Safety Issues Clinical Trial
— DREAM-APDOfficial title:
Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight
Verified date | August 2021 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Among ambulatory peritoneal dialysis patients, does use of the Baxter AMIA peritoneal dialysis cycler with SHARESOURCE connectivity platform achieve dry weight targets better than use of the Baxter Home Choice Pro cycler.
Status | Active, not recruiting |
Enrollment | 28 |
Est. completion date | April 2022 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Adults aged > 21 years with ESRD on peritoneal dialysis Exclusion Criteria: - Unable to commit to 12 months of monitoring. - Unable to stand safely on scale for weight - Hospitalization for heart failure, volume overload, or cardiovascular disease within the last 3 months. - Peritonitis within the past 3 months. - Not responsible for self-care of peritoneal dialysis (proxy care will be excluded). - Patients residing in a nursing home or other institutionalized individuals. - Inability or unwillingness to provide informed consent (lacks decision making capacity) - Alcohol, substance use, or other social conditions which preclude close follow-up and reliable participation, in the opinion of the primary nephrology physician or study investigator. |
Country | Name | City | State |
---|---|---|---|
United States | Home Dialysis Therapies of San Diego | Chula Vista | California |
United States | Home Dialysis Therapies of San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Baxter Healthcare Corporation, Home Dialysis Therapies of San Diego, Scripps Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3 month average of difference between the actual vs. prescribed dry weight | The investigators will evaluate the average difference between the actual dry weight vs. prescribed dry weight achieved through use of Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity compared to use of HomeChoicePRO. | 3 months | |
Secondary | Nursing burden related to use of AMIA with SHARESOURCE | The investigators will observe the number of nursing time hours per month dedicated to patient care for patients using AMIA with SHARESOURCE compared to patients using HomeChoicePRO. | 12 months | |
Secondary | Patient Quality of Life while using AMIA with SHARESOURCE: Kidney Disease and Quality of Life -36 questionaire | The investigators will assess quality of life scores using the Kidney Disease and Quality of Life -36 questionaire survey of patients using AMIA with SHARESOURCE compared to patients using HomeChoicePRO. The survey assesses 5 areas pertaining to quality of life on dialysis which include 1) physical component score 2) mental component score 3) burden 4) symptoms 5) effects. Patient answers are compared to their national demographic and reported on a scale of 0-100. The higher the score the better. The scores for each component will be reported and tracked separately. | 12 months |
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