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Symptom Management Program for Hemodialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01620580
First Posted: June 15, 2012
Last Update Posted: June 15, 2012
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.
Information provided by (Responsible Party):
Francess Danquah, The University of Texas Health Science Center, Houston
  Purpose
Self-management intervention may decrease symptom burden and improve functioning over time.

Condition Intervention
Haemodialysis-induced Symptom Behavioral: Self-management Behavioral: Dietary Information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Symptom Management Program for Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Francess Danquah, The University of Texas Health Science Center, Houston:

Primary Outcome 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:

    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:
  • 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).


Estimated Enrollment: 60
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Principal Investigator: Francess V Danquah, PhD The University of Texas Health Science Center, Houston
  More Information

Publications:
Responsible Party: Francess Danquah, Assistant Professor, Nursing, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01620580     History of Changes
Other Study ID Numbers: HSC-SN-11-0465
First Submitted: October 24, 2011
First Posted: June 15, 2012
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