StrokeNCT06212167
Nursing Interventions on Stroke Patient Care: Quality of Life, Hopelessness, Anxiety and Depression
A study testing Nursing Interventions for Stroke Patient Care in people with Stroke and Depression, run by Kocaeli University at 2 sites in Turkey (Türkiye).
Trial summary
In our research, it was aimed to determine the effect of nursing interventions applied face to face at the time of discharge and then via tele-nursing method to the caregivers of patients in intensive care and diagnosed with stroke, on the quality of life, care burden, hopelessness, anxiety and depression levels of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Depression, Anxiety
- What is being tested?
- Nursing Interventions for Stroke Patient Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 15 Jul 2025
- 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
- Having a patient in the Neurology Intensive Care Unit with a diagnosis of stroke,
- The patient is at the stage of being discharged from the intensive care unit,
- Being literate,
- Having a smart phone and being able to use it,
- Having internet access and at least 4GB internet package,
- Volunteering to participate in the research.
Who cannot join
- Caregivers who are not reachable by phone calls at home,
- Caregivers who do not have continuity in home telenursing training and consultancy practices will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kocaeli University
Kocaeli
Sakarya University
Sakarya
Ferhat Koç
Türkan Acar, Associate Professor
About this study
Official title: The Effect of Nursing Interventions on Stroke Patient Care: Caregivers' Quality of Life, Care Burden, Hopelessness, Anxiety and Depression Levels
In our research, it was aimed to determine the effect of nursing interventions applied face to face at the time of discharge and then via tele-nursing method to the caregivers of patients in intensive care and diagnosed with stroke, on the quality of life, care burden, hopelessness, anxiety and depression levels of the caregivers. This research will be conducted as a randomized, pre-test, post-test single group intervention study, at the Neurology Intensive Care Unit of Sakarya University Training and Research Hospital, between March and June 2023. With a 95% confidence interval, 5% margin of error, 0.54 effect size and 95% representativeness of the population, the group was calculated as 47 people, and the sample was determined as 56 people in total, with 20% reserve. The sample of the study will be selected by simple random sampling method among the caregivers of stroke patients who meet the inclusion criteria and agree to participate in the research. During the discharge process, Information Forms, Zarit Caregiving Burden Scale, Beck Hopelessness Scale, Adult Caregiver Quality of Life Survey, and Hospital Anxiety Depression Scale will be administered face to face to the participants as a pre-test. 12 weeks after the first measurement, Zarit Caregiving Burden Scale, Beck Hopelessness Scale, Adult Caregiver Quality of Life Questionnaire, Hospital Anxiety Depression Scale will be administered as posttest. In addition to routine discharge training, participants will be provided with 'Education and Care Practices for Stroke Patients'. These applications; It will be performed for those who care for stroke patients in the hospital for a week, and then at home, twice a week, for a total of 7 weeks, via telenursing method. Written consent will be obtained from caregivers after explaining the purpose of the research and the purpose for which the results will be used. Participants will be informed that their information will not be shared with others and the confidentiality policy will be adhered to. In order to make comparisons before and after the training, participants will be asked to fill out data collection forms with a nickname they can easily remember and not forget in the pre-test. They will be asked to write the same pseudonyms when filling out the post-test data collection forms. Participants will be asked to fill out data collection forms individually, but it will be stated that they can contact the researchers if they have questions.
- Conditions
- Stroke, Depression, Anxiety, Care Burden, Hopefulness
- Being tested
- Nursing Interventions for Stroke Patient Care
- Medical subject headings
- Stroke, Depression, Anxiety Disorders, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Interventions for Stroke Patient CareBehavioural
In the first phase of the research, the relatives of the patients who are in the hospital every day for a week during the routine and discharge process will be included in a training program. These trainings will be explained didactically to the caregiver at the bedside by the research supervisor and the intensive care nurse, the practices will be demonstrated with demonstrations, and the caregiver will be asked to apply them themselves. Then, the researchers will call the caregivers and make an appointment for an online meeting twice a week (7 weeks - 14 times). During these meetings, the training the caregivers need will be explained again and any questions they have will be answered. The researcher will also conduct motivational interviews with the caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Nursing Interventions for Stroke Patient Care | Experimental | Within the scope of nursing interventions for caregivers;
* Oral or enteral nutrition application steps and the use of necessary materials will be explained,
* Oral or enteral drug administration, in-bed exercises, suctioning, simple ROM exercises, in-bed bathing, pressure sore care, position change, oral care, and whole body care will be taught,
* Videos regarding the use of all medical devices and materials to be taken home with the patient will be shown and demonstration methods will be used,
* Information about the storage conditions of drugs, side effects and nutrition will be explained, supported by powerpoint presentations,
* Motivational interviews will be held regarding communication with the stroke patient and the emotional state of the caregivers. Receives: Behavioral: Nursing Interventions for Stroke Patient Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Caregiving Burden Scale
It was developed by Zarit, Reever and Bach-Peterson in 1980. It is a scale used to evaluate the distress experienced by caregivers of individuals in need of care. The Turkish validity-reliability study of the scale was conducted by İnci and Erdem in 2008. It consists of 22 statements that determine the impact of caregiving on the individual's life. The scale has a Likert-type rating ranging from 1 to 5, such as never, rarely, sometimes, often or almost always. A high scale score indicates that the distress experienced is high. The scoring range is between 0-88, and if the scores obtained are between 0-24 points, "light load"; Between 25 and 33 points is defined as "moderate burden"; Between 34 and 88 points are considered as "severe burden". In the scale form adapted to Turkish, the internal consistency coefficient was found to be 0.95, and the test-retest invariance coefficient was 0.90.
Measured: 1 month
Beck Hopelessness Scale
Beck hopelessness scale was developed by Beck and Weissman (1974). The validity and reliability study of the scale in our country was conducted by Seber, Dilbaz, Kaptanoğlu and Tekin. Durak and Palabıyıkoğlu (1994) conducted a study to examine the validity and factor structure of the scale on a large sample, including physical and psychiatric patients. Beck hopelessness scale consists of 20 true-false situations. 11 of these are correct and 9 are incorrect. Each answer receives 0 or 1 point. The sum of the scores constitutes the despair score. A high score from the scale indicates a high level of hopelessness. Items 1, 6, 13, 15 and 19 describe feelings about the future; Items 2, 3, 9, 11, 12, 16, 17 and 20 describe loss of motivation; Articles 4, 7, 8, 14 and 18 express expectations about the future. Seber et al. (1993), in their hopelessness scale validity and reliability study, determined the Cronbach's alpha coefficient for the entire scale as 0.86.
Measured: 1 month
Adult Caregiver Quality of Life Survey
It is a scale developed by Joseph, Becker, Elwick and Silburn (2012) and its validity and reliability in Turkish was confirmed by Gençer (2020). The scale provides the opportunity to evaluate caregiver quality of life in 8 different areas (caregiving, caregiving preference, patient care stress, financial issues, personal development, appreciation, ability to provide care, and caregiver satisfaction). Each sub-dimension of the scale consists of 5 items. Within forty questions, scoring is applied according to the answers as "Always = 3", "Most of the time = 2", "Sometimes = 1" and "Never = 0", while "6, 7, 8, 9, 10, 11, 12, 13" , 14, 15, 16, 19, 37, 38" questions are coded in reverse (3-2-1-0) and scored. Total score varies between 0-120. 0-40 points indicate "low quality of life", 41-80 points indicate "average quality of life" and 81-120 points indicate "high quality of life". The Adult Caregiver Quality of Life Survey Cronbach's Alpha value was determined as 0.945.
Measured: 1 month
Hospital Anxiety Depression Scale:
Developed by Zigmond and Snaith (1983), hospital anxiety is a four-point Likert type scale consisting of a total of 14 items measuring the level of depression, seven of which (odd numbers) measure anxiety and the other seven (even numbers) measure depression. Aydemir et al. Turkish validity and reliability study was conducted by (1997). Evaluation is made based on the total score. This scale was preferred because it is widely used in both healthy individuals and patients, is easy to apply, and scale scores are not affected by physical symptoms and temporary fluctuations in mood.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start15 Feb 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Yilmaz Bulut, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212167
- Sponsor's protocol ID
- E-16214662-050.01.04-244840-41
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Interventions on Stroke Patient Care: Caregivers' Quality of Life, Care Burden, Hopelessness, Anxiety and Depression Levels
- ClinicalTrials.gov ID
- NCT06212167
- Acronym / sponsor ID
- E-16214662-050.01.04-244840-41
- Conditions
- Stroke, Depression, Anxiety, Care Burden, Hopefulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 18 Jan 2024 (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.
In our research, it was aimed to determine the effect of nursing interventions applied face to face at the time of discharge and then via tele-nursing method to the caregivers of patients in intensive care and diagnosed with stroke, on the quality of life, care burden, hopelessness, anxiety and depression levels of the caregivers. This research will be conducted as a randomized, pre-test, post-test single group intervention study, at the Neurology Intensive Care Unit of Sakarya University Training and Research Hospital, between March and June 2023. With a 95% confidence interval, 5% margin of error, 0.54 effect size and 95% representativeness of the population, the group was calculated as 47 people, and the sample was determined as 56 people in total, with 20% reserve. The sample of the study will be selected by simple random sampling method among the caregivers of stroke patients who meet the inclusion criteria and agree to participate in the research. During the discharge process, Information Forms, Zarit Caregiving Burden Scale, Beck Hopelessness Scale, Adult Caregiver Quality of Life Survey, and Hospital Anxiety Depression Scale will be administered face to face to the participants as a pre-test. 12 weeks after the first measurement, Zarit Caregiving Burden Scale, Beck Hopelessness Scale, Adult Caregiver Quality of Life Questionnaire, Hospital Anxiety Depression Scale will be administered as posttest. In addition to routine discharge training, participants will be provided with 'Education and Care Practices for Stroke Patients'. These applications; It will be performed for those who care for stroke patients in the hospital for a week, and then at home, twice a week, for a total of 7 weeks, via telenursing method. Written consent will be obtained from caregivers after explaining the purpose of the research and the purpose for which the results will be used. Participants will be informed that their information will not be shared with others and the confidentiality policy will be adhered to. In order to make comparisons before and after the training, participants will be asked to fill out data collection forms with a nickname they can easily remember and not forget in the pre-test. They will be asked to write the same pseudonyms when filling out the post-test data collection forms. Participants will be asked to fill out data collection forms individually, but it will be stated that they can contact the researchers if they have questions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing Interventions for Stroke Patient Care | Experimental | Behavioral: Nursing Interventions for Stroke Patient CareWithin the scope of nursing interventions for caregivers; * Oral or enteral nutrition application steps and the use of necessary materials will be explained, * Oral or enteral drug administration, in-bed exercises, suctioning, simple ROM exercises, in-bed bathing, pressure sore care, position change, oral care, and whole body care will be taught, * Videos regarding the use of all medical devices and materials to be taken home with the patient will be shown and demonstration methods will be used, * Information about the storage conditions of drugs, side effects and nutrition will be explained, supported by powerpoint presentations, * Motivational interviews will be held regarding communication with the stroke patient and the emotional state of the caregivers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a patient in the Neurology Intensive Care Unit with a diagnosis of stroke,
- The patient is at the stage of being discharged from the intensive care unit,
- Being literate,
- Having a smart phone and being able to use it,
- Having internet access and at least 4GB internet package,
Key exclusion criteria (2 listed)
- Caregivers who are not reachable by phone calls at home,
- Caregivers who do not have continuity in home telenursing training and consultancy practices will be excluded from the study.
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 |
|---|---|---|
| Nursing Interventions for Stroke Patient CareIn the first phase of the research, the relatives of the patients who are in the hospital every day for a week during the routine and discharge process will be included in a training program. These trainings will be explained didactically to the caregiver at the bedside by the research supervisor and the intensive care nurse, the practices will be demonstrated with demonstrations, and the caregiver will be asked to apply them themselves. Then, the researchers will call the caregivers and make an appointment for an online meeting twice a week (7 weeks - 14 times). During these meetings, the training the caregivers need will be explained again and any questions they have will be answered. The researcher will also conduct motivational interviews with the caregivers. | Behavioural | Nursing Interventions for Stroke Patient Care |
Primary outcome
Zarit Caregiving Burden Scale
Time frame: 1 month
It was developed by Zarit, Reever and Bach-Peterson in 1980. It is a scale used to evaluate the distress experienced by caregivers of individuals in need of care. The Turkish validity-reliability study of the scale was conducted by İnci and Erdem in 2008. It consists of 22 statements that determine the impact of caregiving on the individual's life. The scale has a Likert-type rating ranging from 1 to 5, such as never, rarely, sometimes, often or almost always. A high scale score indicates that the distress experienced is high. The scoring range is between 0-88, and if the scores obtained are between 0-24 points, "light load"; Between 25 and 33 points is defined as "moderate burden"; Between 34 and 88 points are considered as "severe burden". In the scale form adapted to Turkish, the internal consistency coefficient was found to be 0.95, and the test-retest invariance coefficient was 0.90.
Beck Hopelessness Scale
Time frame: 1 month
Beck hopelessness scale was developed by Beck and Weissman (1974). The validity and reliability study of the scale in our country was conducted by Seber, Dilbaz, Kaptanoğlu and Tekin. Durak and Palabıyıkoğlu (1994) conducted a study to examine the validity and factor structure of the scale on a large sample, including physical and psychiatric patients. Beck hopelessness scale consists of 20 true-false situations. 11 of these are correct and 9 are incorrect. Each answer receives 0 or 1 point. The sum of the scores constitutes the despair score. A high score from the scale indicates a high level of hopelessness. Items 1, 6, 13, 15 and 19 describe feelings about the future; Items 2, 3, 9, 11, 12, 16, 17 and 20 describe loss of motivation; Articles 4, 7, 8, 14 and 18 express expectations about the future. Seber et al. (1993), in their hopelessness scale validity and reliability study, determined the Cronbach's alpha coefficient for the entire scale as 0.86.
Adult Caregiver Quality of Life Survey
Time frame: 1 month
It is a scale developed by Joseph, Becker, Elwick and Silburn (2012) and its validity and reliability in Turkish was confirmed by Gençer (2020). The scale provides the opportunity to evaluate caregiver quality of life in 8 different areas (caregiving, caregiving preference, patient care stress, financial issues, personal development, appreciation, ability to provide care, and caregiver satisfaction). Each sub-dimension of the scale consists of 5 items. Within forty questions, scoring is applied according to the answers as "Always = 3", "Most of the time = 2", "Sometimes = 1" and "Never = 0", while "6, 7, 8, 9, 10, 11, 12, 13" , 14, 15, 16, 19, 37, 38" questions are coded in reverse (3-2-1-0) and scored. Total score varies between 0-120. 0-40 points indicate "low quality of life", 41-80 points indicate "average quality of life" and 81-120 points indicate "high quality of life". The Adult Caregiver Quality of Life Survey Cronbach's Alpha value was determined as 0.945.
Hospital Anxiety Depression Scale:
Time frame: 1 month
Developed by Zigmond and Snaith (1983), hospital anxiety is a four-point Likert type scale consisting of a total of 14 items measuring the level of depression, seven of which (odd numbers) measure anxiety and the other seven (even numbers) measure depression. Aydemir et al. Turkish validity and reliability study was conducted by (1997). Evaluation is made based on the total score. This scale was preferred because it is widely used in both healthy individuals and patients, is easy to apply, and scale scores are not affected by physical symptoms and temporary fluctuations in mood.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Interventions for Stroke Patient Care in people with Stroke and Depression, run by Kocaeli University at 2 sites 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TUBA YILMAZ BULUT, Dr. (+905343435109, tuba_yilmaz1991@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Caregiving Burden Scale (time frame: 1 month). The study lists 4 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 18 Jan 2024.