DiabetesNCT02779556
Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
A study testing ACP Living with Diabetes Guide and ADA Living Well with Diabetes Workbook in people with Diabetes, run by University of Arkansas at 6 sites in United States.
Trial summary
The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes. The primary aims are to: 1. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- ACP Living with Diabetes Guide and ADA Living Well with Diabetes Workbook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Nov 2016to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 years of age or older
- English speaking
- active patient at regional family medical center study site
- confirmed diagnosis of type 2 diabetes as documented in the electronic health record
- recent Hemoglobin A1c reading of >7.5% and less than or equal to 10%
Who cannot join
- uncorrectable visual impairments
- hearing impairments
- cognitive impairments
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
UAMS Family Medical Center Northwest
Fayetteville, Arkansas, 72703
UAMS Family Medical Center Fort Smith
Fort Smith, Arkansas, 72901
UAMS Family Medical Center Jonesboro
Jonesboro, Arkansas, 72401
UAMS Family Medical Center Magnolia
Magnolia, Arkansas, 71753
UAMS Family Medical Center Pine Bluff
Pine Bluff, Arkansas, 71603
UAMS Family Medical Center Texarkana
Texarkana, Arkansas, 71854
About this study
The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.
The primary aims are to:
- test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;
- compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level. The secondary aims are to:
- investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
- determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and
- assess the costs associated with implementing the intervention from a health system perspective.
Read the detailed description
The investigators will test the effectiveness and fidelity of embedding the American College of Physicians (ACP) diabetes health literacy intervention among patient-centered medical homes throughout rural Arkansas. Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that have been designed for individuals with lower literacy skills, that can be readily implemented and sustained among rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on the team developed an evidence-based, patient-centered, low literacy ACP intervention promoting diabetes self-care that includes:
- a diabetes guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change;
- a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans');
- a training module for physicians, nurses, and medical assistants that prepares providers to assume educator/counselor roles with the Diabetes Guide as a teaching tool;
- electronic tracking and monitoring tools for primary care practices.
While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, it has not yet been comprehensively tested in practices, and its optimal implementation is not known. The investigators now have a unique opportunity to learn from prior evaluation, modify and disseminate an ACP health literacy intervention among patients with type 2 diabetes cared at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices are embedding care coordination services that can be leveraged to improve chronic disease management. All are supervised by a new University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy. The investigators' revised intervention will blend outsourced and clinic-based approaches and redeploy health coaches for counseling self-management mostly via phone, but also at the point-of-care. This is a feasible way to reach rural, vulnerable patients. The investigators will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.
The primary aims are to:
- test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;
- compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level. The secondary aims are to:
- investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
- determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and
- assess the costs associated with implementing the intervention from a health system perspective.
- Conditions
- Diabetes
- Being tested
- ACP Living with Diabetes Guide, ADA Living Well with Diabetes Workbook
- Keywords
- Health Literacy, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP Living with Diabetes GuideOther
American Colleges of Physicians (ACP) Living Well with Diabetes Guide
ADA Living Well with Diabetes WorkbookOther
American Diabetes Association (ADA) Living Well with Diabetes Workbook
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Other | ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months Receives: Other: ADA Living Well with Diabetes Workbook |
| Intervention | Other | ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months Receives: Other: ACP Living with Diabetes Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C (HbA1C)
HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.
Measured: Six months
Hemoglobin A1C (HbA1C)
HbA1C will be obtained from patients' electronic health records, defined as the value closest to 12 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.
Measured: Twelve months
Secondary outcomes (2)
Diabetes Knowledge
A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.
Measured: Three months
Diabetes Knowledge (0-13)
A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start7 Nov 2016
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Louisiana State University Health Sciences Center Shreveport, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Kristie Hadden, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779556
- Sponsor's protocol ID
- 204290
- Other IDs
- 1R01DK107572-01A1
- Status last verified
- Dec 2021
- First submitted
- 4 May 2016
- Last updated
- 15 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators are committed to the open and timely dissemination of the research outcomes. Plans for sharing resources with the scientific community include presentations and publications in peer-reviewed journals. The final data set will be made available to NIH investigators upon request. Consulting with program officer to ensure data sharing compliance.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
- ClinicalTrials.gov ID
- NCT02779556
- Acronym / sponsor ID
- 204290
- Conditions
- Diabetes
- Keywords
- Health Literacy, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Northwestern University, Louisiana State University Health Sciences Center Shreveport, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Posted 15 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.
The primary aims are to:
- test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;
- compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level. The secondary aims are to:
- investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
- determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and
- assess the costs associated with implementing the intervention from a health system perspective.
Detailed description
The investigators will test the effectiveness and fidelity of embedding the American College of Physicians (ACP) diabetes health literacy intervention among patient-centered medical homes throughout rural Arkansas. Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that have been designed for individuals with lower literacy skills, that can be readily implemented and sustained among rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on the team developed an evidence-based, patient-centered, low literacy ACP intervention promoting diabetes self-care that includes:
- a diabetes guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change;
- a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans');
- a training module for physicians, nurses, and medical assistants that prepares providers to assume educator/counselor roles with the Diabetes Guide as a teaching tool;
- electronic tracking and monitoring tools for primary care practices.
While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, it has not yet been comprehensively tested in practices, and its optimal implementation is not known. The investigators now have a unique opportunity to learn from prior evaluation, modify and disseminate an ACP health literacy intervention among patients with type 2 diabetes cared at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices are embedding care coordination services that can be leveraged to improve chronic disease management. All are supervised by a new University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy. The investigators' revised intervention will blend outsourced and clinic-based approaches and redeploy health coaches for counseling self-management mostly via phone, but also at the point-of-care. This is a feasible way to reach rural, vulnerable patients. The investigators will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.
The primary aims are to:
- test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;
- compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level. The secondary aims are to:
- investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
- determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and
- assess the costs associated with implementing the intervention from a health system perspective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Other | Other: ADA Living Well with Diabetes WorkbookADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months |
| Intervention | Other | Other: ACP Living with Diabetes GuideACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 years of age or older
- English speaking
- active patient at regional family medical center study site
- confirmed diagnosis of type 2 diabetes as documented in the electronic health record
- recent Hemoglobin A1c reading of >7.5% and less than or equal to 10%
Key exclusion criteria (3 listed)
- uncorrectable visual impairments
- hearing impairments
- cognitive impairments
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 |
|---|---|---|
| ACP Living with Diabetes GuideAmerican Colleges of Physicians (ACP) Living Well with Diabetes Guide | Other | Intervention |
| ADA Living Well with Diabetes WorkbookAmerican Diabetes Association (ADA) Living Well with Diabetes Workbook | Other | Enhanced Usual Care |
Primary outcome
Hemoglobin A1C (HbA1C)
Time frame: Six months
HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.
Hemoglobin A1C (HbA1C)
Time frame: Twelve months
HbA1C will be obtained from patients' electronic health records, defined as the value closest to 12 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.
2 secondary outcomes
Diabetes Knowledge
Time frame: Three months
Diabetes Knowledge (0-13)
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The investigators are committed to the open and timely dissemination of the research outcomes. Plans for sharing resources with the scientific community include presentations and publications in peer-reviewed journals. The final data set will be made available to NIH investigators upon request. Consulting with program officer to ensure data sharing compliance.
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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.
Kristie Hadden, PhD principal investigator
University of Arkansas
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP Living with Diabetes Guide and ADA Living Well with Diabetes Workbook in people with Diabetes, run by University of Arkansas at 6 sites 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 5 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 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 15 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin A1C (HbA1C) (time frame: Six months). 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?
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 15 Dec 2021.