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

• Sponsor: Akdeniz University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04174638
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.6
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

• 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Disease; Adherence, Treatment; Quality of Life; Satisfaction, Patient	Other: Motivational Interviewing and Education Based on Watson's Theory of Human Caring	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study is a parallel group randomized controlled studyThis study is a parallel group randomized controlled study
• Masking: Single (Participant)
• Masking Description: Single blinding was provided that included inclusion criteria and agreement to participate in the study
• Primary Purpose: Supportive Care
• Official Title: Effect of Motivational Interviewing and Education Based on Watson's Theory of Human Caring in Individuals Receiving Hemodialysis: Randomized Controlled Trial
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Jun 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: "Intervention Group" 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.	Other: Motivational Interviewing and Education Based on Watson's Theory of Human Caring; 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 intervention performed before the hemodialysis session in a separate room in the hemodialysis unit.
No Intervention: "Control Group" The control group received routine hemodialysis treatment and nursing care in the hemodialysis unit.

Outcome Measures

Primary Outcome Measures

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

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

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

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

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

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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 1.2. and 6. questions or 3., 4. and 5. 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

Exclusion Criteria:

• Patients who had psychiatric disease

• Patients who had diagnosis of malignancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Şefika Tuğba Yangöz	Antalya		Turkey	07070

Sponsors and Collaborators

• Akdeniz University

Investigators

• Study Director: Zeynep ÖZER, PhD, RN, Akdeniz University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 6, 2017

More Information

Additional Information:

• he effect of nursing counseling on improving knowledge, adherence to treatment and quality of life of patients undergoing hemodialysis.
• Quality of life in hemodialysis patients and the relationship with mortality, hospitalizations and poor treatment adherence
• The Effect of Nursing Counseling on Improving Knowledge, Adherence to Treatment and Quality of Life of Patients Undergoing Hemodialysis
• Adherence to dietary and fluid restrictions among patients undergoing hemodialysis: An observational study

Publications

• Beto JA, Schury KA, Bansal VK. Strategies to promote adherence to nutritional advice in patients with chronic kidney disease: a narrative review and commentary. Int J Nephrol Renovasc Dis. 2016 Feb 2;9:21-33. doi: 10.2147/IJNRD.S76831. eCollection 2016. Review.
• Efe D, Kocaöz S. Adherence to diet and fluid restriction of individuals on hemodialysis treatment and affecting factors in Turkey. Jpn J Nurs Sci. 2015 Apr;12(2):113-23. doi: 10.1111/jjns.12055. Epub 2014 Aug 13.
• Kim K, Kang GW, Woo J. The Quality of Life of Hemodialysis Patients Is Affected Not Only by Medical but also Psychosocial Factors: a Canonical Correlation Study. J Korean Med Sci. 2018 Apr 2;33(14):e111. doi: 10.3346/jkms.2018.33.e111.
• Marcus C. Strategies for improving the quality of verbal patient and family education: a review of the literature and creation of the EDUCATE model. Health Psychol Behav Med. 2014 Jan 1;2(1):482-495. Epub 2014 Apr 28.
• Nabolsi MM, Wardam L, Al-Halabi JO. Quality of life, depression, adherence to treatment and illness perception of patients on haemodialysis. Int J Nurs Pract. 2015 Feb;21(1):1-10. doi: 10.1111/ijn.12205. Epub 2013 Oct 11.
• Tarverdizade Asl P, Lakdizaji S, Ghahramanian A, Seyedrasooli A, Ghavipanjeh Rezaiy S. Effectiveness of Text Messaging and Face to Face Training on Improving Knowledge and Quality of Life of Patients undergoing Hemodialysis: a Randomized Clinical Trial. J Caring Sci. 2018 Jun 1;7(2):95-100. doi: 10.15171/jcs.2018.015. eCollection 2018 Jun.

• Responsible Party: Şefika Tuğba YANGÖZ, Principal Investigator, Akdeniz University
• ClinicalTrials.gov Identifier: NCT04174638
• Other Study ID Numbers: Akdeniz University
• First Posted: Nov 22, 2019
• Last Update Posted: Feb 23, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Şefika Tuğba YANGÖZ, Principal Investigator, Akdeniz University: Compliance; Motivational Interviewing; Models, Nursing; Nursing; Patient Satisfaction; Quality of Life; Randomized Controlled Trial; Renal Dialysis

Study Results

Participant Flow

Recruitment Details	This randomized controlled study was conducted between April 2019-2020 with total of 60 patients included 32 intervention and 28 control groups who were receiving hemodialysis treatment in the Hemodialysis Unit of Akdeniz University Hospital.
Pre-assignment Detail	60 individuals were randomized into two groups. There were no individuals who did not continue during the follow-up, and no individuals were excluded from the analysis for any reason

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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 was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
Period Title: Overall Study
STARTED	32	28
COMPLETED	32	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention Group	Control Group	Total
Arm/Group Description	The intervention group was given 15 minute motivational interviewing for four month period, one session education at the first motivational interviewing and educational booklet based on Watson Human Care Theory.	The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.	Total of all reporting groups
Overall Participants	32	28	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.12 (17.23)	51.39 (18.53)	54.98 (18.02)
Sex: Female, Male (Count of Participants)
Female	11 34.4%	13 46.4%	24 40%
Male	21 65.6%	15 53.6%	36 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	32 100%	28 100%	60 100%
The duration of hemodialysis treatment (Count of Participants)
3 months-3 years	18 56.3%	21 75%	39 65%
4-6 years	9 28.1%	5 17.9%	14 23.3%
7 years and over	5 15.6%	2 7.1%	7 11.7%
Hemodialysis Access (Count of Participants)
Catheter	6 18.8%	11 39.3%	17 28.3%
Arteriovenous Fistula	26 81.3%	17 60.7%	43 71.7%
Arteriovenous Greft	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12
Description	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.
Time Frame	baseline and 12 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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 was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
Measure Participants	32	28
Knowledge sub-scale	1.37 (3.54)	-0.17 (1.44)
Behaviour sub-scale	3.31 (4.23)	0.50 (3.92)
Attitude sub-scale	6.46 (1.86)	2.21 (2.52)
Total score	11.15 (5.26)	2.53 (4.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was p=0.05. The p value was the value of the total score of the Fluid Control in Hemodialysis Patients Scale.
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Change From Baseline in Adherence to Diet on the Scale for Dietary Behaviors in Hemodialysis Patients at Week 12
Description	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.
Time Frame	Baseline and 12 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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 was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
Measure Participants	32	28
Mean (Standard Deviation) [score on a scale]	7.62 (5.51)	3.10 (4.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was p=0.05.
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Change From Baseline in Adherence to Drug Management on the Modified Morisky Scale at Week 12
Description	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
Time Frame	Baseline and 12 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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 was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
Measure Participants	32	28
Knowledge sub-dimension	1.00 (0.67)	0.46 (0.50)
Motivation sub-dimension	0.68 (0.47)	0.71 (0.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Control Group
	Comments	It was calculated for detect of difference in mean the knowledge sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was p=0.05.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Control Group
	Comments	It was calculated for detect of difference in mean the motivation sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was p=0.05.
	Method	t-test, 2 sided
	Comments

4. Primary Outcome

Title	Change From Baseline in Adherence to Participation in Dialysis Sessions on the Hemodialysis Session Participation Form at Week 4,8,12
Description	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.
Time Frame	baseline and 4, 8, 12 week

Outcome Measure Data

Analysis Population Description

This analysis was not performed because all participants in the intervention and control group attended all monthly sessions.

Arm/Group Title	"Intervention Group"	"Control Group"
Arm/Group Description	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. Motivational Interviewing and Education Based on Watson's Theory of Human Caring: 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 intervention performed before the hemodialysis session in a separate room in the hemodialysis unit.	The control group received routine hemodialysis treatment and nursing care in the hemodialysis unit.
Measure Participants	0	0

5. Primary Outcome

Title	The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12
Description	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.
Time Frame	12 week

Outcome Measure Data

Analysis Population Description

This analysis was performed to intervention group. Because this questionnaire evaluate the satisfaction with nursing care based on Watson's Theory of Human Caring. The intervention group received nursing care based on Watson's Theory of Human Caring, the control group received routine nursing care that not based on Watson's Theory of Human Caring or other nursing theories.Data were not collected from participants in the Control Group

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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 routine hemodialysis treatment and nursing care in the hemodialysis unit
Measure Participants	32	0
Deliver my care with loving-kindness	6.40 (0.49)
Meet my basic human needs.	6.43 (0.66)
Have helping and trusting relationships with me.	6.34 (0.70)
Create a caring environment that helps me to heal.	6.25 (0.67)
Value my personal beliefs and faith, allowing for	6.37 (0.65)

6. Primary Outcome

Title	The Mean of Satisfaction From the Motivational Interviewing Evaluated With Motivational Interview Evaluation Form at Week 12
Description	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.
Time Frame	12 week

Outcome Measure Data

Analysis Population Description

This analysis was performed to intervention group. Because this form evaluate the satisfaction with motivational interviewing. The intervention group received motivational interviewing, the control group received routine nursing care. Data were not collected from participants in the Control Group.

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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 routine hemodialysis treatment and nursing care in the hemodialysis unit
Measure Participants	32	0
Mean (Standard Deviation) [score on a scale]	4.5 (0.5)

7. Primary Outcome

Title	Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12
Description	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.
Time Frame	baseline and 12 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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 was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
Measure Participants	32	28
Physical functions sub-dimension	3.83 (9.33)	2.36 (6.82)
Mental functions sub-dimension	6.60 (9.52)	3.50 (7.92)
Burden of kidney disease sub-dimension	14.06 (22.33)	4.68 (9.56)
Symptoms/problems sub-dimension	11.45 (9.96)	10.49 (11.31)
Effects of kidney disease on daily life sub-dimension	18.74 (15.30)	13.72 (8.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Control Group
	Comments	It was calculated for detect of difference in mean the physical functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.297
	Comments	The threshold for statistical significance was p=0.05.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Control Group
	Comments	It was calculated for detect of difference in mean the mental functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.742
	Comments	The threshold for statistical significance was p=0.05
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Control Group
	Comments	It was calculated for detect of difference in mean the burden of kidney disease sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.719
	Comments	The threshold for statistical significance was p=0.05.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Control Group
	Comments	It was calculated for detect of difference in mean the symptoms/problems sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.063
	Comments	The threshold for statistical significance was p=0.05
	Method	t-test, 2 sided
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Control Group
	Comments	It was calculated for detect of difference in mean the effects of kidney disease on daily life sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was p=0.05.
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Intervention Group		Control Group
Arm/Group Description	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 was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
All Cause Mortality
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/28 (0%)
Serious Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.