StrokeTEMpESTNCT03708835
The Effect of Transitional Care Model-Based Interventions for Stroke Patients and Their Caregivers
A study testing Transitional care model in people with Stroke, run by The Scientific and Technological Research Council of Turkey at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Transitional care model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 20 Dec 2018
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Show all 13Show fewer
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed 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.
- Conditions
- Stroke
- Being tested
- Transitional care model
- Keywords
- Stroke patient, home care, family caregiver, transitional care model, caregiving competence, health literacy, burnout
- Medical subject headings
- Stroke, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional care modelOther
Also called hospital interview, home visit, telephone interview, web-based training
In this study, the feasibility and impact of a transitional care model from hospital to home for stroke patients and caregivers will be tested.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Three months after discharge
Patients' assessed emergency service visiting after being discharged.
- 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
- No
- 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?
- Was your patient hospitalized again?
- No
- Yes If yes, how many times was he/she hospitalized and why? (Routine control, emergency service, hospitalization in the clinic, etc.)
Measured: Three months after discharge
Patients' assessed bedsore develop in your patient after being discharged
Did bedsore develop in your patient after being discharged?
- Yes
- No
Measured: Three months after discharge
Secondary outcomes (1)
Caregivers' System Usability Scale (SUS)
System Usability Scale (SUS):The scale developed by Brooke (1996) Norman and Skinner (2006) was adapted to Turkish by Kadirhan et al., (2015). The scale consists of ten items. Caregivers evaluate the use of the web page. Scale items are rated with 5-point Likert type scaling method as "1"=Strongly disagree ''2"=Disagree, "3" = Neutral, "4"= Agree, "5"= Strongly agree. Items 2.4.6.8 and 10 are reversed. A score ranging from 0 to 100 is obtained by multiplying the score by 2.5.
Measured: Three months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Mar 2018
- Primary completion1 Aug 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Scientific and Technological Research Council of Turkey
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University
- Responsible party
- Principal investigator, Yasemin Demir, The Scientific and Technological Research Council of Turkey
- Investigators
- Yasemin DEMİR AVCI, PhD, Principal investigator, The Scientific and Technological Resarch Council Of Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708835
- Sponsor's protocol ID
- 118S653
- Acronym
- TEMpEST
- Status last verified
- Nov 2020
- First submitted
- 24 May 2018
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 2276631Karaman 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.
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.
PubMed 2270302Kadirhan Z, Gül A, Battal A. Sistem kullanılabilirlik ölçeği: geçerlik ve güvenirlik çalışması. Educational Sciences and Practice. 2015;14(28):149-167.
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
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.
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.
PubMed 17213046Schaufeli, 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.
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.
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.
PubMed 20194559Kucukdeveci 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.
PubMed 11386402Yalın H. İnme sonrası hastaların fonksiyonel durum, engellilik ve yaşam kaliteleri. M.Ü. Sağlık Bilimleri Enstitüsü, Doktora Tezi, 2011, İstanbul, (Danışman: Prof. Dr. Necmiye SABUNCU).
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.
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.
PubMed 36749850Demir 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.
PubMed 34263236
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03708835
- Acronym / sponsor ID
- TEMpEST / 118S653
- Conditions
- Stroke
- Keywords
- Stroke patient, home care, family caregiver, transitional care model, caregiving competence, health literacy, burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- The Scientific and Technological Research Council of TurkeyUniversity, hospital or other
- Collaborators
- Akdeniz University
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transitional Care Model is applied | Experimental | Other: Transitional care modelTypes 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 |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transitional care modelAlso: hospital interview, home visit, telephone interview, web-based trainingIn this study, the feasibility and impact of a transitional care model from hospital to home for stroke patients and caregivers will be tested. | Other | Transitional Care Model is applied |
Primary outcome
Caregivers' Competence assessed by Caregiving Competence Scale
Time frame: Three months after discharge
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.
Caregivers' Preparedness assessed by Preparedness for Caregiving Scale
Time frame: Three months after discharge
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.
Caregivers' e-Health Literacy assessed by e-Health Literacy Scale
Time frame: Three months after discharge
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.
Caregivers' Burnout assessed by Maslach Burnout Inventory-General Form
Time frame: Three months after discharge
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.
Patients' assessed emergency service visiting after being discharged.
Time frame: Three months after discharge
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.)
Patients' assessed bedsore develop in your patient after being discharged
Time frame: Three months after discharge
Did bedsore develop in your patient after being discharged? 1. Yes 2. No
1 secondary outcome
Caregivers' System Usability Scale (SUS)
Time frame: Three months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Results publication: PubMed 2276631Pearlin 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.
- Results publicationKaraman 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.
- Results publication: PubMed 2270302Archbold 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.
- Results publicationKadirhan Z, Gül A, Battal A. Sistem kullanılabilirlik ölçeği: geçerlik ve güvenirlik çalışması. Educational Sciences and Practice. 2015;14(28):149-167.
- Results publicationBrooke 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
- Results publicationCoşkun 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.
- Results publication: PubMed 17213046Norman 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.
- Results publicationSchaufeli, 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.
- Results publicationGündüz 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.
- Results publication: PubMed 20194559van 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.
- Results publication: PubMed 11386402Kucukdeveci 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.
- Results publicationYalın H. İnme sonrası hastaların fonksiyonel durum, engellilik ve yaşam kaliteleri. M.Ü. Sağlık Bilimleri Enstitüsü, Doktora Tezi, 2011, İstanbul, (Danışman: Prof. Dr. Necmiye SABUNCU).
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin DEMİR AVCI, PhD principal investigator
The Scientific and Technological Resarch Council Of Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional care model in people with Stroke, run by The Scientific and Technological Research Council of Turkey at 1 site in Turkey (Türkiye).
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 13 inclusion and 4 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: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregivers' Competence assessed by Caregiving Competence Scale (time frame: Three months after discharge). The study lists 6 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 NCT03708835, which also lists 15 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 19 Nov 2020.