Trial Outcomes & Findings for Motivational Strategies To Empower African Americans To Improve Dialysis Adherence (NCT NCT05003115)
NCT ID: NCT05003115
Last Updated: 2024-04-23
Results Overview
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.
COMPLETED
NA
30 participants
Week 8, i.e. the maintenance phase, days 31 through 60 post-randomization
2024-04-23
Participant Flow
Participant milestones
| Measure |
Control
Standard Care
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only 14 control participants were captured for this survey.
Baseline characteristics by cohort
| Measure |
Control
n=15 Participants
Standard Care
|
Intervention
n=14 Participants
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).
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 Years
n=15 Participants
|
57 Years
n=14 Participants
|
57 Years
n=29 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants
|
5 Participants
n=14 Participants
|
13 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants
|
9 Participants
n=14 Participants
|
16 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
28 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
28 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
14 participants
n=14 Participants
|
29 participants
n=29 Participants
|
|
Adherence
|
94.43 percentage of minutes completed
n=15 Participants
|
94.64 percentage of minutes completed
n=14 Participants
|
94.54 percentage of minutes completed
n=29 Participants
|
|
Perceived Kidney Disease Self-Management Scale
|
35 units on a scale
n=15 Participants
|
30 units on a scale
n=14 Participants
|
32 units on a scale
n=29 Participants
|
|
Perceived Expectancies Index
|
39 units on a scale
n=15 Participants
|
39 units on a scale
n=14 Participants
|
39 units on a scale
n=29 Participants
|
|
Life Orientation Test - Revised
|
24 units on a scale
n=15 Participants
|
24 units on a scale
n=14 Participants
|
24 units on a scale
n=29 Participants
|
|
Healthcare Climate Questionnaire
|
7.0 units on a scale
n=14 Participants • Only 14 control participants were captured for this survey.
|
5.3 units on a scale
n=14 Participants • Only 14 control participants were captured for this survey.
|
6.3 units on a scale
n=28 Participants • Only 14 control participants were captured for this survey.
|
|
Autonomous Regulation
|
7.0 units on a scale
n=15 Participants
|
6.8 units on a scale
n=14 Participants
|
7.0 units on a scale
n=29 Participants
|
|
Apathy Evaluation Scale
|
26 units on a scale
n=15 Participants
|
25 units on a scale
n=14 Participants
|
26 units on a scale
n=29 Participants
|
PRIMARY outcome
Timeframe: Week 8, i.e. the maintenance phase, days 31 through 60 post-randomizationAbstraction 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.
Outcome measures
| Measure |
Control
n=15 Participants
Standard Care
|
Intervention
n=14 Participants
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).
|
|---|---|---|
|
Dialysis Treatment Adherence
|
95.85 percentage of minutes completed
Interval 85.19 to 99.37
|
93.26 percentage of minutes completed
Interval 80.35 to 99.01
|
SECONDARY outcome
Timeframe: Week 8Population: 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.
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
Outcome measures
| Measure |
Control
n=15 Participants
Standard Care
|
Intervention
n=12 Participants
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).
|
|---|---|---|
|
Change in Autonomous Regulation
|
7.0 score on a scale
Interval 7.0 to 7.0
|
6.8 score on a scale
Interval 6.4 to 7.0
|
SECONDARY outcome
Timeframe: Week 8Population: 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.
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.
Outcome measures
| Measure |
Control
n=15 Participants
Standard Care
|
Intervention
n=12 Participants
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).
|
|---|---|---|
|
Change in Autonomy Support
|
7.0 score on a scale
Interval 6.8 to 7.0
|
5.2 score on a scale
Interval 4.4 to 6.0
|
SECONDARY outcome
Timeframe: Week 8Population: 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.
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).
Outcome measures
| Measure |
Control
n=15 Participants
Standard Care
|
Intervention
n=12 Participants
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).
|
|---|---|---|
|
Change in Perceived Competence
|
38 score on a scale
Interval 35.0 to 40.0
|
34 score on a scale
Interval 32.0 to 36.0
|
SECONDARY outcome
Timeframe: Week 8Population: 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.
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.
Outcome measures
| Measure |
Control
n=15 Participants
Standard Care
|
Intervention
n=12 Participants
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).
|
|---|---|---|
|
Change in Apathy
|
26 score on a scale
Interval 24.0 to 28.0
|
26 score on a scale
Interval 23.0 to 28.0
|
SECONDARY outcome
Timeframe: Week 8Population: 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.
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).
Outcome measures
| Measure |
Control
n=15 Participants
Standard Care
|
Intervention
n=12 Participants
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).
|
|---|---|---|
|
Change in Optimism
|
24 score on a scale
Interval 22.0 to 26.0
|
22 score on a scale
Interval 21.0 to 24.0
|
SECONDARY outcome
Timeframe: 8 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Control
n=15 Participants
Standard Care
|
Intervention
n=12 Participants
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).
|
|---|---|---|
|
Perceived Expectancies Index
|
43 score on a scale
Interval 37.0 to 45.0
|
40 score on a scale
Interval 34.0 to 44.0
|
Adverse Events
Control
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ebele Umeukeje
Vanderbilt University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place