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

NCT06723912 | Recruiting

• 1 other identifier: YKOCAK
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialytic Patients

Keywords

Health action process approach; hemodialysis; quality of life; treatment adherence; care

Outcome Measures

Primary Outcomes (37)

• 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".

  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".

  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".

  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".

  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.

  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.

  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'.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Beginning of the study (week 0), week 6 (at the end of the program), 3rd month, and 6th month

Study Arms (2)

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.

Other: Health Action Process Approach-Based Program

Interventions

Health Action Process Approach-Based Program 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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Participation in a program based on the Health Action Process Approach related to the subject

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Kahramanmaraş Necip Fazıl City Hospital

Kahramanmaraş, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: October 23, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)