Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)
Purpose
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.
Conditions
- Kidney Diseases
- Cardiometabolic Risk Factors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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. 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- Statistician
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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Experimental Group 1 - Communication |
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. |
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Experimental Group 2 - Social Support Effectiveness |
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. |
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Experimental Group 3 - Communication and Social Support Effectiveness |
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. |
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Placebo Comparator Group 4 - Wait-listed Control |
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. |
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More Details
- Status
- Completed
- Sponsor
- University of Alabama at Birmingham
Study Contact
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.