Trial Outcomes & Findings for The Effect of Motivational Interviewing and Education Based on Watson's Theory of Human Caring in Hemodialysis (NCT NCT04174638)

Last Updated: 2021-02-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

baseline and 12 week

Results posted on

2021-02-23

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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.	Control Group The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
Overall Study STARTED	32	28
Overall Study COMPLETED	32	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=32 Participants 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.	Control Group n=28 Participants The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.	Total n=60 Participants Total of all reporting groups
Age, Continuous	58.12 years STANDARD_DEVIATION 17.23 • n=5 Participants	51.39 years STANDARD_DEVIATION 18.53 • n=7 Participants	54.98 years STANDARD_DEVIATION 18.02 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
The duration of hemodialysis treatment 3 months-3 years	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
The duration of hemodialysis treatment 4-6 years	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
The duration of hemodialysis treatment 7 years and over	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Hemodialysis Access Catheter	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Hemodialysis Access Arteriovenous Fistula	26 Participants n=5 Participants	17 Participants n=7 Participants	43 Participants n=5 Participants
Hemodialysis Access Arteriovenous Greft	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 week

Outcome measures

Outcome measures
Measure	Intervention Group n=32 Participants 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.	Control Group n=28 Participants The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12 Knowledge sub-scale	1.37 units on a scale Standard Deviation 3.54	-0.17 units on a scale Standard Deviation 1.44
Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12 Behaviour sub-scale	3.31 units on a scale Standard Deviation 4.23	0.50 units on a scale Standard Deviation 3.92
Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12 Attitude sub-scale	6.46 units on a scale Standard Deviation 1.86	2.21 units on a scale Standard Deviation 2.52
Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12 Total score	11.15 units on a scale Standard Deviation 5.26	2.53 units on a scale Standard Deviation 4.72

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=32 Participants 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.	Control Group n=28 Participants The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
Change From Baseline in Adherence to Diet on the Scale for Dietary Behaviors in Hemodialysis Patients at Week 12	7.62 score on a scale Standard Deviation 5.51	3.10 score on a scale Standard Deviation 4.99

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention Group n=32 Participants 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.	Control Group n=28 Participants The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
Change From Baseline in Adherence to Drug Management on the Modified Morisky Scale at Week 12 Motivation sub-dimension	0.68 units on a scale Standard Deviation 0.47	0.71 units on a scale Standard Deviation 0.26
Change From Baseline in Adherence to Drug Management on the Modified Morisky Scale at Week 12 Knowledge sub-dimension	1.00 units on a scale Standard Deviation 0.67	0.46 units on a scale Standard Deviation 0.50

PRIMARY outcome

Timeframe: baseline and 4, 8, 12 week

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

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 week

Population: 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

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=32 Participants 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.	Control Group The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12 Deliver my care with loving-kindness	6.40 units on a scale Standard Deviation 0.49	—
The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12 Meet my basic human needs.	6.43 units on a scale Standard Deviation 0.66	—
The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12 Have helping and trusting relationships with me.	6.34 units on a scale Standard Deviation 0.70	—
The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12 Create a caring environment that helps me to heal.	6.25 units on a scale Standard Deviation 0.67	—
The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12 Value my personal beliefs and faith, allowing for	6.37 units on a scale Standard Deviation 0.65	—

PRIMARY outcome

Timeframe: 12 week

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=32 Participants 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.	Control Group The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
The Mean of Satisfaction From the Motivational Interviewing Evaluated With Motivational Interview Evaluation Form at Week 12	4.5 score on a scale Standard Deviation 0.5	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=32 Participants 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.	Control Group n=28 Participants The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit.
Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12 Physical functions sub-dimension	3.83 units on a scale Standard Deviation 9.33	2.36 units on a scale Standard Deviation 6.82
Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12 Mental functions sub-dimension	6.60 units on a scale Standard Deviation 9.52	3.50 units on a scale Standard Deviation 7.92
Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12 Burden of kidney disease sub-dimension	14.06 units on a scale Standard Deviation 22.33	4.68 units on a scale Standard Deviation 9.56
Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12 Symptoms/problems sub-dimension	11.45 units on a scale Standard Deviation 9.96	10.49 units on a scale Standard Deviation 11.31
Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12 Effects of kidney disease on daily life sub-dimension	18.74 units on a scale Standard Deviation 15.30	13.72 units on a scale Standard Deviation 8.12

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Sefika Tugba Yangoz

Akdeniz University

Phone: +905058039716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place