Clinical trial NCT05003115: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
Official title: MoVE: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Keywords: Dialysis treatment adherence; Hemodialysis; African American
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Dialysis Treatment Adherence
timeFrame: Week 8, i.e. the maintenance phase, days 31 through 60 post-randomization
Secondary outcomes:
measure: Change in Autonomous Regulation
timeFrame: Week 8
measure: Change in Autonomy Support
timeFrame: Week 8
measure: Change in Perceived Competence
timeFrame: Week 8
measure: Change in Apathy
timeFrame: Week 8
measure: Change in Optimism
timeFrame: Week 8
measure: Perceived Expectancies Index
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Dialysis Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Dialysis Clinic East
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ebele M Umeukeje, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: