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

Stroke Clinical Trial

Official title: The Effect of Transitional Care Model-Based Interventions for Stroke Patients and Their Caregivers on Increasing Caregivers' Competence and on Patient Outcomes: A Randomized Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

Study Protocol Minimum three interviews would be carried out in the hospital with the caregivers meeting the inclusion criteria after stroke patients are hospitalized. The first interview would be carried out within 24-48 hours after the hospitalization. The second interview would be carried out on the following day after the first interview. The third interview would be carried out two days after the second interview. If required, interview would be carried out in the hospital every day. The home visit will be realized by the coordination center or researcher within 5 working days after discharge. Caregivers will be called by the coordinator once at a certain hour every day in the first week after discharge and between the second and twelfth weeks. In addition, communication with the phone will constantly continue when needed. 24/7 access to the website, which is prepared for family members / caregivers of stroke patients, will be available for three months from discharge. The Intervention to be Applied to Control Group Preparation of control group for discharge would be made by clinical staff based on routine program of the hospital. 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. Randomization Simple randomization method was used in order to randomly select stroke patients and caregivers and to assign the intervention and control group impartially. The simple randomization method will be used for selecting the caregivers of stroke patients, planned to have participated in the study, incidentally from the universe, and for assigning the intervention and control group detachedly. Randomization was performed by using the https://www.randomizer.org/ website and the intervention and control group were determined according to the list obtained. The patients and caregivers will be participated according to this sequence number. Pre-tests will be collected by the researcher. Data Collection Forms It was planned to use separate assessment instruments for the caregivers and the patients. Assessment instruments to be used for the caregivers are descriptive information, E-health literacy scale, Caregiving Competence Scale, Preparedness for Caregiving Scale, and Maslach Burnout Inventory-General Form. Descriptive information, Modified Ranking Scale for confinement level, Functional Independence Measure (Küçükdeveci et al., 2001), evaluation of rehospitalization of patients, LACE index (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)) and Braden Scale (Pınar and Oğuz, 1998) for evaluating pressure sores were planned to be used as assessment instruments to be used for the patients. ;

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT03708835
• Study type: Interventional
• Source: The Scientific and Technological Research Council of Turkey
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Completion date: December 20, 2018