NCT01620580

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

8 months

First QC Date

October 24, 2011

Last Update Submit

June 14, 2012

Conditions

Haemodialysis-induced Symptom

Keywords

sleep disturbancetirednessitching & numbness

Outcome Measures

Primary Outcomes (1)

  • Decrease symptom burden

    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.

    8 weeks

Secondary Outcomes (1)

  • Feasibility of implementing self management intervention

    5 weeks

Study Arms (2)

Self Management Strategies

ACTIVE COMPARATOR

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

Dietary Information

ACTIVE COMPARATOR

Control arm

Behavioral: Dietary Information

Interventions

Self-managementBEHAVIORAL

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

Also known as: Behavioral
Self Management Strategies
Dietary InformationBEHAVIORAL

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.

Also known as: Behavioral
Dietary Information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DaVita Summit Dialysis

Houston, Texas, 77003, United States

Location

DaVita Houston Dialysis

Houston, Texas, 77011, United States

Location

Related Publications (3)

  • 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.

    PMID: 11298204BACKGROUND

  • Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

    PMID: 37651553DERIVED

  • Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

    PMID: 33283264DERIVED

MeSH Terms

Conditions

ParasomniasFatiguePruritusHypesthesia

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSomatosensory DisordersSensation DisordersNeurologic Manifestations

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Francess V Danquah, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Nursing

Study Record Dates

First Submitted

October 24, 2011

First Posted

June 15, 2012

Study Start

September 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

US(2)