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The Effect of Discharge Education Based on Roy Adaptation Model on Palliative Care Patients and Caregivers

Primary Purpose

Nurse's Role, Nutritional Deficiency, Adaptation Reaction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Discharge training based on Roy adaptation model
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nurse's Role focused on measuring Discharge training, Nutrition, Quality of life, Adaptation, Palliative care

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 65 years of age or older, Receiving inpatient treatment in a palliative care clinic for an existing oncological disease, To be discharged home after the end of palliative care treatment, Continuing home nutritional support (Percutaneous Endoscopic Gastrostomy/PEG) during hospitalization and after discharge, NRS-2002 malnutrition risk score of 3 and above during hospitalization (data to be obtained from the patient file), To have the ability to understand and speak Turkish, To be able to communicate by phone, No disability in terms of state of consciousness and sensory organs, Volunteering to participate in the research. Exclusion Criteria: Patients who do not meet the inclusion criteria, patients who die or whose condition worsens during the research process, and patients who do not volunteer to participate in the research and their caregivers will be excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Group: Discharge training based on the Roy adaptation model

    Control Group: Standard discharge training

    Arm Description

    Oncologic palliative care patients and caregivers in this group will receive discharge training based on the Roy adaptation model.

    Oncologic palliative care patients and caregivers in this group will not receive any training other than the discharge training routinely applied in the clinic.

    Outcomes

    Primary Outcome Measures

    Quality of Life Scale
    The quality of life of palliative care patients will be assessed using the EORTC QLQ-C30 Quality of Life Scale (consisting of 30 items, the first 28 of which are four-point Likert-type scales and the items are None: 1, Somewhat: 2, Somewhat: 3 or Very: 4 points. Question 29 asks the patient to rate their health on a scale from 1 to 7 (1: Very poor and 7: Excellent) and question 30 asks the patient to rate their overall quality of life. High scores in this section indicate a high quality of life and low scores indicate a low quality of life.) The World Health Organization Quality of Life Scale (It consists of 26 questions related to physical, mental, environmental, social relations and general health status. Each domain is calculated over 20 points or 100 points. A high score indicates a high quality of life).
    Compliance Scale
    The adaptation of palliative care patients will be determined using the Difficulty of Adaptation in the Elderly Assessment Scale (a four-point Likert-type scale consisting of 24 items, scored as "not at all, a little, quite, a lot"). As the score obtained from the scale increases, the level of adaptation to old age decreases. The adaptation of caregivers will be determined using the Coping and Adaptation Process Scale. The scale, which is based on the Roy Adaptation Model and the concepts related to the cognitive process it defines and used to determine the coping and adaptation strategies of individuals in critical and difficult situations, is a four-point Likert-type scale consisting of five sub-dimensions and 47 items (each statement is answered "never, rarely, sometimes, always"). As the scores obtained from the scale increase, it is evaluated as the use of effective coping methods and adaptation increases.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2023
    Last Updated
    April 22, 2023
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05840393
    Brief Title
    The Effect of Discharge Education Based on Roy Adaptation Model on Palliative Care Patients and Caregivers
    Official Title
    The Effect of Roy Adaptation Model-Based Discharge Training on Quality of Life and Adaptation of Palliative Care Patients and Caregivers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    February 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This research will be carried out in order to reveal how the discharge education that will be formed in line with the Roy Adaptation Model for oncological palliative care patients and caregivers will affect the nutritional outcomes, quality of life and adaptation difficulties of the patients, coping and adaptation processes of caregivers, their quality of life and their level of knowledge about nutritional care.
    Detailed Description
    Today, with the improvement of living conditions and the development of technology in the field of medicine, life expectancy and the elderly population are increasing every day. This situation leads to an increase in the number of individuals with chronic diseases and increases the need for palliative care services day by day. In palliative care; meeting the needs of patients, families and caregivers, ensuring an increase in the quality of life by supporting patients physically, psychologically, socially and spiritually in the last period of their lives, and providing care according to the needs of the individual and family / caregivers in the process of death and mourning. Patients in need of palliative care face many problems such as pain, nausea, vomiting, fatigue, depression, dyspnea, dehydration, constipation, weakness, fatigue, delirium, disorientation and malnutrition that develop due to the disease and reduce the quality of life. In the care of palliative patients, caregivers play an important role in symptom control and helping the patient to maintain life activities, especially nutrition.İnforming healthy/patient individuals and their families/caregivers about healthy lifestyle changes is within the scope of the nurse's educational and counseling roles. In the palliative care process, it is stated that the lack of discharge training on nutrition may lead to significant problems.Nurses need to benefit from theories and models while applying qualified nursing care to the individual, family or community, managing the health of the people to whom they apply nursing care, supporting them to adapt to the new process they live in, and explaining the data they obtain in a scientific sense. In this direction, in this study, the effect of the discharge training to be created in line with the Roy Adaptation Model, one of the nursing models, on oncological palliative care patients with malnutrition and receiving nutritional support and their caregivers will be revealed. This research will be conducted in a prospective, randomized experimental design with pretest-posttest experimental and control groups. The sample size of the study will consist of oncological palliative care patients and caregivers who meet the inclusion criteria and agree to participate in the study. The patients and caregivers to be included in the sample of the study will be randomly divided into two groups as experimental and control groups. The sample size of the study was calculated by power analysis. The power of the study was determined as 42 oncological palliative care patients and caregivers (minimum n=21 patients and caregivers for each group) as a result of the analysis performed according to the data of a referenced study (taking the effect size as 0.9, 80% power value and 0.05% margin of error and confidence interval). In order to increase the reliability of the study and to be able to apply parametric tests, the total sample size was determined as n:60, including 30 oncological palliative care patients and caregivers of the experimental group and 30 oncological palliative care patients and caregivers of the control group, taking into account data losses (dropout from the study, death, etc.). Randomization in the study will be provided by using the randomization method in simple random order. Patients were randomly selected to the experimental and control groups. The data will be evaluated with the SPSS (Statistical Package of SocialSciences) 24.0 package program. Data; Descriptive Information Form Specific to Oncologic Palliative Care Patients, Nutritional Risk Screening Test-2002 (NRS-2002), EORTC QLQ-C30 Quality of Life Scale, Scale for Assessing Difficulties of Adaptation in the Elderly, Nutritional Follow-up Form, Telephone Counseling Follow-up Form, Descriptive Information Form Specific to Caregivers of Oncologic Palliative Care Patients, Coping and Adaptation Process Scale, World Health Organization Quality of Life Scale (WHOQOL-BREF-TR), Information Form Including Opinions on Nutritional Care will be collected.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nurse's Role, Nutritional Deficiency, Adaptation Reaction
    Keywords
    Discharge training, Nutrition, Quality of life, Adaptation, Palliative care

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Controlled Trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group: Discharge training based on the Roy adaptation model
    Arm Type
    Experimental
    Arm Description
    Oncologic palliative care patients and caregivers in this group will receive discharge training based on the Roy adaptation model.
    Arm Title
    Control Group: Standard discharge training
    Arm Type
    No Intervention
    Arm Description
    Oncologic palliative care patients and caregivers in this group will not receive any training other than the discharge training routinely applied in the clinic.
    Intervention Type
    Other
    Intervention Name(s)
    Discharge training based on Roy adaptation model
    Intervention Description
    The Roy Adaptation Model consists of four main areas of adaptation. In this study, the content of the discharge education given within the scope of the adaptation areas of the Roy Adaptation Model will be continued with information such as home nutrition process, pain, anxiety, fear, stress and coping methods, addressing changing roles and responsibilities, communication, problem solving and utilizing social support. A booklet will be prepared to increase the effectiveness of discharge training based on the Roy Adaptation Model and the booklet will be used as a guide in the training program.
    Primary Outcome Measure Information:
    Title
    Quality of Life Scale
    Description
    The quality of life of palliative care patients will be assessed using the EORTC QLQ-C30 Quality of Life Scale (consisting of 30 items, the first 28 of which are four-point Likert-type scales and the items are None: 1, Somewhat: 2, Somewhat: 3 or Very: 4 points. Question 29 asks the patient to rate their health on a scale from 1 to 7 (1: Very poor and 7: Excellent) and question 30 asks the patient to rate their overall quality of life. High scores in this section indicate a high quality of life and low scores indicate a low quality of life.) The World Health Organization Quality of Life Scale (It consists of 26 questions related to physical, mental, environmental, social relations and general health status. Each domain is calculated over 20 points or 100 points. A high score indicates a high quality of life).
    Time Frame
    Pre-discharge and 3-month post-discharge follow-up of the patients
    Title
    Compliance Scale
    Description
    The adaptation of palliative care patients will be determined using the Difficulty of Adaptation in the Elderly Assessment Scale (a four-point Likert-type scale consisting of 24 items, scored as "not at all, a little, quite, a lot"). As the score obtained from the scale increases, the level of adaptation to old age decreases. The adaptation of caregivers will be determined using the Coping and Adaptation Process Scale. The scale, which is based on the Roy Adaptation Model and the concepts related to the cognitive process it defines and used to determine the coping and adaptation strategies of individuals in critical and difficult situations, is a four-point Likert-type scale consisting of five sub-dimensions and 47 items (each statement is answered "never, rarely, sometimes, always"). As the scores obtained from the scale increase, it is evaluated as the use of effective coping methods and adaptation increases.
    Time Frame
    Pre-discharge and 3-month post-discharge follow-up of the patients

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 65 years of age or older, Receiving inpatient treatment in a palliative care clinic for an existing oncological disease, To be discharged home after the end of palliative care treatment, Continuing home nutritional support (Percutaneous Endoscopic Gastrostomy/PEG) during hospitalization and after discharge, NRS-2002 malnutrition risk score of 3 and above during hospitalization (data to be obtained from the patient file), To have the ability to understand and speak Turkish, To be able to communicate by phone, No disability in terms of state of consciousness and sensory organs, Volunteering to participate in the research. Exclusion Criteria: Patients who do not meet the inclusion criteria, patients who die or whose condition worsens during the research process, and patients who do not volunteer to participate in the research and their caregivers will be excluded from the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ELİF TUĞBA UYGUN
    Phone
    +90 539 505 26 37
    Email
    elftugb9@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aylin ÖZAKGÜL
    Organizational Affiliation
    Istanbul University - Cerrahpasa (IUC)
    Official's Role
    Study Director

    12. IPD Sharing Statement

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