No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
128 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for patients with stage 4 chronic kidney disease and their caregivers. Participants will receive training to help improve decision-making and support for managing the patient's condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with stage 4 chronic kidney disease.
I can read and speak English.
I have a designated caregiver who will join the trial.
You may not be able to join if
I am currently receiving hospice care.
I am on dialysis.
I have severe mental illness that is not treated.
I have moderate to severe dementia.
I have active suicidal thoughts.
I have uncorrected hearing loss.
I struggle with substance abuse.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, an optimization trial approach to develop and refine the decision partnering skills of persons with stage 4 chronic kidney disease and their caregivers. Using a 2x2x2 full factorial design, 64 dyads (patients and one identified caregiver) will be randomized to receive one…
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, an optimization trial approach to develop and refine the decision partnering skills of persons with stage 4 chronic kidney disease and their caregivers. Using a 2x2x2 full factorial design, 64 dyads (patients and one identified caregiver) will be randomized to receive one or more lay coach-delivered decision partnering training components, based on Pearlin's Stress-Health Model of Family Caregiving and Rini's Social Support Effectiveness theory. The components include: 1) caregiver coaching on effective decision support (1 vs. 3 sessions); 2) caregiver decision support communication training (1 session vs. none); and 3) patient social support effectiveness psychoeducation (yes vs. no).
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* Patients
1. Age ≥18;
2. EMR documented diagnosis of stage 4 CKD (2 eGFR 29-15 within 90 days);
3. Ability to speak and read English and complete baseline questionnaires;
4. Patients must have an enrolled caregiver
Exclusion Criteria:
* Patients
1. Receiving hospi…
Inclusion Criteria:
* Patients
1. Age ≥18;
2. EMR documented diagnosis of stage 4 CKD (2 eGFR 29-15 within 90 days);
3. Ability to speak and read English and complete baseline questionnaires;
4. Patients must have an enrolled caregiver
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.
Inclusion Criteria:
* Caregivers
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
3. Caring for a patient with CKD;
4. Ability to speak and read English and complete baseline questionnaires;
5. Caregivers must have an enrolled patient.
Exclusion Criteria:
* Caregivers 1) Self-reported unmedicated mental illness, Moderate-severe dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse ascertained by scripted study introduction questioning.
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