Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447317
Status:
COMPLETED
Last Update Posted:
2010-05-17
First Post:
2007-03-12
Brief Title:
Dietary Adherence Enhancement in Peritoneal Dialysis BalanceWise-PD
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Dietary Adherence Enhancement in Peritoneal Dialysis
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BalanceWise-PD
Brief Summary:
This randomized study will pilot test an intervention based on self-efficacy theory and involving personal digital assistant PDA-based dietary self-monitoring to improve adherence to the peritoneal dialysis dietary regimen 60 individuals 21 years of age or older who are on continuous ambulatory peritoneal dialysis or nightly cycler peritoneal dialysis will be recruited to the study Participants will be randomized to one of 2 groups Group A will receive a 4-month active intervention of decreasing intensity over time delivered via mail telephone and during regularly scheduled dialysis clinic visits Group B will receive a 4-month attention control experience in which they receive reinforcement of standard dietary education With this study the investigators will
1 Explore the impact of the intervention on dietary sodium intake
2 Explore the intervention on blood pressure
3 Explore the impact of the intervention on morning post dialysis weight ie weight after conclusion of continuous cycling peritoneal dialysis CCPD or after long dwell for continuous ambulatory peritoneal dialysis CAPD patients AND
4 Explore the feasibility and acceptability of the intervention
1 Explore the impact of the intervention on dietary sodium intake
2 Explore the intervention on blood pressure
3 Explore the impact of the intervention on morning post dialysis weight ie weight after conclusion of continuous cycling peritoneal dialysis CCPD or after long dwell for continuous ambulatory peritoneal dialysis CAPD patients AND
4 Explore the feasibility and acceptability of the intervention
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None