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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03386773
Recruitment Status : Completed
First Posted : December 29, 2017
Results First Posted : September 26, 2022
Last Update Posted : September 26, 2022
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Susan Moore, Colorado School of Public Health

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: 16-week program Behavioral: Patient generated health data Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Engaging Disadvantaged Patients in Sharing Patient Generated Health Data and Patient Reported Outcomes Through Health Information Technology
Actual Study Start Date : November 2, 2018
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : August 31, 2020

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

Behavioral: Patient generated health data
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.

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




Primary Outcome Measures :
  1. Patient Engagement (Patient Activation Measure) [ Time Frame: 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 reported here.


Secondary Outcome Measures :
  1. Weight Loss [ Time Frame: 16 weeks ]
    Change in absolute percent weight

  2. Healthy Days HRQOL-4 Measure [ Time Frame: 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.

  3. Healthy Days Symptoms Measure [ Time Frame: 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.

  4. Number of Patients Who Responded to Text Messages [ Time Frame: 16 weeks ]
    Text message response to prompts for weight data.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386773


Locations
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United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Susan L Moore, PhD, MSPH Colorado School of Public Health
  Study Documents (Full-Text)

Documents provided by Susan Moore, Colorado School of Public Health:
Informed Consent Form  [PDF] November 12, 2018

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Responsible Party: Susan Moore, Associate Director, mHealth Impact Lab, Colorado School of Public Health
ClinicalTrials.gov Identifier: NCT03386773    
Other Study ID Numbers: 17-1082
First Posted: December 29, 2017    Key Record Dates
Results First Posted: September 26, 2022
Last Update Posted: September 26, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: An enhanced entity-relationship (EER) model will be created for the PGHD elements and PROMs used in the study. Knowledge representation techniques will be utilized to describe the model in ontological terms. Concepts from the UMLS Metathesaurus will be used to create a mapping to the SNOMED-CT clinical vocabulary. Modeled information will be structured using Fast Healthcare Interoperability Resource (FHIR) standards and packaged as a set of FHIR resources. Each FHIR resource includes: 1) common definitions and representations; 2) a common metadata set; and 3) a human-readable part to aid user interpretation. Products will include a detailed EER schema, an interface and requirements assessment, an ontology, and a list of UMLS concepts and SNOMED-CT terms used in ontology mapping.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan Moore, Colorado School of Public Health:
patient generated health data
patient reported outcome measures
health information technology
mobile health
consumer health informatics