NCT03386773

Reporting Patient Generated Health Data and Patient Reported Outcomes With Health Information Technology

Completed NA Results posted Last updated 26 September 2022

What this trial tests

NA trial testing 16-week program in Obesity in 300 participants. Completed in 31 August 2020.

Timeline

2 November 2018

Primary endpoint
19 July 2019

31 August 2020

Quick facts

Lead sponsor	Denver Health and Hospital Authority
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	300
Start date	2 November 2018
Primary completion	19 July 2019
Estimated completion	31 August 2020
Sites	1 location across United States

Drugs / interventions tested

• 16-week program
• Patient generated health data

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Denver Health and Hospital Authority

Who can join

18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Engagement (Patient Activation Measure) Primary · Baseline, Post-Intervention

Patient Engagement will be measured by participant performance on the Patient Activation Measurement (PAM)-13 tool. This validated instrument helps to show patients' motivation for being an active participant in managing their health. Each of the 13 items on the tool is rated on a four-point per-item scale, then converted to a total PAM score. The total PAM score is transformed into a scale score with values that range from 0 to 100 based on the calibration tables for the instrument, with higher numbers reflecting better scores and indicative of increased engagement. The scale score is reporte

Baseline

Group	Value	95% CI
Intervention	70.2	± 17.9
Control	67.6	± 16.9

Follow-Up

Group	Value	95% CI
Intervention	72.7	± 18.9
Control	70.3	± 20.1

Weight Loss Secondary · 16 weeks

Change in absolute percent weight

Group	Value	95% CI
Intervention	0.65	± 5
Control	-0.29	± 8

Healthy Days HRQOL-4 Measure Secondary · 16 weeks

Healthy days will be measured by participant performance on the Health Related Quality of Life Scores (HRQOL)-4 questionnaire. This questionnaire is scored based on participant reported number of days experiencing poor physical or mental health. The scale ranges from 1-30, with lower scores being better in that they indicate fewer poor health days.

Group	Value	95% CI
Intervention	18.83	± 11.66
Control	17.93	± 11.71

Healthy Days Symptoms Measure Secondary · 16 weeks

Patient Reported Outcomes Measures, Healthy Days Symptoms Score - lower scores are better, save for Energy where a higher score is better. Minimum value is 0, maximum value is 30.

Pain

Group	Value	95% CI
Intervention	3.38	± 6.52
Control	5.51	± 9.20

Sad

Group	Value	95% CI
Intervention	3.11	± 5.16
Control	4.15	± 7.02

Anxious

Group	Value	95% CI
Intervention	4.51	± 6.77
Control	5.65	± 7.82

Sleep

Group	Value	95% CI
Intervention	9.23	± 10.15
Control	9.98	± 10.45

Energy

Group	Value	95% CI
Intervention	18.28	± 10.12
Control	15.35	± 10.55

Number of Patients Who Responded to Text Messages Secondary · 16 weeks

Text message response to prompts for weight data.

Responded less than prompted

Group	Value	95% CI
Intervention	104
Control	93

Responded as many times as prompted

Group	Value	95% CI
Intervention	7
Control	3

Responded more than prompted

Group	Value	95% CI
Intervention	4
Control	8

Did not respond

Group	Value	95% CI
Intervention	35
Control	46

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.