Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

Study Overview
=================
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: Explore the impact of the intervention on dietary sodium intake, Explore the intervention on blood pressure, 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 Explore the feasibility and acceptability of the intervention

Official Title
-----------------
Dietary Adherence Enhancement in Peritoneal Dialysis

Conditions
-----------------
End-Stage Renal Disease

Intervention / Treatment
-----------------
* Behavioral: BalanceWise-PD
* Behavioral: Attention control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Intervention | Behavioral: BalanceWise-PD<br>* Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring<br>|
| Other: B<br>Attention control, standard dietary education | Behavioral: Attention control<br>* Standard peritoneal dialysis dietary education<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary sodium intake as assessed from 3-day recalls. |  | baseline and 4 months | 
| 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 | 
| Feasibility and acceptability of PDA-based dietary monitoring. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake of protein, calories, and phosphorus. |  | baseline and 4 months | 
| Perceived dietary barriers. |  | baseline and 4 months | 
| Perceived dietary therapeutic efficacy. |  | baseline and 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peritoneal dialysis, diet, sodium