Trial Outcomes & Findings for Reporting Patient Generated Health Data and Patient Reported Outcomes With Health Information Technology (NCT NCT03386773)
NCT ID: NCT03386773
Last Updated: 2022-09-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
Baseline, Post-Intervention
Results posted on
2022-09-26
Participant Flow
Participant milestones
| Measure |
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.
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
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 Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
123
|
115
|
|
Overall Study
NOT COMPLETED
|
27
|
35
|
Reasons for withdrawal
| Measure |
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.
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
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 Study
Lost to Follow-up
|
24
|
33
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Reporting Patient Generated Health Data and Patient Reported Outcomes With Health Information Technology
Baseline characteristics by cohort
| Measure |
Intervention
n=150 Participants
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
n=150 Participants
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
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.76 years
STANDARD_DEVIATION 13.96 • n=5 Participants
|
44.30 years
STANDARD_DEVIATION 14.14 • n=7 Participants
|
45.12 years
STANDARD_DEVIATION 13.85 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
114 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
35 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown/Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
68 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=5 Participants
|
150 participants
n=7 Participants
|
300 participants
n=5 Participants
|
|
Language
English
|
95 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Language
Spanish
|
55 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-InterventionPopulation: The number of participants analyzed reflects the number for which complete data were available.
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.
Outcome measures
| Measure |
Intervention
n=123 Participants
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
n=115 Participants
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.
|
|---|---|---|
|
Patient Engagement (Patient Activation Measure)
Baseline
|
70.2 score on a scale
Standard Deviation 17.9
|
67.6 score on a scale
Standard Deviation 16.9
|
|
Patient Engagement (Patient Activation Measure)
Follow-Up
|
72.7 score on a scale
Standard Deviation 18.9
|
70.3 score on a scale
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The number of participants analyzed reflects the number for which complete weight data were available.
Change in absolute percent weight
Outcome measures
| Measure |
Intervention
n=125 Participants
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
n=108 Participants
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.
|
|---|---|---|
|
Weight Loss
|
0.65 percent change in weight
Standard Deviation 5
|
-0.29 percent change in weight
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The number of participants analyzed reflects the number for which complete data were available.
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.
Outcome measures
| Measure |
Intervention
n=121 Participants
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
n=113 Participants
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.
|
|---|---|---|
|
Healthy Days HRQOL-4 Measure
|
18.83 score on a scale
Standard Deviation 11.66
|
17.93 score on a scale
Standard Deviation 11.71
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The number of participants analyzed reflects the number for which complete data were available.
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.
Outcome measures
| Measure |
Intervention
n=123 Participants
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
n=116 Participants
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.
|
|---|---|---|
|
Healthy Days Symptoms Measure
Pain
|
3.38 score on a scale
Standard Deviation 6.52
|
5.51 score on a scale
Standard Deviation 9.20
|
|
Healthy Days Symptoms Measure
Sad
|
3.11 score on a scale
Standard Deviation 5.16
|
4.15 score on a scale
Standard Deviation 7.02
|
|
Healthy Days Symptoms Measure
Anxious
|
4.51 score on a scale
Standard Deviation 6.77
|
5.65 score on a scale
Standard Deviation 7.82
|
|
Healthy Days Symptoms Measure
Sleep
|
9.23 score on a scale
Standard Deviation 10.15
|
9.98 score on a scale
Standard Deviation 10.45
|
|
Healthy Days Symptoms Measure
Energy
|
18.28 score on a scale
Standard Deviation 10.12
|
15.35 score on a scale
Standard Deviation 10.55
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Intervention and control patients who received prompts to respond with weight data by text message to the study team.
Text message response to prompts for weight data.
Outcome measures
| Measure |
Intervention
n=150 Participants
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
n=150 Participants
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.
|
|---|---|---|
|
Number of Patients Who Responded to Text Messages
Did not respond
|
35 Participants
|
46 Participants
|
|
Number of Patients Who Responded to Text Messages
Responded less than prompted
|
104 Participants
|
93 Participants
|
|
Number of Patients Who Responded to Text Messages
Responded as many times as prompted
|
7 Participants
|
3 Participants
|
|
Number of Patients Who Responded to Text Messages
Responded more than prompted
|
4 Participants
|
8 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Susan L. Moore, PhD, MSPH
Colorado School of Public Health
Phone: 303-724-8858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place