An interventional study of Geriatric Care Model and Usual Care in Chronic Kidney Diseases, Dialysis and Geriatric, sponsored by Duke University. Enrolling by invitation at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Duke University · Not applicable, Interventional, and Health services research
The objectives of this study are to refine the dialysis care model with key stakeholder input and conduct a pilot randomized controlled trial (RCT) to obtain evidence critical to inform a definitive RCT.
The investigators designed a new dialysis care model that includes a centralized geriatric team that uses information from the Geriatric screen for OLder Dialysis patients (GOLD) to develop individualized recommendations for geriatric syndrome management based on the patient's priorities. The study population is older adults receiving hemodialysis and dialysis staff. The investigators will have patient participants complete the care model and undergo geriatric evaluation. This phase will be referred to as refinement aim 1. The investigators will then assess agreement of each GOLD instrument with its corresponding geriatric evaluation. The investigators will assess acceptability and feasibility of the care model through surveys and interviews with patients and dialysis staff to complete refinement aim 2. Once the new dialysis care model is redefined, the investigators will conduct the third phase, pilot RCT (geriatric care model vs. usual care) and assess geriatric problem management at 4 months, as well as, patient reported outcomes, physical function, and health care utilization at intervals up to 12 months. The analyses will include 1) measure of agreement using Cohen's kappa, 2) qualitative rapid analyses, 3) descriptive statistics from acceptability and feasibility surveys, 4) descriptive statistics from pilot RCT data, and 5) tests for difference in geriatric problem management between treatment and control groups. The study does not involve activity from participants that would exceed normal or routine care so there are negligible physical, financial, or legal risks.
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's planned enrollment of 120 is above the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Participants will receive usual dialysis care for 12 months, then they will receive the geriatric care model.
Behavioral: Usual Care
Participants will complete the GOLD, along with a few additional short surveys and a Short Physical Performance Battery. Information gathered will guide the research geriatric team's recommendation report to the participants' dialysis care team. The dialysis teams will receive training on how to use the recommendation report and local resources to initiate geriatric problem management. Participants will be seen every 4 months for follow-up for roughly 12 months.
Behavioral: Geriatric Care Model
First, older adults complete the Geriatric screen for OLder adults receiving Dialysis (GOLD), a battery of validated, self-administered geriatric screening instruments, used to identify Geriatric 5M-related problems. Then, a research team with geriatrics expertise leads patient prioritization of GOLD-identified problems in a telehealth visit and provides the dialysis team with guideline-directed, individualized recommendations for geriatric problem management.
Participants will continue to receive standard of care. Then after 12 months, they will follow the Geriatric Care Model. They will complete the Geriatric screen for OLder adults receiving Dialysis (GOLD), a battery of validated, self-administered geriatric screening instruments, used to identify Geriatric 5M-related problems. Then, a research team with geriatrics expertise leads patient prioritization of GOLD-identified problems in a telehealth visit and provides the dialysis team with guideline-directed, individualized recommendations for geriatric problem management.
Change in geriatric problem management as measured by survey
Problems include depression, anxiety, difficulty with memory, difficulty with daily activities, falling or fear of falling, obtaining and following instructions for taking medications, having unwelcome side effects from medications, not having enough support from others, and not having access to or eating enough food. The score for each problem ranges from 0 to 4, where a higher score indicates better management of the problem.
Time frame: Baseline, 4 months
Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial)
Time frame: up to 12 months
Practicality as measured by number of participants who needed study personnel assistance to complete the GOLD electronically
Time frame: up to 12 months
Fidelity as measured by the Care model recommendation checklist
Care model recommendation checklist includes a recommendation informed by the GOLD, recommendation align with patient priority, recommendation received by clinician, and recommendation decision
Time frame: Baseline, 4 months
Retention as measured by number of participants who complete the study
Time frame: up to 12 months
Recruitment as measured by number of participants enrolled
Time frame: up to 12 months
Plan to share: No
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