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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174638
• Other study ID #: Akdeniz University
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: June 17, 2020

Study information

• Verified date: February 2021
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 17, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Treatment
• Quality of Life
• Renal Disease
• Satisfaction, Patient

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sefika Tugba Yangöz	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12	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.	baseline and 12 week
Primary	Change From Baseline in Adherence to Diet on the Scale for Dietary Behaviors in Hemodialysis Patients at Week 12	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.	Baseline and 12 week
Primary	Change From Baseline in Adherence to Drug Management on the Modified Morisky Scale at Week 12	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	Baseline and 12 week
Primary	Change From Baseline in Adherence to Participation in Dialysis Sessions on the Hemodialysis Session Participation Form at Week 4,8,12	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.	baseline and 4, 8, 12 week
Primary	The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12	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.	12 week
Primary	The Mean of Satisfaction From the Motivational Interviewing Evaluated With Motivational Interview Evaluation Form at Week 12	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.	12 week
Primary	Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12	Kidney Disease Quality of Life Instrument 36 item: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.	baseline and 12 week

External Links

•   Adherence to dietary and fluid restrictions among patients undergoing hemodialysis: An observational study
•   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