Symptom Management Program for Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francess Danquah, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01620580
First received: October 24, 2011
Last updated: June 14, 2012
Last verified: June 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Symptom Management Program for Hemodialysis Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Decrease symptom burden [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620580

Locations
United States, Texas
DaVita Houston Dialysis
Houston, Texas, United States, 77011
DaVita Summit Dialysis
Houston, Texas, United States, 77003
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

Additional 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
Study First Received: October 24, 2011
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
sleep disturbance
tiredness
itching & numbness

ClinicalTrials.gov processed this record on July 23, 2014