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NCT04174638

The Effect of Motivational Interviewing and Education Based on Watson's Theory of Human Caring in Hemodialysis

Completed NA Results posted Last updated 23 February 2021
What this trial tests

NA trial testing Motivational Interviewing and Education Based on Watson's Theory of Human Caring in Renal Disease in 60 participants. Completed in 17 June 2020.

Timeline
1 April 2019
Primary endpoint
1 April 2020
17 June 2020

Quick facts

Lead sponsorAkdeniz University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment60
Start date1 April 2019
Primary completion1 April 2020
Estimated completion17 June 2020
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Akdeniz University

Who can join

18 and older, any sex, with Renal Disease or Adherence, Treatment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12 Primary · baseline and 12 week

This scale measure adherence to fluid intake.The scale had 24 items and 3 point likert scale. It was included three sub-dimensions: knowledge, behaviors, and attitudes. The knowledge sub-dimension included 7 items and it's score ranged from 7-21. A high score indicates that individuals have higher levels of knowledge about fluid intake. The behavior sub-dimension included 11 items and it's score ranged from 11-33. A high score indicates that individuals' behavior is positive in adherence to fluid intake. The attitudes sub-dimension included 6 items and it's score ranged from 6-18. A high score

Knowledge sub-scale
GroupValue95% CI
Intervention Group1.37± 3.54
Control Group-0.17± 1.44
Behaviour sub-scale
GroupValue95% CI
Intervention Group3.31± 4.23
Control Group0.50± 3.92
Attitude sub-scale
GroupValue95% CI
Intervention Group6.46± 1.86
Control Group2.21± 2.52
Total score
GroupValue95% CI
Intervention Group11.15± 5.26
Control Group2.53± 4.72
Change From Baseline in Adherence to Diet on the Scale for Dietary Behaviors in Hemodialysis Patients at Week 12 Primary · Baseline and 12 week

Scale for Dietary Behaviors in Hemodialysis Patients: This scale evaluate adherence to diet management in hemodialysis patients. The scale had 13 items and 5 point likert scale. The score ranged from 13-65. High score indicates that adherence to diet management is high. The scale was developed in Turkey.The change between week 12 score and baseline score was reported.

GroupValue95% CI
Intervention Group7.62± 5.51
Control Group3.10± 4.99
Change From Baseline in Adherence to Drug Management on the Modified Morisky Scale at Week 12 Primary · Baseline and 12 week

Modified Morisky Scale: This scale evaluate adherence to drug management. It is consist of six items and two sub-dimensions:knowledge and motivation. The lowest and highest score is between 0-3 for each sub-dimension. A score higher than zero each sub-dimension indicates high knowledge and motivation in the adherence to drug management. The change between week 12 score and baseline score was reported

Knowledge sub-dimension
GroupValue95% CI
Intervention Group1.00± 0.67
Control Group0.46± 0.50
Motivation sub-dimension
GroupValue95% CI
Intervention Group0.68± 0.47
Control Group0.71± 0.26
The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12 Primary · 12 week

Watson Caritas Patient Score: This questionnaire evaluate the satisfaction with nursing care based on Watson's Theory of Human Caring. It is a likert-type form consist of five items. The score of each item ranged from 1-7. As the mean score from each item approaches 7, it shows that individuals are satisfied with care. This questionnaire will perform only to the intervention group. The mean score of the each item of the questionnaire was reported. The data were not collected for this Outcome Measure from participants in the "Control Group" Arm/Group.

Deliver my care with loving-kindness
GroupValue95% CI
Intervention Group6.40± 0.49
Meet my basic human needs.
GroupValue95% CI
Intervention Group6.43± 0.66
Have helping and trusting relationships with me.
GroupValue95% CI
Intervention Group6.34± 0.70
Create a caring environment that helps me to heal.
GroupValue95% CI
Intervention Group6.25± 0.67
Value my personal beliefs and faith, allowing for
GroupValue95% CI
Intervention Group6.37± 0.65
The Mean of Satisfaction From the Motivational Interviewing Evaluated With Motivational Interview Evaluation Form at Week 12 Primary · 12 week

Motivational Interview Evaluation Form: This form was used to evaluated the satisfaction with motivational interviewing and it was prepared by the researcher. This form consists of a item that includes evaluating the motivational interviewing satisfaction with likert scale and two items that include evaluating the inadequacies of the interviewing with open-ended question. The total mean score ranged from 1-5. As the mean score from first item approaches 5, it shows that individuals are satisfied with motivational interviewing.This form will perform only to the intervention group. The mean of t

GroupValue95% CI
Intervention Group4.5± 0.5
Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12 Primary · baseline and 12 week

Kidney Disease Quality of Life Instrument 36 ıtem:This instrument evaluate quality of life of individuals with chronic kidney disease. The KDQOL-36 consists of 36 items and five sub-dimensions: physical and mental functions, kidney disease burden, symptoms and problems, effects of kidney disease on daily life. The scoring of the each sub-scale ranges from 0 to 100. A higher score in each sub-dimension is an indicator of better health and quality of life. The change between week 12 score and baseline score was reported.

Physical functions sub-dimension
GroupValue95% CI
Intervention Group3.83± 9.33
Control Group2.36± 6.82
Mental functions sub-dimension
GroupValue95% CI
Intervention Group6.60± 9.52
Control Group3.50± 7.92
Burden of kidney disease sub-dimension
GroupValue95% CI
Intervention Group14.06± 22.33
Control Group4.68± 9.56
Symptoms/problems sub-dimension
GroupValue95% CI
Intervention Group11.45± 9.96
Control Group10.49± 11.31
Effects of kidney disease on daily life sub-dimension
GroupValue95% CI
Intervention Group18.74± 15.30
Control Group13.72± 8.12

Sponsor's own description

* Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to fluid intake in individuals receiving hemodialysis treatment. * Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to diet in individuals receiving hemodialysis treatment. * Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to drug management in individuals receiving hemodialysis treatment. * Intervention group who receiving Motivational interviewing and education based on Watson's Theory of Human Caring would satisfied with introduced intervention. * Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing quality of life in individuals receiving hemodialysis treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effects of motivational interviewing and an education programme based on Watson's theory of human caring on adults receiving haemodialysis: randomised controlled trial.
    Yangöz ŞT, Özer Z. · · 2025 · PMID 40255930 · DOI 10.1177/17449871241290450

Verify or expand the search:

Other recruiting trials for Renal Disease

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04174638.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing