CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
16-week program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03386773
NCT03386773N/ACompleted

Engaging Disadvantaged Patients in Sharing Patient Generated Health Data and Patient Reported Outcomes Through Health Information Technology

Denver Health and Hospital Authority·interventional·Posted Dec 29, 2017·Updated Sep 26, 2022

In Brief

A clinical study evaluating 16-week program and Patient generated health data for Obesity. Completed, enrolled 300 participants across 1 site.

Detailed Summary

This study will assess the feasibility of using patient-centered, commercial off-the-shelf (COTS) health information technology (IT) solutions to collect patient generated health data (PGHD) and patient-reported outcomes (PROs) from diverse, low-income disadvantaged populations. These data will then be mapped and reported in a way that will allow them to be made actionable and used to improve health care quality and delivery. The data mapping will be designed for data collection through technology such as mobile apps and wearables, and will be intended to support integration into interoperable electronic health records (EHRs), clinical information systems, and big data infrastructures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 29, 2017
Enrollment StartNov 2, 2018
Primary CompletionJul 19, 2019
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.5 years ago

Interventions

16-week programbehavioral

16-week program where patients will receive regular health promotion messaging about (a) food, nutrition, and diet; and (b) exercise and physical activity.

Patient generated health databehavioral

Intervention patients will be asked to track patient generated health data and patient reported outcomes. PGHD elements related to weight management will be collected through a mobile health app loaded on their phones and/or through using a fitness tracker, depending on patient preference, and to share that information with the research team. Patient-reported outcomes (PRO) measures will be collected pre-and-post-intervention. Intervention patients will also be asked to provide answers to patient-reported outcomes measures on a weekly basis.