The Effect of Transitional Care Model-Based Interventions for Stroke Patients and Their Caregivers

NCT03708835 | Completed DMC

• 1 other identifier: 118S653
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke affects both the patient's and the caregiver's whole life by creating permanent damages. Patients and their families need further information and support in the transition from hospital to home. For stroke patients and their families after discharge, transition models can be used to provide continuously and rapidly the service by establishing a communication network between the institutions. In this study, the feasibility and impact of a transitional care model from hospital to home for stroke patients and caregivers will be tested. The purpose of the project is to assess the effect of Transitional Care Model (TCM)-based interventions for stroke patients and their caregivers on caregivers' competence, in increasing their readiness to care and electronic health literacy, in reducing their burnout, and on patient results. Types of interventions that are applied to stroke patients and caregivers based on Transitional Care Model are hospital interview, home visit, telephone interview and web-based training. As stated in TCM, the intervention was planned to be performed three months after discharge. Multiple interventions including at least three face-to-face interviews at the hospital, distance education via Web and telephone communication for three months, and one home visit within seven days after discharge will be performed in order to increase health literacy levels and caregiving competence of the caregivers and to reduce burnout. In pre-tests and post-tests to be applied to the caregivers, the effectiveness of the support programs provided will be assessed quantitatively by the electronic health literacy, caregiving competence, and burnout scales. The satisfaction with the intervention will be evaluated qualitatively. Rate of return to the hospital, risk of pressure sore, and time of access to home health services will be assessed in stroke patients. As a result of web-based distance education, home visit, telephone communication service and informing at the hospital, caregivers of stroke patients will begin to receive information about what patients experience during their treatment and about all what patients need after treatment. The website to be prepared for caregivers of stroke patients will be put into service also for the control group upon completion of the data collection of the intervention group and the website will also continue to be used after the project is completed.

Conditions

Stroke

Keywords

Stroke patient; home care; family caregiver; transitional care model; caregiving competence; health literacy; burnout

Outcome Measures

Primary Outcomes (6)

• Caregivers' Competence assessed by Caregiving Competence Scale

  Caregiver Competence Scale: The scale, developed by Pearling et al., (1990), is a Likert type scale consisting of four questions. It is rated as "1" = Not at all competent "2" = Just a Little Competent "3" = Fairly Competent, and "4" = Very competent ". While the lowest score to be obtained from the scale is 4, the highest score is 16. Higher scores signify higher competence of caregiving.

  Three months after discharge

• Caregivers' Preparedness assessed by Preparedness for Caregiving Scale

  Preparedness for Caregiving Scale: The scale, developed by Archold et al., (1990) and adapted to Turkish by Karaman and Karadakovan (2014), is a Likert type scale consisting of 9 questions. It is rated as "0"=Not ready, "1"=Not ready enough, "2"=Partly ready "3"=Quite ready, and "4"=Completely ready. While the lowest score to be obtained from the scale is 0, the highest score is 32. Higher scores signify higher competence of caregiving.

  Three months after discharge

• Caregivers' e-Health Literacy assessed by e-Health Literacy Scale

  e-Health Literacy Scale: The scale developed by Norman and Skinner (2006) was adapted to Turkish by Coşkun and Bebiş (2015). The scale consists of eight items and measures the internet usage with two items and the internet attitude with six items. Scale items are rated with 5-point Likert type scaling method as "1"=Strongly disagree ''2"=Disagree, "3" = Neutral, "4"= Agree, "5"= Strongly agree. The lowest score of the scale is 8 and the highest score is 40.

  Three months after discharge

• Caregivers' Burnout assessed by Maslach Burnout Inventory-General Form

  Maslach Burnout Inventory-General Form (MBI-GF): The inventory, developed by Schaufeli et al., (1996) and adapted to Turkish by Gündüz et al., (2013), is a Likert-type scale consisting of 15 items and three subscales. The emotional exhaustion subscale is composed of 5 items (1, 4, 7, 10, and 13), the depersonalization subscale is composed of 5 items (2, 5, 8, and 11) and the personal accomplishment subscale is composed of 5 items (3, 6, 9, 12, 14, and 15). The views on each item are scored as "1"=Never, "2"=Sometimes, "3"=Usually, "4"=Mostly, "5"=Always. The high score in the emotional exhaustion and depersonalization subscales and the low score in the personal accomplishment (reverse scored) subscale indicate burnout. In the scoring, three separate burnout scores are calculated for each person.

  Three months after discharge

• Patients' assessed emergency service visiting after being discharged.

  1. Did you take your patient to the emergency service after being discharged apart from the outpatient clinic appointments (neurology and physiotherapy clinics) required to be performed routinely 1. No 2. Yes If yes, how many times did you apply to the emergency department within the three months after discharge of your patient?............................................... What is the reason for your patient's application to the emergency department? 2. Was your patient hospitalized again? 1. No 2. Yes If yes, how many times was he/she hospitalized and why? (Routine control, emergency service, hospitalization in the clinic, etc.)

  Three months after discharge

• Patients' assessed bedsore develop in your patient after being discharged

  Did bedsore develop in your patient after being discharged? 1. Yes 2. No

  Three months after discharge

Secondary Outcomes (1)

• Caregivers' System Usability Scale (SUS)

  Three months after discharge

Study Arms (2)

Transitional Care Model is applied

EXPERIMENTAL

Types of interventions that are applied to stroke caregivers and patient based on Transitional Care Model are hospital interview, home visit, telephone interview and web-based training. Multiple interventions including at least three face-to-face interviews at the hospital, distance education via Web and telephone communication for three months,and one home visit within seven days after discharge will be performed in order to increase health literacy levels and caregiving competence of the caregivers and to reduce burnout. In pre-tests and post-tests to be applied to the caregivers. Rate of return to the hospital, risk of pressure sore, and time of access to home health services will be assessed in stroke patients

Other: Transitional care model

Routine hospital schedule

NO INTERVENTION

In the first interview after the admission to the hospital, the pretest will be applied to intervention and control groups and the posttest would be applied to the groups at the end of three months after discharge. After taking the posttest, the website will be made available to the control group.

Interventions

Transitional care model OTHER

In this study, the feasibility and impact of a transitional care model from hospital to home for stroke patients and caregivers will be tested.

Also known as: hospital interview, home visit, telephone interview, web-based training

Transitional Care Model is applied

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients;
• Being voluntary to participate in the study,
• Being hospitalized in Health Sciences University Antalya Training and Research Hospital Neurology Clinic due to the diagnoses of (stroke, hemorrhage, infarct, cerebrovascular event and cerebral infarction),
• Residing in central districts of Antalya city
• Having a stroke for the first time,
• Being at level 3 and 4 according to theModified Rankin Scale (Yalın, 2011).
• Being at least semi-dependent according to the functional independence measure
• Having a score of ≥10 according to LACE index (Van Walraven et al.,) (length of stay \[L\], acuity of the admission \[A\], comorbidity of the patient \[C\] and emergency department use in the duration of 6 months before admission \[E\]),
• For caregivers;
• Being primarily responsible for the care of the patient (fulfilling the activities of daily living of the patient during the intervention),
• Providing care to a stroke patient for the first time,
• Having an internet access,
• Minimum one member of the family uses the internet,

You may not qualify if:

• The patient have a dependence history other than stroke,
• The caregiver has no internet access and/or does not use the internet,
• The care is provided for a fee,
• The patient and the caregiver do not reside in the same house or apartment building or in a near building

Sponsors & Collaborators

• The Scientific and Technological Research Council of Turkey: lead
• Akdeniz University: collaborator

Study Sites (1)

Yasemin Demi̇r Avci̇

Antalya, 07058, Turkey (Türkiye)

Location

Related Publications (15)

• Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of concepts and their measures. Gerontologist. 1990 Oct;30(5):583-94. doi: 10.1093/geront/30.5.583.

  PMID: 2276631 RESULT

• Karaman S, Karadakovan A. The study on the validity and reliability of preparedness for caregiving scale in family caregivers of stroke patients. Ege Üniversitesi Hemşirelik Fakültesi Dergisi. 2015;31(1):1-10.

  RESULT

• Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Res Nurs Health. 1990 Dec;13(6):375-84. doi: 10.1002/nur.4770130605.

  PMID: 2270302 RESULT

• Kadirhan Z, Gül A, Battal A. Sistem kullanılabilirlik ölçeği: geçerlik ve güvenirlik çalışması. Educational Sciences and Practice. 2015;14(28):149-167.

  RESULT

• Brooke J. SUS: A quick and dirty usability scale. In P. Jordan, B. Thomas, B.Weerdmeester, I. Mcclelland (Eds.), Usability Evaluation in Industry. London: Taylor & Francis. 1996, p:189-194

  RESULT

• Coşkun S, Bebiş H. Adolesanlarda e-sağlık okuryazarlığı ölçeği: Türkçe geçerlik ve güvenirlik çalışması. Gülhane Tıp Derg. 2015;57:378-384 doi: 10.5455/gulhane. 157832.

  RESULT

• Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27.

  PMID: 17213046 RESULT

• Schaufeli, W. B., Leiter, M. P., Maslach, C. & Jackson, S. E. (Eds.) Maslach Burnout Inventory-General Survey (MBI-GS). Palo Alto, CA: Consulting Psychologists Press. 1996.

  RESULT

• Gündüz B, Çapri B, Gökçakan Z. Mesleki tükenmişlik, işle bütünleşme ve iş doyumu arasındaki ilişkilerin incelenmesi. Journal of Educational Sciences Research International E-Journal, 2013;3: 29-49. doi:http://dx.doi.org/10.12973/jesr.2013.312a.

  RESULT

• van Walraven C, Dhalla IA, Bell C, Etchells E, Stiell IG, Zarnke K, Austin PC, Forster AJ. Derivation and validation of an index to predict early death or unplanned readmission after discharge from hospital to the community. CMAJ. 2010 Apr 6;182(6):551-7. doi: 10.1503/cmaj.091117. Epub 2010 Mar 1.

  PMID: 20194559 RESULT

• Kucukdeveci AA, Yavuzer G, Elhan AH, Sonel B, Tennant A. Adaptation of the Functional Independence Measure for use in Turkey. Clin Rehabil. 2001 Jun;15(3):311-9. doi: 10.1191/026921501676877265.

  PMID: 11386402 RESULT

• Yalın H. İnme sonrası hastaların fonksiyonel durum, engellilik ve yaşam kaliteleri. M.Ü. Sağlık Bilimleri Enstitüsü, Doktora Tezi, 2011, İstanbul, (Danışman: Prof. Dr. Necmiye SABUNCU).

  RESULT

• Pınar R, Oğuz S. Norton ve Braden Bası Yarası Değerlendirme ölçeklerinin yatağa bağımlı aynı hasta grubunda güvenirlik ve geçerliğinin sınanması. VI. Ulusal Hemşirelik Kongresi- UluslarArası Katılımlı Kongre Kitabı, Damla Matbaacılık Ltd. Şti., 1998;172-175.

  RESULT

• Demir Avci Y, Gozum S. Effects of Transitional Care Model-Based Interventions for Stroke Patients and Caregivers on Caregivers' Competence and Patient Outcomes: Randomized Controlled Trial. Comput Inform Nurs. 2023 Oct 1;41(10):805-814. doi: 10.1097/CIN.0000000000000991.

  PMID: 36749850 DERIVED

• Demir Avci Y, Gozum S. Effect of Transitional Care Model-Based Interventions for Patients with Stroke and Their Caregivers on Increasing Caregiver Competence and Patient Outcomes: A Study Protocol for a Randomized Controlled Trial. Florence Nightingale J Nurs. 2021 May 11;29(2):176-185. doi: 10.5152/FNJN.2021.19214. eCollection 2021 Jun.

  PMID: 34263236 DERIVED

MeSH Terms

Conditions

Stroke; Burnout, Psychological

Interventions

House Calls; Interviews as Topic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Yasemin DEMİR AVCI, PhD

  The Scientific and Technological Resarch Council Of Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The result will be evaluated by the statistician
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Scientific and Technological Research Council of Turkey

Model Details: Types of interventions that are applied to stroke patients and caregivers based on Transitional Care Model are hospital interview, home visit, telephone interview and web-based training.

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: October 17, 2018
• Study Start: March 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: December 20, 2018
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The study is completed
• Access Criteria: After the study is published as an article

Locations

TU (1)