Symptom Management Program for Hemodialysis Patients

Haemodialysis-induced Symptom Clinical Trial

Official title:

Symptom Management Program for Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620580
• Other study ID #: HSC-SN-11-0465
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: June 14, 2012
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Haemodialysis-induced Symptom

Intervention

Behavioral:
• 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
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.

Locations

Country	Name	City	State
United States	DaVita Houston Dialysis	Houston	Texas
United States	DaVita Summit Dialysis	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dodd M, Janson S, Facione N, Faucett J, Froelicher ES, Humphreys J, Lee K, Miaskowski C, Puntillo K, Rankin S, Taylor D. Advancing the science of symptom management. J Adv Nurs. 2001 Mar;33(5):668-76. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease symptom burden	The study aims are: 1. To compare the differences between the self management intervention and control group on the following outcomes: Decreased symptoms: itching, tiredness, numbness, sleep disturbance (difficulty falling asleep & difficulty staying asleep); Adherence to treatment diary Improved social functioning, physical functioning and emotional status.	8 weeks	No
Secondary	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).	5 weeks	No