Motivational Strategies To Empower African Americans To Improve Dialysis Adherence

NCT ID: NCT05003115

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2023-01-09

Brief Summary

This study addresses the need to rigorously advance the science and understanding of the development, feasibility, acceptability and adoption of novel culturally-sensitive motivational strategies to improve dialysis treatment adherence among African Americans with end-stage kidney disease (ESKD). This study specifically aims to:

1. Gain advanced skills in the development and implementation of novel culturally sensitive motivational strategies

2. Acquire critical preliminary data for an R01-funded phase II efficacy trial testing the use of these motivational strategies to improve dialysis treatment adherence.

Detailed Description

Hemodialysis treatment non-adherence is a public health issue because of its association with excessive hospitalizations, high morbidity, mortality, and increased financial costs. Compared to whites, African Americans have a four-fold higher prevalence of end stage kidney disease (EKSD), higher non-adherence rates to hemodialysis, and higher odds of hospitalizations. Motivational interviewing, an evidence-based intervention that creates a bond between patients and providers, targets improvement in motivation-related psychosocial factors associated with adherence behaviors. Interventions for such factors are typically developed based on the dominant culture and may not be valid and generalizable to minority groups. Culturally tailored interventions lead to more durable change in African Americans yet there is a lack of studies testing the efficacy of such approaches to improve hemodialysis treatment adherence in African Americans. Use of culturally tailored motivational interviewing in African Americans with ESKD will promote health equity by improving dialysis treatment adherence, reducing hospitalizations, and enhancing other critical outcomes.

Our long-term goal is to establish culturally sensitive strategies and multi-level interactions to improve outcomes in kidney disease. The overall objective of this project is to evaluate the efficacy of a culturally tailored motivational interviewing intervention developed using a rigorous theoretical framework on improving hemodialysis treatment adherence in African Americans with ESKD. The central hypothesis is that culturally tailored motivational interviewing will lead to improved hemodialysis treatment adherence. We will test this hypothesis in the following Specific Aims in a randomized clinical trial (RCT) in African American patients with ESKD. Compared to usual dialysis care, we aim to: Evaluate the efficacy of 8 weeks of culturally tailored motivational interviewing (MoVE) on improving hemodialysis adherence at (1) 3 months, and (2) 6 months post-randomization. At the successful completion of the proposed research, the expected outcomes will include evidence of the efficacy of culturally tailored motivational interviewing on improving hemodialysis treatment adherence in African American patients with ESKD. The proposed research is innovative because of the novel application of a culturally tailored, evidence-based behavioral intervention developed using a rigorous theoretical network (PEN-3); the use of specifically-trained health coaches to optimize the intervention delivery; and the focus on understanding and overrepresented African American patients with ESKD to address the public health issue of hemodialysis treatment of non-adherence. Study results will provide a strong basis for conducting an effectiveness and implementation trial, which is expected to have a significant impact on hemodialysis adherence, hospitalizations, morbidity, and mortality. This research strongly aligns with NIDDK's mission to promote health equity by addressing health disparities in kidney disease.

Hemodialysis treatment non-adherence is an important modifiable contributor to end stage kidney disease (ESKD), with critical public health relevance to patients, providers, and health systems due to its association with excessive hospitalizations, exorbitant financial burden, and increase morbidity and mortality. Compared to Whites, African Americans ESKD patients have a four-fold higher ESKD prevalence, persistently higher hospitalization and rehospitalization risk, and higher rates of dialysis treatment non-adherence. The goals of this proposal are to: (1) evaluate the efficacy of culturally tailored motivational interviewing on improving hemodialysis treatment adherence in African Americans; (2) provide a strong basis for conducting a future effectiveness and implementation trial using evidence-based, culturally tailored motivational interviewing intervention to improve hemodialysis adherence, and reduce hospitalizations, morbidity, mortality, and exorbitant financial burden associated with dialysis treatment non-adherence; and (3) promote health equity by reducing existing health disparities and optimizing outcomes in ESKD.

Conditions

End Stage Renal Disease on Dialysis

Study Design

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

Study Groups

Standard of Care

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Motivational interviewing intervention

Group Type: EXPERIMENTAL

Motivational interviewing

Intervention Type: BEHAVIORAL

In this trial, motivational interviewing (MI) is the intervention. The MI sessions will embody the spirit of MI (PACE - Partnership, Acceptance, Compassion and Evocation) and the use of MI strategies (OARS - Open-ended questions, Affirmations, Reflections and Summaries) and MI communication processes (engagement, focusing, evoking and planning).

Interventions

Motivational interviewing

In this trial, motivational interviewing (MI) is the intervention. The MI sessions will embody the spirit of MI (PACE - Partnership, Acceptance, Compassion and Evocation) and the use of MI strategies (OARS - Open-ended questions, Affirmations, Reflections and Summaries) and MI communication processes (engagement, focusing, evoking and planning).

Intervention Type: BEHAVIORAL

Other Intervention Names

MI

Eligibility Criteria

Inclusion Criteria

• African American
• Receiving hemodialysis treatments
• Been on hemodialysis for more than 30 days
• 18 years of age and older
• Within a 3-month look back at the time of screening, patients who have missed at least one dialysis session or shortened at least one dialysis session by 15 minutes.

Exclusion Criteria

• Not self-identified as African American
• Impaired with mental status or severe illness
• Non-English speaking
• No documented evidence of dialysis treatment non-adherence
• Missed or shortened treatments due to hospitalizations or excused travel
• Terminal condition
• Living in a nursing home/rehab
• Planned transplant within the next 3 months
• Planned conversion to peritoneal dialysis within the next 3 months

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

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ebele Umeukeje

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebele M Umeukeje, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt Dialysis Clinic

Nashville, Tennessee, United States

Vanderbilt Dialysis Clinic East

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R03DK129626-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

211127 - MoVE

Identifier Type: -

Identifier Source: org_study_id