N/A
Completed N=300
Reporting Patient Generated Health Data and Patient Reported Outcomes With Health Information Technology
Source: ClinicalTrials.gov NCT03386773 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Patient Engagement (Patient Activation Measure) — 70.2; 67.6; 72.7; 70.3 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Engagement (Patient Activation Measure) |
70.2; 67.6; 72.7; 70.3 | — |
| SECONDARY Weight Loss |
0.65; -0.29 | — |
| SECONDARY Healthy Days HRQOL-4 Measure |
18.83; 17.93 | — |
| SECONDARY Healthy Days Symptoms Measure |
3.38; 5.51; 3.11; 4.15; 4.51; 5.65 | — |
| SECONDARY Number of Patients Who Responded to Text Messages |
104; 93; 7; 3; 4; 8 | — |
Eligibility Criteria
Inclusion Criteria
- BMI of 25.0-39.9,
- Has a smartphone
- English or Spanish as primary language
- assessed at "medium health risk" according a risk stratification algorithm based on clinical criteria, diagnostic scoring, and health care utilization
Exclusion Criteria
- Does not meet inclusion criteria
Data sourced from ClinicalTrials.gov (NCT03386773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.