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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Obesity
Interventions Behavioral: 16-week program
Behavioral: Patient generated health data
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 150 150
Completed 123 115
Not Completed 27 35
Reason Not Completed
Lost to Follow-up             24             33
Withdrawal by Subject             3             2
Arm/Group Title Intervention Control Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 150 150 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 150 participants 300 participants
45.76  (13.96) 44.30  (14.14) 45.12  (13.85)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
Female
114
  76.0%
107
  71.3%
221
  73.7%
Male
35
  23.3%
42
  28.0%
77
  25.7%
Non-binary
1
   0.7%
0
   0.0%
1
   0.3%
Unknown/Missing
0
   0.0%
1
   0.7%
1
   0.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
Hispanic or Latino
68
  45.3%
88
  58.7%
156
  52.0%
Not Hispanic or Latino
51
  34.0%
35
  23.3%
86
  28.7%
Unknown or Not Reported
31
  20.7%
27
  18.0%
58
  19.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
  12.0%
16
  10.7%
34
  11.3%
White
97
  64.7%
110
  73.3%
207
  69.0%
More than one race
9
   6.0%
6
   4.0%
15
   5.0%
Unknown or Not Reported
26
  17.3%
18
  12.0%
44
  14.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 150 participants 150 participants 300 participants
150 150 300
Language  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
English
95
  63.3%
97
  64.7%
192
  64.0%
Spanish
55
  36.7%
53
  35.3%
108
  36.0%
1.Primary Outcome
Title Patient Engagement (Patient Activation Measure)
Hide Description 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.
Time Frame Baseline, Post-Intervention
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number for which complete data were available.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 123 115
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 70.2  (17.9) 67.6  (16.9)
Follow-Up 72.7  (18.9) 70.3  (20.1)
2.Secondary Outcome
Title Weight Loss
Hide Description Change in absolute percent weight
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number for which complete weight data were available.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 125 108
Mean (Standard Deviation)
Unit of Measure: percent change in weight
0.65  (5) -0.29  (8)
3.Secondary Outcome
Title Healthy Days HRQOL-4 Measure
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number for which complete data were available.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 121 113
Mean (Standard Deviation)
Unit of Measure: score on a scale
18.83  (11.66) 17.93  (11.71)
4.Secondary Outcome
Title Healthy Days Symptoms Measure
Hide Description 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number for which complete data were available.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 123 116
Mean (Standard Deviation)
Unit of Measure: score on a scale
Pain 3.38  (6.52) 5.51  (9.20)
Sad 3.11  (5.16) 4.15  (7.02)
Anxious 4.51  (6.77) 5.65  (7.82)
Sleep 9.23  (10.15) 9.98  (10.45)
Energy 18.28  (10.12) 15.35  (10.55)
5.Secondary Outcome
Title Number of Patients Who Responded to Text Messages
Hide Description Text message response to prompts for weight data.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intervention and control patients who received prompts to respond with weight data by text message to the study team.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 150 150
Measure Type: Count of Participants
Unit of Measure: Participants
Responded less than prompted
104
  69.3%
93
  62.0%
Responded as many times as prompted
7
   4.7%
3
   2.0%
Responded more than prompted
4
   2.7%
8
   5.3%
Did not respond
35
  23.3%
46
  30.7%
Time Frame 16 weeks (duration of each participant's participation)
Adverse Event Reporting Description Standard definitions are used.
 
Arm/Group Title Intervention Control
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/150 (0.00%) 
Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/150 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/150 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan L. Moore, PhD, MSPH
Organization: Colorado School of Public Health
Phone: 303-724-8858
EMail: susan.l.moore@cuanschutz.edu
Layout table for additonal information
Responsible Party: Susan Moore, Colorado School of Public Health
ClinicalTrials.gov Identifier: NCT03386773    
Other Study ID Numbers: 17-1082
First Submitted: December 14, 2017
First Posted: December 29, 2017
Results First Submitted: January 16, 2021
Results First Posted: September 26, 2022
Last Update Posted: September 26, 2022