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Enrolling by Invitation

NCT Number: NCT05793138

Dialysis Geriatric Care Model

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Dialysis Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Geriatric Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • community-dwelling dialysis patients 55 and older
  • may have cognitive impairment

Patient Exclusion Criteria:

  • advanced dementia
  • non-English or Spanish speaking
  • nursing home residents
  • hospice enrollees

Treatment and study plan

Geriatric Care Model

Behavioral

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.

Usual Care

Behavioral

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.

Primary outcomes

  1. Change in geriatric problem management as measured by survey

    Time frame: Baseline, 4 months

    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.

Secondary outcomes

  1. Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial)

    Time frame: up to 12 months

  2. Practicality as measured by number of participants who needed study personnel assistance to complete the GOLD electronically

    Time frame: up to 12 months

  3. Fidelity as measured by the Care model recommendation checklist

    Time frame: Baseline, 4 months

    Care model recommendation checklist includes a recommendation informed by the GOLD, recommendation align with patient priority, recommendation received by clinician, and recommendation decision

  4. Retention as measured by number of participants who complete the study

    Time frame: up to 12 months

  5. Recruitment as measured by number of participants enrolled

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study title

Integration of Geriatric Care Into Dialysis Clinics

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 31, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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