End-Stage Renal Disease
Conditions
Keywords
peritoneal dialysis, diet, sodium
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 (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
Interventions
BEHAVIORALBalanceWise-PD
Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring
BEHAVIORALAttention control
Standard peritoneal dialysis dietary education
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dietary sodium effluent and urine concentration. | baseline and 4 months |
| Morning blood pressure. | baseline and 4 months |
| Morning post dialysis weight. | baseline and 4 months |
| Dietary sodium intake as assessed from 3-day recalls. | baseline and 4 months |
| Feasibility and acceptability of PDA-based dietary monitoring. | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Perceived dietary barriers. | baseline and 4 months |
| Perceived dietary therapeutic efficacy. | baseline and 4 months |
| Dietary intake of protein, calories, and phosphorus. | baseline and 4 months |
Countries
United States
Outcome results
None listed