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

Primary Purpose

Kidney Diseases, Cardiometabolic Risk Factors

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Kidney Diseases focused on measuring decision support, decision-making, patient activation, caregiving

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1 - Communication

Group 2 - Social Support Effectiveness

Group 3 - Communication and Social Support Effectiveness

Group 4 - Wait-listed Control

Arm Description

Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed.

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.

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.

Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. After 12 week data collection, they 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.

Outcomes

Primary Outcome Measures

Acceptability of Intervention and Study Procedures
Through qualitative interviews, participant reported experiences with the ImPart Multi intervention and trial procedures.
Feasibility of Intervention Delivery and Data Collection
Proportion of participants who complete assigned intervention group and study related assessments.

Secondary Outcome Measures

Decision-making process using the Decision Conflict Scale (DCS)
16 items total; measures perceptions of uncertainty in choosing options, factors contributing to uncertainty and feeling that decisions were informed and values-based
Decision-making process using the Social Support Effectiveness-Questionnaire
25 items measuring perceptions of help received in last 3 months
Patient Wellbeing using the Kidney Disease Quality of Life Scale (KDQOL-36)
36 items measure 3 components:physical health, mental health, and kidney disease health.
Care partner well being using the PROMIS Global Health 10
10 items measure global health-related quality of life in 2 domains, physical and mental health
Dyadic Interaction using the Dyadic Coping Inventory
37 item instrument designed to measure perceived communication and dyadic coping in close relationships when one or both partners is stressed.

Full Information

First Posted
September 27, 2023
Last Updated
September 27, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT06067009
Brief Title
Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)
Acronym
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Cardiometabolic Risk Factors
Keywords
decision support, decision-making, patient activation, caregiving

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Statistician
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Communication
Arm Type
Experimental
Arm Description
Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed.
Arm Title
Group 2 - Social Support Effectiveness
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3 - Communication and Social Support Effectiveness
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 4 - Wait-listed Control
Arm Type
Placebo Comparator
Arm Description
Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. After 12 week data collection, they 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.
Intervention Type
Behavioral
Intervention Name(s)
ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of Intervention and Study Procedures
Description
Through qualitative interviews, participant reported experiences with the ImPart Multi intervention and trial procedures.
Time Frame
Baseline to 12 weeks Groups 1, 2 and 3; 24 weeks Group 4
Title
Feasibility of Intervention Delivery and Data Collection
Description
Proportion of participants who complete assigned intervention group and study related assessments.
Time Frame
Groups 1, 2, 3 and 4 baseline through to 12 weeks; Group 4 only baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Decision-making process using the Decision Conflict Scale (DCS)
Description
16 items total; measures perceptions of uncertainty in choosing options, factors contributing to uncertainty and feeling that decisions were informed and values-based
Time Frame
baseline, and 24 weeks after baseline
Title
Decision-making process using the Social Support Effectiveness-Questionnaire
Description
25 items measuring perceptions of help received in last 3 months
Time Frame
baseline and 12 weeks after baseline
Title
Patient Wellbeing using the Kidney Disease Quality of Life Scale (KDQOL-36)
Description
36 items measure 3 components:physical health, mental health, and kidney disease health.
Time Frame
baseline and 12 weeks after baseline
Title
Care partner well being using the PROMIS Global Health 10
Description
10 items measure global health-related quality of life in 2 domains, physical and mental health
Time Frame
baseline and 12 weeks after baseline
Title
Dyadic Interaction using the Dyadic Coping Inventory
Description
37 item instrument designed to measure perceived communication and dyadic coping in close relationships when one or both partners is stressed.
Time Frame
baseline and 12 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shena Gazaway, Phd, RN
Phone
2059755304
Email
gazaways@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shena Gazaway, PhD
Organizational Affiliation
UAB School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0001
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shena Gazaway, Phd, RN
Phone
205-975-5304
Email
gazaways@uab.edu
Email
gazaways@uab.edu
First Name & Middle Initial & Last Name & Degree
Shena Gazaway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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