Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

Not Applicable

Completed

• Conditions: End-Stage Renal Disease
• Interventions: Behavioral: BalanceWise-PD; Behavioral: Attention control

• Registration Number: NCT00447317
• Lead Sponsor: University of Pittsburgh

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-14
• Study Start: 2007-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-14
• Last Update Posted: 2010-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	BalanceWise-PD	Intervention
B	Attention control	Attention control, standard dietary education

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Dialysis Clinics, Inc.; 🇺🇸 Pittsburgh, Pennsylvania, United States