Hemodialysis PatientsNCT05986708
Application of Guided Self- Determination (GSD) Method in Hemodialysis Patients
A study testing interview in people with Hemodialysis Patients, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- End-stage renal failure hospitalized due to emergency,
- Receiving HD treatment for a reason other than end-stage renal disease,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University Faculty of Health Sciences
Eskişehir, 26480
About this study
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
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.
Read the 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.
- Conditions
- Hemodialysis Patients
- Being tested
- interview
- Keywords
- guided self-determintion, hemodialysis, treatment adherence, quality of life, fluid control, anxiety
- Medical subject headings
- Treatment Adherence and Compliance, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: interview |
| control | No intervention | No intervention was made to the individuals in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 0, week 6, and week 18 of the study
Secondary outcomes (5)
The change in intradialytic weight (kg) in hemodialysis patients
Interdialytic weight was measured by the weight difference between two hemodialysis sessions.
Measured: week 0, week 6, and week 18 of the study
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.
Measured: week 0, week 6, and week 18 of the study
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.
Measured: week 0, week 6, and week 18 of the study
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.
Measured: week 0, week 6, and week 18 of the study
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.
Measured: week 0, week 6, and week 18 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start6 Apr 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fusun Uzgor, Eskisehir Osmangazi University
- Investigators
- Füsun Uzgör, Principal investigator, eskişehir osmangazi university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986708
- Sponsor's protocol ID
- EskisehirOsmangaziU
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05986708
- Acronym / sponsor ID
- EskisehirOsmangaziU
- Conditions
- Hemodialysis Patients
- Keywords
- guided self-determintion, hemodialysis, treatment adherence, quality of life, fluid control, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: interviewThe intervention group conducted 6 sessions of interviews with the researcher using the worksheets within the scope of the guided self-determination method. |
| control | No intervention | –No intervention was made to the individuals in the control group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between the ages of 18-70,
- Literate,
- Having end-stage renal failure,
- Receiving HD treatment,
- Able to communicate in Turkish,
Key exclusion criteria (2 listed)
- End-stage renal failure hospitalized due to emergency,
- Receiving HD treatment for a reason other than end-stage renal disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewIn 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. | Other | intervention |
Primary outcome
The change in treatment adherence in hemodialysis patients
Time frame: week 0, week 6, and week 18 of the study
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.
The change in fluid control in hemordialysis patients
Time frame: week 0, week 6, and week 18 of the study
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.
The change in self-efficancy in hemodialysis patients
Time frame: week 0, week 6, and week 18 of the study
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.
The change in quality of life in hemodialysis patients
Time frame: week 0, week 6, and week 18 of the study
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.
The change in anxiety level in hemodialysis patients
Time frame: week 0, week 6, and week 18 of the study
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.
5 secondary outcomes
The change in intradialytic weight (kg) in hemodialysis patients
Time frame: week 0, week 6, and week 18 of the study
The change in serum potassium (mEq/L) value in hemodialysis patients
Time frame: week 0, week 6, and week 18 of the study
The change in serum phosphorus (mmol/L) value in hemodialysis patients
Time frame: week 0, week 6, and week 18 of the study
The change in serum calcium (mg/dl) in hemodialysis patients
Time frame: week 0, week 6, and week 18 of the study
The change in serum albumin (g/dl) in hemodialysis patients
Time frame: week 0, week 6, and week 18 of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Hemodialysis Patients
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Füsun Uzgör principal investigator
eskişehir osmangazi university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interview in people with Hemodialysis Patients, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in treatment adherence in hemodialysis patients (time frame: week 0, week 6, and week 18 of the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.