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

NCT05958602 | Unknown

• 2 other identifiers: DSMESPilot2024RFA-DK-20-032
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Number of Referrals from Study Stakeholders

  Number of referrals from study stakeholders to DSMES programs in Jefferson County, AL.

  3 months

• Number of Participants Enrolled in DSMES Study

  Number of Participants Enrolled in DSMES Study

  3 months

• Number of DSMES Sessions Attended by Participants

  Number of DSMES sessions attended

  2 months

• Number of DSMES Participants with at Least 80% Session Retention

  Number of participants completing 4 of 5 DSMES sessions

  2 months

• Change in HbA1C of Participants

  Change in HbA1C

  Baseline, 3 months, and 6 months

Secondary Outcomes (2)

• Change in Self-Care Knowledge

  6 months

• App Engagement

  6 months

Study Arms (4)

Technology

EXPERIMENTAL

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).

Behavioral: Technology

Standard DSMES Only

ACTIVE COMPARATOR

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

Behavioral: Standard DSMES Only

Traditional DSMES Recruitment Methods

ACTIVE COMPARATOR

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.

Behavioral: Traditional Recruitment Methods

CHW-Led DSMES Recruitment Methods

EXPERIMENTAL

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.

Behavioral: CHW-Led Recruitment Methods

Interventions

Technology BEHAVIORAL

See previous response.

Technology

Standard DSMES Only BEHAVIORAL

See previous response.

Standard DSMES Only

Traditional Recruitment Methods BEHAVIORAL

See previous response.

Traditional DSMES Recruitment Methods

CHW-Led Recruitment Methods BEHAVIORAL

See previous response.

CHW-Led DSMES Recruitment Methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedsPLUS Consulting: lead
• Lister Hill Center for Health Policy: collaborator
• Jenkins Public Health Consulting LLC: collaborator
• National Institutes of Health (NIH): collaborator

Related Publications (23)

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• 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.

  PMID: 30532235 BACKGROUND

• 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].

  BACKGROUND

• 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.

  PMID: 30728941 BACKGROUND

• 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].

  BACKGROUND

• 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].

  BACKGROUND

• 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.

  PMID: 30223759 BACKGROUND

• 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].

  BACKGROUND

• 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.

  PMID: 28970034 BACKGROUND

• 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.

  PMID: 35899815 BACKGROUND

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  PMID: 26658704 BACKGROUND

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  PMID: 25789104 BACKGROUND

• 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.

  PMID: 29886773 BACKGROUND

• 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.

  PMID: 34078203 BACKGROUND

• 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.

  PMID: 35227635 BACKGROUND

• 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.

  PMID: 32124483 BACKGROUND

• 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.

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• 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.

  PMID: 33743839 BACKGROUND

• 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.

  BACKGROUND

• 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].

  BACKGROUND

• US Census Bureau. (2022a). Quick facts: Birmingham city. Available at https://www.census.gov/quickfacts/birminghamcityalabama. Accessed on [June 22, 2023].

  BACKGROUND

• US Census Bureau. (2022b). Quick facts: Jefferson County. Available at https://www.census.gov/quickfacts/jeffersoncountyalabama. Accessed on [June 22, 2023].

  BACKGROUND

• 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.

  PMID: 23937988 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Technology

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

• Dashauna M Ballard, PhD, MPH

  Lister Hill Center for Health Policy University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Pauline K Long, PharmD

  MedsPLUS Consulting LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline K Long, PharmD

CONTACT

2056504636; drpauline@medsplusconsulting.com

Jennifer S Campbell, PharmD

CONTACT

2056504636; drjennifer@medsplusconsulting.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 24, 2023
• Study Start: April 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share