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Набор скоро начнётся NCT05441306

Personal Health Libraries for Formerly Incarcerated Individuals

Без фазы С лечением Personal Health Information Incarcerated Individuals

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Personal Health Library (PerHL) + MyChart, Epic®MyChart.
Кому может быть актуально
Состояния в реестре: Personal Health Information, Incarcerated Individuals. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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

Подробное описание

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.

Вмешательства

  • Устройство Personal Health Library (PerHL) + MyChart
    Participants randomized to the PerHL arm will have access to PerHL + the standard of care patient portal (Epic®MyChart).
  • Устройство Epic®MyChart
    Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart).

Первичные конечные точки

  • Acceptance - Intention to use [Срок оценки: 1 month post enrollment]
  • Acceptance - Intention to use [Срок оценки: 3 month post enrollment]
  • Use of Personal health information technology [Срок оценки: 1 month post enrollment]
  • Use of Personal health information technology [Срок оценки: 3 month post enrollment]
Вторичные конечные точки (12)
  • Perceived ease of use for the app [Срок оценки: 1 month post enrollment]
  • Perceived ease of use for the app [Срок оценки: 3 month post enrollment]
  • Perceived usefulness of the app [Срок оценки: 1 month post enrollment]
  • Perceived usefulness of the app [Срок оценки: 3 month post enrollment]
  • Attitude towards use of technology [Срок оценки: 1 month post enrollment]
  • Attitude towards use of technology [Срок оценки: 3 month post enrollment]
  • Completeness of data [Срок оценки: 1 month post enrollment]
  • Completeness of data [Срок оценки: 3 month post enrollment]
  • General self-efficacy [Срок оценки: 1 month post enrollment]
  • General self-efficacy [Срок оценки: 3 month post enrollment]
  • Medication adherence [Срок оценки: 1 month post enrollment]
  • Medication adherence [Срок оценки: 3 month post enrollment]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Yale School of Medicine — New Haven

Идентификаторы

NCT: NCT05441306 · 2000028862 · 1R01LM013477-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗