Dialysis Geriatric Care Model

NCT05793138 | Enrolling By Invitation

• 1 other identifier: Pro00112850
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases; Dialysis; Geriatric

Keywords

Dialysis; Quality of life; Care Model

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 4, 8, 12 months

Secondary Outcomes (5)

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

  up to 12 months

• Practicality as measured by number of resources utilized by study personnel to conduct RCT (randomized controlled trial)

  up to 12 months

• Fidelity as measured by number of completed study visits

  up to 12 months

• Retention as measured by number of participants who complete the study

  up to 12 months

• Recruitment as measured by number of participants enrolled

  up to 12 months

Study Arms (2)

Usual Care

PLACEBO COMPARATOR

Participants will receive usual dialysis care for 12 months, then they will receive the geriatric care model.

Behavioral: Usual Care

Geriatric Care Model

ACTIVE COMPARATOR

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

Interventions

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.

Geriatric Care Model

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.

Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Rasheeda K Hall, MD, MBA, MHS, FASN

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 31, 2023
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)