Clinical trial NCT05986708: Application of Guided Self- Determination (GSD) Method in Hemodialysis Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Patients
Keywords: guided self-determintion
hemodialysis
treatment adherence
quality of life
fluid control
anxiety
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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,

Primary outcomes:
measure: The change in treatment adherence in hemodialysis patients
timeFrame: week 0, week 6, and week 18 of the study
measure: The change in fluid control in hemordialysis patients
timeFrame: week 0, week 6, and week 18 of the study
measure: The change in self-efficancy in hemodialysis patients
timeFrame: week 0, week 6, and week 18 of the study
measure: The change in quality of life in hemodialysis patients
timeFrame: week 0, week 6, and week 18 of the study
measure: The change in anxiety level in hemodialysis patients
timeFrame: week 0, week 6, and week 18 of the study
Secondary outcomes:
measure: The change in intradialytic weight (kg) in hemodialysis patients
timeFrame: week 0, week 6, and week 18 of the study
measure: The change in serum potassium (mEq/L) value in hemodialysis patients
timeFrame: week 0, week 6, and week 18 of the study
measure: The change in serum phosphorus (mmol/L) value in hemodialysis patients
timeFrame: week 0, week 6, and week 18 of the study
measure: The change in serum calcium (mg/dl) in hemodialysis patients
timeFrame: week 0, week 6, and week 18 of the study
measure: The change in serum albumin (g/dl) in hemodialysis patients
timeFrame: week 0, week 6, and week 18 of the study
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University Faculty of Health Sciences
Study officials:
affiliation: eskişehir osmangazi university
name: Füsun Uzgör
role: PRINCIPAL_INVESTIGATOR
References: