search
Back to results

Improving Recruitment and Retention for Diabetes Self-Management Education and Support

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Technology
Standard DSMES Only
Traditional Recruitment Methods
CHW-Led Recruitment Methods
Sponsored by
MedsPLUS Consulting
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes focused on measuring community health worker, dsmes, diabetes self-management education and support, Jefferson County, Alabama, diabetes technology, A1C, diabetes, stakeholder engagement, SDoH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must be a resident of Jefferson County, Alabama Must have an ICD-10 diagnosis of diabetes Must have a primary care provider Must be able to read, write, and converse in English Must own and be able to utilize a smartphone with internet access Must be willing to visit MedsPLUS Consulting in downtown Birmingham on 3 separate occasions (transportation may be provided, if approved). Must be willing to attend and participate in five, two-hour education sessions over the course of 10 weeks Exclusion Criteria: Currently enrolled in a diabetes-related study Currently enrolled in a lifestyle change program Does not have or cannot get access to a home blood glucose monitor Does not have or cannot get access to a smartphone with internet access

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Technology

    Standard DSMES Only

    Traditional DSMES Recruitment Methods

    CHW-Led DSMES Recruitment Methods

    Arm Description

    The interventional group will receive a standard, evidence-based DSMES curriculum and supplemental diabetes education-related technology to assess an improvement in participation, retention, engagement, and clinical outcomes (HbA1C).

    The control group will receive a standard, evidence-based DSMES curriculum only to assess an improvement in participation, retention, engagement and clinical outcomes (HbA1C)

    The traditional DSMES recruitment method participants will be recruited using traditional methods such as flyers, word of mouth, and media ads to assess the effectiveness of traditional methods on recruiting and enrollment into to pharmacist-led DSMES programs.

    The CHW-led DSMES recruitment model participants will be recruited utilizing a CHW-led, multidirectional recruitment process involving community health workers (CHWs), primary care physicians, and community pharmacists to assess the effectiveness of a multidirectional recruitment process into pharmacist-led DSMES programs.

    Outcomes

    Primary Outcome Measures

    Number of Referrals from Study Stakeholders
    Number of referrals from study stakeholders to DSMES programs in Jefferson County, AL.
    Number of Participants Enrolled in DSMES Study
    Number of Participants Enrolled in DSMES Study
    Number of DSMES Sessions Attended by Participants
    Number of DSMES sessions attended
    Number of DSMES Participants with at Least 80% Session Retention
    Number of participants completing 4 of 5 DSMES sessions
    Change in HbA1C of Participants
    Change in HbA1C

    Secondary Outcome Measures

    Change in Self-Care Knowledge
    Measure change in diabetes self-care knowledge utilizing the Diabetes Self-Management Questionnaire a 16-question survey broken down into 4 sub-scales (glucose management, dietary control, physical activity, and healthcare use). The rating scale utilizes a 4-point Likert scale ranging from 0 to 3 (where 0 means it does not apply to the participant and 3 means it applies to the participant very much). For each sub-scale, the minimum score is zero and the maximum score is 10, and higher scores are indicative of better self-care. Additionally, there is one item that requires participants to rate their perceived self-care using the 4-point Likert scale indicated above.
    App Engagement
    Number of participants who used app at least two times a week during the intervention

    Full Information

    First Posted
    June 22, 2023
    Last Updated
    July 20, 2023
    Sponsor
    MedsPLUS Consulting
    Collaborators
    Lister Hill Center for Health Policy, Jenkins Public Health Consulting LLC, National Institutes of Health (NIH)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05958602
    Brief Title
    Improving Recruitment and Retention for Diabetes Self-Management Education and Support
    Official Title
    Improving Recruitment and Retention for Diabetes Self-Management Education and Support by Bridging Clinical-Community Linkages and Supplemental Diabetes Education Technology: A Socio-Ecological Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2024 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    MedsPLUS Consulting
    Collaborators
    Lister Hill Center for Health Policy, Jenkins Public Health Consulting LLC, National Institutes of Health (NIH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This randomized clinical trial aims to examine the effectiveness of utilizing CHWs (community health workers) and supplemental diabetes education technology to improve DSMES (diabetes self-management education and support) participation, retention, engagement, and clinical outcomes in adults in Jefferson County, AL living with diabetes. The main questions this study aims to answer are as follows: 1) Is the utilization of a multi-directional recruitment model via partnerships with community health workers and local primary care providers versus traditional recruitment methods (including using flyers, word of mouth, and media ads) effective in increasing recruitment and retention of people living with diabetes into a pharmacist-led DSMES program? 2) Is the utilization of the HICO Health Mobile application and provider dashboard as a supplementary tool alongside a standard DSMES curriculum effective at improving patient participation, retention, engagement, and clinical outcomes in a pharmacist-led DSMES program versus standard DSMES alone in Jefferson County, AL? After eligibility screenings and enrollment, participants will be randomized into two groups: one group will receive standard DSMES programming based on the 7 Self Care Behaviors and one group will receive standard DSMES programming and access to HICO Health, a diabetes-related mobile health application. The study team plans to evaluate whether a CHW- recruitment strategy will lead to an increase in referral and enrollment and whether incorporating the HICO Health application will lead to better retention, engagement, and clinical outcomes in terms of HbA1C levels. This novel project will utilize continued stakeholder engagement, community health workers, and diabetes-related technology which we hope will increase the uptake and retention of participants in DSMES in Jefferson County, AL.
    Detailed Description
    Diabetes is of increasing public health concern in Alabama due to high prevalence, incidence, and mortality rates. It was estimated that direct medical expenses for those diagnosed with diabetes in Alabama were about $4.2 billion in 2021 (American Diabetes Association, 2021). Due to the overall burden of the disease, there has been an increased focus on developing innovative strategies such as community-based interventions and diabetes education. The project aims to improve participation, retention, engagement, and clinical outcomes (HbA1C) of adults aged 18 and over living with diabetes in Jefferson County, Alabama in diabetes self-management education and support programs where the population lives, works, and plays. Leveraging a dynamic, multi-directional recruitment model through a collaborative partnership with community health workers (CHWs) and local primary care providers and a diabetes-related mobile application, the investigators plan to test, via a randomized controlled trial (RCT), the combined effects of a community health worker-led, muli-directional recruitment process versus a traditional recruiting process involving flyers, word-of-mouth, and media ads. The investigators also propose to assess the effectiveness of adding a diabetes-related mobile application (HICO Health) that, through a user-friendly interface, allows patients to review on-demand, evidence-based videos, nutrition education, and behavior change surveys to supplement standard DSMES curriculum, as well as a tool to collect patient entered clinical data such as blood pressure and blood sugar readings. The HICO Health package also includes a provider dashboard that allows the diabetes care team to monitor, in real-time, patient clinical data as well as communicate to patients via the HIPAA-compliant messaging function. The specific aims of the study are as follows: Aim 1: To examine the effectiveness of utilizing a multi-directional recruitment model involving community health workers and primary care providers versus traditional recruitment methods (including using flyers, word of mouth, and media ads) to recruit people living with diabetes into a pharmacist-led DSMES program. Aim 2: To conduct a pilot/feasibility study comparing using the HICO Health app as a supplement to a standard DSMES curriculum to improve patient participation, retention, and patient clinical outcomes in a pharmacist-led DSMES program versus the standard DSMES alone in Jefferson County, AL. Throughout the project, the study team and the diabetes care team will frequently communicate with the study stakeholders to seek input on relevant aspects of the study such as the engagement of CHWs, the stakeholders' perspective on the recruitment process, the number of participants referred and enrolled, and the clinical outcomes of the participants, to name a few. The evidence from the study will play a crucial role in establishing scalable and sustainable DSMES recruitment and delivery models to not only increase accessibility, participation, and retention in DSMES programs but also improve clinical outcomes in people living with diabetes in Jefferson County.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes, Diabetes Mellitus, Type 2
    Keywords
    community health worker, dsmes, diabetes self-management education and support, Jefferson County, Alabama, diabetes technology, A1C, diabetes, stakeholder engagement, SDoH

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Technology
    Arm Type
    Experimental
    Arm Description
    The interventional group will receive a standard, evidence-based DSMES curriculum and supplemental diabetes education-related technology to assess an improvement in participation, retention, engagement, and clinical outcomes (HbA1C).
    Arm Title
    Standard DSMES Only
    Arm Type
    Active Comparator
    Arm Description
    The control group will receive a standard, evidence-based DSMES curriculum only to assess an improvement in participation, retention, engagement and clinical outcomes (HbA1C)
    Arm Title
    Traditional DSMES Recruitment Methods
    Arm Type
    Active Comparator
    Arm Description
    The traditional DSMES recruitment method participants will be recruited using traditional methods such as flyers, word of mouth, and media ads to assess the effectiveness of traditional methods on recruiting and enrollment into to pharmacist-led DSMES programs.
    Arm Title
    CHW-Led DSMES Recruitment Methods
    Arm Type
    Experimental
    Arm Description
    The CHW-led DSMES recruitment model participants will be recruited utilizing a CHW-led, multidirectional recruitment process involving community health workers (CHWs), primary care physicians, and community pharmacists to assess the effectiveness of a multidirectional recruitment process into pharmacist-led DSMES programs.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Technology
    Intervention Description
    See previous response.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard DSMES Only
    Intervention Description
    See previous response.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Traditional Recruitment Methods
    Intervention Description
    See previous response.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CHW-Led Recruitment Methods
    Intervention Description
    See previous response.
    Primary Outcome Measure Information:
    Title
    Number of Referrals from Study Stakeholders
    Description
    Number of referrals from study stakeholders to DSMES programs in Jefferson County, AL.
    Time Frame
    3 months
    Title
    Number of Participants Enrolled in DSMES Study
    Description
    Number of Participants Enrolled in DSMES Study
    Time Frame
    3 months
    Title
    Number of DSMES Sessions Attended by Participants
    Description
    Number of DSMES sessions attended
    Time Frame
    2 months
    Title
    Number of DSMES Participants with at Least 80% Session Retention
    Description
    Number of participants completing 4 of 5 DSMES sessions
    Time Frame
    2 months
    Title
    Change in HbA1C of Participants
    Description
    Change in HbA1C
    Time Frame
    Baseline, 3 months, and 6 months
    Secondary Outcome Measure Information:
    Title
    Change in Self-Care Knowledge
    Description
    Measure change in diabetes self-care knowledge utilizing the Diabetes Self-Management Questionnaire a 16-question survey broken down into 4 sub-scales (glucose management, dietary control, physical activity, and healthcare use). The rating scale utilizes a 4-point Likert scale ranging from 0 to 3 (where 0 means it does not apply to the participant and 3 means it applies to the participant very much). For each sub-scale, the minimum score is zero and the maximum score is 10, and higher scores are indicative of better self-care. Additionally, there is one item that requires participants to rate their perceived self-care using the 4-point Likert scale indicated above.
    Time Frame
    6 months
    Title
    App Engagement
    Description
    Number of participants who used app at least two times a week during the intervention
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must be a resident of Jefferson County, Alabama Must have an ICD-10 diagnosis of diabetes Must have a primary care provider Must be able to read, write, and converse in English Must own and be able to utilize a smartphone with internet access Must be willing to visit MedsPLUS Consulting in downtown Birmingham on 3 separate occasions (transportation may be provided, if approved). Must be willing to attend and participate in five, two-hour education sessions over the course of 10 weeks Exclusion Criteria: Currently enrolled in a diabetes-related study Currently enrolled in a lifestyle change program Does not have or cannot get access to a home blood glucose monitor Does not have or cannot get access to a smartphone with internet access
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pauline K Long, PharmD
    Phone
    2056504636
    Ext
    102
    Email
    drpauline@medsplusconsulting.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jennifer S Campbell, PharmD
    Phone
    2056504636
    Ext
    103
    Email
    drjennifer@medsplusconsulting.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dashauna M Ballard, PhD, MPH
    Organizational Affiliation
    Lister Hill Center for Health Policy University of Alabama at Birmingham
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Pauline K Long, PharmD
    Organizational Affiliation
    MedsPLUS Consulting LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29449096
    Citation
    Adam L, O'Connor C, Garcia AC. Evaluating the Impact of Diabetes Self-Management Education Methods on Knowledge, Attitudes and Behaviours of Adult Patients With Type 2 Diabetes Mellitus. Can J Diabetes. 2018 Oct;42(5):470-477.e2. doi: 10.1016/j.jcjd.2017.11.003. Epub 2017 Nov 23.
    Results Reference
    background
    PubMed Identifier
    30532235
    Citation
    Adu MD, Malabu UH, Malau-Aduli AEO, Malau-Aduli BS. Users' preferences and design recommendations to promote engagements with mobile apps for diabetes self-management: Multi-national perspectives. PLoS One. 2018 Dec 10;13(12):e0208942. doi: 10.1371/journal.pone.0208942. eCollection 2018.
    Results Reference
    background
    Citation
    Alabama Department of Public Health. (2020). Diabetes. Available at https://www.alabamapublichealth.gov/healthrankings/assets/2020_sha_health_indicator_13.pdf. Accessed on [August 14, 2022].
    Results Reference
    background
    PubMed Identifier
    30728941
    Citation
    Alcantara-Aragon V. Improving patient self-care using diabetes technologies. Ther Adv Endocrinol Metab. 2019 Jan 28;10:2042018818824215. doi: 10.1177/2042018818824215. eCollection 2019.
    Results Reference
    background
    Citation
    American Association of Diabetes Educators (2014). Competencies for diabetes educators. Available at https://www.diabeteseducator.org/docs/default-source/legacy-docs/_resources/pdf/general/comp002.pdf?sfvrsn=9. Accessed on [August 10, 2022].
    Results Reference
    background
    Citation
    American Diabetes Association. (2021). The burden of diabetes in Alabama. Available at https://diabetes.org/sites/default/files/2021-10/ADV_2021_State_Fact_sheets_Alabama.pdf. Accessed on [August 14, 2022].
    Results Reference
    background
    PubMed Identifier
    30223759
    Citation
    Adjei Boakye E, Varble A, Rojek R, Peavler O, Trainer AK, Osazuwa-Peters N, Hinyard L. Sociodemographic Factors Associated With Engagement in Diabetes Self-management Education Among People With Diabetes in the United States. Public Health Rep. 2018 Nov;133(6):685-691. doi: 10.1177/0033354918794935. Epub 2018 Sep 17.
    Results Reference
    background
    Citation
    Centers for Disease Control and Prevention. (2021). Diabetes self-management education. Available at https://www.cdc.gov/diabetes/dsmes-toolkit/standards/index.html. Accessed on [August 14, 2022].
    Results Reference
    background
    PubMed Identifier
    28970034
    Citation
    Chatterjee S, Davies MJ, Heller S, Speight J, Snoek FJ, Khunti K. Diabetes structured self-management education programmes: a narrative review and current innovations. Lancet Diabetes Endocrinol. 2018 Feb;6(2):130-142. doi: 10.1016/S2213-8587(17)30239-5. Epub 2017 Sep 29. Erratum In: Lancet Diabetes Endocrinol. 2018 Feb;6(2):e2.
    Results Reference
    background
    PubMed Identifier
    35899815
    Citation
    Kavookjian J, LaManna JB, Davidson P, Davis JW, Fahim SM, McDaniel CC, Ekong G, Todd A, Yehl K, Cox C. Impact of Diabetes Self-Management Education/Support on Self-Reported Quality of Life in Youth With Type 1 or Type 2 Diabetes. Sci Diabetes Self Manag Care. 2022 Oct;48(5):406-436. doi: 10.1177/26350106221115450. Epub 2022 Jul 28.
    Results Reference
    background
    PubMed Identifier
    26658704
    Citation
    Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: A systematic review of the effect on glycemic control. Patient Educ Couns. 2016 Jun;99(6):926-43. doi: 10.1016/j.pec.2015.11.003. Epub 2015 Nov 22.
    Results Reference
    background
    PubMed Identifier
    25789104
    Citation
    Hunt CW. Technology and diabetes self-management: An integrative review. World J Diabetes. 2015 Mar 15;6(2):225-33. doi: 10.4239/wjd.v6.i2.225.
    Results Reference
    background
    PubMed Identifier
    29886773
    Citation
    Hildebrand JA, Billimek J, Olshansky EF, Sorkin DH, Lee JA, Evangelista LS. Facilitators and barriers to research participation: perspectives of Latinos with type 2 diabetes. Eur J Cardiovasc Nurs. 2018 Dec;17(8):737-741. doi: 10.1177/1474515118780895. Epub 2018 Jun 11.
    Results Reference
    background
    PubMed Identifier
    34078203
    Citation
    Krall JS, Kanter JE, Ruppert KM, Arena VC, Solano FX, Siminerio LM. Effect of a Primary Care-Based Diabetes Education Model on Provider Referrals and Patient Participation. Sci Diabetes Self Manag Care. 2021 Feb;47(1):74-84. doi: 10.1177/0145721720981840.
    Results Reference
    background
    PubMed Identifier
    35227635
    Citation
    Narindrarangkura P, Boren SA, Khan U, Day M, Simoes EJ, Kim MS. SEE-Diabetes, a patient-centered diabetes self-management education and support for older adults: Findings and information needs from patients' perspectives. Prim Care Diabetes. 2022 Jun;16(3):395-403. doi: 10.1016/j.pcd.2022.02.008. Epub 2022 Feb 25.
    Results Reference
    background
    PubMed Identifier
    32124483
    Citation
    Olesen K, Folmann Hempler N, Drejer S, Valeur Baumgarten S, Stenov V. Impact of patient-centred diabetes self-management education targeting people with type 2 diabetes: an integrative review. Diabet Med. 2020 Jun;37(6):909-923. doi: 10.1111/dme.14284. Epub 2020 Mar 20.
    Results Reference
    background
    PubMed Identifier
    26048904
    Citation
    Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Hess Fischl A, Maryniuk MD, Siminerio L, Vivian E. Diabetes Self-management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Diabetes Care. 2015 Jul;38(7):1372-82. doi: 10.2337/dc15-0730. Epub 2015 Jun 5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    33743839
    Citation
    Shirvani T, Javadivala Z, Azimi S, Shaghaghi A, Fathifar Z, Devender Bhalla HDR, Abdekhoda M, Nadrian H. Community-based educational interventions for prevention of type II diabetes: a global systematic review and meta-analysis. Syst Rev. 2021 Mar 20;10(1):81. doi: 10.1186/s13643-021-01619-3.
    Results Reference
    background
    Citation
    Siminerio, L. M., Ruppert, K., Emerson, S., Solano, F. X., & Piatt, G. A. (2008). Delivering diabetes self-management education (DSME) in primary care: the Pittsburgh regional initiative for diabetes education (PRIDE). Disease Management & Health Outcomes, 16, 267-272.
    Results Reference
    background
    Citation
    UAB Medicine. (2019). Community Health Needs Assessment. Available at https://www.uabmedicine.org/documents/142028/185199/CHNA+UAB+2019_FINAL+Approved.pdf/0634e584-3ac6-fdb9-9262-5f33c4a0cbdd. Accessed on [August 14, 2022].
    Results Reference
    background
    Citation
    US Census Bureau. (2022a). Quick facts: Birmingham city. Available at https://www.census.gov/quickfacts/birminghamcityalabama. Accessed on [June 22, 2023].
    Results Reference
    background
    Citation
    US Census Bureau. (2022b). Quick facts: Jefferson County. Available at https://www.census.gov/quickfacts/jeffersoncountyalabama. Accessed on [June 22, 2023].
    Results Reference
    background
    PubMed Identifier
    23937988
    Citation
    Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013 Aug 13;11:138. doi: 10.1186/1477-7525-11-138.
    Results Reference
    background

    Learn more about this trial

    Improving Recruitment and Retention for Diabetes Self-Management Education and Support

    We'll reach out to this number within 24 hrs