Chronic Kidney Diseases Clinical Trial
Official title:
Integration of Geriatric Care Into Dialysis Clinics
Verified date | May 2024 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 194 |
Est. completion date | August 31, 2028 |
Est. primary completion date | August 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 4, 8, 12 months | |
Secondary | Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial) | up to 12 months | ||
Secondary | Practicality as measured by number of resources utilized by study personnel to conduct RCT (randomized controlled trial) | up to 12 months | ||
Secondary | Fidelity as measured by number of completed study visits | up to 12 months | ||
Secondary | Retention as measured by number of participants who complete the study | up to 12 months | ||
Secondary | Recruitment as measured by number of participants enrolled | up to 12 months |
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