Application of Guided Self- Determination (GSD) Method in Hemodialysis Patients

Hemodialysis Patients Clinical Trial

Official title:

The Effect of Guided Self-Determination (GSD) Method on Treatment Adherence, Fluid Control, Self-Efficancy, Anxiety and Quality of Life in Patients Undergoing Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05986708
• Other study ID #: EskisehirOsmangaziU
• Status: Completed
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: August 2023
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess how guided self-determination method affects adherence to treatment, fluid control, self-efficacy, anxiety level and quality of life in hemodialysis patients.

The population of the study consisted of patients who received HD treatment at Private Eskişehir Anatolian Dialysis Center and Eskişehir Osmangazi University Health, Practice and Research Hospital Dialysis Unit between April 2022 and October 2022. The sample of the study was 65 patients who met the inclusion criteria in the specified population.

Individual Identification Form, Biological/Biochemical Data Form, End Stage Renal Failure Compliance Scale, Hemodialysis Patients Fluid Control Scale, General Self-Efficacy Scale, Beck Anxiety Scale and SF-36 Quality of Life Scale Short Form were used to collect research data.

Description:

Guided Self- Determination (GSD) is a self-management support intervention aimed at supporting decision making and problem solving and helping patients suffering from a chronic disease to improve their life skills. GSD aims to support and develop the self management ability of the patients' chronic illness according to their own needs and desires by sharing psychosocial aspects, enabling active involvement of the patient in goal setting and treatment decisions, and thus developing positive autonomy and responsibility in the patient. This method is based on the idea that there is a potential for change in the patient-nurse relationship to support mutual understanding and cooperation.

This method consists of interviews using structured self-evaluation forms based on theories. It aims to guide the patient to gain skills for self-determination and self management by using these self-evaluation forms in thinking, goal setting, and problem solving .The self-assessment forms include four themes: the patient-healthcare professional relationship, illness and life, the relationship between ideal and reality, and working for change. The aim is to guide patients and healthcare professionals through mutual thinking using a six-step interaction process. These six stages are (i) establishing a clear mutual patient-nurse relationship (ii) self-discovery, (iii) self-understanding, (iv) shared decision making, (v) action, and (vi) feedback from action. In each interview, the patient fills out the self-evaluation forms in advance to encourage sharing before and during the interview with the nurses.

In our study, there are 2 groups; intervention and control groups. In addition to routine treatment and care, the patients in the intervention group were interviewed by the researcher once a week for 6 weeks, with a total of 6 sessions of directed self-determination, each session being approximately 30 min-1 hour before HD treatment. The interview time was determined in consultation with the patients, and when the patient forgot/missed an interview, he was offered an appointment for another interview if he wanted to continue the study. Evaluations of the patients in both groups was performed with biological and/or biochemical data, ESRD-SQ, General Self-Efficacy Scale, HHSSK, SF-36 Quality of Life Scale Short Form and the Beck Anxiety Scale at the end of the interviews (week 6) and week 18, conducted within the scope of guided self-determination method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18-70,

• Literate,

• Having end-stage renal failure,

• Receiving HD treatment,

• Able to communicate in Turkish,

• No hearing or vision loss,

• Conscious Open,

• Patients who volunteer to participate in the study.

Exclusion Criteria:

• End-stage renal failure hospitalized due to emergency,

• Receiving HD treatment for a reason other than end-stage renal disease,

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Other:
• interview
In addition to routine treatment and care, the patients in the application group were interviewed by the researcher once a week for 6 weeks, within the first hour of HD treatment, for a total of 6 sessions, each session being approximately 30 minutes-1 hour, within the scope of the guided self-determination method.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Faculty of Health Sciences	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in treatment adherence in hemodialysis patients	Treatment adherence was evaluated in study with the End Stage Kidney Disease Adherence Scale (ESRD-AQ) .The End Stage Kidney Disease Adherence Scale evaluates patients' participation in hemodialysis treatment, their medication use, their adherence with fluid restriction and diet.; The validity and reliability analysis of the scale was made on 9 items. The total score that can be obtained from the scale varies between 0-1200. As the score obtained from the scale increases, the level of adherence to treatment increases.	week 0, week 6, and week 18 of the study
Primary	The change in fluid control in hemordialysis patients	Fluid control was evaluated with "Fluid Control in Hemodialysis Patients Scale". This scale has a total of 24 items and three sub-dimensions. Information sub-dimension: 1.-7. from questions; behavior sub-dimension 8.-18. From the questions; attitude sub-dimension 19.-24. consists of questions. The lowest score obtained from the scale is 24, the highest score is 72, and as the score increases, patients' compliance with fluid control increases.	week 0, week 6, and week 18 of the study
Primary	The change in self-efficancy in hemodialysis patients	Self-efficancy was evaluated at 0th week, 6th weeks and 18th weeks in study with General Self-Efficancy Scale".This scale has a total of 24 items. Each of the 10 items in the scale receives scores ranging from 1 to 4. The lowest score obtained from the scale is evaluated as 10 and the highest score as 40, and as the scale score increases, the self-efficacy score increases.	week 0, week 6, and week 18 of the study
Primary	The change in quality of life in hemodialysis patients	The change in quality of life in hemodialysis patients was evaluated with the Short Form of the Quality of Life Scale (SF 36). The scale consists of 36 questions and the last four weeks of the individuals are questioned. The scale consists of eight sub-dimensions and the sub-dimensions is evaluated separately. On the scale, "0" indicates poor health, "100" indicates good health.	week 0, week 6, and week 18 of the study
Primary	The change in anxiety level in hemodialysis patients	Anxiety level was evaluated with Beck Anxiety Inventory. It is a self-assessment scale consisting of 21 items and scored between 0-3. With the questions asked to the person, it is questioned to what extent the feeling of distress has disturbed him in the last week. Scores from the scale range from 0 to 63, with 8-15 points = mild anxiety, 16-25 points = moderate anxiety, 26-63 points = severe anxiety.	week 0, week 6, and week 18 of the study
Secondary	The change in intradialytic weight (kg) in hemodialysis patients	Interdialytic weight was measured by the weight difference between two hemodialysis sessions.	week 0, week 6, and week 18 of the study
Secondary	The change in serum potassium (mEq/L) value in hemodialysis patients	Serum potassium value was taken from the patient file. Normal serum potassium is 3.5 to 5.5 mEq/L.	week 0, week 6, and week 18 of the study
Secondary	The change in serum phosphorus (mmol/L) value in hemodialysis patients	Serum phosphorus value was taken from the patient file. Normal serum phosphorus value is 3.5 to 5.5 mmol/L.	week 0, week 6, and week 18 of the study
Secondary	The change in serum calcium (mg/dl) in hemodialysis patients	Serum calcium value was taken from the patient file. Normal serum calcium value is 8.6 to 10.0 mg/dl.	week 0, week 6, and week 18 of the study
Secondary	The change in serum albumin (g/dl) in hemodialysis patients	Serum calcium value was taken from the patient file. Normal serum albumin value is 3.4 to 4.8 g/dl.	week 0, week 6, and week 18 of the study