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Nurse's RoleNCT05840393

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

A study testing Discharge training based on Roy adaptation model in people with Nurse's Role and Nutritional Deficiency, run by Istanbul University - Cerrahpasa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Discharge training based on Roy adaptation model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Jun 2023to 28 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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,
Show all 9Show fewer
  • To be able to communicate by phone,
  • No disability in terms of state of consciousness and sensory organs,
  • Volunteering to participate in the research.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

ELİF TUĞBA UYGUN contact

+90 539 505 26 37

elftugb9@gmail.com

About this study

Official title: The Effect of Roy Adaptation Model-Based Discharge Training on Quality of Life and Adaptation of Palliative Care Patients and Caregivers

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.

Read the 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.

Being tested
Discharge training based on Roy adaptation model
Keywords
Discharge training, Nutrition, Quality of life, Adaptation, Palliative care
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Discharge training based on Roy adaptation modelOther

    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.

Study groups in NCT05840393
Study groupRoleWhat they receive
Intervention Group: Discharge training based on the Roy adaptation modelExperimentalOncologic palliative care patients and caregivers in this group will receive discharge training based on the Roy adaptation model.
Receives: Other: Discharge training based on Roy adaptation model
Control Group: Standard discharge trainingNo interventionOncologic palliative care patients and caregivers in this group will not receive any training other than the discharge training routinely applied in the clinic.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Pre-discharge and 3-month post-discharge follow-up of the patients

  2. 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.

    Measured: Pre-discharge and 3-month post-discharge follow-up of the patients

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion28 Feb 2024 (estimated)

Resources

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
Model description
Randomized Controlled Trial
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05840393
Sponsor's protocol ID
EUYGUN
Status last verified
Apr 2023
First submitted
29 Mar 2023
Last updated
3 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014 Mar 12;311(10):1052-60. doi: 10.1001/jama.2014.304.

    PubMed 24618967
  • Fitch MI, Fliedner MC, O'Connor M. Nursing perspectives on palliative care 2015. Ann Palliat Med. 2015 Jul;4(3):150-5. doi: 10.3978/j.issn.2224-5820.2015.07.04.

    PubMed 26231811
  • Stajduhar KI, Funk L, Cohen SR, Williams A, Bidgood D, Allan D, Norgrove L, Heyland D. Bereaved family members' assessments of the quality of end-of-life care: what is important? J Palliat Care. 2011 Winter;27(4):261-9.

    PubMed 22372280
  • Starke J, Schneider H, Alteheld B, Stehle P, Meier R. Short-term individual nutritional care as part of routine clinical setting improves outcome and quality of life in malnourished medical patients. Clin Nutr. 2011 Apr;30(2):194-201. doi: 10.1016/j.clnu.2010.07.021.

    PubMed 20937544
  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PubMed 8433390
  • Barker LA, Gout BS, Crowe TC. Hospital malnutrition: prevalence, identification and impact on patients and the healthcare system. Int J Environ Res Public Health. 2011 Feb;8(2):514-27. doi: 10.3390/ijerph8020514. Epub 2011 Feb 16.

    PubMed 21556200
  • Burgos R, Sarto B, Elio I, Planas M, Forga M, Canton A, Trallero R, Munoz MJ, Perez D, Bonada A, Salo E, Lecha M, Enrich G, Salas-Salvado J; Group for the Study of Malnutrition in Hospitals in Catalonia. Prevalence of malnutrition and its etiological factors in hospitals. Nutr Hosp. 2012 Mar-Apr;27(2):469-76. doi: 10.1590/S0212-16112012000200018.

    PubMed 22732970
  • Elia M. Defining, Recognizing, and Reporting Malnutrition. Int J Low Extrem Wounds. 2017 Dec;16(4):230-237. doi: 10.1177/1534734617733902. Epub 2017 Nov 16.

    PubMed 29145755
  • Yoder LH. Using the Roy adaptation model: a program of research in a Military Nursing Research Service. Nurs Sci Q. 2005 Oct;18(4):321-3; discussion 320. doi: 10.1177/0894318405280382. No abstract available.

    PubMed 16294464
  • Guzelant A, Goksel T, Ozkok S, Tasbakan S, Aysan T, Bottomley A. The European Organization for Research and Treatment of Cancer QLQ-C30: an examination into the cultural validity and reliability of the Turkish version of the EORTC QLQ-C30. Eur J Cancer Care (Engl). 2004 May;13(2):135-44. doi: 10.1111/j.1365-2354.2003.00435.x.

    PubMed 15115469
  • Kaya A, Boz I. The development of the Professional Values Model in Nursing. Nurs Ethics. 2019 May;26(3):914-923. doi: 10.1177/0969733017730685. Epub 2017 Sep 20.

    PubMed 28929939
  • Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.

    PubMed 12765673
  • Lopez-Contreras MJ, Torralba C, Zamora S, Perez-Llamas F. Nutrition and prevalence of undernutrition assessed by different diagnostic criteria in nursing homes for elderly people. J Hum Nutr Diet. 2012 Jun;25(3):239-46. doi: 10.1111/j.1365-277X.2012.01237.x. Epub 2012 Feb 23.

    PubMed 22360373

Questions about this trial

What is this clinical trial studying?

A study testing Discharge training based on Roy adaptation model in people with Nurse's Role and Nutritional Deficiency, run by Istanbul University - Cerrahpasa.

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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ELİF TUĞBA UYGUN (+90 539 505 26 37, elftugb9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life Scale (time frame: Pre-discharge and 3-month post-discharge follow-up of the patients). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05840393, which also lists 13 linked publications.

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 3 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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