Adherence, Treatment, Quality of Life, Renal Disease, Satisfaction, Patient
Conditions
Keywords
Compliance, Motivational Interviewing, Models, Nursing, Nursing, Patient Satisfaction, Quality of Life, Randomized Controlled Trial, Renal Dialysis
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.
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.
Interventions
OTHERMotivational 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.
Sponsors
Akdeniz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Single blinding was provided that included inclusion criteria and agreement to participate in the study
Intervention model description
This study is a parallel group randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Turkey (Türkiye)
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 details
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
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group 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. | 32 |
| Control Group The control group was given routine hemodialysis treatment and nursing care in the hemodialysis unit. | 28 |
| Total | 60 |
Baseline characteristics
| Characteristic | Intervention Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 58.12 years STANDARD_DEVIATION 17.23 | 54.98 years STANDARD_DEVIATION 18.02 | 51.39 years STANDARD_DEVIATION 18.53 |
| Hemodialysis Access Arteriovenous Fistula | 26 Participants | 43 Participants | 17 Participants |
| Hemodialysis Access Arteriovenous Greft | 0 Participants | 0 Participants | 0 Participants |
| Hemodialysis Access Catheter | 6 Participants | 17 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 32 Participants | 60 Participants | 28 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 24 Participants | 13 Participants |
| Sex: Female, Male Male | 21 Participants | 36 Participants | 15 Participants |
| The duration of hemodialysis treatment 3 months-3 years | 18 Participants | 39 Participants | 21 Participants |
| The duration of hemodialysis treatment 4-6 years | 9 Participants | 14 Participants | 5 Participants |
| The duration of hemodialysis treatment 7 years and over | 5 Participants | 7 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 28 |
| other Total, other adverse events | 0 / 32 | 0 / 28 |
| serious Total, serious adverse events | 0 / 32 | 0 / 28 |
Outcome results
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.
Time frame: Baseline and 12 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | 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 |
| Control Group | Change From Baseline in Adherence to Diet on the Scale for Dietary Behaviors in Hemodialysis Patients at Week 12 | 3.10 score on a scale | Standard Deviation 4.99 |
p-value: <0.001t-test, 2 sided
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
Time frame: Baseline and 12 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | 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 |
| Intervention Group | 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 |
| Control Group | Change From Baseline in Adherence to Drug Management on the Modified Morisky Scale at Week 12 | Knowledge sub-dimension | 0.46 units on a scale | Standard Deviation 0.5 |
| Control Group | Change From Baseline in Adherence to Drug Management on the Modified Morisky Scale at Week 12 | Motivation sub-dimension | 0.71 units on a scale | Standard Deviation 0.26 |
Comparison: 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.p-value: <0.001t-test, 2 sided
Comparison: 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.p-value: <0.001t-test, 2 sided
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.
Time frame: baseline and 12 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | 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 |
| Intervention Group | 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 |
| Intervention Group | 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 |
| Intervention Group | 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 |
| Control Group | Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12 | Total score | 2.53 units on a scale | Standard Deviation 4.72 |
| Control Group | Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12 | Knowledge sub-scale | -0.17 units on a scale | Standard Deviation 1.44 |
| Control Group | Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12 | Attitude sub-scale | 2.21 units on a scale | Standard Deviation 2.52 |
| Control Group | Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12 | Behaviour sub-scale | 0.50 units on a scale | Standard Deviation 3.92 |
p-value: <0.001t-test, 2 sided
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.
Time frame: 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.
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 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | 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 |
| Intervention Group | 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 |
| Intervention Group | 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 |
| Intervention Group | 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 15.3 |
| Intervention Group | 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 |
| Control Group | 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 | 13.72 units on a scale | Standard Deviation 8.12 |
| Control Group | Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12 | Physical functions sub-dimension | 2.36 units on a scale | Standard Deviation 6.82 |
| Control Group | Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12 | Mental functions sub-dimension | 3.50 units on a scale | Standard Deviation 7.92 |
| Control Group | 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 | 4.68 units on a scale | Standard Deviation 9.56 |
| Control Group | Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12 | Symptoms/problems sub-dimension | 10.49 units on a scale | Standard Deviation 11.31 |
Comparison: 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.p-value: 0.297t-test, 2 sided
Comparison: 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.p-value: 0.742t-test, 2 sided
Comparison: 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.p-value: 0.719t-test, 2 sided
Comparison: 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.p-value: 0.063t-test, 2 sided
Comparison: 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.p-value: <0.001t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | 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
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | 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 |
| Intervention Group | 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 |
| Intervention Group | 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 0.7 |
| Intervention Group | 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 |
| Intervention Group | 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 |