[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06693661":3,"trial-entities:NCT06693661":159,"trial-summary:NCT06693661":163},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":47,"secondary_outcomes":55,"sex":111,"minimum_age":112,"maximum_age":113,"healthy_volunteers":114,"eligibility_criteria":115,"std_ages":131,"locations":134,"central_contacts":148,"overall_officials":154,"references":157,"see_also_links":158},"NCT06693661","STUDY00007938","Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease","Improving Access to Nephrology Treatment and Care Among Patients at Greatest Risk for Kidney Failure","RECRUITING","2028-03","2026-06","2026-06-04","2026-03-10","Emory University","OTHER",true,"Through the use of community-engaged processes, this project seeks to develop and implement clinical decision support (CDS) and a kidney health coaching (KHC) intervention. The CDS seeks to streamline workflows to effectively screen, identify, and link to care for those patients with advanced chronic kidney disease (CKD).\n\nThe overall project goals are to 1.) Design and conduct community-engaged clinical trials to test new interventions that dismantle the systemic factors that contribute to kidney health disparities. 2.) Foster research collaborations between investigators, people living with kidney disease, community-based organizations, and other key stakeholders.\n\nResearchers aim to assess whether the KHC intervention is effective at delaying the transition to kidney replacement therapy (KRT) and central venous catheter use or death.","The team aims to implement multi-level, multi-component interventions across primary care and acute care access points and nephrology care, using an experimental 2-group randomized controlled trial, to assess the effectiveness of a kidney health coaching intervention on delaying a) the transition to kidney replacement therapy and central venous catheter use and b) death.\n\nThe research team will deliver patient-centered kidney health coaching through full-time kidney health coaches (KHCs), who have lived experience with chronic kidney disease (CKD) and have been selected for certain personality characteristics. The KHCs have undergone training to deliver patient support that aligns with the constructs of the Chronic Care Model: Clinical information systems, Patient self-management, and treatment decision-making support, Delivery system redesign, and Community resources.\n\nParticipants enrolled in the intervention will receive 6 months of kidney health coaching. Those eligible for participation will be invited to participate and undergo the informed consent process via telephone. Next, study staff will administer the baseline assessment via telephone interview for those who consent.",[19],"Kidney Diseases",[21,22,23,24],"African American","Health Disparities","Chronic Care Model (CCM)","Kidney Health Coach (KHC)","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},600,"ESTIMATED",[33,40],{"type":14,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"Kidney Health Coaching","The intervention entails support from a KHC that includes:\n\n* An initial rapport-building call\n* Ongoing telephone support at least twice a month for six months\n* Meeting the patient at all in-person clinic appointments\n* Documenting interactions in the EMR using a customized platform\n\nTelephone support begins with a social determinants of health (SDoH) screening tool to identify barriers and facilitators to CKD self-management and appointment adherence. This tool provides access to local resources based on the patient's ZIP code. Subsequent calls will follow up on resource usage, review CKD educational materials and treatment options, complete the Decision Aid for Renal Therapy tool, and facilitate communication through the patient portal. Each call will start with specific goals (e.g., review National Kidney Foundation CKD materials) and conclude with goals for the next session.",[37],"Intervention: Kidney Health Coaching",[39],"KHC Protocol",{"type":14,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"Usual Care","ER Discharge (d\u002Fc): Participants may receive consultations and support from Care Management in the ER, such as transportation or medication assistance. Follow-up by a social worker varies post-discharge.\n\nHospital d\u002Fc: All hospitalized patients are assessed by the care management team to identify psychosocial needs and begin discharge planning, which may include follow-up appointments and resources. High-risk patients receive additional follow-up from a care transitions coordinator for 30 days post-discharge.\n\nPrimary Care: Patients in primary care clinics have access to various support services. Those recently hospitalized or identified as high-risk receive care coordination from social workers. Internal referrals are managed by referral coordinators, while external referrals come from clinic staff. Discharge information is provided after visits.\n\nNephrology: There are no coordinated support services for chronic kidney disease (CKD) patients receiving nephrology care.",[44],"Control: Usual Care",[46],"Control",[48,52],{"measure":49,"description":50,"timeFrame":51},"Time-to-Kidney Replacement Therapy w\u002FCentral Venous Catheter","Composite measure of time to transition to Kidney Replacement Therapy (KRT) using a central venous catheter (CVC) over the course of the study period","Throughout study participation up to 12 months",{"measure":53,"description":54,"timeFrame":51},"Time-to-death","Composite measure of time to death over the course of the study period. A record of death in the electronic medical record (EMR), and the date of death will be recorded. If the data is not available in EMR, national death statistics will be checked, and the patient's family will be asked.",[56,59,62,65,68,71,75,78,81,84,87,90,93,96,99,102,105,108],{"measure":57,"description":58,"timeFrame":51},"Time to progression to end stage kidney disease (ESKD)","Composite measure of time to ESKD diagnosis over the course of the study period. Progression to ESKD will be analyzed using monthly data collected from the EMR, capturing each participant's progression characterized by a significant loss of kidney function (defined as a glomerular filtration rate (GFR) of less than 15 mL\u002Fmin) requiring KRT. Time to event will be calculated for all participants at the end of the follow-up period.",{"measure":60,"description":61,"timeFrame":51},"Time-to-optimal Kidney Replacement Therapy (KRT) referral","Composite measure of time to referral for optimal KRT start over the course of the study. This includes referral for vascular surgery, preemptive kidney transplant evaluation, and\u002For home dialysis initiation. Data will be collected monthly from the EMR.",{"measure":63,"description":64,"timeFrame":51},"Number of participants who transition-to-Kidney Replacement Therapy w\u002FCentral Venous Catheter","Number of participants who transitioned to Kidney Replacement Therapy (KRT) with the use of a central venous catheter (CVC) during the course of the study.",{"measure":66,"description":67,"timeFrame":51},"Mortality rate","Mortality during study participation.",{"measure":69,"description":70,"timeFrame":51},"Nephrology appointment attendance","Continuous measure of nephrology appointment adherence measured as the ratio of # appointments attended to # appointments scheduled during the course of the study. At the end of the follow-up period for all participants, the researchers will calculate the proportion of appointments attended as a measure of appointment adherence. This will be captured from the Emory Healthcare appointment-keeping system.",{"measure":72,"description":73,"timeFrame":74},"CKD Symptom Burden","Self-reported occurrence of physical and emotional symptoms commonly experienced in individuals with CKD. Participants will complete a 29-item CKD Symptom Burden questionnaire that captures the frequency at which patients experience symptoms. Response options are on a 4-point scale (0 'never' to 4 'every day'). The summed total score ranges from 0 to 29. The greater the frequency of symptoms, the poorer the health-related and self-perceived quality of life.","Baseline, 6 months and 12 months",{"measure":76,"description":77,"timeFrame":74},"Quality of Life Scale","Participants will complete a 10-item phone survey that assesses their perceived quality of life. Responses are recorded on a 5-point scale, with total scores ranging from 10 to 50; higher scores indicate better self-reported health-related quality of life.",{"measure":79,"description":80,"timeFrame":74},"Patient activation Score","Patient activation will be measured using the Patient Activation Measure (PAM), completed by phone. PAM is a validated self-reported questionnaire designed to assess an individual's knowledge, skills, and confidence in managing their well-being. It captures participants' agreement with 22 statements regarding their self-efficacy in maintaining health, measured on a scale from \"Strongly Disagree\" to \"Strongly Agree.\" The response options are on a 4-point scale. Scores range from 0 to 100, with higher scores indicating greater activation.",{"measure":82,"description":83,"timeFrame":74},"Decisional conflict scale","Decisional conflict will be measured using the Decisional Conflict Scale (DCS). The DCS measures personal perceptions of uncertainty in choosing options. The survey will be conducted over the phone to capture the level of agreement a participant has with 16 statements regarding their ability to make an informed decision, measured on a scale from \"Strongly Disagree\" to \"Strongly Agree.\" The response options are on a 5-point scale. Scores can range from 16 to 70. Higher Scores indicate higher decisional conflicts.",{"measure":85,"description":86,"timeFrame":74},"Medical Mistrust Organization Score","Medical mistrust organization will be measured using the Medical Mistrust Index adapted to address general mistrust of healthcare providers. Participants will answer the questions over the phone. Questions will capture their level of agreement with seven statements regarding healthcare organizations. Responses are measured on a 4-point scale, ranging from \"Strongly Disagree\" to \"Strongly Agree\". Scores can range from 7 to 28.",{"measure":88,"description":89,"timeFrame":74},"Discrimination in Medical Settings (DMS) Scale","DMS Scale is a validated, 7-item, 5-point Likert survey (1=never, 5=almost always) adapted from the Everyday Discrimination Scale to measure patients' self-reported experiences of, or perceptions of, mistreatment by healthcare providers due to factors like race, sex, or age. It assesses, for instance, if a patient is treated with less courtesy, respect, or receives poorer service, ranging from 7 to 35. There is no single \"official\" cutoff score that defines the presence of discrimination for everyone, as the DMS Scale is designed to measure the frequency of experiences on a continuous spectrum, with higher scores indicating more frequent experiences of discrimination.",{"measure":91,"description":92,"timeFrame":74},"CKD treatment Knowledge","To measure participants' CKD treatment knowledge, they will complete a 9-item yes\u002Fno questionnaire over the phone. The research team will count the number of correct responses, resulting in a score ranging from 0 to 9.",{"measure":94,"description":95,"timeFrame":74},"Rotterdam Renal Replacement Knowledge test","KRT knowledge will be measured using the Rotterdam Renal Replacement Knowledge test. Participants will complete the 21-item test over the phone, assessing their understanding of renal replacement therapy. The research team will count the correct responses, allowing scores to range from 0 to 21. Higher scores suggest a better understanding of KRT, indicating preparedness to make informed decisions about treatment options.",{"measure":97,"description":98,"timeFrame":74},"Shared Decision-Making Score","Shared decision-making will be measured using the Shared Decision-Making Q-9. Participants will respond by phone to 16 statements regarding their ability to make informed decisions, using a 5-point scale from \"Strongly Disagree\" to \"Strongly Agree.\" Scores will range from 16 to 80.\n\nInterpretation of Scores:\n\nLow Score (16-40): Indicates poor shared decision-making, suggesting the patient may feel uninformed or not involved in their care.\n\nModerate Score (41-60): Reflects a moderate level of shared decision-making, indicating some collaboration occurs but that improvements are needed.\n\nHigh Score (61-80): Suggests strong shared decision-making, where patients feel well-informed and actively involved in their healthcare decisions.",{"measure":100,"description":101,"timeFrame":74},"Brief Health Literacy Screening Tool (BRIEF)","The BRIEF tool is a four-question screening test where clinicians can ask patients four questions to determine their health literacy level (the degree to which one can read, understand, exchange, and use health information and resources). Each item is worth 1 to 5 points depending on the response (1=Always, 5=Never). The values for the four responses are added for a total score, which ranges from a minimum of 4 to a maximum of 20.\n\nInterpretation of Scores:\n\nLimited (4 -12): Not able to read most low-literacy health materials; will need repeated oral instructions; materials should have illustrations or videotapes. Will need low literacy materials; may not be able to read a prescription label.) Marginal (13 - 16): Will be able to read and comprehend most patient education materials.\n\nAdequate (17 - 20): Will be able to read and comprehend most patient education materials.",{"measure":103,"description":104,"timeFrame":74},"Participants with Health-Related Social Needs","Health-Related Social Needs (HRSN) Identified via the Accountable Health Communities Health-Related Social Needs (AHC HRSN) Screening Tool. HRSNs will be identified using the AHC HRSN Screening Tool, which includes five core domains (housing instability, food insecurity, transportation problems, utility help needs, interpersonal safety). Outcomes reflect the number of participants with one or more HRSNs.",{"measure":106,"description":107,"timeFrame":74},"Patient Health Questionnaire (PHQ-9)","The Patient Health Questionnaire-9 (PHQ-9) is a self-administered 9-item tool used to screen, diagnose, and monitor the severity of depression in adults. It assesses symptoms over the past two weeks based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria, with scores ranging from 0 to 27. A score of \\>=10 typically indicates moderate depression, requiring further clinical evaluation.\n\nInterpretation of Scores:\n\n0-4: Minimal or no depression (monitor) 5-9: Mild depression (use clinical judgment) 10-14: Moderate depression (active treatment) 15-19: Moderately severe depression 20-27: Severe depression",{"measure":109,"description":110,"timeFrame":74},"General Anxiety Disorder (GAD-7)","The Generalized Anxiety Disorder scale-7 (GAD-7) is a seven-item diagnostic tool validated in both the primary care setting and the general population, with reporting scores from 0 to 3 on all questions. It investigates how often the patient has been bothered by seven different symptoms of anxiety during the last two weeks, with response options such as \" not at all,\" \" several days ',\" more than half the days,\" and \" nearly daily \" scored as 0, 1, 2, and 3, respectively. The scores of 5, 10, and 15 are taken as cut-off points for mild, moderate, and severe anxiety, respectively.\n\nInterpretation of Scores:\n\n0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety","ALL","18 Years",null,false,{"inclusion":116,"exclusion":121,"raw_text":130},[117,118,119,120],"Identifies as African American or Black","Two estimated glomerular filtration rates (eGFRs) \\\u003C 29 separated by at least 90 days but within the past 2 years, or a Kidney Failure Risk Equation (KFRE) score of 10% or greater likelihood of kidney failure within the next 2 years","Had an encounter at Emory Healthcare through an ambulatory visit or inpatient stay (i.e., ER or hospital visit within the previous 2 months","Stated willingness to comply with all study procedures and availability for the duration of the study",[122,123,124,125,126,127,128,129],"Currently on dialysis","currently receiving hospice care or other types of conservative management for terminal illness","Currently on waitlist, or referred for\u002For completed a transplant evaluation visit within the past 2 years","Kidney or another solid organ transplant","Active cancer treatment","Non-English speaking","Participating in another treatment or intervention study at the time of enrollment","Currently pregnant or planning to become pregnant at the time of recruitment","Inclusion Criteria:\n\n* Identifies as African American or Black\n* Two estimated glomerular filtration rates (eGFRs) \\\u003C 29 separated by at least 90 days but within the past 2 years, or a Kidney Failure Risk Equation (KFRE) score of 10% or greater likelihood of kidney failure within the next 2 years\n* Had an encounter at Emory Healthcare through an ambulatory visit or inpatient stay (i.e., ER or hospital visit within the previous 2 months\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Currently on dialysis\n* currently receiving hospice care or other types of conservative management for terminal illness\n* Currently on waitlist, or referred for\u002For completed a transplant evaluation visit within the past 2 years\n* Kidney or another solid organ transplant\n* Active cancer treatment\n* Non-English speaking\n* Participating in another treatment or intervention study at the time of enrollment\n* Currently pregnant or planning to become pregnant at the time of recruitment",[132,133],"ADULT","OLDER_ADULT",[135,144],{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":140,"geoPoint":141},"Emory University Hospital Midtown","Atlanta","Georgia","30308","United States",{"lat":142,"lon":143},33.749,-84.38798,{"facility":145,"status":8,"city":137,"state":138,"zip":146,"country":140,"geoPoint":147},"Emory Healthcare System","30322",{"lat":142,"lon":143},[149],{"name":150,"role":151,"phone":152,"email":153},"Kimberly R Jacob Arriola, PhD, MPH","CONTACT","404-727-2600","kjacoba@emory.edu",[155],{"name":150,"affiliation":13,"role":156},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":160,"biomarkers":162},[161],"Chronic Kidney Disease",[],{"nct_id":4,"found":15,"summary":164,"prompt_version":174},{"design":165,"status":166,"heading":167,"summary":168,"follow_up":169,"word_count":170,"commitments":171,"compensation":172,"drugs_mentioned":173},"This is an interventional study with a planned enrollment of 600 participants. It uses a randomized controlled trial design, meaning participants will be randomly assigned to either receive Kidney Health Coaching or usual care.","completed","Kidney Health Coaching for Advanced Kidney Disease","This study, called \"Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease,\" is testing if Kidney Health Coaching can help people with advanced kidney disease. You might be able to join if you identify as African American or Black, are 18 or older, and have specific kidney function test results (eGFR less than 29) or a high risk of kidney failure. The study aims to see if this coaching can delay the need for kidney replacement therapy (like dialysis) or a central venous catheter, and also delay death. The coaching involves support from a Kidney Health Coach, who has personal experience with kidney disease, through phone calls and in-person meetings for six months. The study compares this coaching to usual care, which might include support from care management at the hospital.","Participants will be followed throughout study participation up to 12 months to measure the time to kidney replacement therapy and death.",132,"If you participate, you would receive ongoing telephone support at least twice a month for six months, and the Kidney Health Coach would meet you at all in-person clinic appointments. You would also complete a baseline assessment via telephone interview.","Not stated in the trial record.",[34,41],"v2"]