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DiabetesNCT05958602

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

A study testing Technology, Standard DSMES Only and Traditional Recruitment Methods in people with Diabetes and Diabetes Mellitus, Type 2, run by MedsPLUS Consulting.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
Technology, Standard DSMES Only and Traditional Recruitment Methods
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Apr 2024to Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Pauline K Long, PharmD contact

2056504636 ext. 102

drpauline@medsplusconsulting.com

Jennifer S Campbell, PharmD contact

2056504636 ext. 103

drjennifer@medsplusconsulting.com

About this study

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

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.

Read the 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.

Being tested
Technology, Standard DSMES Only, Traditional Recruitment Methods, CHW-Led Recruitment Methods
Keywords
community health worker, dsmes, diabetes self-management education and support, Jefferson County, Alabama, diabetes technology, A1C, diabetes, stakeholder engagement, SDoH
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TechnologyBehavioural

    See previous response.

  • Standard DSMES OnlyBehavioural

    See previous response.

  • Traditional Recruitment MethodsBehavioural

    See previous response.

  • CHW-Led Recruitment MethodsBehavioural

    See previous response.

Study groups in NCT05958602
Study groupRoleWhat they receive
TechnologyExperimentalThe 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).
Receives: Behavioral: Technology
Standard DSMES OnlyActive comparatorThe control group will receive a standard, evidence-based DSMES curriculum only to assess an improvement in participation, retention, engagement and clinical outcomes (HbA1C)
Receives: Behavioral: Standard DSMES Only
Traditional DSMES Recruitment MethodsActive comparatorThe 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.
Receives: Behavioral: Traditional Recruitment Methods
CHW-Led DSMES Recruitment MethodsExperimentalThe 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.
Receives: Behavioral: CHW-Led Recruitment Methods

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Referrals from Study Stakeholders

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

    Measured: 3 months

  2. Number of Participants Enrolled in DSMES Study

    Number of Participants Enrolled in DSMES Study

    Measured: 3 months

  3. Number of DSMES Sessions Attended by Participants

    Number of DSMES sessions attended

    Measured: 2 months

  4. Number of DSMES Participants with at Least 80% Session Retention

    Number of participants completing 4 of 5 DSMES sessions

    Measured: 2 months

  5. Change in HbA1C of Participants

    Change in HbA1C

    Measured: Baseline, 3 months, and 6 months

Secondary outcomes (2)

  1. 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.

    Measured: 6 months

  2. App Engagement

    Number of participants who used app at least two times a week during the intervention

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2023
  2. Study startApr 2024 (estimated)
  3. Primary completionFeb 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05958602
Sponsor's protocol ID
DSMESPilot2024
Other IDs
RFA-DK-20-032
Status last verified
Jul 2023
First submitted
22 Jun 2023
Last updated
24 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29449096

  • 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.

    PubMed 30532235

  • 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.

    PubMed 30728941

  • 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].

  • 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.

    PubMed 30223759

  • 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.

    PubMed 28970034

  • 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.

    PubMed 35899815

  • 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.

    PubMed 26658704

  • 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.

    PubMed 25789104

  • 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.

    PubMed 29886773

  • 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.

    PubMed 34078203

  • 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.

    PubMed 35227635

Questions about this trial

What is this clinical trial studying?

A study testing Technology, Standard DSMES Only and Traditional Recruitment Methods in people with Diabetes and Diabetes Mellitus, Type 2, run by MedsPLUS Consulting.

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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pauline K Long, PharmD (2056504636 ext. 102, drpauline@medsplusconsulting.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Referrals from Study Stakeholders (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05958602, which also lists 23 linked publications.

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 24 Jul 2023.

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