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Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00447317
First received: March 12, 2007
Last updated: May 14, 2010
Last verified: May 2010
History of Changes
  Purpose

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

Condition Intervention
End-Stage Renal Disease
 Behavioral: BalanceWise-PD
Behavioral: Attention control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Dietary Adherence Enhancement in Peritoneal Dialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Dietary sodium intake as assessed from 3-day recalls. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Dietary sodium effluent and urine concentration. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Morning blood pressure. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Morning post dialysis weight. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Feasibility and acceptability of PDA-based dietary monitoring. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dietary intake of protein, calories, and phosphorus. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Perceived dietary barriers. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • Perceived dietary therapeutic efficacy. [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Intervention
 Behavioral: BalanceWise-PD
Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring
B
Attention control, standard dietary education
 Behavioral: Attention control
Standard peritoneal dialysis dietary education

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447317

Locations
United States, Pennsylvania
Dialysis Clinics, Inc.
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Mary A Sevick, ScD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Mary Ann Sevick, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00447317     History of Changes
Other Study ID Numbers: R21 DK067181
Study First Received: March 12, 2007
Last Updated: May 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
peritoneal dialysis
diet
sodium

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013