Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

Completed · Not applicable

Conditions studied: End-Stage Renal Disease

In brief

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 (i.e. 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

Key facts

Study ID

NCT00447317

Run by

University of Pittsburgh

People needed

60

Starts

2007-11-01

Expected to finish

2009-11-01

Last updated by the study team

2010-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The investigators will recruit those individuals:
• who are 18 years of age or older,
• who are literate, community-dwelling adults, and
• who have been receiving maintenance PD for at least 3 months. Individuals on maintenance PD less than 3 months are excluded to allow for patients to adjust to the PD regimen, and for stabilization of nutritional status in the early weeks of dialysis (i.e. they may be considered for the study after 3 months of dialysis)

You may not qualify if…

• Excluded from the study will be individuals:
• who are deemed by dialysis center staff to have a problem with cognitive function and to be chronically noncompliant to the dialysis regimen (e.g. misses multiple appointments and dialysis treatments),
• those who cannot read or write, those who do not speak English,
• those who plan to move out of the area or change dialysis centers within the next 5 months,
• those with a terminal illness and life expectancy of less than 12 months,
• those who are scheduled for a living donor transplant,
• individuals who cannot see the PDA screen or use the stylus to make selections from the PDA screen, or
• individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake

Where it is running

• Dialysis Clinics, Inc. — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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