Effect of Access to Dietary Intervention in a Dialysis Unit

Condition(s) studied

Investigational drug(s) / intervention(s)

Access to dietary treatment: Dietary treatment using current nutrition guidelines, dialogic communication and Nutrition Care Process repeatedly by weekly access to a dietitian for four month.

Study summary

Objective:

The aim of this study is to explore the effect of access to individual dietary counselling by a dietitian in the dialysis unit on biochemical values (phosphorus and potassium), diet, nutritional status, quality of life (QoL) and health literacy (HL).

Hypothesis: Having access to a dietitian can better laboratory values and affect dietary intake, nutritional status, QoL and HL in a positive matter.

Method:

Pilot cluster RCT study in three the dialysis units in Region Zealand. Clustering of people on dialysis the same day to either intervention or control group. The groups is expected to be similar regarding clinical characteristics.

Primary outcome: Change in average p-phosphate Secondary outcomes: Change in average p-potassium, number of phosphate binders, number of potassium binders, HeartDiet-score, Nutritional Status, Adherence to diet (End Stage Renal Disease Adherence Questionnaire), Quality of life (Kidney Disease Quality of Life Short Form) and Health literacy (Health Literacy Questionnaire)

Intervention:

The intervention group receives an initial individual dietary interview, monthly follow-up and weekly access to a dietitian in the dialysis unit for four months. The control group receives usual care with referral to a dietitian when needed.

Eligibility

Primary outcome measure(s)

• Average phosphate — At baseline and after 5 month at the end of the intervention period (last phosphate value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)
  Difference in average phosphate-level between groups

Trial sites (3)

More Zealand University Hospital trials in Denmark

Other trials for the same condition