End Stage Renal Disease on Dialysis
Conditions
Keywords
Dialysis treatment adherence; Hemodialysis; African American
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.
Interventions
BEHAVIORALMotivational 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).
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis Treatment Adherence | Week 8, i.e. the maintenance phase, days 31 through 60 post-randomization | Abstraction of dialysis treatment adherence data from the dialysis units' records which includes data on every treatment that occurred or should have occurred within the time frame. Records will reflect dialysis treatments which were completed, shortened, missed or did not occur due to hospitalizations, ER visits or travel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Autonomy Support | Week 8 | Change in autonomy support will be measured by the 6-item Health Care Climate (HCC) questionnaire. Questions range in score from 1 to 7, and overall score is a mean of all items (range 1 - 7). Lower scores reflect less autonomous support, and higher scores reflect greater autonomous support. |
| Change in Perceived Competence | Week 8 | Change in perceived competence will be measured by the 8-item Perceived Kidney Disease Self-Management Scale (PKDSMS) questionnaire.Each question ranges in score from 1 to 5. Four of the items (#s 1, 2, 6, 7) are reversed-scored. The score is the sum of the 8 individual items. The total PKDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's (dialysis). |
| Change in Autonomous Regulation | Week 8 | Change in autonomous regulation will be measured by the 6-item Autonomous Regulation (AR) questionnaire. Questions range in score from 1 to 7, and overall score is a mean of all items (range 1 - 7). Lower scores reflect less autonomous regulation, and higher scores reflect greater autonomous regulation |
| Change in Optimism | Week 8 | Change in optimism will be measured by the 10-item Life Orientation Test - Revised (LOT-R) questionnaire which assesses individual differences in generalized optimism versus pessimism. Only 6 of the 10 items on the revised LOT are used to derive an optimism score. Four of the items are filler items and are not used in scoring. Of the 6 survey questions utilized, each question ranges in score from 1 to 5. Thus, scores in principle can range from 6 to 30. There are no 'cut-offs' for optimism or pessimism; the scale is a continuous dimension of variability between the two with higher scores indicating high optimism (low pessimism) and lower scores indicating high pessimism (low optimism). |
| Perceived Expectancies Index | 8 Weeks | The Dispositional Optimism items are #s 1, 3, 5, & 7; The Perceived Competence items are #s 2, 4, 6, & 8. Items # 2, 5, 6, & 7 need to be reverse scored. The overall score is calculated by summating the scores after reverse scoring 2,5,6, and 7. The score ranges from 8-48 with 48 being the highest perceived expectancies. The score can also be broken down into the above scales. |
| Change in Apathy | Week 8 | Change in apathy will be measured by the 7-item Apathy Evaluation Scale survey (AES-S) which measures three domains of apathy: deficits in goal-directed behavior; a decrement in goal-related thought content; and emotional indifference with flat affect. Each question ranges in score from 1 to 4. Item 3 is reverse-scored and then the sum of the 7 item scores is calculated. Range of scores is 7-28, with higher scores indicating more apathy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Standard Care | 15 |
| Intervention Motivational interviewing intervention
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). | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Adherence | 94.43 percentage of minutes completed | 94.54 percentage of minutes completed | 94.64 percentage of minutes completed |
| Age, Continuous | 57 Years | 57 Years | 57 Years |
| Apathy Evaluation Scale | 26 units on a scale | 26 units on a scale | 25 units on a scale |
| Autonomous Regulation | 7.0 units on a scale | 7.0 units on a scale | 6.8 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 28 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Healthcare Climate Questionnaire | 7.0 units on a scale | 6.3 units on a scale | 5.3 units on a scale |
| Life Orientation Test - Revised | 24 units on a scale | 24 units on a scale | 24 units on a scale |
| Perceived Expectancies Index | 39 units on a scale | 39 units on a scale | 39 units on a scale |
| Perceived Kidney Disease Self-Management Scale | 35 units on a scale | 32 units on a scale | 30 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 28 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 participants | 29 participants | 14 participants |
| Sex: Female, Male Female | 8 Participants | 13 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 1 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Dialysis Treatment Adherence
Abstraction of dialysis treatment adherence data from the dialysis units' records which includes data on every treatment that occurred or should have occurred within the time frame. Records will reflect dialysis treatments which were completed, shortened, missed or did not occur due to hospitalizations, ER visits or travel.
Time frame: Week 8, i.e. the maintenance phase, days 31 through 60 post-randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Dialysis Treatment Adherence | 95.85 percentage of minutes completed |
| Intervention | Dialysis Treatment Adherence | 93.26 percentage of minutes completed |
p-value: 0.10195% CI: [-14.17, 1.44]Regression, Linear
Secondary
Change in Apathy
Change in apathy will be measured by the 7-item Apathy Evaluation Scale survey (AES-S) which measures three domains of apathy: deficits in goal-directed behavior; a decrement in goal-related thought content; and emotional indifference with flat affect. Each question ranges in score from 1 to 4. Item 3 is reverse-scored and then the sum of the 7 item scores is calculated. Range of scores is 7-28, with higher scores indicating more apathy.
Time frame: Week 8
Population: 14 participants were reflected in the intervention arm of the participant flow module. Only 12 participants completed the (AES-S) survey. The remaining 2 dropped out of the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Change in Apathy | 26 score on a scale |
| Intervention | Change in Apathy | 26 score on a scale |
p-value: 0.99495% CI: [-2.23, 2.25]Regression, Linear
Secondary
Change in Autonomous Regulation
Change in autonomous regulation will be measured by the 6-item Autonomous Regulation (AR) questionnaire. Questions range in score from 1 to 7, and overall score is a mean of all items (range 1 - 7). Lower scores reflect less autonomous regulation, and higher scores reflect greater autonomous regulation
Time frame: Week 8
Population: 14 participants were reflected in the intervention arm of the participant flow module. Only 12 of those completed the AR survey - the remaining 2 dropped out of the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Change in Autonomous Regulation | 7.0 score on a scale |
| Intervention | Change in Autonomous Regulation | 6.8 score on a scale |
p-value: 0.7895% CI: [-0.79, 0.59]Regression, Linear
Secondary
Change in Autonomy Support
Change in autonomy support will be measured by the 6-item Health Care Climate (HCC) questionnaire. Questions range in score from 1 to 7, and overall score is a mean of all items (range 1 - 7). Lower scores reflect less autonomous support, and higher scores reflect greater autonomous support.
Time frame: Week 8
Population: 14 participants were reflected in the intervention arm of the participant flow module. Only 12 participants completed the (HCC) questionnaire. The remaining 2 dropped out of the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Change in Autonomy Support | 7.0 score on a scale |
| Intervention | Change in Autonomy Support | 5.2 score on a scale |
p-value: 0.31495% CI: [-2.83, 0.94]Regression, Linear
Secondary
Change in Optimism
Change in optimism will be measured by the 10-item Life Orientation Test - Revised (LOT-R) questionnaire which assesses individual differences in generalized optimism versus pessimism. Only 6 of the 10 items on the revised LOT are used to derive an optimism score. Four of the items are filler items and are not used in scoring. Of the 6 survey questions utilized, each question ranges in score from 1 to 5. Thus, scores in principle can range from 6 to 30. There are no 'cut-offs' for optimism or pessimism; the scale is a continuous dimension of variability between the two with higher scores indicating high optimism (low pessimism) and lower scores indicating high pessimism (low optimism).
Time frame: Week 8
Population: 14 participants were reflected in the intervention arm of the participant flow module. Only 12 participants completed the (LOT-R) questionnaire. The remaining 2 dropped out of the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Change in Optimism | 24 score on a scale |
| Intervention | Change in Optimism | 22 score on a scale |
p-value: 0.25895% CI: [-3.33, 0.89]Regression, Linear
Secondary
Change in Perceived Competence
Change in perceived competence will be measured by the 8-item Perceived Kidney Disease Self-Management Scale (PKDSMS) questionnaire.Each question ranges in score from 1 to 5. Four of the items (#s 1, 2, 6, 7) are reversed-scored. The score is the sum of the 8 individual items. The total PKDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's (dialysis).
Time frame: Week 8
Population: 14 participants were reflected in the intervention arm of the participant flow module. Only 12 participants completed the (PKDSMS) questionnaire. The remaining 2 dropped out of the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Change in Perceived Competence | 38 score on a scale |
| Intervention | Change in Perceived Competence | 34 score on a scale |
p-value: 0.67995% CI: [-6, 3.92]Regression, Linear
Secondary
Perceived Expectancies Index
The Dispositional Optimism items are #s 1, 3, 5, & 7; The Perceived Competence items are #s 2, 4, 6, & 8. Items # 2, 5, 6, & 7 need to be reverse scored. The overall score is calculated by summating the scores after reverse scoring 2,5,6, and 7. The score ranges from 8-48 with 48 being the highest perceived expectancies. The score can also be broken down into the above scales.
Time frame: 8 Weeks
Population: 14 participants were reflected in the intervention arm of the participant flow module. Only 12 participants completed the survey. The remaining 2 dropped out of the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Perceived Expectancies Index | 43 score on a scale |
| Intervention | Perceived Expectancies Index | 40 score on a scale |
p-value: 0.85795% CI: [-4.75, 3.96]Regression, Linear