Decision support training for chronic kidney disease dyads: the ImPart Study protocol.
Shena Gazaway, Rachel Wells, Orlando M Gutierrez...
https://pubmed.ncbi.nlm.nih.gov/41449447/Actively Recruiting
Led by University of Alabama at Birmingham · Updated on 2026-01-26
128
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to develop and refine decision partnering skills between patients with stage 4 chronic kidney disease CKD and their caregivers. It focuses on improving how these dyads make health-related decisions throughout the illness, addressing gaps in current interventions that often exclude caregivers and overlook broader decision-making beyond specific medical treatments. The study uses the Multiphase Optimization Strategy MOST to test different training components efficiently. Participants are randomized into one of eight groups receiving various combinations of caregiver coaching sessions, caregiver communication training, and patient psychoeducation. The intervention is delivered via telehealth and includes weekly sessions and monthly follow-up calls to support decision-making partnerships. Components tested include differing numbers of coaching sessions and the presence or absence of communication and psychoeducation training. Participants and their caregivers engage in assessments at baseline, 12 weeks, and 24 weeks to evaluate the feasibility, acceptability, and preliminary impact of the intervention components. Measures include decision conflict, social support effectiveness, distress, quality of life, and dyadic coping. The study lasts 24 weeks, with close monitoring of intervention completion and data collection processes to inform future trials.
CONDITIONS
A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
S
Shena Gazaway, Phd, RN
A
Alicia Cole, MS
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University of Alabama at Birmingham
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | ImPart (advanced support, communication, and psychoeducation) | ImPart (basic social support only) | Usual care for CKD patients and caregivers |
|---|---|---|---|
| What it is | A comprehensive behavioral program for CKD dyads, combining advanced social support, caregiver-patient communication enhancement, and psychoeducation. Developed with stakeholder input and tailored to patients and caregivers. | A simplified intervention offering only basic social support for CKD dyads, with no structured communication or psychoeducation components. | Standard care for CKD patients and caregivers focuses on medical management, basic education about CKD, and general emotional support. Structured dyadic decision-support interventions and expanded social support are not routinely integrated in most clinical settings. |
| Role in trial | Serves as the most intensive intervention arm, intended to maximize decision-support, communication, and education for CKD dyads. | Acts as the comparator arm with minimal intervention, providing only basic social support. Used to measure effects of adding communication and psychoeducation. | In routine care, patients and caregivers receive medical follow-up and general support tailored to CKD severity. Formalized decision-support is uncommon outside research. |
| Primary use or purpose | Designed to strengthen the medical decision-making partnership and support emotional well-being of both patient and caregiver during advanced CKD care. | Aims to provide emotional support and social engagement for patients and caregivers without structured decision-making or educational modules. | Provides ongoing medical management, education about CKD, and basic emotional support, typically lacking structured communication or decision-support training. |
| How it is given or performed | Delivered by trained facilitators in structured sessions, combining education modules, communication training, and advanced social support. Sessions include interactive activities for both patient and caregiver. | Delivered through scheduled basic support sessions, without additional structured education or communication exercises. | Routine care involves regular medical appointments, printed educational materials, and general psychosocial support from the healthcare team. No formalized dyadic decision-support sessions are part of standard care. |
| Evidence status or maturity | Currently under evaluation; evidence from ongoing trial and protocol highlights feasibility and acceptability for CKD dyads. No published outcomes on effectiveness yet. | Serves as a control in trial; basic social support is widely used but lacks published evidence for structured decision-support effectiveness in CKD dyads. | Routine care and psychosocial support are established for advanced CKD management, but structured dyadic decision-support interventions are not standard or well-studied. Guidelines recognize caregiver involvement and stress education and emotional support. |
| Important limitations | The ImPart intervention is currently experimental, requiring time and engagement from both patients and caregivers. Its efficacy, integration into routine care, and impact on diverse populations remain unproven until results are published. | Basic social support alone lacks structured decision-support; may not address complex communication or educational needs for CKD dyads. No trial-proven outcomes for decision-making effectiveness. | Routine care offers general support but rarely includes structured decision-support or advanced communication training for CKD dyads. Effectiveness at improving shared decision-making is limited by absence of formalized interventions. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or telephone)
Duration - Up to 4 weeks depending on intervention components assigned
Participants receive behavioral intervention sessions designed to improve decision-making partnerships between patients with stage 4 Chronic Kidney Disease and their caregivers via telehealth or telephone. Sessions include social support, communication training, and psychoeducation.
1 to 4 weekly sessions (in-person or telephone), plus monthly follow-up calls for up to 24 weeks
Duration - Up to 24 weeks after intervention start
Participants complete follow-up assessments to evaluate intervention feasibility, acceptability, and preliminary efficacy over 24 weeks.
Assessments at baseline, 12 weeks, and 24 weeks (in-person or telephone)
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
8
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Shena Gazaway, Rachel Wells, Orlando M Gutierrez...
https://pubmed.ncbi.nlm.nih.gov/41449447/University of Alabama at Birmingham
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor