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临床试验/NCT04174638
NCT04174638已完成不适用

Effect of Motivational Interviewing and Education Based on Watson's Theory of Human Caring in Individuals Receiving Hemodialysis: Randomized Controlled Trial

Akdeniz University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12

研究概览

简要总结

  • 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.

详细描述

The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring. The control group received usual care. Adherence to fluid intake, diet and drug management, physical parameters and quality of life was measured at baseline and 12th week. The patient satisfaction was measured in the intervention group at 12th week.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Single blinding was provided that included inclusion criteria and agreement to participate in the study

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients who were receive hemodialysis at Hemodialysis Unit of University Hospital in Antalya, Turkey
  • •Patients who had 1 and above from Diet And Fluid Non-Adherence Questionnaire total score
  • •Patients who had 0 or 1 score from 1.
  • •questions or 3.,
  • •questions in the Modified Morisky Scale.
  • •Patients who receiving Hemodialysis treatment for at least 3 months
  • •Patients who were over 18 years of age,
  • •Patients who had orientation of individual, place and time
  • •Patients who were literate
  • •Patients who no barriers to written or verbal communication
  • •Patients who agree to participate in the study

排除标准

  • •Patients who had psychiatric disease
  • •Patients who had diagnosis of malignancy

研究组 & 干预措施

"Intervention Group"

Experimental

The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring.

干预措施: Motivational Interviewing and Education Based on Watson's Theory of Human Caring (Other)

"Control Group"

No Intervention

The control group received routine hemodialysis treatment and nursing care in the hemodialysis unit.

结局指标

主要结局

Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12

时间窗: 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 indicates that individuals' attitudes is positive in adherence to fluid intake. The Fluid Control in Hemodialysis Patients Scale is evaluated on the total score. The lowest and highest score is between 24 and 72. High score indicates that adherence to fluid intake is high.The scale was developed in Turkey. The change between week 12 score and baseline score was reported.

The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12

时间窗: 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.

Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12

时间窗: 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.

Change From Baseline in Adherence to Diet on the Scale for Dietary Behaviors in Hemodialysis Patients at Week 12

时间窗: 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.

Change From Baseline in Adherence to Drug Management on the Modified Morisky Scale at Week 12

时间窗: 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

Change From Baseline in Adherence to Participation in Dialysis Sessions on the Hemodialysis Session Participation Form at Week 4,8,12

时间窗: baseline and 4, 8, 12 week

Hemodialysis Session Participation Form: This form was used to evaluated the adherence to participation in dialysis sessions at monthly and it was prepared by the researcher. It consisted of yes and no items. If the participant attended all monthly sessions, yes item was marked, if not, no was marked, and the number of sessions did not attend was noted. It was calculated that the mean of the monthly hemodialysis sessions they did not attend. The change between week 4, 8, 12 score and baseline score was reported.

The Mean of Satisfaction From the Motivational Interviewing Evaluated With Motivational Interview Evaluation Form at Week 12

时间窗: 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 the Motivational Interview Evaluation Form was reported.The data were not collected for this Outcome Measure from participants in the "Control Group" Arm/Group.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Şefika Tuğba YANGÖZ

Principal Investigator

Akdeniz University

研究点 (1)

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