The ROAMM-EHR Study

Официальное название

ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients

Обзор

In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes.

Подробное описание

This pilot study aims to evaluate the feasibility of collecting patient generated health data (PGHD) remotely for aiding care management of patients with chronic limb threatening ischemia following vascular bypass or revascularization. DRemote data collected from a publicly available smartwatch will be displayed on an EHR interface for providers to view PGHD. The test of feasibility entails multiple components that include implementing a provider interface for viewing and acting on PGHD, establishing safety, ensuring quality assurance (e.g. quality of remote data collection), successful recruitment and retention of participants, and sufficient remote response rates from patients.

Вмешательства

• Поведенческое Actionable remotely generated health data
  Remotely captured, patient generated health data will be used to inform provider care following re-vascular surgery in patients with chronic limb threatening ischemia
• Поведенческое Non-Actionable remotely generated health data
  Remotely captured, patient generated health data is captured, but will not be used to inform provider care following re-vascular surgery in patients with chronic limb threatening ischemia

Первичные конечные точки

• 6-min walk distance [Срок оценки: Baseline and approximately 30 days post-surgery]

Вторичные конечные точки (1)

• self-reported quality of life [Срок оценки: Baseline and approximately 30 days post-surgery]

Критерии участия

Критерии включения

• age >= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery \[endovascular or open re-vascularization (bypass)\].

Критерии исключения

• High risk of post-surgical amputation based on study physician judgement, non-english speaker, diagnosis of an age-related dementia (e.g. Alzheimer's Disease); unable to communicate because of severe hearing loss; uncorrectable vision impairment that compromises clinical assessments or would cause a safety concern, other significant co-morbid disease that in the opinion of the investigators and study physician would impair the ability to participate in the study or be a safety concern

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

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Institute of Aging — Gainesville

Идентификаторы

NCT: NCT06263322 · IRB202200419 · R21AG073769

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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