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Dialysis Geriatric Care Model

Primary Purpose

Chronic Kidney Diseases, Dialysis, Geriatric

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Geriatric Care Model
Usual Care
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Diseases focused on measuring Dialysis, Quality of life, Care Model

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient Inclusion Criteria: community-dwelling dialysis patients 55 and older may have cognitive impairment; however, patients with severe cognitive impairment will require a caregiver present to participate in the study (mini MoCA <6) Patient Exclusion Criteria: advanced dementia non-English speaking nursing home residents hospice enrollees

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Usual Care

    Geriatric Care Model

    Arm Description

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

    While specifics of the intervention will be finalized after aim 2, the investigators anticipate participants will complete the GOLD and telehealth prioritization visit. 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.

    Outcomes

    Primary Outcome Measures

    Change in geriatric problem management as measured by survey
    Problems include depression, 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 Outcome Measures

    Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial)
    Practicality as measured by number of resources utilized by study personnel to conduct RCT (randomized controlled trial)
    Fidelity as measured by number of completed study visits
    Retention as measured by number of participants who complete the study
    Recruitment as measured by number of participants enrolled

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05793138
    Brief Title
    Dialysis Geriatric Care Model
    Official Title
    Integration of Geriatric Care Into Dialysis Clinics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 8, 2024 (Anticipated)
    Primary Completion Date
    March 31, 2028 (Anticipated)
    Study Completion Date
    March 31, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases, Dialysis, Geriatric
    Keywords
    Dialysis, Quality of life, Care Model

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    194 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive usual dialysis care for 12 months, then they will receive the geriatric care model.
    Arm Title
    Geriatric Care Model
    Arm Type
    Active Comparator
    Arm Description
    While specifics of the intervention will be finalized after aim 2, the investigators anticipate participants will complete the GOLD and telehealth prioritization visit. 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Geriatric Care Model
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in geriatric problem management as measured by survey
    Description
    Problems include depression, 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, 8, 12 months
    Secondary Outcome Measure Information:
    Title
    Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial)
    Time Frame
    up to 12 months
    Title
    Practicality as measured by number of resources utilized by study personnel to conduct RCT (randomized controlled trial)
    Time Frame
    up to 12 months
    Title
    Fidelity as measured by number of completed study visits
    Time Frame
    up to 12 months
    Title
    Retention as measured by number of participants who complete the study
    Time Frame
    up to 12 months
    Title
    Recruitment as measured by number of participants enrolled
    Time Frame
    up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Patient Inclusion Criteria: community-dwelling dialysis patients 55 and older may have cognitive impairment; however, patients with severe cognitive impairment will require a caregiver present to participate in the study (mini MoCA <6) Patient Exclusion Criteria: advanced dementia non-English speaking nursing home residents hospice enrollees
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Megan A Reaves, MS
    Phone
    9196602272
    Email
    megan.reaves@duke.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rasheeda K Hall, MD, MBA, MHS, FASN
    Phone
    9196606861
    Email
    rasheeda.hall@duke.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rasheeda K Hall, MD, MBA, MHS, FASN
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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