Impact of a Personal Digital Assistant (PDA) - Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-01-31

Brief Summary

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With this study the investigators will test, in a randomised clinical trial (RCT), the efficacy of a behavioral dietary adherence enhancement intervention paired with PDA-based dietary self-monitoring for controlling sodium intake. Seventy hemodialysis patients will be recruited from units in Pittsburgh, Pennsylvania. Participants will be randomized to a 4-month PDA-based dietary counseling intervention or to a 4-month attention control. Potential participants will be stratified by whether or not they have diabetes. Data on primary and secondary outcomes will be obtained at baseline and four months. Primary dependent variables are:

1. adherence to dietary sodium targets as assessed from 3-day food recalls,
2. average monthly interdialytic weight gain, and
3. average pulse pressure. Secondary dependent variables are:
4. adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls, (5) serum potassium and phosphorus levels determined on a monthly basis, and (6) nutritional status as determined from serum albumin. Laboratory data, interdialytic weight gain, and blood pressure data will be obtained per dialysis center routine and abstracted from the medical record. Three-day food recalls will be obtained at baseline, 4 and 8 months and analyzed using the Nutrient Data System.

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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

Education in the hemodialysis diet.

Group Type ACTIVE_COMPARATOR

Standard hemodialysis dietary instruction

Intervention Type BEHAVIORAL

Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.

B

Education in the hemodialysis diet. Behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.

Group Type EXPERIMENTAL

Behavioral counseling plus PDA-based self-monitoring of diet

Intervention Type BEHAVIORAL

Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments. In addition they receive behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.

Interventions

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Standard hemodialysis dietary instruction

Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.

Intervention Type BEHAVIORAL

Behavioral counseling plus PDA-based self-monitoring of diet

Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments. In addition they receive behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Those individuals who are 21 years of age or older
* Literate
* Community-dwelling adults
* Receiving maintenance HD for at least 3 months

Exclusion Criteria

* Individuals 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 6 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.
* Those individuals with a score ≤ 26 on the Mini Mental Status Exam.
* Also excluded will be individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No