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Completed

NCT Number: NCT01620580

Symptom Management Program for Hemodialysis Patients

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

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Key information

Conditions

Haemodialysis-induced Symptom Fatigue Hypesthesia Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Pruritus Sensation Disorders Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Sleep Wake Disorders Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DaVita Houston Dialysis, Houston, Texas, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18 years old,
  • on HD three times a week,
  • received HD for ≥ six months,
  • read and write English,
  • have telephone service.

Exclusion criteria

  • history of dementia,
  • acquired immunodeficiency syndrome (AIDS) and active cancer, and
  • inability to give informed consent.

Treatment and study plan

Self-Management

Behavioral

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 names: Behavioral

Dietary Information

Behavioral

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 names: Behavioral

Primary outcomes

  1. Decrease symptom burden

    Time frame: 8 weeks

    The study aims are:

    • 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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 15, 2012
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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