StrokeNCT04648098
Effect of Post-stroke Discharge Training
A study testing Discharge training and telephone counseling in people with Stroke and Caregiver Burnout, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of post-stroke discharge training and telephone counseling service on patients' functional status and caregiver burden. The study was conducted with 69 stroke patients (34 in the intervention group and 35 in the control group) and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Caregiver Burnout
- What is being tested?
- Discharge training and telephone counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2017to 29 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the age of 18 and over (for patients and caregivers)
- having undergone a hemorrhagic or ischemic stroke (for patients)
- being literate (for caregivers)
- being primarily responsible for the care of the stroke patient during the hospital stay and at home after discharge (for caregivers)
- using a mobile or home phone (for caregivers)
- being open to communication and collaboration (for caregivers)
Who cannot join
- Rankin Scale score of 4 above (for patients)
- Having problem in terms of hearing and understanding (for caregivers)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Post-stroke Discharge Training and Telephone Counseling Service on Patients' Functional Status and Caregiver Burden: A Randomised Control Trial
The aim of this study was to determine the effect of post-stroke discharge training and telephone counseling service on patients' functional status and caregiver burden. The study was conducted with 69 stroke patients (34 in the intervention group and 35 in the control group) and their caregivers. In the study, data were collected before discharge and three months after discharge. Discharge training and telephone counseling (one week after discharge and once a month for three months) were given to the caregivers of the patients in the intervention group.
Read the detailed description
This study, which was planned as a randomised controlled study, was conducted university hospital neurology clinic in Turkey. A total of 80 participants who met the inclusion criteria were randomised to either the intervention and control groups.
In this study, Patient Information Form, Modified Rankin Scale and Barthel Index were used to collect data about patients, while Caregiver Information Form and Caregiver Burden Scale were used to collect data about caregivers Pre-tests were applied to patients and caregivers in the intervention and control groups before discharge. After the pre-tests were applied to the caregivers in the intervention group, discharge training was given.
- Conditions
- Stroke, Caregiver Burnout
- Being tested
- Discharge training and telephone counseling
- Medical subject headings
- Stroke, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge training and telephone counselingOther
The discharge training was given by using different teaching methods in the form of verbal expression, demonstration, and question and answer. The care guide prepared by the researchers in line with the literature was used as a training material for stroke patients and their caregivers.The training varied according to the learning level of individuals but took an average of 40-60 minutes.
Consultation service was given to the caregivers one week after discharge and once a month for three months by telephone call.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention group | Experimental | Discharge training and telephone counseling Receives: Other: Discharge training and telephone counseling |
| No Intervention: Control Group | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden Scale
Caregiver Burden Scale, developed by Zarit et al. (1980), was used to evaluate the care burden of patient relatives. There are 22 expressions in the scale that determine the effect of caregiving on the individual's life. The score obtained from the five-point Likert scale is minimum 0 and maximum 88.A high score on the scale indicates that the problem experienced by the caregiver is high.
Measured: Change from baseline score at the end of the third month
The Barthel Index
The Barthel Index to developed by Mahoney and Barthel in 1965 to evaluate physical independence in daily life activities. Index consists of 10 items that include daily life activities and is used to evaluate the level of functional independence. Items in the scale are graded between 0 and 15 points in 5 increments according to the question. The score ranges from 0 to 100 (0-20 points fully dependent, 21-61 points highly dependent, 62-90 points moderately dependent, 91-99 points slightly dependent, 100 points fully independent).
Measured: Change from baseline score at the end of the third month
Modified Rankin Scale
Modified Rankin Scale evaluating the functional limitation and degree of addiction occurring in the patient after stroke was evaluated in seven categories (0: No symptoms, 1: No obvious deficits, 2: Mild deficits, 3: Moderate deficits, 4: Severe deficits, 5: Very severe deficit and 6: Death).
Measured: Change from baseline score at the end of the third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start4 Mar 2017
- Primary completion8 Apr 2018
- Study completion29 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional (Clinical Trial)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Collaborators
- Trakya University
- Responsible party
- Principal investigator, Deniz Ezgi Bitek, Kırklareli University
- Investigators
- Özgül EROL, Study director, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648098
- Sponsor's protocol ID
- interventional
- Status last verified
- Mar 2023
- First submitted
- 18 Nov 2020
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Post-stroke Discharge Training and Telephone Counseling Service on Patients' Functional Status and Caregiver Burden: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04648098
- Acronym / sponsor ID
- interventional
- Conditions
- Stroke, Caregiver Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Collaborators
- Trakya University
- Study start
- 4 Mar 2017 (actual)
- Primary completion
- 8 Apr 2018 (actual)
- Study completion
- 29 Apr 2018 (actual)
- First posted
- 1 Dec 2020 (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.
The aim of this study was to determine the effect of post-stroke discharge training and telephone counseling service on patients' functional status and caregiver burden. The study was conducted with 69 stroke patients (34 in the intervention group and 35 in the control group) and their caregivers. In the study, data were collected before discharge and three months after discharge. Discharge training and telephone counseling (one week after discharge and once a month for three months) were given to the caregivers of the patients in the intervention group.
Detailed description
This study, which was planned as a randomised controlled study, was conducted university hospital neurology clinic in Turkey. A total of 80 participants who met the inclusion criteria were randomised to either the intervention and control groups.
In this study, Patient Information Form, Modified Rankin Scale and Barthel Index were used to collect data about patients, while Caregiver Information Form and Caregiver Burden Scale were used to collect data about caregivers Pre-tests were applied to patients and caregivers in the intervention and control groups before discharge. After the pre-tests were applied to the caregivers in the intervention group, discharge training was given.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional (Clinical Trial)
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group | Experimental | Other: Discharge training and telephone counselingDischarge training and telephone counseling |
| No Intervention: Control Group | No intervention | –Routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- the age of 18 and over (for patients and caregivers)
- having undergone a hemorrhagic or ischemic stroke (for patients)
- being literate (for caregivers)
- being primarily responsible for the care of the stroke patient during the hospital stay and at home after discharge (for caregivers)
- using a mobile or home phone (for caregivers)
Key exclusion criteria (2 listed)
- Rankin Scale score of 4 above (for patients)
- Having problem in terms of hearing and understanding (for caregivers)
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 |
|---|---|---|
| Discharge training and telephone counselingThe discharge training was given by using different teaching methods in the form of verbal expression, demonstration, and question and answer. The care guide prepared by the researchers in line with the literature was used as a training material for stroke patients and their caregivers.The training varied according to the learning level of individuals but took an average of 40-60 minutes. Consultation service was given to the caregivers one week after discharge and once a month for three months by telephone call. | Other | Experimental: Intervention group |
Primary outcome
Caregiver Burden Scale
Time frame: Change from baseline score at the end of the third month
Caregiver Burden Scale, developed by Zarit et al. (1980), was used to evaluate the care burden of patient relatives. There are 22 expressions in the scale that determine the effect of caregiving on the individual's life. The score obtained from the five-point Likert scale is minimum 0 and maximum 88.A high score on the scale indicates that the problem experienced by the caregiver is high.
The Barthel Index
Time frame: Change from baseline score at the end of the third month
The Barthel Index to developed by Mahoney and Barthel in 1965 to evaluate physical independence in daily life activities. Index consists of 10 items that include daily life activities and is used to evaluate the level of functional independence. Items in the scale are graded between 0 and 15 points in 5 increments according to the question. The score ranges from 0 to 100 (0-20 points fully dependent, 21-61 points highly dependent, 62-90 points moderately dependent, 91-99 points slightly dependent, 100 points fully independent).
Modified Rankin Scale
Time frame: Change from baseline score at the end of the third month
Modified Rankin Scale evaluating the functional limitation and degree of addiction occurring in the patient after stroke was evaluated in seven categories (0: No symptoms, 1: No obvious deficits, 2: Mild deficits, 3: Moderate deficits, 4: Severe deficits, 5: Very severe deficit and 6: Death).
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 10 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Özgül EROL study director
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discharge training and telephone counseling in people with Stroke and Caregiver Burnout, run by Kırklareli University 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 6 inclusion and 2 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 10 Mar 2023. 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?
Caregiver Burden Scale (time frame: Change from baseline score at the end of the third month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2023.