Renal DialysisNCT03432988
Impact of Nurses´ Solution-focused Communication on the Fluid Adherence of Adult Patients on Hemodialysis
A study testing Nursing Solution-Focused in people with Renal Dialysis, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Nursing Solution-Focused
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2016to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 0
Who cannot join
- 0
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Design A single-group quasi-experimental design was carried out. The IDWG was the dependent variable, expressed as the weight gain in kilograms between dialysis sessions. A base-line was established by taking IDWG data for one month; after the nurses training, IDWG data were taken for another month. Follow-up was carried out six months later.
Methods
Participants 36 patients of a hemodialysis unit in a public hospital were invited to participate in the study. All accepted and gave written informed consent. Nurses were two women (39 and 37 years old) and one man (30 years old).
The intervention Training. 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.
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 nurses had accomplished the weight reduction. Nurses were trained to invite patients to share specific behavioral details and also to describe their own behavior from the perspective of significant family members. Nurses were also taught 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.
In the case of IDWG worsening, nurses were encouraged to validate patients´ difficulties and empathize with their predicament.
A repeated measure analysis of variance (ANOVA) and Student's t were used to analyze the changes in patient's IDWG over time.
- Conditions
- Renal Dialysis
- Being tested
- Nursing Solution-Focused
- Keywords
- Nursing Solution-Focused, hemodialysis, Psychosocial intervention, Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Solution-FocusedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nursing Solution-Focused |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANOVA
Analysis of Variance
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Apr 2016
- Primary completion29 Jul 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María del Carmen Neipp, Universidad Miguel Hernandez de Elche
- Investigators
- Alberto Pastor, Study chair, Universidad Miguel Hernández de Elche.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432988
- Sponsor's protocol ID
- UMH-SFNursing
- Status last verified
- Feb 2018
- First submitted
- 6 Feb 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 10773748Idier 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.
PubMed 21924423Kugler 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.
PubMed 20954134McAllister 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.
PubMed 12622862McGee 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.
PubMed 16294686Morgan L. A decade review: methods to improve adherence to the treatment regimen among hemodialysis patients. Nephrol Nurs J. 2000 Jun;27(3):299-304.
PubMed 11249328Matteson 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.
PubMed 20796047Bowles 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.
PubMed 11686749Beyebach 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.
PubMed 29992599
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nurses´ Solution-focused Communication on the Fluid Adherence of Adult Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT03432988
- Acronym / sponsor ID
- UMH-SFNursing
- Conditions
- Renal Dialysis
- Keywords
- Nursing Solution-Focused, hemodialysis, Psychosocial intervention, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 29 Jul 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design A single-group quasi-experimental design was carried out. The IDWG was the dependent variable, expressed as the weight gain in kilograms between dialysis sessions. A base-line was established by taking IDWG data for one month; after the nurses training, IDWG data were taken for another month. Follow-up was carried out six months later.
Methods
Participants 36 patients of a hemodialysis unit in a public hospital were invited to participate in the study. All accepted and gave written informed consent. Nurses were two women (39 and 37 years old) and one man (30 years old).
The intervention Training. 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.
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 nurses had accomplished the weight reduction. Nurses were trained to invite patients to share specific behavioral details and also to describe their own behavior from the perspective of significant family members. Nurses were also taught 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.
In the case of IDWG worsening, nurses were encouraged to validate patients´ difficulties and empathize with their predicament.
A repeated measure analysis of variance (ANOVA) and Student's t were used to analyze the changes in patient's IDWG over time.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nurses in the hemodialysis service | Experimental | Behavioral: Nursing Solution-FocusedNursing 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 0
Key exclusion criteria (1 listed)
- 0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing Solution-FocusedTwo 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. | Behavioural | nurses in the hemodialysis service |
Primary outcome
ANOVA
Time frame: Three months
Analysis of Variance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Background: PubMed 10773748Baines 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.
- Background: PubMed 21924423Idier 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.
- Background: PubMed 20954134Kugler 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.
- Background: PubMed 12622862McAllister 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.
- Background: PubMed 16294686McGee 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.
- Background: PubMed 11249328Morgan L. A decade review: methods to improve adherence to the treatment regimen among hemodialysis patients. Nephrol Nurs J. 2000 Jun;27(3):299-304.
- Background: PubMed 20796047Matteson 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.
- Background: PubMed 11686749Bowles 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.
- Derived from this study: PubMed 29992599Beyebach 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Pastor study chair
Universidad Miguel Hernández de Elche.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Solution-Focused in people with Renal Dialysis, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANOVA (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03432988, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.