Symptom Management Program for Hemodialysis Patients

NCT ID: NCT01620580

Last Updated: 2012-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-05-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Haemodialysis-induced Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Self-management

Intervention Type 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

Dietary Information

Control arm

Group Type ACTIVE_COMPARATOR

Dietary Information

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavioral Behavioral

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Francess Danquah

Assistant Professor, Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francess V Danquah, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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DaVita Summit Dialysis

Houston, Texas, United States

Site Status

DaVita Houston Dialysis

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11298204 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37651553 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33283264 (View on PubMed)

Other Identifiers

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HSC-SN-11-0465

Identifier Type: -

Identifier Source: org_study_id

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