Symptom Management Program for Hemodialysis Patients

Not Applicable

Completed

• Conditions: Haemodialysis-induced Symptom
• Interventions: Behavioral: Self-management; Behavioral: Dietary Information

• Registration Number: NCT01620580
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-24
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-14
• Last Update Submitted: 2012-06-14
• Study First Posted: 2012-06-15
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self Management Strategies	Self-management	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 Information	Dietary Information	Control arm

Primary Outcome Measures

Name	Time	Method
Decrease symptom burden	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility of implementing self management intervention	5 weeks	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).

Trial Locations

Locations (2)

DaVita Summit Dialysis; 🇺🇸 Houston, Texas, United States

DaVita Houston Dialysis; 🇺🇸 Houston, Texas, United States