Uncontrolled DiabetesNCT03925948
Health Literacy Intervention for African Americans With Diabetes
A study testing PLAN 4 Success-Diabetes in people with Uncontrolled Diabetes, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uncontrolled Diabetes
- What is being tested?
- PLAN 4 Success-Diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2015to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African Americans residing in Baltimore, Maryland
- had uncontrolled diabetes (defined as HbA1C>7%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wald Community Nursing Center
Baltimore, Maryland, 21205
About this study
Official title: Health Literacy Enhanced Intervention for Inner-city African Americans With Uncontrolled Diabetes: A Pilot Study
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.
- Conditions
- Uncontrolled Diabetes
- Being tested
- PLAN 4 Success-Diabetes
- Keywords
- Type 2 diabetes, African American, numeracy, self-management, glucose control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAN 4 Success-DiabetesBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is a one arm study with all participants enrolled into this arm. Receives: Behavioral: PLAN 4 Success-Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health literacy as assessed by Literacy Assessment in Diabetes (LAD).
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.
Measured: baseline; 12 and 24 weeks
Change in Health literacy as assessed by the Newest Vital Sign
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.
Measured: baseline; 12 and 24 weeks
Secondary outcomes (2)
Change in Diabetes knowledge measured with the validated Diabetes Knowledge Test
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.
Measured: baseline; 12 and 24 weeks
Change in Diabetes self-efficacy measured with Stanford Diabetes Self-Efficacy scale
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.
Measured: baseline; 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start6 May 2015
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Hae-Ra Han, PhD, RN, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925948
- Sponsor's protocol ID
- IRB00061339
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 18728119Han 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.
PubMed 31410294
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy Enhanced Intervention for Inner-city African Americans With Uncontrolled Diabetes: A Pilot Study
- ClinicalTrials.gov ID
- NCT03925948
- Acronym / sponsor ID
- IRB00061339
- Conditions
- Uncontrolled Diabetes
- Keywords
- Type 2 diabetes, African American, numeracy, self-management, glucose control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- 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
- Study start
- 6 May 2015 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: PLAN 4 Success-DiabetesThis is a one arm study with all participants enrolled into this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- African Americans residing in Baltimore, Maryland
- had uncontrolled diabetes (defined as HbA1C>7%)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLAN 4 Success-DiabetesThe 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. | Behavioural | Intervention |
Primary outcome
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.
2 secondary outcomes
Change in Diabetes knowledge measured with the validated Diabetes Knowledge Test
Time frame: baseline; 12 and 24 weeks
Change in Diabetes self-efficacy measured with Stanford Diabetes Self-Efficacy scale
Time frame: baseline; 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Background: PubMed 18728119von 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.
- Derived from this study: PubMed 31410294Han 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hae-Ra Han, PhD, RN principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLAN 4 Success-Diabetes in people with Uncontrolled Diabetes, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health literacy as assessed by Literacy Assessment in Diabetes (LAD). (time frame: baseline; 12 and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03925948, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.