Symptom Management Program for Hemodialysis Patients

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 2012

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).

Interventions

  • 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
  • Behavioral: 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.

Arms, Groups and Cohorts

  • Active Comparator: Self Management Strategies
    • 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.
  • Active Comparator: Dietary Information
    • Control arm

Clinical Trial Outcome Measures

Primary Measures

  • Decrease symptom burden
    • Time Frame: 8 weeks
    • 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.

Secondary Measures

  • Feasibility of implementing self management intervention
    • Time Frame: 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Francess Danquah, Assistant Professor, Nursing – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Francess V Danquah, PhD, Principal Investigator, The University of Texas Health Science Center, Houston

References

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. doi: 10.1046/j.1365-2648.2001.01697.x.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.