Symptom Management Program for Hemodialysis Patients

N/ACompletedNCT01620580

The University of Texas Health Science Center, Houston60 enrolled

Overview

Self-management intervention may decrease symptom burden and improve functioning over time.

Self-management intervention (strategies) may decrease symptom burden (sleep disturbance, tiredness; itching and numbness) and improve functioning (social, physical and emotional) over time(baseline, 3 weeks and 8 weeks).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Haemodialysis-induced Symptom

Interventions

Self-managementBEHAVIORAL

Participants in the intervention group will receive printed self management strategies each of the 5 symptoms, a symptom diary with the self-management strategies and a 15 minutes discussion. The intervention script will instruct participants on how to use the printed strategies by PI and RA #1. Week 3

Dietary InformationBEHAVIORAL

The control or usual care group will receive a symptom diary designed for the control group without any strategies and a 5 minutes discussion on how to complete the diary from RA# 1. The PI will make weekly follow up calls on the same schedule as the intervention group starting week 4 until week 7 for a total of 4 calls focusing on enhancing healthy eating skills \& adherence to renal diet and fluid restriction without discussing any intervention with the group.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. age ≥ 18 years old, 2. on HD three times a week, 3. received HD for ≥ six months, 4. read and write English, 5. have telephone service. Exclusion Criteria: * history of dementia, * acquired immunodeficiency syndrome (AIDS) and active cancer, and * inability to give informed consent.

Locations (2)

DaVita Summit Dialysis

Houston, Texas, United States

DaVita Houston Dialysis

Houston, Texas, United States

Outcomes

Primary Outcomes

Decrease symptom burden

The study aims are: 1\. To compare the differences between the self management intervention and control group on the following outcomes: 1. Decreased symptoms: itching, tiredness, numbness, sleep disturbance (difficulty falling asleep \& difficulty staying asleep); 2. Adherence to treatment diary Improved social functioning, physical functioning and emotional status.

Time frame: 8 weeks

Secondary Outcomes

Feasibility of implementing self management intervention

To evaluate the feasibility of implementing the self management intervention for a larger randomized controlled studyTreatment delivered (number of interventions sessions delivered and strategies used); Treatment receipts (understanding of strategies); and Treatment enactment (reported perception of usefulness of the strategies).

Time frame: 5 weeks

Data from ClinicalTrials.gov

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