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

NCT03386773 | Completed Results

• 1 other identifier: 17-1082
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

patient generated health data; patient reported outcome measures; health information technology; mobile health; consumer health informatics

Outcome Measures

Primary Outcomes (1)

• Patient Engagement (Patient Activation Measure)

  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 reported here.

  Baseline, Post-Intervention

Secondary Outcomes (4)

• Weight Loss

  16 weeks

• Healthy Days HRQOL-4 Measure

  16 weeks

• Healthy Days Symptoms Measure

  16 weeks

• Number of Patients Who Responded to Text Messages

  16 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention patients will engage in a 16-week program where they will receive regular health promotion messaging about (a) food, nutrition, and diet; and (b) exercise and physical activity. Intervention patients will be asked to track patient generated health data (PGHD) elements related to weight management 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.

Behavioral: 16-week program; Behavioral: Patient generated health data

Control

ACTIVE COMPARATOR

Control patients will engage in a 16-week program where they will receive regular health promotion messaging about (a) food, nutrition, and diet; and (b) exercise and physical activity. Patient-reported outcomes measures will be collected pre-and-post-intervention.

Behavioral: 16-week program

Interventions

16-week program BEHAVIORAL

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

Control; Intervention

Patient generated health data BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Patient Generated Health Data

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Records, Personal; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Results Point of Contact

• Title: Susan L. Moore, PhD, MSPH
• Organization: Colorado School of Public Health

susan.l.moore@cuanschutz.edu

303-724-8858

Study Officials

• Susan L Moore, PhD, MSPH

  Colorado School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, mHealth Impact Lab

Model Details: Recruited participants will be randomized to one of two arms, intervention or control. Both intervention and control groups will engage in a 16-week program where they will receive regular health promotion messaging about (a) food, nutrition, and diet; and (b) exercise and physical activity. Intervention patients will be asked to track patient generated health data elements related to weight management 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. Intervention patients will also be asked to provide answers to patient-reported outcomes measures on a weekly basis. If intervention patients do not have a fitness tracker, a low-cost option will be provided for them. Both iOS and Android phone options will be supported. The app will be selected from a limited set of well-established options such as LoseIt!, MyFitnessPal, Apple Health, or Google Fit.

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 29, 2017
• Study Start: November 2, 2018
• Primary Completion: July 19, 2019
• Study Completion: August 31, 2020
• Last Updated: September 26, 2022
• Results First Posted: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)