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

NCT ID: NCT05958602

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-03-31

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Technology

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).

Group Type: EXPERIMENTAL

Technology

Intervention Type: BEHAVIORAL

See previous response.

Standard DSMES Only

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

Group Type: ACTIVE_COMPARATOR

Standard DSMES Only

Intervention Type: BEHAVIORAL

See previous response.

Traditional DSMES Recruitment Methods

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.

Group Type: ACTIVE_COMPARATOR

Traditional Recruitment Methods

Intervention Type: BEHAVIORAL

See previous response.

CHW-Led DSMES Recruitment Methods

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.

Group Type: EXPERIMENTAL

CHW-Led Recruitment Methods

Intervention Type: BEHAVIORAL

See previous response.

Interventions

Technology

See previous response.

Intervention Type: BEHAVIORAL

Standard DSMES Only

See previous response.

Intervention Type: BEHAVIORAL

Traditional Recruitment Methods

See previous response.

Intervention Type: BEHAVIORAL

CHW-Led Recruitment Methods

See previous response.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lister Hill Center for Health Policy

UNKNOWN

Sponsor Role: collaborator

Jenkins Public Health Consulting LLC

UNKNOWN

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

MedsPLUS Consulting

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dashauna M Ballard, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Lister Hill Center for Health Policy University of Alabama at Birmingham

Pauline K Long, PharmD

Role: PRINCIPAL_INVESTIGATOR

MedsPLUS Consulting LLC

Central Contacts

Pauline K Long, PharmD

Role: CONTACT

drpauline@medsplusconsulting.com

2056504636 ext. 102

Jennifer S Campbell, PharmD

Role: CONTACT

drjennifer@medsplusconsulting.com

2056504636 ext. 103

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Other Identifiers

RFA-DK-20-032

Identifier Type: OTHER

Identifier Source: secondary_id

DSMESPilot2024

Identifier Type: -

Identifier Source: org_study_id