An interventional study of Self-management and Dietary Information in Haemodialysis-induced Symptom, sponsored by The University of Texas Health Science Center, Houston. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-15.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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).
The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Self-management
Control arm
Behavioral: Dietary Information
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
Also known as: Behavioral
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.
Also known as: Behavioral
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
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
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston