Community Health Promotion for Reducing Health Disparities

(CEAL-DMV Trial)

Recruiting at 1 trial location

Overseen By Cheryl Himmelfarb, PhD, MSN, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: No phone/internet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

664 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Multi-level, community-digital health promotion intervention?

Research shows that digital health interventions, like those using smartphones and virtual visits, can improve health outcomes for people with chronic diseases, especially in minority groups. These interventions help by providing personalized care and increasing access to healthcare, which can reduce health disparities. ^{1 2 3 4 5}

Is the community-digital health promotion intervention safe for humans?

The research does not provide specific safety data for the community-digital health promotion intervention, but it emphasizes the importance of designing digital health tools with privacy safeguards and usability in mind, which can contribute to their safe use. ^{1 6 7 8 9}

How is the Multi-level, community-digital health promotion intervention treatment different from other treatments for reducing health disparities?

This treatment is unique because it combines digital health tools with community engagement to tailor health interventions specifically for diverse populations, aiming to reduce health disparities by addressing social and structural determinants of health. It uses a participatory approach to design interventions that are context-specific and culturally relevant, which is not commonly seen in traditional health treatments. ^{1 2 4 10 11}

What is the purpose of this trial?

The Community Engagement Alliance against Disparities - Washington District of Columbia, Maryland, Virginia (CEAL DMV), is a multi-community and multi-university consortium. Through collaboration and shared leadership, the CEAL-DMV the consortium- comprising five institutions: George Washington University, Howard University, Johns Hopkins University, Morgan State University, and the University of Maryland, Baltimore-has established a regional structure for bi-directional community involvement to engender trust and foster communication. Each site builds on thriving community partnerships, which have been instrumental in enhancing trust, community capacity, and readiness to reduce health disparities.

Research Team

Cheryl Himmelfarb, PhD, MSN, BS

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for individuals with conditions like diabetes, prediabetes, high blood pressure, or obesity. It's focused on communities in the Washington DC, Maryland, and Virginia areas. Participants should be interested in a digital health promotion intervention that involves their community.

Inclusion Criteria

Self-identify as Black or Latino

Reside in defined geographic area

I have been diagnosed with prediabetes/diabetes, hypertension, or I am overweight/obese.

Exclusion Criteria

I am unable to understand and give consent for treatment.

No access to phone/internet

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multi-level, community-digital health promotion intervention, including CHW-delivered coaching and digital resources

12 months

Regular interactions with community health workers and digital platform access

Follow-up

Participants are monitored for health outcomes such as HbA1c levels, BMI, and blood pressure

6-9 months

Delayed Control Intervention

Participants receive a standardized 12-month text message campaign and educational content

12 months

Treatment Details

Interventions

• Multi-level, community-digital health promotion intervention

Trial Overview The trial tests a multi-level community-digital health promotion intervention designed to reduce health disparities related to diabetes, prediabetes, high blood pressure, and obesity through improved communication and trust within the community.

Participant Groups

Group I: Multi-level, community-digital health promotion intervention Experimental Treatment 1 Intervention

Participants will receive a multi-level, community-digital health promotion intervention. 1. Community-level: Community Health Workers will assess needs of individuals including through a survey and facilitate access to the Medi digital resource platform. 2. Individual level: CHW-delivered coaching on behavior-change goals and facilitation to services via the Medi platform. Participants will also receive tailored social media and in person reinforcements and cues to action based on goal attainment 3. Social network level: Participants will receive tailored recommendations sent via social media on nearby parks, recreational facilities, faith-based ministries, and peer groups to support behavior change goals

Group II: Delayed control intervention group Active Control 1 Intervention

At the individual level, participants will receive standardized 12-month text message (SMS) campaign. At the community-level, the investigators will equip community-based organization partners and community health workers with chronic disease educational content. Participants will also receive recommendations for health events and fairs locally.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

La Clinica del Pueblo

Collaborator

Trials

1

Recruited

660+

Coaching Salud Holistica

Collaborator

Trials

1

Recruited

660+

The Medi Inc.

Collaborator

Trials

1

Recruited

660+

Baltimore CONNECT

Collaborator

Trials

1

Recruited

660+

Rivera Group

Collaborator

Trials

1

Recruited

660+

Westat

Collaborator

Trials

49

Recruited

39,700+

Findings from Research

Digital health interventions have the potential to improve care for chronic diseases by providing accessible and personalized support, but they may also unintentionally increase health inequities among marginalized groups.

To effectively reduce health disparities, it is crucial to develop context-specific digital health solutions, foster partnerships across sectors, and actively involve historically marginalized communities in the design and implementation of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying a Social Determinants of Health Framework to Guide Digital Innovations That Reduce Disparities in Chronic Disease. Goldstein, SP., Tovar, A., Espel-Huynh, HM., et al.[2023]

A co-design process involving 16 participants (8 patients with atrial fibrillation and 8 clinicians) led to the development of a digital health intervention that addresses key challenges such as medication adherence and patient education.

The intervention incorporates user-generated ideas focused on risk factor modification and remote management of atrial fibrillation episodes, demonstrating a human-centered approach that can enhance engagement and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Virtual Inclusive Digital Health Intervention Design to Promote Health Equity (iDesign) Framework for Atrial Fibrillation: Co-design and Development Study. Isakadze, N., Molello, N., MacFarlane, Z., et al.[2022]

The study demonstrated the feasibility of a multidisciplinary intervention using health coach-facilitated virtual visits and a cloud-based glucose monitoring system to improve access to care for uninsured, poorly-controlled diabetic patients, with 100% participant satisfaction in recommending the intervention.

Participants in the intervention group had significantly more documented contacts with patient-centered medical home (PCMH) providers (median of nine) compared to the control group (median of four), suggesting enhanced chronic disease management through the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial. Emerson, JF., Welch, M., Rossman, WE., et al.[2018]

Current digital health solutions have not effectively reached diverse user groups or addressed health inequities, highlighting a need for more inclusive approaches.

The paper proposes a multilevel framework for digital health equity and identifies five promising intervention types, suggesting that future efforts should focus on improving policies and practices to enhance access and effectiveness for all individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilevel Determinants of Digital Health Equity: A Literature Synthesis to Advance the Field. Lyles, CR., Nguyen, OK., Khoong, EC., et al.[2023]

Digital and mobile health (mHealth) interventions have been shown to effectively improve health outcomes for minority patients suffering from chronic conditions like diabetes, congestive heart failure, and chronic respiratory diseases.

The paper highlights various electronic and digital strategies, such as telephones and mobile platforms, that have been implemented to enhance chronic disease management, particularly focusing on their impact on racial and ethnic minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Improve Management of Chronic Conditions Among Racial and Ethnic Minorities. Doshi, R., Aseltine, RH., Sabina, AB., et al.[2021]

Underserved groups often do not benefit equally from eHealth interventions due to usability issues and broader barriers to technology adoption, highlighting the need for tailored solutions.

The authors identified five key principles for designing effective eHealth interventions for underserved populations, including addressing communication inequalities, engaging stakeholders, ensuring usability, protecting privacy, and balancing open science with participant protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing Effective eHealth Interventions for Underserved Groups: Five Lessons From a Decade of eHealth Intervention Design and Deployment. Lee, EW., McCloud, RF., Viswanath, K.[2022]

The SIPsmartER intervention, which lasted 6 months and involved 155 participants, effectively reduced sugary beverage intake among rural, low socioeconomic adults, with high satisfaction ratings across all components of the program.

Participants with varying health literacy levels reported similar satisfaction with the intervention, indicating that a health literacy universal precautions approach is effective and acceptable for both high and low health literacy groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of health literacy on rural adults' satisfaction with a multi-component intervention to reduce sugar-sweetened beverage intake. Bailey, AN., Porter, KJ., Hill, JL., et al.[2019]

In Mississippi, nearly half of adults (46.8%) consume sugar-sweetened beverages (SSBs) at least once a day, with those having lower health literacy (HL) being 1.7 times more likely to consume SSBs compared to those with higher HL.

Adults who do not use or notice menu labeling (ML) at fast-food restaurants are significantly more likely to consume SSBs, with nonusers having 2.3 times the odds of daily SSB consumption compared to ML users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of Health Literacy and Menu-Labeling Usage With Sugar-Sweetened Beverage Intake Among Adults in Mississippi, 2016. Lee, SH., Zhang, L., Rubin, DL., et al.[2022]

A CME program was developed to improve primary care physicians' skills in communicating cancer risks and facilitating shared decision-making with patients who have low health literacy, involving 18 physicians and 73 patients in a cluster randomized controlled trial.

Baseline assessments revealed that while physicians felt confident in their communication skills, patients reported feeling poorly involved in decision-making, highlighting a significant gap that the training aims to address.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer risk communication with low health literacy patients: a continuing medical education program. Price-Haywood, EG., Roth, KG., Shelby, K., et al.[2021]

The study involved 86 participants who contributed to the development of tailored notifications for a mobile health intervention aimed at reducing sodium intake and increasing physical activity to lower blood pressure.

Community-generated notifications were found to be more effective, using direct and relatable language, while also addressing specific cultural and social needs, highlighting the importance of incorporating local perspectives in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Community Participatory Approach to Creating Contextually Tailored mHealth Notifications: myBPmyLife Project. Hellem, AK., Casetti, A., Bowie, K., et al.[2023]

The digital divide in consumer information technologies has decreased, allowing for greater use of mobile health (mHealth), telehealth, and social media to improve access to health interventions for underserved populations.

Despite the potential of CIT-enabled interventions, the evidence supporting their effectiveness in health disparity populations is still developing, highlighting the need for better design, evaluation, and inclusive practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Interventions Using Consumer Information Technology as Tools to Advance Health Equity. Bakken, S., Marden, S., Arteaga, SS., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Applying a Social Determinants of Health Framework to Guide Digital Innovations That Reduce Disparities in Chronic Disease. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

The Virtual Inclusive Digital Health Intervention Design to Promote Health Equity (iDesign) Framework for Atrial Fibrillation: Co-design and Development Study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Multilevel Determinants of Digital Health Equity: A Literature Synthesis to Advance the Field. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Interventions to Improve Management of Chronic Conditions Among Racial and Ethnic Minorities. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Designing Effective eHealth Interventions for Underserved Groups: Five Lessons From a Decade of eHealth Intervention Design and Deployment. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The impact of health literacy on rural adults' satisfaction with a multi-component intervention to reduce sugar-sweetened beverage intake. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Associations of Health Literacy and Menu-Labeling Usage With Sugar-Sweetened Beverage Intake Among Adults in Mississippi, 2016. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Cancer risk communication with low health literacy patients: a continuing medical education program. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A Community Participatory Approach to Creating Contextually Tailored mHealth Notifications: myBPmyLife Project. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Behavioral Interventions Using Consumer Information Technology as Tools to Advance Health Equity. [2020]