An interventional study of ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease in Kidney Diseases and Cardiometabolic Risk Factors, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other
The purpose is to explore the feasibility and acceptability of participation in a decision-support training program led by lay navigators. ImPart-Multi, an education-telehealth-based program, is designed to empower Black chronic kidney disease patients (CKD) and their care partners to seek the resources and support needed to be activated allies when making health-related decisions.
Participants, both caregivers and patients, completed surveys at study start and at 12 weeks of enrollment. Patients only, based on random assignment, then completed either 1, 3, or 4 education sessions via telehealth or audio connection. Caregivers were not restricted from attending sessions, but were not required. Both patients and caregivers then repeated survey measures at 12 weeks of enrollment. Caregiver and patient participants also completed an interview to share their thoughts on the version of the program they recieved (patients) caregiver interviews focused on if they were able to review mateirals send to the patient, and/or if they noticed a difference in communication, information sharing, etc. after the patient compelted their session(s), and other factors of interest.
Black people with chronic kidney disease and uncontrolled high blood pressure face a higher risk of developing severe cardiovascular disease and face an additional risk of their kidney disease getting worse more quickly. Many things add to this risk, including living in areas with lower access to support resources and lower quality of communication and information sharing with medical team members. Over the past 18 months, our team has worked in partnership with a group of community advisory members, two who are living with chronic kidney disease, two who are care partners of someone with chronic kidney disease, and one who has experience as a social worker in a dialysis clinic. Together the team and the community advisory board created a program focused on teaching skills for health-related decision-making. The program consists of education on 1) communication, 2) social support usefulness, or 3) a combination of both. The team seeks to understand how these sessions, alone or together, impact how the person with chronic kidney disease makes decisions and how they feel they receive support from their care partner and/or medical team. In addtion, the team also seeks to understand if there are benefits to the person with chronic kidney disease and their care partner's quality of life and how the two work together to cope with the illness experience. The goal is to positively impact health promotion by teaching answer-seeking behaviors to people with high-risk chronic kidney disease.
The team is seeking to recruit 32 Black adults with stage 3 or 4 chronic kidney disease and one identified care partner from the University of Alabama at Birmingham (UAB) Chronic Kidney Disease Clinic and Cooper Green Primary and Kidney Specialty Care Clinic. In the study, there are four groups the dyad can be randomized to: Group 1 will participate in one session on communication, Group 2 will receive 3 sessions on social support effectiveness; and Group 3 will have both communication and social support sessions. Group 4 will not participate in the sessions at all through the 12 week timerame. Caregivers were not madated to attend sessions, but did compelte data collection, so we could understand potential impact and thus they are by proxy assigned to the same group as their patient. All groups will be asked to complete surveys and one interview about their experience three months after the program is done. After this data collection, the participants in Group 4 will be invited to participate in the session combination they choose, so they receive potential benefit from their participation. The wait-listed group will not repeat measures after they expereince sessions, the focus is fariness and desire to ensure they recieved sessions as a part of their study participation.
The education sessions were delivered to patients over video conference connection with those lacking access or the ability to connect using audio only.
The plan is to share results scientifically and in the community as a team. For community sharing the team will conduct group classes, developed from content that was shared as beneficial in the interviews at Cooper Green and the UAB Chronic Kidney Disease Clinic and in two community-based locations that the community advisory group identifies. The team, including our community advisory croup members, will also write articles to submit to science-based journals. The results of this project will be used to prepare and submit an application to receive more funding to evaluate this program with a larger group of people from other areas in the state or the country.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 22 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Inclusion Criteria:
Patients
Inclusion Criteria:
Care partner
Exclusion Criteria:
Patients
Exclusion Criteria:
Patient participants in this group completed one session of communication training and had 1 follow up call a month after the session has been completed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.
Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
Patient participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.
Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
Patient participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks.
Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
Patient participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. After 12 week data collection, the patient will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made.
Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
ImPart-Multi is a psychoeducational, decision support training program, designed to impact Black chronic kidney disease patients with concurrent metabolic disease and their care partners' ability to 1. contemplate the decision needed, 2. request resources/support, and 3. make an informed patient-centered decision. Participants will participate in either communication training, social support effectiveness training, or a combination of both.
Acceptability Interviews (Investigator Developed)
Through qualitative interviews, participants reported if ImPart-Mulit participation and trial procedures were acceptable.
Time frame: Completed at 12 week survey data collection
Feasibility of Intervention Measure
The FIM is a 4 question survey asking questions regarding how feasible it was to complete the ImPart-Multi Intervention on a 5 point likert scale (1-5). The closer the mean to 5 the greater preceived feasibiltiy. Only patients completed sessions, so only patient data is represented in this measures outcomes. The closer to 5 the mean, the more feasiable the intervention was precieved. All patients did not complete this measure.
Time frame: 12 weeks
Decision Conflict Scale (DCS)
The decision conflict scale is a 16-item total scale, using a 0-4 Likert scale to assess decision conflict. The total sum score was used as an indicator of overall decision conflict. The higher the number (mean), the greater the decision conflict. Total instrument scores range from 0-100.
Time frame: From enrollment to end of study at 12 weeks
Social Support Effectiveness-Questionnaire
The Social Support Effectiveness Questionnaire is a 25-item measuring perceptions of help received in the last 3 months for patients only, on a likert scale 0-4. Total scores range from 0-80, Likert scale 0-4, with higher scores indicating greater social support.
Time frame: From enrollment to end of study at 12 weeks
Kidney Disease Quality of Life Scale (KDQOL-36)
The KDQOL-36 is a 36-item instrument measuring 3 domains: Symptoms and problems of kidney disease, effect of kidney disease, and burden of kidney disease, using a Likert scale 1-5. All domains' total scores can range from 0 to 100. For the symptoms and problems of kidney disease scale, greater numbers indicates greater quality of life. For the effects of kidney disease, the greater the number (mean), the more the patient feels the disease and its treatment have less negative impact on their life, indicating a better quality of life in that specific area. For the burden of kideny disease subscale higher scores means a better, less burdensome quality of life
Time frame: From enrollment to end of study at 12 weeks
PROMIS Global Health 10
The PROMIS Global Health is a 10 items measure of global health-related quality of life in 2 domains, physical and mental health. social domains. It yields two summary scores: Global Physical Health (GPH): Reflects physical health, fatigue, pain, and ability to perform physical activities. Global Mental Health (GMH): Reflects mental health, emotional distress, and satisfaction with social activities and roles. Each item uses a 5-point Likert scale (e.g., Excellent to Poor, Never to Always). Pain is rated on a 0-10 numeric scale and recoded to a 5-point scale for scoring. Raw scores for GPH and GMH are calculated by summing four designated items for each domain. Raw scores are converted to T-scores using PROMIS scoring tables or the HealthMeasures Scoring Service. T-scores are standardized to the U.S. general population (Mean = 50, SD = 10). Higher T-scores indicate better health status.
Time frame: From enrollment to end of study at 12 weeks
Dyadic Coping Inventory
The Dyadic Coping Inventory is a 37 item instrument designed to measure perceived communication and dyadic coping. The total score ranges from 35-175, items are scored 1-5 (rarely to ofetn). Higher scores indicated better dyadic coping: below 111 (low); 111-145 (normal); and above 145 (high).
Time frame: From enrollment to end of study at 12 weeks
| Milestone | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control |
|---|---|---|---|---|
| Started | 6 | 6 | 6 | 4 |
| Baseline data completion -patients | 3 | 3 | 3 | 2 |
| Baseline data completion - caregivers | 3 | 3 | 3 | 2 |
| 12 week data collection - patient | 3 | 2 | 2 | 2 |
| 12 week data collection - caregivers | 3 | 2 | 2 | 2 |
| Completed | 6 | 4 | 4 | 4 |
| Not completed | 0 | 2 | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 | 2 | 0 |
Through qualitative interviews, participants reported if ImPart-Mulit participation and trial procedures were acceptable.
| Participants | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control |
|---|---|---|---|---|
| Theme ImPart-Multi Acceptable | 3 | 2 | 2 | 2 |
| Study Procedures Acceptable | 6 | 2 | 4 | 3 |
The FIM is a 4 question survey asking questions regarding how feasible it was to complete the ImPart-Multi Intervention on a 5 point likert scale (1-5). The closer the mean to 5 the greater preceived feasibiltiy. Only patients completed sessions, so only patient data is represented in this measures outcomes. The closer to 5 the mean, the more feasiable the intervention was precieved. All patients did not complete this measure.
| unites on a scale | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control |
|---|---|---|---|---|
| Feasibility of Intervention Measure | 1.67 ± 1.15 | 3 ± 0 | 4 ± 0 | 3 ± 0 |
The decision conflict scale is a 16-item total scale, using a 0-4 Likert scale to assess decision conflict. The total sum score was used as an indicator of overall decision conflict. The higher the number (mean), the greater the decision conflict. Total instrument scores range from 0-100.
| units on a scale | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control |
|---|---|---|---|---|
| Decision Conflict Scale Baseline | 22.40 ± 28.13 | 28.13 ± 17.75 | 30.47 ± 9.94 | 24.22 ± 14.37 |
| Decision Conflict Scale 12 week | 16.15 ± 14.18 | 25.01 ± 13.26 | 13.23 ± 26.56 | 11.05 ± 19.92 |
The Social Support Effectiveness Questionnaire is a 25-item measuring perceptions of help received in the last 3 months for patients only, on a likert scale 0-4. Total scores range from 0-80, Likert scale 0-4, with higher scores indicating greater social support.
| units on a scale | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control |
|---|---|---|---|---|
| SSES baseline | 68.00 ± 11.53 | 59.97 ± 8.74 | 62.00 ± 6.25 | 61.18 ± 11.80 |
| SSES 12 weeks | 76.00 ± 3.61 | 46.5 ± 21.92 | 50.00 ± 8.49 | 57.50 ± 7.78 |
The KDQOL-36 is a 36-item instrument measuring 3 domains: Symptoms and problems of kidney disease, effect of kidney disease, and burden of kidney disease, using a Likert scale 1-5. All domains' total scores can range from 0 to 100. For the symptoms and problems of kidney disease scale, greater numbers indicates greater quality of life. For the effects of kidney disease, the greater the number (mean), the more the patient feels the disease and its treatment have less negative impact on their life, indicating a better quality of life in that specific area. For the burden of kideny disease subscale higher scores means a better, less burdensome quality of life
| units on a scale | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control |
|---|---|---|---|---|
| KDQOL Symptom/problem list baseline | 95.45 ± 7.88 | 62.88 ± 22.07 | 78.85 ± 8.54 | 75.00 ± 6.43 |
| KDQOL Symptom/problem list 12 week | 100 ± 0.00 | 71.59 ± 8.03 | 75.00 ± 16.01 | 72.73 ± 22.50 |
| KD QOL Effects of kidney disease baseline | 93.75 ± 10.83 | 66.67 ± 17.21 | 89.58 ± 7.22 | 87.50 ± .0 |
| KD QOL Effects of kidney disease 12 weeks | 95.84 ± 10.83 | 84.38 ± 4.42 | 82.82 ± 2.21 | 81.25 ± .0 |
| KD QOL Burden of kidney disease baseline | 93.75 ± 10.83 | 70.83 ± 31.48 | 81.25 ± 16.54 | 87.50 ± 0.00 |
| KD QOL Burden of kidney disease 12 week | 100.00 ± .00 | 81.25 ± .00 | 84.38 ± 4.42 | 75.00 ± 26.52 |
The PROMIS Global Health is a 10 items measure of global health-related quality of life in 2 domains, physical and mental health. social domains. It yields two summary scores: Global Physical Health (GPH): Reflects physical health, fatigue, pain, and ability to perform physical activities. Global Mental Health (GMH): Reflects mental health, emotional distress, and satisfaction with social activities and roles. Each item uses a 5-point Likert scale (e.g., Excellent to Poor, Never to Always). Pain is rated on a 0-10 numeric scale and recoded to a 5-point scale for scoring. Raw scores for GPH and GMH are calculated by summing four designated items for each domain. Raw scores are converted to T-scores using PROMIS scoring tables or the HealthMeasures Scoring Service. T-scores are standardized to the U.S. general population (Mean = 50, SD = 10). Higher T-scores indicate better health status.
| T-scores (converted) | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control |
|---|---|---|---|---|
| PROMIS 10 baseline Physical Health t-Score | 34.87 ± 13.21 | 38.20 ± 1.39 | 31.57 ± 10.10 | 46.56 ± 6.01 |
| PROMIS 10 12 week Physical Health t-Score | 38.20 ± 1.39 | 36.10 ± 5.23 | 33.65 ± 1.77 | 45.00 ± 3.82 |
| PROMIS 10 baseline Mental Health t-Score | 38.17 ± 11.87 | 40.0 ± 4.92 | 32.57 ± 6.47 | 49.55 ± 5.30 |
| PROMIS 10 12 week Mental Health t-Score | 37.87 ± 6.15 | 41.15 ± 3.32 | 28.20 ± 4.38 | 50.90 ± 7.21 |
The Dyadic Coping Inventory is a 37 item instrument designed to measure perceived communication and dyadic coping. The total score ranges from 35-175, items are scored 1-5 (rarely to ofetn). Higher scores indicated better dyadic coping: below 111 (low); 111-145 (normal); and above 145 (high).
| units on a scale | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control |
|---|---|---|---|---|
| Dyadic Coping Inventory baseline | 137.1667 ± 5.31 | 133.00 ± 11.71 | 116.50 ± 16.26 | 83.25 ± 33.32 |
| Dyadic Coping Inventory 12 weeks | 138.67 ± 10.80 | 112.75 ± 11.21 | 134.25 ± 2.06 | 97.67 ± 28.89 |
Collected over From enrollment until 4 weeks post-survey (12-week data collection), to allow for receiving survey responses before interviews were scheduled, so as not to influence quantitative survey collection (thus up to 16 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 - Communication | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Group 2 - Social Support Effectiveness | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Group 3 - Communication and Social Support Effectiveness | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Group 4 - Wait-listed Control | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control | Total |
|---|---|---|---|---|---|
| patients — <=18 years | 0 | 0 | 0 | 0 | 0 |
| patients — Between 18 and 65 years | 2 | 0 | 0 | 0 | 2 |
| patients — >=65 years | 1 | 3 | 3 | 2 | 9 |
| caregivers — <=18 years | 0 | 0 | 0 | 0 | 0 |
| caregivers — Between 18 and 65 years | 2 | 2 | 2 | 1 | 7 |
| caregivers — >=65 years | 1 | 1 | 1 | 1 | 4 |
| Sex: Female, Male(Participants) | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control | Total |
|---|---|---|---|---|---|
| Patients — Female | 2 | 2 | 1 | 2 | 7 |
| Patients — Male | 1 | 1 | 2 | 0 | 4 |
| Caregivers — Female | 3 | 1 | 2 | 2 | 8 |
| Caregivers — Male | 0 | 2 | 1 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control | Total |
|---|---|---|---|---|---|
| patients — American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| patients — Asian | 0 | 0 | 0 | 0 | 0 |
| patients — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| patients — Black or African American | 3 | 3 | 2 | 2 | 10 |
| patients — White | 0 | 0 | 0 | 0 | 0 |
| patients — More than one race | 0 | 0 | 0 | 0 | 0 |
| patients — Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
| caregivers — American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| caregivers — Asian | 0 | 0 | 0 | 0 | 0 |
| caregivers — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| caregivers — Black or African American | 3 | 3 | 3 | 1 | 10 |
| caregivers — White | 0 | 0 | 0 | 1 | 1 |
| caregivers — More than one race | 0 | 0 | 0 | 0 | 0 |
| caregivers — Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control | Total |
|---|---|---|---|---|---|
| Patients — Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Patients — Not Hispanic or Latino | 3 | 3 | 2 | 2 | 10 |
| Patients — Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
| caregivers — Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| caregivers — Not Hispanic or Latino | 3 | 3 | 3 | 2 | 11 |
| caregivers — Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Group 1 - Communication | Group 2 - Social Support Effectiveness | Group 3 - Communication and Social Support Effectiveness | Group 4 - Wait-listed Control | Total |
|---|---|---|---|---|---|
| United States | 6 | 6 | 6 | 4 | 22 |
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University of Alabama at Birmingham