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出境医 / 临床实验 / Health Literacy Intervention for African Americans With Diabetes

Health Literacy Intervention for African Americans With Diabetes

Study Description
Brief Summary:
Disparities in diagnosis and control of type 2 diabetes mellitus are most evident in African Americans (AAs) with lower socioeconomic status. Health literacy is an important predictor of adequate self-management and control of diabetes. The purpose of this pilot study was to test the feasibility and preliminary efficacy of a health literacy-enhanced diabetes intervention -Prevention through Lifestyle intervention And Numeracy (PLAN) 4 Success-Diabetes, in inner-city, low-income AAs with uncontrolled diabetes. To evaluate the feasibility, acceptability, and preliminary efficacy of the intervention, the investigators conducted a pilot study with 24-week follow-up. The investigators that participation in the PLAN 4 Success-diabetes intervention would be associated with a reduction in glucose outcomes and improvements in psychosocial variables.

Condition or disease Intervention/treatment Phase
Uncontrolled Diabetes Behavioral: PLAN 4 Success-Diabetes Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The investigators used a single-arm pre- and post-test design for this pilot study in which the investigators assessed the feasibility, acceptability, and preliminary efficacy of the PLAN 4 Success-Diabetes in inner-city AAs in Baltimore, Maryland. Community-dwelling AAs were recruited via referrals from inner-city federally-qualified health clinics. Nineteen of 30 participants who completed the baseline survey received the study intervention which consisted of four-week health literacy training and disease knowledge education followed by two home visits and monthly phone counseling for over 6 months.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Health Literacy Enhanced Intervention for Inner-city African Americans With Uncontrolled Diabetes: A Pilot Study
Actual Study Start Date : May 6, 2015
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention
This is a one arm study with all participants enrolled into this arm.
 Behavioral: PLAN 4 Success-Diabetes
The study intervention-PLAN 4 Success-Diabetes-consisted of four 1 to 1 ½-hour weekly health literacy training and disease knowledge education sessions for four weeks (4 in-person sessions), followed by two home visits and monthly phone counseling for over 6 months (5 phone sessions). The intervention is theory-driven and builds on von Wagner's model to incorporate key elements such as health literacy, disease knowledge, and self-efficacy for better glucose outcomes.
Outcome Measures
Primary Outcome Measures :
  1. Change in Health literacy as assessed by Literacy Assessment in Diabetes (LAD). [ Time Frame: baseline; 12 and 24 weeks ]
    The Literacy Assessment in Diabetes (LAD) has high reliability and validity indices. The items on the LAD are scored as correct/incorrect, with total possible scores ranging from 0 to 60. Higher scores indicated higher health literacy levels.

  2. Change in Health literacy as assessed by the Newest Vital Sign [ Time Frame: baseline; 12 and 24 weeks ]
    The Newest Vital Sign consists of four items and measures numeracy. After reviewing a nutrition label, participants are asked to answer questions based on some calculation of the nutritional information (e.g., fat, sodium) presented on the label. Total possible scores range from 0 to 4, with one point assigned for each correct response.


Secondary Outcome Measures :
  1. Change in Diabetes knowledge measured with the validated Diabetes Knowledge Test [ Time Frame: baseline; 12 and 24 weeks ]
    The Diabetes Knowledge Test assesses diabetes knowledge, medications, diet, and management with questions such as "What effect will an infection most likely have on blood glucose." Correct responses are given a score of one.

  2. Change in Diabetes self-efficacy measured with Stanford Diabetes Self-Efficacy scale [ Time Frame: baseline; 12 and 24 weeks ]
    The Stanford Diabetes Self-Efficacy scale assesses participant's efficacy in managing diabetes and maintaining healthy lifestyles. The scale asks how confident participants are in managing different tasks such as eating meals every 4 to 5 hours every day or breakfast every day measured on a Likert scale of 0 "not at all confident" to 10 "totally confident." Participant scores are the means across all items in the instrument.


Other Outcome Measures:
  1. Change in Diabetes self-care index [ Time Frame: baseline; 12 and 24 weeks ]
    This index included seven questions on smoking, alcohol consumption, meal planning, consumption of high fat foods, consumption of high sugar foods, consumption of sodium, and medium or high intensity exercise. These questions were coded into dichotomous responses with participation in healthy behaviors coded as "1" and active participation in negative health behaviors coded as "0". A summary score for the index could range 0-7 and higher scores indicate better self-care.

  2. Change in Social support as assessed by modified Medical Outcomes Study-Social Support Survey (mMOS-SS) [ Time Frame: baseline; 12 and 24 weeks ]
    mMOS-SS is a shorter version (10 items) of the Medical Outcomes Study-Social Support Survey (MOS-SS) which includes 19 items. The original version was used to measure social support in community dwelling chronically ill persons. mMOS-SS covers emotional and instrumental domains of social support with strong evidence of reliability and validity. Example items include: "How often is someone available to take you to the doctor if you need it" or "How often is someone available who understands your problems?" Response options are from all of the time (5 point) to none of the time (1 point) with higher scores indicating higher levels of social support (total score range=10 to 50).

  3. Change in Depression status as assessed by the Patient Health Questionnaire (PHQ)-9 [ Time Frame: baseline; 12 and 24 weeks ]
    The Patient Health Questionnaire (PHQ)-9 addresses the severity of depressive symptoms based on the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). The PHQ-9 has 9 items scored from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 27. Individuals are asked whether any symptom(s) have been experienced over the past 2 weeks. Evidence of reliability, validity, sensitivity, and specificity has been reported in community samples.

  4. Change in Quality of Life as assessed by the EuroQol Quality of Life scale [ Time Frame: baseline; 12 and 24 weeks ]
    It contains the EQ-5D-3L that provides a single index of health status. The EQ-5D-3L assess five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depressions. Responses show if participants do not have difficulty, have some problems or have severe difficulty within the domains. Summary scores for the sample were created across each of the five items (range 0-2) with higher scores indicating better quality of life. A component of this scale is the EuroQol visual analogue scale (EQ-VAS) which participants can use a number from 0-100 to identify participant's health state.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African Americans residing in Baltimore, Maryland
  • had uncontrolled diabetes (defined as HbA1C>7%)

Exclusion Criteria:

  • Unable to give informed consent
  • Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
  • Hematological condition that would affect HbA1C assay, e.g., hemolytic anemia, sickle cell anemia
Contacts and Locations

Locations
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United States, Maryland
Wald Community Nursing Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Brancati Center for the Advancement of Community Care
Center for Community Innovation and Scholarship at the Johns Hopkins University
East Baltimore Medical Center
Shepherds Clinic
John Hopkins Aftercare Clinic
Investigators
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Principal Investigator: Hae-Ra Han, PhD, RN Johns Hopkins University
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE May 6, 2015
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Change in Health literacy as assessed by Literacy Assessment in Diabetes (LAD). [ Time Frame: baseline; 12 and 24 weeks ]
    The Literacy Assessment in Diabetes (LAD) has high reliability and validity indices. The items on the LAD are scored as correct/incorrect, with total possible scores ranging from 0 to 60. Higher scores indicated higher health literacy levels.
  • Change in Health literacy as assessed by the Newest Vital Sign [ Time Frame: baseline; 12 and 24 weeks ]
    The Newest Vital Sign consists of four items and measures numeracy. After reviewing a nutrition label, participants are asked to answer questions based on some calculation of the nutritional information (e.g., fat, sodium) presented on the label. Total possible scores range from 0 to 4, with one point assigned for each correct response.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Change in Diabetes knowledge measured with the validated Diabetes Knowledge Test [ Time Frame: baseline; 12 and 24 weeks ]
    The Diabetes Knowledge Test assesses diabetes knowledge, medications, diet, and management with questions such as "What effect will an infection most likely have on blood glucose." Correct responses are given a score of one.
  • Change in Diabetes self-efficacy measured with Stanford Diabetes Self-Efficacy scale [ Time Frame: baseline; 12 and 24 weeks ]
    The Stanford Diabetes Self-Efficacy scale assesses participant's efficacy in managing diabetes and maintaining healthy lifestyles. The scale asks how confident participants are in managing different tasks such as eating meals every 4 to 5 hours every day or breakfast every day measured on a Likert scale of 0 "not at all confident" to 10 "totally confident." Participant scores are the means across all items in the instrument.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 22, 2019)
  • Change in Diabetes self-care index [ Time Frame: baseline; 12 and 24 weeks ]
    This index included seven questions on smoking, alcohol consumption, meal planning, consumption of high fat foods, consumption of high sugar foods, consumption of sodium, and medium or high intensity exercise. These questions were coded into dichotomous responses with participation in healthy behaviors coded as "1" and active participation in negative health behaviors coded as "0". A summary score for the index could range 0-7 and higher scores indicate better self-care.
  • Change in Social support as assessed by modified Medical Outcomes Study-Social Support Survey (mMOS-SS) [ Time Frame: baseline; 12 and 24 weeks ]
    mMOS-SS is a shorter version (10 items) of the Medical Outcomes Study-Social Support Survey (MOS-SS) which includes 19 items. The original version was used to measure social support in community dwelling chronically ill persons. mMOS-SS covers emotional and instrumental domains of social support with strong evidence of reliability and validity. Example items include: "How often is someone available to take you to the doctor if you need it" or "How often is someone available who understands your problems?" Response options are from all of the time (5 point) to none of the time (1 point) with higher scores indicating higher levels of social support (total score range=10 to 50).
  • Change in Depression status as assessed by the Patient Health Questionnaire (PHQ)-9 [ Time Frame: baseline; 12 and 24 weeks ]
    The Patient Health Questionnaire (PHQ)-9 addresses the severity of depressive symptoms based on the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). The PHQ-9 has 9 items scored from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 27. Individuals are asked whether any symptom(s) have been experienced over the past 2 weeks. Evidence of reliability, validity, sensitivity, and specificity has been reported in community samples.
  • Change in Quality of Life as assessed by the EuroQol Quality of Life scale [ Time Frame: baseline; 12 and 24 weeks ]
    It contains the EQ-5D-3L that provides a single index of health status. The EQ-5D-3L assess five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depressions. Responses show if participants do not have difficulty, have some problems or have severe difficulty within the domains. Summary scores for the sample were created across each of the five items (range 0-2) with higher scores indicating better quality of life. A component of this scale is the EuroQol visual analogue scale (EQ-VAS) which participants can use a number from 0-100 to identify participant's health state.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Health Literacy Intervention for African Americans With Diabetes
Official Title  ICMJE Health Literacy Enhanced Intervention for Inner-city African Americans With Uncontrolled Diabetes: A Pilot Study
Brief Summary Disparities in diagnosis and control of type 2 diabetes mellitus are most evident in African Americans (AAs) with lower socioeconomic status. Health literacy is an important predictor of adequate self-management and control of diabetes. The purpose of this pilot study was to test the feasibility and preliminary efficacy of a health literacy-enhanced diabetes intervention -Prevention through Lifestyle intervention And Numeracy (PLAN) 4 Success-Diabetes, in inner-city, low-income AAs with uncontrolled diabetes. To evaluate the feasibility, acceptability, and preliminary efficacy of the intervention, the investigators conducted a pilot study with 24-week follow-up. The investigators that participation in the PLAN 4 Success-diabetes intervention would be associated with a reduction in glucose outcomes and improvements in psychosocial variables.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
The investigators used a single-arm pre- and post-test design for this pilot study in which the investigators assessed the feasibility, acceptability, and preliminary efficacy of the PLAN 4 Success-Diabetes in inner-city AAs in Baltimore, Maryland. Community-dwelling AAs were recruited via referrals from inner-city federally-qualified health clinics. Nineteen of 30 participants who completed the baseline survey received the study intervention which consisted of four-week health literacy training and disease knowledge education followed by two home visits and monthly phone counseling for over 6 months.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Uncontrolled Diabetes
Intervention  ICMJE Behavioral: PLAN 4 Success-Diabetes
The study intervention-PLAN 4 Success-Diabetes-consisted of four 1 to 1 ½-hour weekly health literacy training and disease knowledge education sessions for four weeks (4 in-person sessions), followed by two home visits and monthly phone counseling for over 6 months (5 phone sessions). The intervention is theory-driven and builds on von Wagner's model to incorporate key elements such as health literacy, disease knowledge, and self-efficacy for better glucose outcomes.
Study Arms  ICMJE Experimental: Intervention
This is a one arm study with all participants enrolled into this arm.
Intervention: Behavioral: PLAN 4 Success-Diabetes
Publications *
  • von Wagner C, Steptoe A, Wolf MS, Wardle J. Health literacy and health actions: a review and a framework from health psychology. Health Educ Behav. 2009 Oct;36(5):860-77. doi: 10.1177/1090198108322819. Epub 2008 Aug 26. Review.
  • Han HR, Nkimbeng M, Ajomagberin O, Grunstra K, Sharps P, Renda S, Maruthur N. Health literacy enhanced intervention for inner-city African Americans with uncontrolled diabetes: a pilot study. Pilot Feasibility Stud. 2019 Aug 8;5:99. doi: 10.1186/s40814-019-0484-8. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2019) 		19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 1, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • African Americans residing in Baltimore, Maryland
  • had uncontrolled diabetes (defined as HbA1C>7%)

Exclusion Criteria:

  • Unable to give informed consent
  • Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
  • Hematological condition that would affect HbA1C assay, e.g., hemolytic anemia, sickle cell anemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925948
Other Study ID Numbers  ICMJE IRB00061339
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • Brancati Center for the Advancement of Community Care
  • Center for Community Innovation and Scholarship at the Johns Hopkins University
  • East Baltimore Medical Center
  • Shepherds Clinic
  • John Hopkins Aftercare Clinic
Investigators  ICMJE
Principal Investigator: Hae-Ra Han, PhD, RN Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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