Trial Outcomes & Findings for Reducing Assessment Barriers for Patients With Low Literacy (NCT NCT03584490)
NCT ID: NCT03584490
Last Updated: 2024-10-15
Results Overview
A primary outcome of this study will be the degree of DIF in NIH PROMIS questionnaire Anxiety subscale observed across adequate versus low health literacy. The outcome will be measured by a McFadden pseudo-R-square (R2), which captures the degree to which health-literacy group determines probability of response type for each item. The pseudo R2 is an analogue to R2 used in linear regression. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). PROMIS is scaled by T-scores, referenced against the US population mean. Items are aggregated using item response theory, but aggregation is not relevant here because the McFadden pseudo-R2 is evaluated for each item. We report the maximum DIF value across items by condition. Pseudo-R2 values express how much health literacy and/or health literacy's interaction with anxiety determine the probability of response. Higher values correspond to higher DIF; lower values correspond to lower DIF.
COMPLETED
NA
729 participants
6 months
2024-10-15
Participant Flow
Participant milestones
| Measure |
Pen-and-paper Format
Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health.
Phone Administration of Questionnaires: This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
|
Computerized Talking Touchscreen
This group will receive the Computerized Talking Touchscreen intervention.
Based on randomization, participants in this group will receive a computerized talking touchscreen version of our health questionnaires, which allows the participant to have questions and answer choices read aloud to them by the computer.
Computerized Talking Touchscreen: The intervention is a computerized talking touchscreen designed to aid people with low health literacy.
All Participants in both arms will complete a battery of health questionnaires. One group will complete questionnaires in traditional pen-and-paper format. The other group will receive the computerized talking touchscreen, which reads questions to participants on demand.
Phone Administration of Questionnaires: This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
|
|---|---|---|
|
Overall Study
STARTED
|
362
|
367
|
|
Overall Study
COMPLETED
|
235
|
230
|
|
Overall Study
NOT COMPLETED
|
127
|
137
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Assessment Barriers for Patients With Low Literacy
Baseline characteristics by cohort
| Measure |
Pen-and-paper Format
n=362 Participants
Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health.
Phone Administration of Questionnaires: This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention.
|
Computerized Talking Touchscreen
n=367 Participants
This group will receive the Computerized Talking Touchscreen intervention.
Based on randomization, participants in this group will receive a computerized talking touchscreen version of our health questionnaires, which allows the participant to have questions and answer choices read aloud to them by the computer.
Computerized Talking Touchscreen: The intervention is a computerized talking touchscreen designed to aid people with low health literacy.
All Participants in both arms will complete a battery of health questionnaires. One group will complete questionnaires in traditional pen-and-paper format. The other group will receive the computerized talking touchscreen, which reads questions to participants on demand.
Phone Administration of Questionnaires: This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention.
|
Total
n=729 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.75 years
n=99 Participants
|
48.93 years
n=107 Participants
|
49.5 years
n=206 Participants
|
|
Sex/Gender, Customized
sex · Male
|
141 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
281 Participants
n=206 Participants
|
|
Sex/Gender, Customized
sex · Female
|
221 Participants
n=99 Participants
|
227 Participants
n=107 Participants
|
448 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
97 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
265 Participants
n=99 Participants
|
256 Participants
n=107 Participants
|
521 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
164 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
322 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
74 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
362 participants
n=99 Participants
|
367 participants
n=107 Participants
|
729 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsA primary outcome of this study will be the degree of DIF in NIH PROMIS questionnaire Anxiety subscale observed across adequate versus low health literacy. The outcome will be measured by a McFadden pseudo-R-square (R2), which captures the degree to which health-literacy group determines probability of response type for each item. The pseudo R2 is an analogue to R2 used in linear regression. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). PROMIS is scaled by T-scores, referenced against the US population mean. Items are aggregated using item response theory, but aggregation is not relevant here because the McFadden pseudo-R2 is evaluated for each item. We report the maximum DIF value across items by condition. Pseudo-R2 values express how much health literacy and/or health literacy's interaction with anxiety determine the probability of response. Higher values correspond to higher DIF; lower values correspond to lower DIF.
Outcome measures
| Measure |
Pen-and-paper Format
n=362 Participants
Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health.
Phone Administration of Questionnaires: This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
|
Computerized Talking Touchscreen
n=367 Participants
This group will receive the Computerized Talking Touchscreen intervention.
Based on randomization, participants in this group will receive a computerized talking touchscreen version of our health questionnaires, which allows the participant to have questions and answer choices read aloud to them by the computer.
Computerized Talking Touchscreen: The intervention is a computerized talking touchscreen designed to aid people with low health literacy.
All Participants in both arms will complete a battery of health questionnaires. One group will complete questionnaires in traditional pen-and-paper format. The other group will receive the computerized talking touchscreen, which reads questions to participants on demand.
Phone Administration of Questionnaires: This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
|
|---|---|---|
|
The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Anxiety Subscale
|
0.06 Pseudo-R2
|
0.02 Pseudo-R2
|
PRIMARY outcome
Timeframe: 6 monthsA primary outcome of this study will be the degree of DIF observed in the Patient Health Questionnaire (PHQ-9), a questionnaire used to measure depression across adequate versus low health literacy. The outcome will be measured by a McFadden pseudo-R-square (R2), which captures the degree to which health-literacy group determines probability of response type for each item. Pseudo-R2 is an analogue to R2 used in linear regression. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Normally items are aggregated by a sum score, but the aggregation is not relevant to this study because the McFadden pseudo-R2 is evaluated for each item, not for aggregate scores. We report the maximum DIF value across items by condition. Pseudo-R2 values express how much health literacy and/or health literacy's interaction with depression determine the probability of response. Higher values correspond to higher DIF; lower values correspond to lower DIF.
Outcome measures
| Measure |
Pen-and-paper Format
n=362 Participants
Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health.
Phone Administration of Questionnaires: This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
|
Computerized Talking Touchscreen
n=367 Participants
This group will receive the Computerized Talking Touchscreen intervention.
Based on randomization, participants in this group will receive a computerized talking touchscreen version of our health questionnaires, which allows the participant to have questions and answer choices read aloud to them by the computer.
Computerized Talking Touchscreen: The intervention is a computerized talking touchscreen designed to aid people with low health literacy.
All Participants in both arms will complete a battery of health questionnaires. One group will complete questionnaires in traditional pen-and-paper format. The other group will receive the computerized talking touchscreen, which reads questions to participants on demand.
Phone Administration of Questionnaires: This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
|
0.00 Pseudo-R2
|
0.02 Pseudo-R2
|
PRIMARY outcome
Timeframe: 6 monthsA primary outcome will be the degree of DIF in NIH PROMIS questionnaire Depression subscale observed across adequate versus low health literacy. The outcome will be measured by a McFadden pseudo-R-square (R2), which captures the degree to which health-literacy group determines probability of response type for each item. The pseudo R2 is an analogue to R2 used in linear regression. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). PROMIS is scaled by T-scores, referenced against the US population mean. Items are aggregated using item response theory, but aggregation is not relevant here because the McFadden pseudo-R2 is evaluated for each item. We report the maximum DIF value across items by condition. Pseudo-R2 values express how much health literacy and/or health literacy's interaction with depression determine the probability of response. Higher values correspond to higher DIF; lower values correspond to lower DIF.
Outcome measures
| Measure |
Pen-and-paper Format
n=362 Participants
Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health.
Phone Administration of Questionnaires: This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
|
Computerized Talking Touchscreen
n=367 Participants
This group will receive the Computerized Talking Touchscreen intervention.
Based on randomization, participants in this group will receive a computerized talking touchscreen version of our health questionnaires, which allows the participant to have questions and answer choices read aloud to them by the computer.
Computerized Talking Touchscreen: The intervention is a computerized talking touchscreen designed to aid people with low health literacy.
All Participants in both arms will complete a battery of health questionnaires. One group will complete questionnaires in traditional pen-and-paper format. The other group will receive the computerized talking touchscreen, which reads questions to participants on demand.
Phone Administration of Questionnaires: This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
|
|---|---|---|
|
The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Depression Subscale
|
0.04 Pseudo-R2
|
0.04 Pseudo-R2
|
Adverse Events
Pen-and-paper Format
Computerized Talking Touchscreen
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place