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Sponsors and Collaborators: |
University of Pittsburgh National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00447317 |
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:
Condition | Intervention |
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End-Stage Renal Disease |
Behavioral: BalanceWise-PD Behavioral: Attention control |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Dietary Adherence Enhancement in Peritoneal Dialysis |
Estimated Enrollment: | 60 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Intervention
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Behavioral: BalanceWise-PD
Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring
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B
Attention control, standard dietary education
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Behavioral: Attention control
Standard peritoneal dialysis dietary education
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The investigators will recruit those individuals:
Exclusion Criteria:
Excluded from the study will be individuals:
Contact: Beth M Hall, BA | (412) 586-9791 | hallbm@upmc.edu |
Contact: Rita Marsh, MSN | (412) 586-9614 | marshrm2@upmc.edu |
United States, Pennsylvania | |
Dialysis Clinics, Inc. | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Principal Investigator: Mary Ann Sevick, ScD, RN |
Principal Investigator: | Mary A Sevick, ScD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Mary Ann Sevick ) |
Study ID Numbers: | R21 DK067181 |
Study First Received: | March 12, 2007 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00447317 |
Health Authority: | United States: Institutional Review Board |
peritoneal dialysis diet sodium |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |