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Symptom Management Program for Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01620580
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : June 15, 2012
Sponsor:
Information provided by (Responsible Party):
Francess Danquah, The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
Self-management intervention may decrease symptom burden and improve functioning over time.

Condition or disease Intervention/treatment Phase
Haemodialysis-induced Symptom Behavioral: Self-management Behavioral: Dietary Information Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Symptom Management Program for Hemodialysis Patients
Study Start Date : September 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
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.

 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

Other Name: Behavioral
Active Comparator: Dietary Information
Control arm
 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.
Other Name: Behavioral


Outcome Measures
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Primary Outcome Measures :
  1. 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:

    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 :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620580


Locations
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United States, Texas
DaVita Summit Dialysis
Houston, Texas, United States, 77003
DaVita Houston Dialysis
Houston, Texas, United States, 77011
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Francess V Danquah, PhD The University of Texas Health Science Center, Houston
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Francess Danquah, Assistant Professor, Nursing, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01620580    
Other Study ID Numbers: HSC-SN-11-0465
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: June 2012
Keywords provided by Francess Danquah, The University of Texas Health Science Center, Houston:
sleep disturbance
tiredness
itching & numbness