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Clinical Trials/NCT00447317
NCT00447317
Completed
Not Applicable

Dietary Adherence Enhancement in Peritoneal Dialysis

University of Pittsburgh1 site in 1 country60 target enrollmentNovember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End-Stage Renal Disease
Sponsor
University of Pittsburgh
Enrollment
60
Locations
1
Primary Endpoint
Dietary sodium intake as assessed from 3-day recalls.
Status
Completed
Last Updated
15 years ago

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:

  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
Registry
clinicaltrials.gov
Start Date
November 2007
End Date
November 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Dietary sodium intake as assessed from 3-day recalls.

Time Frame: baseline and 4 months

Dietary sodium effluent and urine concentration.

Time Frame: baseline and 4 months

Morning blood pressure.

Time Frame: baseline and 4 months

Morning post dialysis weight.

Time Frame: baseline and 4 months

Feasibility and acceptability of PDA-based dietary monitoring.

Time Frame: 4 months

Secondary Outcomes

  • 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)

Study Sites (1)

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