Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

End-Stage Renal Disease Clinical Trial

— BalanceWise-PD  

Official title:

Dietary Adherence Enhancement in Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447317
• Other study ID #: R21DK067181
• Status: Completed
• Phase: N/A
• First received: March 12, 2007
• Last updated: May 14, 2010
• Start date: November 2007
• Est. completion date: November 2009

Study information

• Verified date: May 2010
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Behavioral:
• BalanceWise-PD
Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring
• Attention control
Standard peritoneal dialysis dietary education

Locations

Country	Name	City	State
United States	Dialysis Clinics, Inc.	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary sodium intake as assessed from 3-day recalls.		baseline and 4 months	No
Primary	Dietary sodium effluent and urine concentration.		baseline and 4 months	No
Primary	Morning blood pressure.		baseline and 4 months	No
Primary	Morning post dialysis weight.		baseline and 4 months	No
Primary	Feasibility and acceptability of PDA-based dietary monitoring.		4 months	No
Secondary	Dietary intake of protein, calories, and phosphorus.		baseline and 4 months	No
Secondary	Perceived dietary barriers.		baseline and 4 months	No
Secondary	Perceived dietary therapeutic efficacy.		baseline and 4 months	No