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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06067009
Acronym
ImPart-Multi
Enrollment
22
Registered
2023-10-04
Start date
2024-03-20
Completion date
2025-02-25
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometabolic Risk Factors, Kidney Diseases

Keywords

decision support, decision-making, patient activation, caregiving

Brief 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 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.

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.

Interventions

BEHAVIORALImPart-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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Statistician

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients 1. 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) 2. Ability to speak and read English and complete baseline questionnaires; 3. Patients must have a care partner enrolled in the study - the team will assist any patient in identifying a care partner, if interested. Inclusion Criteria: * Care partner 1. 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"; 2. Ability to speak and read English and complete baseline questionnaires; 3. Care partners must have an enrolled patient.

Exclusion criteria

* Patients 1. Receiving hospice; 2. Receiving dialysis; 3. Medical record documentation of active unmedicated severe mental illness, moderate-severe dementia, suicidal ideation, uncorrected hearing loss, and active substance abuse.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability Interviews (Investigator Developed)Completed at 12 week survey data collectionThrough qualitative interviews, participants reported if ImPart-Mulit participation and trial procedures were acceptable.
Feasibility of Intervention Measure12 weeksThe 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.

Secondary

MeasureTime frameDescription
Decision Conflict Scale (DCS)From enrollment to end of study at 12 weeksThe 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.
Social Support Effectiveness-QuestionnaireFrom enrollment to end of study at 12 weeksThe 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.
Kidney Disease Quality of Life Scale (KDQOL-36)From enrollment to end of study at 12 weeksThe 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
PROMIS Global Health 10From enrollment to end of study at 12 weeksThe 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.
Dyadic Coping InventoryFrom enrollment to end of study at 12 weeksThe 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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORShena Gazaway, PhD

UAB School of Nursing

Participant flow

Pre-assignment details

As a condition of enrollment, patients and caregivers completed baseline surveys. The number of participants indicates individual participant numbers, not the total number of dyads.

Baseline characteristics

Characteristic
Age, Categorical
caregivers
<=18 years
0 Participants
Age, Categorical
caregivers
>=65 years
1 Participants
Age, Categorical
caregivers
Between 18 and 65 years
7 Participants
Age, Categorical
patients
<=18 years
0 Participants
Age, Categorical
patients
>=65 years
9 Participants
Age, Categorical
patients
Between 18 and 65 years
2 Participants
Ethnicity (NIH/OMB)
caregivers
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
caregivers
Not Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
caregivers
Unknown or Not Reported
0 Participants
Ethnicity (NIH/OMB)
Patients
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Patients
Not Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Patients
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
caregivers
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
caregivers
Asian
0 Participants
Race (NIH/OMB)
caregivers
Black or African American
3 Participants
Race (NIH/OMB)
caregivers
More than one race
0 Participants
Race (NIH/OMB)
caregivers
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
caregivers
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
caregivers
White
0 Participants
Race (NIH/OMB)
patients
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
patients
Asian
0 Participants
Race (NIH/OMB)
patients
Black or African American
10 Participants
Race (NIH/OMB)
patients
More than one race
0 Participants
Race (NIH/OMB)
patients
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
patients
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
patients
White
0 Participants
Region of Enrollment
United States
6 Participants
Sex: Female, Male
Caregivers
Female
3 Participants
Sex: Female, Male
Caregivers
Male
2 Participants
Sex: Female, Male
Patients
Female
2 Participants
Sex: Female, Male
Patients
Male
1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 60 / 60 / 4
other
Total, other adverse events
0 / 60 / 60 / 60 / 4
serious
Total, serious adverse events
0 / 60 / 60 / 60 / 4

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026