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Kidney DiseasesImPart-MultiNCT06067009

Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)

A study testing ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease in people with Kidney Diseases and Cardiometabolic Risk Factors, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Diseases, Cardiometabolic Risk Factors
What is being tested?
ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteUnited States
Study dates
20 Mar 2024to 25 Feb 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients
  • Electronic medical record (EMR) documented diagnosis of stage 3 or 4 CKD (2 estimated glomerular filtration rate [eGFR] between 45-15 within 90 days); and concurrent cardiometabolic disease (hypertension and/or diabetes)
  • Ability to speak and read English and complete baseline questionnaires;
  • Patients must have a care partner enrolled in the study - the team will assist any patient in identifying a care partner, if interested.
  • Care partner
  • Age ≥18; 2) Self-endorsing or identified by the patient as "a relative, friend, or partner that has a close relationship with you and who assists you with your medical decisions and who may or may not live in the same residence as you and who is not paid for their help";
  • Ability to speak and read English and complete baseline questionnaires;
  • Care partners must have an enrolled patient.

Who cannot join

  • Patients
  • Receiving hospice;
  • Receiving dialysis;
  • Medical record documentation of active unmedicated severe mental illness, moderate-severe dementia, suicidal ideation, uncorrected hearing loss, and active substance abuse.
  • Care partner 1. Self-reported unmedicated mental illness, mild-severe dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse ascertained by study introduction questioning.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-0001

Other trials in United States

About this study

Official title: A Feasibility Trial of a Stakeholder-Enhanced, Lay-Navigator-Delivered Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads

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.

Read the detailed description

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.

Being tested
ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
Keywords
decision support, decision-making, patient activation, caregiving
Medical subject headings
Kidney Diseases, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic diseaseBehavioural

    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.

Study groups in NCT06067009
Study groupRoleWhat they receive
Group 1 - CommunicationExperimentalPatient 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.
Receives: Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
Group 2 - Social Support EffectivenessExperimentalPatient 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.
Receives: Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
Group 3 - Communication and Social Support EffectivenessExperimentalPatient 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.
Receives: Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
Group 4 - Wait-listed ControlPlacebo comparatorPatient 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.
Receives: Behavioral: ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability Interviews (Investigator Developed)

    Through qualitative interviews, participants reported if ImPart-Mulit participation and trial procedures were acceptable.

    Measured: Completed at 12 week survey data collection

  2. 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.

    Measured: 12 weeks

Secondary outcomes (5)
  1. 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.

    Measured: From enrollment to end of study at 12 weeks

  2. 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.

    Measured: From enrollment to end of study at 12 weeks

  3. 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

    Measured: From enrollment to end of study at 12 weeks

  4. 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.

    Measured: From enrollment to end of study at 12 weeks

  5. 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).

    Measured: From enrollment to end of study at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2023
  2. Study start20 Mar 2024
  3. Primary completion10 Feb 2025
  4. Study completion25 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06067009
Sponsor's protocol ID
300011311
Other IDs
UAB
Acronym
ImPart-Multi
Status last verified
Jan 2026
First submitted
27 Sep 2023
Last updated
13 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease in people with Kidney Diseases and Cardiometabolic Risk Factors, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability Interviews (Investigator Developed) (time frame: Completed at 12 week survey data collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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