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Implementation of a Health Action Process Approach-Based Program for People on Hemodialysis Treatment

NCT ID: NCT06723912

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2026-01-31

Brief Summary

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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

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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

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Hemodialytic Patients

Keywords

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Health action process approach hemodialysis quality of life treatment adherence care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Program based on the Health Action Process Approach will be implemented. Hemodialysis Treatment Compliance Handbook will be given.

Group Type EXPERIMENTAL

Health Action Process Approach-Based Program

Intervention Type OTHER

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.

Interventions

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Health Action Process Approach-Based Program

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.

Intervention Type OTHER

Eligibility Criteria

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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

* Participation in a program based on the Health Action Process Approach related to the subject
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Yelda KOÇAK

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kahramanmaraş Necip Fazıl City Hospital

Kahramanmaraş, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Kahramanmaraş Necip Fazıl City Hospital

Role: primary

Other Identifiers

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YKOCAK

Identifier Type: -

Identifier Source: org_study_id