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

NCT05986708 | Completed

• 1 other identifier: EskisehirOsmangaziU
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Patients

Keywords

guided self-determintion; hemodialysis; treatment adherence; quality of life; fluid control; anxiety

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• The change in intradialytic weight (kg) in hemodialysis patients

  week 0, week 6, and week 18 of the study

• The change in serum potassium (mEq/L) value in hemodialysis patients

  week 0, week 6, and week 18 of the study

• The change in serum phosphorus (mmol/L) value in hemodialysis patients

  week 0, week 6, and week 18 of the study

• The change in serum calcium (mg/dl) in hemodialysis patients

  week 0, week 6, and week 18 of the study

• The change in serum albumin (g/dl) in hemodialysis patients

  week 0, week 6, and week 18 of the study

Study Arms (2)

intervention

EXPERIMENTAL

The intervention group conducted 6 sessions of interviews with the researcher using the worksheets within the scope of the guided self-determination method.

Other: interview

control

NO INTERVENTION

No intervention was made to the individuals in the control group.

Interventions

interview OTHER

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.

intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• End-stage renal failure hospitalized due to emergency,
• Receiving HD treatment for a reason other than end-stage renal disease,

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskişehir Osmangazi University Faculty of Health Sciences

Eskişehir, 26480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance; Anxiety Disorders

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Füsun Uzgör

  eskişehir osmangazi university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 14, 2023
• Study Start: April 6, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)