Clinical trial NCT06723912: Implementation of a Health Action Process Approach-Based Program for People on Hemodialysis Treatment
Official title: The Effect of Health Action Process Approach-Based Program on Hemodialysis Patients' Adherence to Treatment and Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialytic Patients
Keywords: Health action process approach
hemodialysis
quality of life
treatment adherence
care
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Not meeting the inclusion criteria
* Participation in a program based on the Health Action Process Approach related to the subject

Primary outcomes:
measure: Changes in the attendance of people receiving hemodialysis treatment at hemodialysis sessions
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Changes in adherence to dietary restriction in people receiving hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Changes in compliance with fluid restriction in people on hemodialysis
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Changes in adherence to medication use among people receiving hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in adherence of people on hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in treatment adherence (dietary adherence) of people receiving hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in treatment adherence (dietary adherence) of people receiving hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in adherence to treatment (adherence to fluid restriction) of people receiving hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in the quality of life of people undergoing hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in URR value of people on haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in haemoglobin value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in potassium value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in sodium value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in creatinine value of people on haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in Kt/V value of people receiving haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in urea value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in calcium value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in phosphorus value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in glucose value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in total protein value of people on haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in MCH value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Changes in ALT values of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in RBC value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Changes in AST values of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in albumin value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Changes in WBC values of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in MCV value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in PLT value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in haematocrit value of people undergoing haemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in blood pressure of a person undergoing hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in the pulse rate of a person receiving hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in respiratory rate of a person receiving hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in oxygen saturation of a person receiving hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in body temperature of the person receiving hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Change in weight at entry and exit of hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Changes in dry weight of a person undergoing hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
measure: Interdialytic weight changes in a person receiving hemodialysis treatment
timeFrame: Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş Necip Fazıl City Hospital
Study officials:
References: