Reducing Assessment Barriers for Patients With Low Literacy

NCT03584490 | Completed Results DMC

• 2 other identifiers: STU002029071R01MD010440-01A1
• Study Type: interventional
• Target: 729
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of health literacy on questionnaire-based measurement.

Conditions

Health Literacy

Outcome Measures

Primary Outcomes (3)

• The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Anxiety Subscale

  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.

  6 months

• Patient Health Questionnaire (PHQ-9)

  A 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.

  6 months

• The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Depression Subscale

  A 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.

  6 months

Study Arms (2)

Pen-and-paper format

ACTIVE COMPARATOR

Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health.

Other: Phone Administration of Questionnaires

Computerized Talking Touchscreen

EXPERIMENTAL

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.

Other: Computerized Talking Touchscreen; Other: Phone Administration of Questionnaires

Interventions

Computerized Talking Touchscreen OTHER

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.

Computerized Talking Touchscreen

Phone Administration of Questionnaires OTHER

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; Pen-and-paper format

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years of age or older
• Be willing to provide informed consent, including signing the consent form
• Be willing to be randomized to administration method
• Be willing to complete questionnaires and interviews
• Be fluent in English and/or Spanish
• Be willing to attend three face-to-face sessions
• Have no plans to move out of the study area in the next six months

You may not qualify if:

• Significant cognitive or neurologic impairment
• Being a prisoner, detainee, or in police custody
• Unable to complete the consent process
• Inadequate vision to see study materials (worse than 20/80 corrected)
• Inadequate hearing or manual dexterity to use the computer system
• Phone-based protocol:
• Access to reliable phone connection
• Be willing to participant in three phone-based sessions
• Unable to complete the consent process
• Inadequate hearing for phone-based assessments

Sponsors & Collaborators

• Northwestern University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (27)

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  PMID: 10022112 BACKGROUND

• Paasche-Orlow MK, Wolf MS. The causal pathways linking health literacy to health outcomes. Am J Health Behav. 2007 Sep-Oct;31 Suppl 1:S19-26. doi: 10.5555/ajhb.2007.31.supp.S19.

  PMID: 17931132 BACKGROUND

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  PMID: 12132978 BACKGROUND

• Baker DW, Parker RM, Williams MV, Clark WS. Health literacy and the risk of hospital admission. J Gen Intern Med. 1998 Dec;13(12):791-8. doi: 10.1046/j.1525-1497.1998.00242.x.

  PMID: 9844076 BACKGROUND

• Davis TC, Arnold C, Berkel HJ, Nandy I, Jackson RH, Glass J. Knowledge and attitude on screening mammography among low-literate, low-income women. Cancer. 1996 Nov 1;78(9):1912-20. doi: 10.1002/(sici)1097-0142(19961101)78:93.0.co;2-0.

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• Bennett CL, Ferreira MR, Davis TC, Kaplan J, Weinberger M, Kuzel T, Seday MA, Sartor O. Relation between literacy, race, and stage of presentation among low-income patients with prostate cancer. J Clin Oncol. 1998 Sep;16(9):3101-4. doi: 10.1200/JCO.1998.16.9.3101.

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• Wolf MS, Davis TC, Osborn CY, Skripkauskas S, Bennett CL, Makoul G. Literacy, self-efficacy, and HIV medication adherence. Patient Educ Couns. 2007 Feb;65(2):253-60. doi: 10.1016/j.pec.2006.08.006. Epub 2006 Nov 21.

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  PMID: 16844451 BACKGROUND

• Williams MV, Baker DW, Parker RM, Nurss JR. Relationship of functional health literacy to patients' knowledge of their chronic disease. A study of patients with hypertension and diabetes. Arch Intern Med. 1998 Jan 26;158(2):166-72. doi: 10.1001/archinte.158.2.166.

  PMID: 9448555 BACKGROUND

• Wolf MS, Davis TC, Arozullah A, Penn R, Arnold C, Sugar M, Bennett CL. Relation between literacy and HIV treatment knowledge among patients on HAART regimens. AIDS Care. 2005 Oct;17(7):863-73. doi: 10.1080/09540120500038660.

  PMID: 16120503 BACKGROUND

• Kalichman SC, Ramachandran B, Catz S. Adherence to combination antiretroviral therapies in HIV patients of low health literacy. J Gen Intern Med. 1999 May;14(5):267-73. doi: 10.1046/j.1525-1497.1999.00334.x.

  PMID: 10337035 BACKGROUND

• Mancuso CA, Rincon M. Impact of health literacy on longitudinal asthma outcomes. J Gen Intern Med. 2006 Aug;21(8):813-7. doi: 10.1111/j.1525-1497.2006.00528.x.

  PMID: 16881939 BACKGROUND

• Coyne KS, Kaplan SA, Chapple CR, Sexton CC, Kopp ZS, Bush EN, Aiyer LP; EpiLUTS Team. Risk factors and comorbid conditions associated with lower urinary tract symptoms: EpiLUTS. BJU Int. 2009 Apr;103 Suppl 3:24-32. doi: 10.1111/j.1464-410X.2009.08438.x.

  PMID: 19302499 BACKGROUND

• Subak LL, Wing R, West DS, Franklin F, Vittinghoff E, Creasman JM, Richter HE, Myers D, Burgio KL, Gorin AA, Macer J, Kusek JW, Grady D; PRIDE Investigators. Weight loss to treat urinary incontinence in overweight and obese women. N Engl J Med. 2009 Jan 29;360(5):481-90. doi: 10.1056/NEJMoa0806375.

  PMID: 19179316 BACKGROUND

• Yost KJ, Webster K, Baker DW, Choi SW, Bode RK, Hahn EA. Bilingual health literacy assessment using the Talking Touchscreen/la Pantalla Parlanchina: Development and pilot testing. Patient Educ Couns. 2009 Jun;75(3):295-301. doi: 10.1016/j.pec.2009.02.020. Epub 2009 Apr 21.

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• Meade CD, Menard J, Martinez D, Calvo A. Impacting health disparities through community outreach: utilizing the CLEAN look (culture, literacy, education, assessment, and networking). Cancer Control. 2007 Jan;14(1):70-7. doi: 10.1177/107327480701400110.

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• McKee MM, Paasche-Orlow MK. Health literacy and the disenfranchised: the importance of collaboration between limited English proficiency and health literacy researchers. J Health Commun. 2012;17 Suppl 3(Suppl 3):7-12. doi: 10.1080/10810730.2012.712627.

  PMID: 23030557 BACKGROUND

• Braveman P. Health disparities and health equity: concepts and measurement. Annu Rev Public Health. 2006;27:167-94. doi: 10.1146/annurev.publhealth.27.021405.102103.

  PMID: 16533114 BACKGROUND

• Osborn CY, Paasche-Orlow MK, Davis TC, Wolf MS. Health literacy: an overlooked factor in understanding HIV health disparities. Am J Prev Med. 2007 Nov;33(5):374-8. doi: 10.1016/j.amepre.2007.07.022.

  PMID: 17950402 BACKGROUND

• Institute of Medicine (US) Committee on Health Literacy; Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: A Prescription to End Confusion. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216032/

  PMID: 25009856 RESULT

• Wolf MS, Gazmararian JA, Baker DW. Health literacy and functional health status among older adults. Arch Intern Med. 2005 Sep 26;165(17):1946-52. doi: 10.1001/archinte.165.17.1946.

  PMID: 16186463 RESULT

• Sudore RL, Yaffe K, Satterfield S, Harris TB, Mehta KM, Simonsick EM, Newman AB, Rosano C, Rooks R, Rubin SM, Ayonayon HN, Schillinger D. Limited literacy and mortality in the elderly: the health, aging, and body composition study. J Gen Intern Med. 2006 Aug;21(8):806-12. doi: 10.1111/j.1525-1497.2006.00539.x.

  PMID: 16881938 RESULT

• Kalichman SC, Rompa D. Functional health literacy is associated with health status and health-related knowledge in people living with HIV-AIDS. J Acquir Immune Defic Syndr. 2000 Dec 1;25(4):337-44. doi: 10.1097/00042560-200012010-00007.

  PMID: 11114834 RESULT

• Scott TL, Gazmararian JA, Williams MV, Baker DW. Health literacy and preventive health care use among Medicare enrollees in a managed care organization. Med Care. 2002 May;40(5):395-404. doi: 10.1097/00005650-200205000-00005.

  PMID: 11961474 RESULT

• Dolan NC, Ferreira MR, Davis TC, Fitzgibbon ML, Rademaker A, Liu D, Schmitt BP, Gorby N, Wolf M, Bennett CL. Colorectal cancer screening knowledge, attitudes, and beliefs among veterans: does literacy make a difference? J Clin Oncol. 2004 Jul 1;22(13):2617-22. doi: 10.1200/JCO.2004.10.149.

  PMID: 15226329 RESULT

• Hurstak EE, Paasche-Orlow MK, Hahn EA, Henault LE, Taddeo MA, Moreno PI, Weaver C, Marquez M, Serrano E, Thomas J, Griffith JW. The mediating effect of health literacy on COVID-19 vaccine confidence among a diverse sample of urban adults in Boston and Chicago. Vaccine. 2023 Apr 6;41(15):2562-2571. doi: 10.1016/j.vaccine.2023.02.059. Epub 2023 Mar 2.

  PMID: 36907736 DERIVED

Results Point of Contact

• Title: James W. Griffith, PhD
• Organization: Northwestern University

j-griffith@northwestern.edu

3125035345

Study Officials

• James Griffith, PhD

  Northwestern University

  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: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor of Medical Social Sciences

Model Details: The study is a two-group, three time-point experimental design. The two study groups are paper-and-pencil questionnaires versus a computerized talking touchscreen interface. The three time points are baseline, 3-month follow-up, and 6-month follow-up. Additionally, due to the COVID-19 pandemic, participants can optionally enroll in a phone-based assessment that includes 3 time-points over 6 months.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: July 12, 2018
• Study Start: September 14, 2018
• Primary Completion: September 9, 2021
• Study Completion: July 31, 2023
• Last Updated: October 15, 2024
• Results First Posted: December 5, 2023

Record last verified: 2024-10

Locations

US (1)