Clinical trial NCT06067009: Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)
Official title: A Feasibility Trial of a Stakeholder-Enhanced, Lay-Navigator-Delivered Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Cardiometabolic Risk Factors
Keywords: decision support
decision-making
patient activation
caregiving
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: We seek to explore the feasibility and acceptability of participation in a decision-support training program led by lay navigators. ImPart-Multi, an education-telehealth-based, is designed to empower Black chronic kidney disease patients (CKD) patients and their care partner to seek the resources and support needed to be activated allies when making health-related decisions.

Participants, based on random assignment, will participate in survey completion at study start and at 12 and 24 weeks of enrollment, and will complete 1, 3, or 4 education sessions via telehealth or audio connection. Participants will also complete an interview to share their thoughts on the program 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 we have 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. We seek 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. We also seek 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. Our goal is to positively impact health promotion by teaching answer-seeking behaviors to people with high-risk chronic kidney disease.

Our team will recruit 32 Black adults with stage 3 or 4 chronic kidney disease and one identified care partner for a total of 64 people 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 of participants: 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. 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.

Participants will be paid $20 when they complete surveys at three points - 1) when starting the study, 2) at the end of three months, and 3) if the participant completes the interview. The education sessions will be delivered over video conference connection with those lacking access or the ability to connect using audio only.

We plan to share our results scientifically and in the community as a team. Our plans for community sharing is through 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. Our 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.

Eligibility criteria: 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Acceptability of Intervention and Study Procedures
timeFrame: Baseline to 12 weeks Groups 1, 2 and 3; 24 weeks Group 4
measure: Feasibility of Intervention Delivery and Data Collection
timeFrame: Groups 1, 2, 3 and 4 baseline through to 12 weeks; Group 4 only baseline to 24 weeks
Secondary outcomes:
measure: Decision-making process using the Decision Conflict Scale (DCS)
timeFrame: baseline, and 24 weeks after baseline
measure: Decision-making process using the Social Support Effectiveness-Questionnaire
timeFrame: baseline and 12 weeks after baseline
measure: Patient Wellbeing using the Kidney Disease Quality of Life Scale (KDQOL-36)
timeFrame: baseline and 12 weeks after baseline
measure: Care partner well being using the PROMIS Global Health 10
timeFrame: baseline and 12 weeks after baseline
measure: Dyadic Interaction using the Dyadic Coping Inventory
timeFrame: baseline and 12 weeks after baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UAB School of Nursing
name: Shena Gazaway, PhD
role: PRINCIPAL_INVESTIGATOR
References: