Hemodialytic PatientsNCT06723912
Implementation of a Health Action Process Approach-Based Program for People on Hemodialysis Treatment
A study testing Health Action Process Approach-Based Program in people with Hemodialytic Patients, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to determine the effect of the Health Action Process Approach (HAPA) based program on the treatment compliance and quality of life of people undergoing hemodialysis treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialytic Patients
- What is being tested?
- Health Action Process Approach-Based Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- Over 18 years of age
- Being literate
- Not having any problems with speech, hearing or vision that may interfere with communication
- No history of neurological or psychiatric disease
- Being on hemodialysis treatment for at least six months
- The vascular access (catheter, fistula or graft) used to administer hemodialysis is working effectively
Who cannot join
- Not meeting the inclusion criteria
- Participation in a program based on the Health Action Process Approach related to the subject
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaraş Necip Fazıl City Hospital
Kahramanmaraş
Kahramanmaraş Necip Fazıl City Hospital, +90344 228 2800, kmaras.necipfazilsh@saglik.gov.tr
About this study
Official title: The Effect of Health Action Process Approach-Based Program on Hemodialysis Patients' Adherence to Treatment and Quality of Life
The aim of the study is to determine the effect of the Health Action Process Approach (HAPA) based program on the treatment compliance and quality of life of people undergoing hemodialysis treatment. The hypotheses of the study are as follows:
- The Health Action Process Approach Based Program has an effect on the treatment compliance of people undergoing hemodialysis treatment.
- The Health Action Process Approach Based Program has an effect on the quality of life of people undergoing hemodialysis treatment.
- The Health Action Process Approach Based Program has an impact on the results of laboratory tests and clinical parameters of people receiving hemodialysis treatment.
Read more
The population of the study will consist of people receiving hemodialysis treatment in the main service building and additional service building of Kahramanmaraş Necip Fazıl City Hospital. Patients who meet the criteria of ''volunteering to participate in the study, being over the age of 18, being literate, not having any problems that may prevent communication, not having a history of neurological or psychiatric disease, being on hemodialysis treatment for at least six months, and the vascular access used for hemodialysis being effective'' will be included in the study. Written informed consent will be obtained from patients who volunteer to participate in the study. At least 32 people who meet the inclusion criteria will be included in each group. The intervention group will receive a program based on the Health Action Process Approach (HAPA). No program will be applied to the control group.
The data collection tools of the study consist of the Participant Information Form, Participant Evaluation Form Based on the Health Action Process Approach, End-Stage Renal Disease Adherence Scale (ESRD-AQ), Fluid Control Scale in Hemodialysis Patients, Diet Information Scale of Hemodialysis Patients, Diet Behavior Scale of Hemodialysis Patients, Quality of Life (SF-36) Form, Laboratory Tests Follow-up Form and Homework Form. Measurements of the groups will be taken at the beginning of the study, week 6 (at the end of the program), month 3 and month 6.
Read the detailed description
The Health Action Process Approach (HAPA) Model was developed by Ralf Schwarzer in 1992 to understand the process of health behavior change. The Health Action Process Approach Model focuses on the "intention-behavior gap", which states that intentions to perform the behavior are sometimes not sufficient to take action to perform the behavior. Other social cognitive models are criticized for this "intention-behavior gap". Because in most of these models, it is stated that intention is the most important predictor for behavior change, and if the intention to perform the behavior is formed, the behavior will occur; however, intentions do not always turn into behavior. In order to close the intention-behavior gap, the HAPA Model proposes to evaluate the pre-intention motivation processes that lead to behavioral intention and the post-intention volitional processes that lead to behavior in two separate stages. The motivation stage of the model includes the components of "risk perception", "outcome expectations" and "action self-efficacy" and it is thought that the formation of behavioral intention depends on these components. The volitional stage of the model includes "action planning", "coping planning", "coping self-efficacy", "improvement self-efficacy" and "social support" and these are effective in the realization and maintenance of health behaviors. The HAPA Model is an important model in terms of providing a detailed and comprehensive description of the motivation processes before the formation of health behavior intention, the transformation of intention into behavior and the maintenance of behavior within these components. The volitional stage of the model includes "action planning", "coping planning", "coping self-efficacy", "improvement self-efficacy" and "social support" and these are effective in the realization and maintenance of health behaviors. The HAPA Model is an important model in terms of providing a detailed and comprehensive description of the motivation processes before the formation of health behavior intention, the transformation of intention into behavior and the maintenance of behavior within these components.
Health Action Process Approach-Based Program: The program is planned for six weeks (six sessions). Sessions will be held once a week for 30-45 minutes. Within the scope of the program, care - structured nursing care plans based on the Health Action Process Approach will be made -, education and counseling will be provided. Sessions will be held in a quiet, calm environment in the hospital, and if such an environment cannot be provided, they will be held at the patient's home. The day, time and place of the sessions will be decided together with the participant after each interview or session. At the beginning of each session, the previous session will be briefly recalled and the homework (SWOT analysis, treatment adherence tracking chart or SMART goal plan) given in the previous session will be evaluated. At the end of each session, the evaluation of that day's session will be carried out briefly.
In the study, two groups will be formed as intervention and control groups. No program will be applied to the intervention group. Routine treatment and care will continue. The control group will receive routine treatment and care as well as a program based on the Health Action Process Approach. Hemodialysis Treatment Adherence Handbook will be given to the intervention group when the study is completed. Participants in both groups will fill out the Health Action Process Approach-Based Participant Evaluation Form, Laboratory Tests Monitoring Form, End Stage Renal Failure Compliance Scale, Fluid Control Scale in Hemodialysis Patients, Dietary Knowledge Scale of Hemodialysis Patients, Dietary Behavior Scale of Hemodialysis Patients and Quality of Life (SF-36) Form. These forms will be completed at the beginning of the study (week 0), week 6 (at the end of the program), month 3 and month 6.
- Conditions
- Hemodialytic Patients
- Being tested
- Health Action Process Approach-Based Program
- Keywords
- Health action process approach, hemodialysis, quality of life, treatment adherence, care
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Action Process Approach-Based ProgramOther
Health Action Process Approach-Based Program: The program is planned for six weeks (six sessions). Sessions will be held once a week for 30-45 minutes. Within the scope of the program, care - structured nursing care plans based on the Health Action Process Approach will be made -, education and counseling will be provided. Sessions will be held in a quiet, calm environment in the hospital, and if such an environment cannot be provided, they will be held at the patient's home. The day, time and place of the sessions will be decided together with the participant after each interview or session. At the beginning of each session, the previous session will be briefly recalled and the homework (SWOT analysis, treatment adherence tracking chart or SMART goal plan) given in the previous session will be evaluated. At the end of each session, the evaluation of that day's session will be carried out briefly.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No program will be applied to the control group. Routine treatment and care in the hospital will continue. At the end of the study, a Handbook for Adherence to Hemodialysis Treatment will be given. |
| Intervention Group | Experimental | Program based on the Health Action Process Approach will be implemented. Hemodialysis Treatment Compliance Handbook will be given. Receives: Other: Health Action Process Approach-Based Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the attendance of people receiving hemodialysis treatment at hemodialysis sessions
Health Action Process Approach Based Participant Evaluation Form: It is a form created by the researcher based on the studies in the literature. There are 11 questions regarding participation in hemodialysis sessions. The questions can be answered "yes", "partially" and "no".
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Changes in adherence to dietary restriction in people receiving hemodialysis treatment
Health Action Process Approach Based Participant Evaluation Form: It is a form created by the researcher based on the studies in the literature. There are 11 questions regarding the compliance of people receiving hemodialysis treatment with dietary restriction. The questions can be answered "yes", "partially" and "no".
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Changes in compliance with fluid restriction in people on hemodialysis
Health Action Process Approach Based Participant Evaluation Form: It is a form created by the researcher based on the studies in the literature. There are 11 questions regarding the compliance of people receiving hemodialysis treatment with fluid restriction. The questions can be answered "yes", "partially" and "no".
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Changes in adherence to medication use among people receiving hemodialysis treatment
Health Action Process Approach Based Participant Evaluation Form: It is a form created by the researcher based on the studies in the literature. There are 11 questions regarding the medication compliance of people receiving hemodialysis treatment. The questions can be answered "yes", "partially" and "no".
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in adherence of people on hemodialysis treatment
End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ): The scale consists of four sections: participation in haemodialysis treatment, medication use, fluid restriction and dietary restriction. A score between 0-1200 can be obtained from the scale. The increase in the score obtained from the scale indicates an increase in treatment compliance. There are no reverse coded items in the scale. Since the items in the scale do not have a homogenous structure, Cronbach's alpha coefficient cannot be calculated.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in treatment adherence (dietary adherence) of people receiving hemodialysis treatment
Dietary Knowledge Scale of Hemodialysis Patients: It was used to evaluate the dietary compliance of people undergoing haemodialysis treatment in detail. The scale has a 3-point Likert type. The questions can be answered as ''true'', ''false'' and ''don't know''. The answers are scored as 1, 0 and 0 respectively. There are no reverse coded items. Scores between 0-18 can be obtained from the scale. The increase in the score indicates that the level of knowledge is good. Cronbach Alpha value is 0.86.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in treatment adherence (dietary adherence) of people receiving hemodialysis treatment
Dietary Behaviour Scale of Hemodialysis Patients: It was used to evaluate the dietary compliance of people undergoing haemodialysis treatment in detail. The scale consists of one sub-dimension and 13 items. The items are scored as ''strongly disagree=1, disagree= 2, undecided= 3, agree= 4, strongly agree= 5''. There are no items that need to be reverse coded. A score between 13-65 can be obtained from the scale. A high score indicates that the behavioural status is 'good'.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in adherence to treatment (adherence to fluid restriction) of people receiving hemodialysis treatment
Fluid Control Scale in Haemodialysis Patients: It was used to evaluate in detail the compliance of people on haemodialysis treatment with fluid restriction. The scale consists of 24 items and three sub-dimensions (knowledge-behaviour-attitude). The items are scored as ''agree=3, undecided=2, disagree=1''. Items 6, 7, 18, 19, 20, 21, 22, 23, 24 are scored by reverse coding. A score between 24-72 can be obtained from the scale. The increase in the score obtained from the scale indicates that the fluid control of the patients also increases.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in the quality of life of people undergoing hemodialysis treatment
Quality of Life (SF-36) Form: It was used to assess the quality of life of people undergoing haemodialysis treatment. The scale consists of eight sub-dimensions (physical function, social function, pain, vitality (energy), role limitation-emotional, role limitation-physical, mental health, general perception of health) and 36 items. The total score of the scale is not calculated and the total scores of the sub-dimensions are calculated separately. The scores that can be obtained vary between 0-100. A high score indicates a high quality of life.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in URR value of people on haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in haemoglobin value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in potassium value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in sodium value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in creatinine value of people on haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in Kt/V value of people receiving haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in urea value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in calcium value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in phosphorus value of people undergoing haemodialysis treatment
Taken from patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in glucose value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in total protein value of people on haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in MCH value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Changes in ALT values of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in RBC value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Changes in AST values of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in albumin value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Changes in WBC values of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in MCV value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in PLT value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in haematocrit value of people undergoing haemodialysis treatment
It will be taken from the patient file.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in blood pressure of a person undergoing hemodialysis treatment
Blood pressure value at the entrance and exit of hemodialysis will be measured.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in the pulse rate of a person receiving hemodialysis treatment
The person's pulse rate will be measured at the entrance and exit of hemodialysis treatment.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in respiratory rate of a person receiving hemodialysis treatment
The respiratory rate of the person will be measured at the entrance and exit of hemodialysis treatment.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in oxygen saturation of a person receiving hemodialysis treatment
Oxygen saturation will be measured at the entrance and exit of hemodialysis treatment.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in body temperature of the person receiving hemodialysis treatment
Body temperature will be measured at the entrance and exit of hemodialysis treatment.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Change in weight at entry and exit of hemodialysis treatment
Hemodialysis treatment entry and exit weight will be weighed.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Changes in dry weight of a person undergoing hemodialysis treatment
The dry weight of the person receiving hemodialysis treatment will be weighed.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Interdialytic weight changes in a person receiving hemodialysis treatment
The interdialytic weight of the person receiving hemodialysis treatment will be weighed.
Measured: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start23 Oct 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialytic 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelda KOÇAK, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723912
- Sponsor's protocol ID
- YKOCAK
- Status last verified
- Nov 2024
- First submitted
- 4 Dec 2024
- Last updated
- 12 Dec 2024
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Action Process Approach-Based Program on Hemodialysis Patients' Adherence to Treatment and Quality of Life
- ClinicalTrials.gov ID
- NCT06723912
- Acronym / sponsor ID
- YKOCAK
- Conditions
- Hemodialytic Patients
- Keywords
- Health action process approach, hemodialysis, quality of life, treatment adherence, care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 9 Dec 2024 (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 the study is to determine the effect of the Health Action Process Approach (HAPA) based program on the treatment compliance and quality of life of people undergoing hemodialysis treatment. The hypotheses of the study are as follows:
- The Health Action Process Approach Based Program has an effect on the treatment compliance of people undergoing hemodialysis treatment.
- The Health Action Process Approach Based Program has an effect on the quality of life of people undergoing hemodialysis treatment.
- The Health Action Process Approach Based Program has an impact on the results of laboratory tests and clinical parameters of people receiving hemodialysis treatment.
The population of the study will consist of people receiving hemodialysis treatment in the main service building and additional service building of Kahramanmaraş Necip Fazıl City Hospital. Patients who meet the criteria of ''volunteering to participate in the study, being over the age of 18, being literate, not having any problems that may prevent communication, not having a history of neurological or psychiatric disease, being on hemodialysis treatment for at least six months, and the vascular access used for hemodialysis being effective'' will be included in the study. Written informed consent will be obtained from patients who volunteer to participate in the study. At least 32 people who meet the inclusion criteria will be included in each group. The intervention group will receive a program based on the Health Action Process Approach (HAPA). No program will be applied to the control group.
The data collection tools of the study consist of the Participant Information Form, Participant Evaluation Form Based on the Health Action Process Approach, End-Stage Renal Disease Adherence Scale (ESRD-AQ), Fluid Control Scale in Hemodialysis Patients, Diet Information Scale of Hemodialysis Patients, Diet Behavior Scale of Hemodialysis Patients, Quality of Life (SF-36) Form, Laboratory Tests Follow-up Form and Homework Form. Measurements of the groups will be taken at the beginning of the study, week 6 (at the end of the program), month 3 and month 6.
Detailed description
The Health Action Process Approach (HAPA) Model was developed by Ralf Schwarzer in 1992 to understand the process of health behavior change. The Health Action Process Approach Model focuses on the "intention-behavior gap", which states that intentions to perform the behavior are sometimes not sufficient to take action to perform the behavior. Other social cognitive models are criticized for this "intention-behavior gap". Because in most of these models, it is stated that intention is the most important predictor for behavior change, and if the intention to perform the behavior is formed, the behavior will occur; however, intentions do not always turn into behavior. In order to close the intention-behavior gap, the HAPA Model proposes to evaluate the pre-intention motivation processes that lead to behavioral intention and the post-intention volitional processes that lead to behavior in two separate stages. The motivation stage of the model includes the components of "risk perception", "outcome expectations" and "action self-efficacy" and it is thought that the formation of behavioral intention depends on these components. The volitional stage of the model includes "action planning", "coping planning", "coping self-efficacy", "improvement self-efficacy" and "social support" and these are effective in the realization and maintenance of health behaviors. The HAPA Model is an important model in terms of providing a detailed and comprehensive description of the motivation processes before the formation of health behavior intention, the transformation of intention into behavior and the maintenance of behavior within these components. The volitional stage of the model includes "action planning", "coping planning", "coping self-efficacy", "improvement self-efficacy" and "social support" and these are effective in the realization and maintenance of health behaviors. The HAPA Model is an important model in terms of providing a detailed and comprehensive description of the motivation processes before the formation of health behavior intention, the transformation of intention into behavior and the maintenance of behavior within these components.
Health Action Process Approach-Based Program: The program is planned for six weeks (six sessions). Sessions will be held once a week for 30-45 minutes. Within the scope of the program, care - structured nursing care plans based on the Health Action Process Approach will be made -, education and counseling will be provided. Sessions will be held in a quiet, calm environment in the hospital, and if such an environment cannot be provided, they will be held at the patient's home. The day, time and place of the sessions will be decided together with the participant after each interview or session. At the beginning of each session, the previous session will be briefly recalled and the homework (SWOT analysis, treatment adherence tracking chart or SMART goal plan) given in the previous session will be evaluated. At the end of each session, the evaluation of that day's session will be carried out briefly.
In the study, two groups will be formed as intervention and control groups. No program will be applied to the intervention group. Routine treatment and care will continue. The control group will receive routine treatment and care as well as a program based on the Health Action Process Approach. Hemodialysis Treatment Adherence Handbook will be given to the intervention group when the study is completed. Participants in both groups will fill out the Health Action Process Approach-Based Participant Evaluation Form, Laboratory Tests Monitoring Form, End Stage Renal Failure Compliance Scale, Fluid Control Scale in Hemodialysis Patients, Dietary Knowledge Scale of Hemodialysis Patients, Dietary Behavior Scale of Hemodialysis Patients and Quality of Life (SF-36) Form. These forms will be completed at the beginning of the study (week 0), week 6 (at the end of the program), month 3 and month 6.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No program will be applied to the control group. Routine treatment and care in the hospital will continue. At the end of the study, a Handbook for Adherence to Hemodialysis Treatment will be given. |
| Intervention Group | Experimental | Other: Health Action Process Approach-Based ProgramProgram based on the Health Action Process Approach will be implemented. Hemodialysis Treatment Compliance Handbook will be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteering to participate in the study
- Over 18 years of age
- Being literate
- Not having any problems with speech, hearing or vision that may interfere with communication
- No history of neurological or psychiatric disease
Key exclusion criteria (2 listed)
- Not meeting the inclusion criteria
- Participation in a program based on the Health Action Process Approach related to the subject
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 |
|---|---|---|
| Health Action Process Approach-Based ProgramHealth Action Process Approach-Based Program: The program is planned for six weeks (six sessions). Sessions will be held once a week for 30-45 minutes. Within the scope of the program, care - structured nursing care plans based on the Health Action Process Approach will be made -, education and counseling will be provided. Sessions will be held in a quiet, calm environment in the hospital, and if such an environment cannot be provided, they will be held at the patient's home. The day, time and place of the sessions will be decided together with the participant after each interview or session. At the beginning of each session, the previous session will be briefly recalled and the homework (SWOT analysis, treatment adherence tracking chart or SMART goal plan) given in the previous session will be evaluated. At the end of each session, the evaluation of that day's session will be carried out briefly. | Other | Intervention Group |
Primary outcome
Changes in the attendance of people receiving hemodialysis treatment at hemodialysis sessions
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Health Action Process Approach Based Participant Evaluation Form: It is a form created by the researcher based on the studies in the literature. There are 11 questions regarding participation in hemodialysis sessions. The questions can be answered "yes", "partially" and "no".
Changes in adherence to dietary restriction in people receiving hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Health Action Process Approach Based Participant Evaluation Form: It is a form created by the researcher based on the studies in the literature. There are 11 questions regarding the compliance of people receiving hemodialysis treatment with dietary restriction. The questions can be answered "yes", "partially" and "no".
Changes in compliance with fluid restriction in people on hemodialysis
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Health Action Process Approach Based Participant Evaluation Form: It is a form created by the researcher based on the studies in the literature. There are 11 questions regarding the compliance of people receiving hemodialysis treatment with fluid restriction. The questions can be answered "yes", "partially" and "no".
Changes in adherence to medication use among people receiving hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Health Action Process Approach Based Participant Evaluation Form: It is a form created by the researcher based on the studies in the literature. There are 11 questions regarding the medication compliance of people receiving hemodialysis treatment. The questions can be answered "yes", "partially" and "no".
Change in adherence of people on hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ): The scale consists of four sections: participation in haemodialysis treatment, medication use, fluid restriction and dietary restriction. A score between 0-1200 can be obtained from the scale. The increase in the score obtained from the scale indicates an increase in treatment compliance. There are no reverse coded items in the scale. Since the items in the scale do not have a homogenous structure, Cronbach's alpha coefficient cannot be calculated.
Change in treatment adherence (dietary adherence) of people receiving hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Dietary Knowledge Scale of Hemodialysis Patients: It was used to evaluate the dietary compliance of people undergoing haemodialysis treatment in detail. The scale has a 3-point Likert type. The questions can be answered as ''true'', ''false'' and ''don't know''. The answers are scored as 1, 0 and 0 respectively. There are no reverse coded items. Scores between 0-18 can be obtained from the scale. The increase in the score indicates that the level of knowledge is good. Cronbach Alpha value is 0.86.
Change in treatment adherence (dietary adherence) of people receiving hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Dietary Behaviour Scale of Hemodialysis Patients: It was used to evaluate the dietary compliance of people undergoing haemodialysis treatment in detail. The scale consists of one sub-dimension and 13 items. The items are scored as ''strongly disagree=1, disagree= 2, undecided= 3, agree= 4, strongly agree= 5''. There are no items that need to be reverse coded. A score between 13-65 can be obtained from the scale. A high score indicates that the behavioural status is 'good'.
Change in adherence to treatment (adherence to fluid restriction) of people receiving hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Fluid Control Scale in Haemodialysis Patients: It was used to evaluate in detail the compliance of people on haemodialysis treatment with fluid restriction. The scale consists of 24 items and three sub-dimensions (knowledge-behaviour-attitude). The items are scored as ''agree=3, undecided=2, disagree=1''. Items 6, 7, 18, 19, 20, 21, 22, 23, 24 are scored by reverse coding. A score between 24-72 can be obtained from the scale. The increase in the score obtained from the scale indicates that the fluid control of the patients also increases.
Change in the quality of life of people undergoing hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Quality of Life (SF-36) Form: It was used to assess the quality of life of people undergoing haemodialysis treatment. The scale consists of eight sub-dimensions (physical function, social function, pain, vitality (energy), role limitation-emotional, role limitation-physical, mental health, general perception of health) and 36 items. The total score of the scale is not calculated and the total scores of the sub-dimensions are calculated separately. The scores that can be obtained vary between 0-100. A high score indicates a high quality of life.
Change in URR value of people on haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in haemoglobin value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in potassium value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in sodium value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in creatinine value of people on haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in Kt/V value of people receiving haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in urea value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in calcium value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in phosphorus value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Taken from patient file.
Change in glucose value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in total protein value of people on haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in MCH value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Changes in ALT values of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in RBC value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Changes in AST values of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in albumin value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Changes in WBC values of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in MCV value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in PLT value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in haematocrit value of people undergoing haemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
It will be taken from the patient file.
Change in blood pressure of a person undergoing hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Blood pressure value at the entrance and exit of hemodialysis will be measured.
Change in the pulse rate of a person receiving hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
The person's pulse rate will be measured at the entrance and exit of hemodialysis treatment.
Change in respiratory rate of a person receiving hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
The respiratory rate of the person will be measured at the entrance and exit of hemodialysis treatment.
Change in oxygen saturation of a person receiving hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Oxygen saturation will be measured at the entrance and exit of hemodialysis treatment.
Change in body temperature of the person receiving hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Body temperature will be measured at the entrance and exit of hemodialysis treatment.
Change in weight at entry and exit of hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Hemodialysis treatment entry and exit weight will be weighed.
Changes in dry weight of a person undergoing hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
The dry weight of the person receiving hemodialysis treatment will be weighed.
Interdialytic weight changes in a person receiving hemodialysis treatment
Time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
The interdialytic weight of the person receiving hemodialysis treatment will be weighed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Hemodialytic Patients
Not yet recruiting
Effect of Exercises on Hemodialysis
Hemodialytic Patients
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.
Kahramanmaraş Necip Fazıl City Hospital
Kahramanmaraş, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Action Process Approach-Based Program in people with Hemodialytic Patients, run by TC Erciyes 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 7 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the attendance of people receiving hemodialysis treatment at hemodialysis sessions (time frame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month). The study lists 37 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 12 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.