NCT03432988

Brief Summary

Aim: To test the hypothesis that fluid adherence in patients on hemodialysis can be improved through nurses´ solution-focused communication with patients on issues of adherence. Design: Single-group quasi-experimental study. Method: A one-month baseline of inter-dialytic weight gain was taken for a group of 36 adult patients in a hospital hemodialysis unit. Then, the nurses of the unit received an 5-hour training in solution-focused communication on issues of fluid adherence and applied it with the patients of the sample. Inter-dialytic weight gains (IDWG) were measured during another month. Six months after the training, IDWG was again measured during one month.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

February 6, 2018

Last Update Submit

February 13, 2018

Conditions

Keywords

Nursing Solution-FocusedhemodialysisPsychosocial interventionAdherence

Outcome Measures

Primary Outcomes (1)

  • ANOVA

    Analysis of Variance

    Three months

Study Arms (1)

nurses in the hemodialysis service

EXPERIMENTAL

Nursing Solution-Focused: Two two-hour training modules were designed by two recognized solution-focused therapy experts. In each module, participants watched videos that illustrated solution-focused communication on fluid adherence, and practiced the skills in role-plays.

Behavioral: Nursing Solution-Focused

Interventions

Two two-hour training modules were designed. In each module, participants watched videos that illustrated solution-focused communication on fluid adherence, and practiced the skills in role-plays. Solution-focused communication on IDWG. In the case of IDWG improvement, nurses were trained to congratulate the patient and then to explore in detail, from a stance of curiosity, how s/he had accomplished the weight reduction. Nurses were trained to invite patients to share specific behavioral details, to describe their own behavior from the perspective of significant family members and also to compliment patients on their accomplishments and to invite them to keep track of anything else they might find useful to control fluid intake over the next days.

nurses in the hemodialysis service

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

María del Carmen Neipp

Elche, Alicante, 03202, Spain

Location

Related Publications (9)

  • Baines LS, Jindal RM. Non-compliance in patients receiving haemodialysis: an in-depth review. Nephron. 2000 May;85(1):1-7. doi: 10.1159/000045622. No abstract available.

    PMID: 10773748BACKGROUND
  • Idier L, Untas A, Koleck M, Chauveau P, Rascle N. Assessment and effects of Therapeutic Patient Education for patients in hemodialysis: a systematic review. Int J Nurs Stud. 2011 Dec;48(12):1570-86. doi: 10.1016/j.ijnurstu.2011.08.006. Epub 2011 Sep 14.

    PMID: 21924423BACKGROUND
  • Kugler C, Maeding I, Russell CL. Non-adherence in patients on chronic hemodialysis: an international comparison study. J Nephrol. 2011 May-Jun;24(3):366-75. doi: 10.5301/JN.2010.5823.

    PMID: 20954134BACKGROUND
  • McAllister M. Doing practice differently: solution-focused nursing. J Adv Nurs. 2003 Mar;41(6):528-35. doi: 10.1046/j.1365-2648.2003.02564.x.

    PMID: 12622862BACKGROUND
  • McGee D, Del Vento A, Bavelas JB. An interactional model of questions as therapeutic interventions. J Marital Fam Ther. 2005 Oct;31(4):371-84. doi: 10.1111/j.1752-0606.2005.tb01577.x. No abstract available.

    PMID: 16294686BACKGROUND
  • Morgan L. A decade review: methods to improve adherence to the treatment regimen among hemodialysis patients. Nephrol Nurs J. 2000 Jun;27(3):299-304.

    PMID: 11249328BACKGROUND
  • Matteson ML, Russell C. Interventions to improve hemodialysis adherence: a systematic review of randomized-controlled trials. Hemodial Int. 2010 Oct;14(4):370-82. doi: 10.1111/j.1542-4758.2010.00462.x. Epub 2010 Aug 27.

    PMID: 20796047BACKGROUND
  • Bowles N, Mackintosh C, Torn A. Nurses' communication skills: an evaluation of the impact of solution-focused communication training. J Adv Nurs. 2001 Nov;36(3):347-54. doi: 10.1046/j.1365-2648.2001.01979.x.

    PMID: 11686749BACKGROUND
  • Beyebach M, Neipp MDC, Garcia-Moreno M, Gonzalez-Sanchez I. IMPACT of nurses' solution-focused communication on the fluid adherence of adult patients on haemodialysis. J Adv Nurs. 2018 Nov;74(11):2654-2657. doi: 10.1111/jan.13792. Epub 2018 Aug 19.

Study Officials

  • Alberto Pastor

    Universidad Miguel Hernández de Elche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 14, 2018

Study Start

April 1, 2016

Primary Completion

July 29, 2016

Study Completion

November 30, 2016

Last Updated

February 14, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Starting one month after publication
Access Criteria
Researcher should write an email to the principal investigator, telling the reasons for asking for the data

Locations