Patient-driven Management of BP in CKD

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
VA Office of Research and Development
Study ID
NCT05546099
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Self-management of BP medications — BEHAVIORAL
    Patients will be educated on how to manage their home BP based on a pre-determined protocol. They will then monitor home BP and adjust meds accordingly and under the guidance of the clinical pharmacist.
  • Self-monitoring of home BP — BEHAVIORAL
    Patients will be educated on how to monitor home BP and will be educated to contact their primary care provider/CKD provider if the BP is above the goal.

Study Details

The proposed research will evaluate if patients managing their blood pressure medications under the guidance of a clinical pharmacist works better to lower blood pressure than patients monitoring their blood pressure at home and the standard care. 60 Veterans with chronic kidney disease (CKD) will be included in the study. The study will further evaluate factors that may influence the Veteran to accept the self-management approach and what factors in the VHA healthcare system affect the implementation of the self-management approach.

Key Dates

Start date
Dec 15, 2022
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Nov 20, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Self-management
    Patients monitor their home BP and self manage their BP medications based on a predesigned titration protocol and under the guidance of the clinical pharmacist.
  • Active Comparator: Self-monitoring
    Patients monitor their home BP and contact their provider if the BP is above the goal.

Primary Outcome Measure

Change in standardized office BP [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Iowa City VA Health Care System, Iowa City, IAIowa CityIowa52246-2292
Diana Jalal, MD
319-338-0581
John E Holman, MA MA
(319) 338-0581
Diana Jalal, MD (PRINCIPAL_INVESTIGATOR)

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