Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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End-Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A

Intervention

Group Type EXPERIMENTAL

BalanceWise-PD

Intervention Type BEHAVIORAL

Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring

B

Attention control, standard dietary education

Group Type OTHER

Attention control

Intervention Type BEHAVIORAL

Standard peritoneal dialysis dietary education

Interventions

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BalanceWise-PD

Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring

Intervention Type BEHAVIORAL

Attention control

Standard peritoneal dialysis dietary education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No