Dietary Adherence Enhancement in Peritoneal Dialysis: Bal... | NCT00447317

Studies
Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

NCT00447317

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

May 17, 2010Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

End-Stage Renal Disease

Interventions

BalanceWise-PD
Attention control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Mar 12, 2007

First Submission Date that Met QC Criteria

Mar 12, 2007

First Posted Date

Mar 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2010

Last Update Posted Date

May 17, 2010Estimated

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Explore the impact of the intervention on dietary sodium intake,
Explore the intervention on blood pressure,
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
Explore the feasibility and acceptability of the intervention

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Intervention	Behavioral: BalanceWise-PD
B	Other	Attention control, standard dietary education	Behavioral: Attention control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BalanceWise-PD	Behavioral	Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Dietary intake of protein, calories, and phosphorus.		baseline and 4 months
Perceived dietary barriers.		baseline and 4 months
Perceived dietary therapeutic efficacy.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mary A Sevick, ScD	University of Pittsburgh	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Dialysis Clinics, Inc.		Pittsburgh	Pennsylvania	15213	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34164803	Derived	McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases