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Not yet recruiting NCT05441306

Personal Health Libraries for Formerly Incarcerated Individuals

No phase Interventional Personal Health Information Incarcerated Individuals

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Personal Health Library (PerHL) + MyChart, Epic®MyChart.
Who it may be relevant to
Registry conditions: Personal Health Information, Incarcerated Individuals. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Acceptance - Intention to use [Time frame: 1 month post enrollment]
  • Acceptance - Intention to use [Time frame: 3 month post enrollment]
  • Use of Personal health information technology [Time frame: 1 month post enrollment]
  • Use of Personal health information technology [Time frame: 3 month post enrollment]
Secondary outcome measures (12)
  • Perceived ease of use for the app [Time frame: 1 month post enrollment]
  • Perceived ease of use for the app [Time frame: 3 month post enrollment]
  • Perceived usefulness of the app [Time frame: 1 month post enrollment]
  • Perceived usefulness of the app [Time frame: 3 month post enrollment]
  • Attitude towards use of technology [Time frame: 1 month post enrollment]
  • Attitude towards use of technology [Time frame: 3 month post enrollment]
  • Completeness of data [Time frame: 1 month post enrollment]
  • Completeness of data [Time frame: 3 month post enrollment]
  • General self-efficacy [Time frame: 1 month post enrollment]
  • General self-efficacy [Time frame: 3 month post enrollment]
  • Medication adherence [Time frame: 1 month post enrollment]
  • Medication adherence [Time frame: 3 month post enrollment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • Yale School of Medicine — New Haven

Identifiers

NCT: NCT05441306 · 2000028862 · 1R01LM013477-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗