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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05958602
• Other study ID #: DSMESPilot2024
• Secondary ID: RFA-DK-20-032
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2025

Study information

• Verified date: July 2023
• Source: MedsPLUS Consulting
• Contact: Pauline K Long, PharmD
• Phone: 2056504636
• Email: drpauline[@]medsplusconsulting.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Technology
See previous response.
• Standard DSMES Only
See previous response.
• Traditional Recruitment Methods
See previous response.
• CHW-Led Recruitment Methods
See previous response.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
MedsPLUS Consulting	Jenkins Public Health Consulting LLC, Lister Hill Center for Health Policy, National Institutes of Health (NIH)

References & Publications (23)

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. — View 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. — View 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. — View 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].

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. — View 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].

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].

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].

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.

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].

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

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

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Referrals from Study Stakeholders	Number of referrals from study stakeholders to DSMES programs in Jefferson County, AL.	3 months
Primary	Number of Participants Enrolled in DSMES Study	Number of Participants Enrolled in DSMES Study	3 months
Primary	Number of DSMES Sessions Attended by Participants	Number of DSMES sessions attended	2 months
Primary	Number of DSMES Participants with at Least 80% Session Retention	Number of participants completing 4 of 5 DSMES sessions	2 months
Primary	Change in HbA1C of Participants	Change in HbA1C	Baseline, 3 months, and 6 months
Secondary	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.	6 months
Secondary	App Engagement	Number of participants who used app at least two times a week during the intervention	6 months