Stroke, IschemicNCT04161820
The Effect of Education Based on the Chronic Care Model (StrokeCARE) in Patients With Ischemic Stroke
A study testing The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke in people with Stroke, Ischemic and Self Efficacy, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Stroke is the third leading cause of death worldwide and is defined as neurological deficit due to ischemic or hemorrhagic causes. The risk of death in the 30 days following recurrent stroke was reported to be between 23% and 41%, and the risk of new disability was between 39% and 53%. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic, Self Efficacy
- What is being tested?
- The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 5 Nov 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Matching the TOAST classification criteria
- Place, time, person orientation
- Based on the Modified Rankin Scale "0,1,2,3"
- 18 years and older
- First diagnosis of ischemic stroke by CT and MRI
- Literate
- Telephone-capable
- No barriers to written or oral communication
Who cannot join
- Diagnosed with psychiatric disease
- Diagnosed with advanced liver or kidney disease
- Malignancy or other neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education and Telephone Follow-up Based on the Chronic Care Model on Self-management, Quality of Life and Patient Satisfaction in Patients With Ischemic Stroke
- Stroke is the third leading cause of death worldwide and is defined as neurological deficit due to ischemic or hemorrhagic causes. The risk of death in the 30 days following recurrent stroke was reported to be between 23% and 41%, and the risk of new disability was between 39% and 53%. Therefore, patient self-management is important in preventing recurrent stroke. The aim of this study was to evaluate the effect of education and telephone follow-up based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke. The study is a randomized controlled experimental study. A total of 68 patients (34 interventions and 34 controls) were randomized into a computer program with 80% power, 95% reliability and 0.05 margin of error. Patients were included in the study according to the inclusion criteria and randomization list. The self-management support component of the Chronic Care Model was implemented using the 5A (ASK, ADVICE, ASSESS, ASSIST, ARRANGE) methodology. The Conceptual-Theoretical-Experimental structure of the research was created. A training booklet for stroke patients was created within the scope of the Chronic Care Model self-management support component. After the pre-tests, the patients who were included in the intervention group were given discharge training with a booklet prepared based on the Chronic Care Model and containing information and recommendations on self-management strategies during their stay in the hospital (0 months). These patients were followed up by telephone on the 7th day, 15th day, 1st month and 2nd month after discharge. No intervention other than routine hospital follow-up was performed for the patients included in the control group.
- The patients who were included in the control and intervention groups were performed to post-tests at the 3rd month outpatient clinic control and metabolic variables of the patients were obtained from the patient clinical information system.
Read the detailed description
Stroke is the third leading cause of death worldwide and is defined as neurological deficit due to ischemic or hemorrhagic causes. Stroke is an important health problem in Turkey as it is common in society and causes death. Stroke patients are reported to be at risk for secondary stroke. The risk of death in the 30 days following recurrent stroke was reported to be between 23% and 41%, and the risk of new disability was between 39% and 53%. Therefore, patient self-management is important in preventing recurrent stroke. One of the most widely accepted and effective models in the international literature for chronic diseases is the Chronic Care Model. The aim of this study was to evaluate the effect of education and telephone follow-up based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke.
The study is a randomized controlled experimental study. The sample of the study included inpatients with stroke in Akdeniz University Hospital Neurology Clinic. A total of 68 patients (34 interventions and 34 controls) were randomized into a computer program with 80% power, 95% reliability and 0.05 margin of error.
In this study, four components of the Chronic Care Model were applied. These elements are self-management support, delivery system design, decision support and clinical information systems. The self-management support component of the Chronic Care Model was implemented using the 5A (ASK, ADVICE, ASSESS, ASSIST, ARRANGE) methodology. The Conceptual-Theoretical-Experimental structure of the research was created.
According to the intervention protocol of the study:
- A training booklet for Stroke Patients was created within the scope of the Chronic Care Model self-management support component. The quality of the booklet was evaluated by the DISCERN measurement tool by the Nursing Faculty and Neurology specialists. The difficulty level of the training booklet was calculated according to Atesman's Readability Formula.
- Three patients with stroke were applied pilot scheme.
- Patients were included in the study according to the inclusion criteria and randomization list.
- Patients in the control and intervention groups were interviewed before discharge (0 months). Preliminary tests were performed after obtaining informed consent from the patients. For this purpose, Personal Information Form, Modified Barthel Index, Stroke Self-Efficacy Questionnaire, Stroke Specific Quality of Life Scale were applied. Metabolic variables (blood pressure, height / weight assessment and laboratory findings [HDL cholesterol, LDL cholesterol, total cholesterol, triglyceride, HbA1c, APTT, PT and INR]) were obtained from the patient clinical information system.
- After the pre-tests, the patients were given discharge training with a booklet prepared based on the Chronic Care Model and containing information and recommendations on self-management strategies during their stay in the hospital (0 months). Trainings were performed in a single session and in the patient room at the clinic, not to exceed 45-50 minutes.
- The patients who were included in the intervention group were followed up by telephone on the 7th day, 15th day, 1st month and 2nd month after discharge.
- Patients were referred to the hospital in unexpected / unpredictable situations during the three-month period.
- No intervention other than routine hospital follow-up was performed for the patients included in the control group.
- The patients who were included in the control and intervention groups were performed to post-tests at the 3rd month outpatient clinic control and metabolic variables of the patients were obtained from the patient clinical information system.
- Conditions
- Stroke, Ischemic, Self Efficacy
- Being tested
- The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke
- Keywords
- Chronic Care Model, Self-management, Stroke, Quality of Life
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic strokeBehavioural
The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke Self-management, quality of life and patient satisfaction were assessed by scales at the first interview and 3 months later. Metabolic variables of the patients were obtained from the patient clinical information system at the first interview and 3 months later.
| Study group | Role | What they receive |
|---|---|---|
| Education and telephone follow ups based on the CCM | Experimental | After the pre-tests (self-management, quality of life and patient satisfaction were assessed by scales at the first interview), the patients were given discharge training with a booklet prepared based on the Chronic Care Model (CCM) and containing information and recommendations on self-management strategies during their stay in the hospital (0 months). Trainings were performed in a single session and in the patient room at the clinic, not to exceed 45-50 minutes. The patients who were included in the intervention group were followed up by phone on the 7th day, 15th day, 1st month and 2nd month after discharge. Patients were referred to the hospital in unexpected / unpredictable situations during the three-month period.
Self-management, quality of life and patient satisfaction were assessed by scales at the first interview and 3 months later. Metabolic variables of the patients were obtained from the patient clinical information system at the first interview and 3 months later. Receives: Behavioral: The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Has an effect on improving self-management skills
The Stroke Self-Efficacy Questionnaire (SSEQ): In this study, the final 13-item SSEQ was used for collecting data. Each item is scored on a 4-point scale (0 "not at all confident" to 3 "very confident"). The 4-point scale provides a score range 0-39. A higher score indicates a higher self-efficacy. In this study, Turkish Version of the questionnaire was used.
Measured: 3 months
Has an effect on improving quality of life
Stroke Spesific Quality of Life Scale (SS-QOL) is a disease-specific QOL measure. It consists of 49 items encompassing 12 domains, which include the social role, mobility, energy, language, self-care, mood, personality, thinking, upper extremity function, family role, vision, and work/productivity. Each item is ranked on a five-point Likert scale in which level one means completely agreed while level five means completely disagree. The summary score of this scale is an un-weighted average of the 12 domains. The total score ranges from 49 to 245, with higher scores indicating a better QOL. In this study, Turkish Version of the scale was used.
Measured: 3 months
Has an effect on improving patient satisfaction
The Patient Assessment of Chronic Illness Care (PACIC) is a relatively brief 20-item questionnaire designed to assess the extent to which care is aligned with the Chronic Care Model. It consists five factors and, 20-item. The increase in the scale scores shows that individuals with chronic disease are highly satisfied with the care they receive. In this study, Turkish Version of the questionnaire was used.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Sep 2018
- Primary completion30 Oct 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simge KALAV, Akdeniz University
- Investigators
- Hicran Bektas, PhD, RN, Study chair, Akdeniz University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161820
- Sponsor's protocol ID
- 023
- Status last verified
- Nov 2019
- First submitted
- 8 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalav S, Bektas H, Unal A. Effects of Chronic Care Model-based interventions on self-management, quality of life and patient satisfaction in patients with ischemic stroke: A single-blinded randomized controlled trial. Jpn J Nurs Sci. 2022 Jan;19(1):e12441. doi: 10.1111/jjns.12441. Epub 2021 Jul 15.
PubMed 34264000
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Telephone Follow-up Based on the Chronic Care Model on Self-management, Quality of Life and Patient Satisfaction in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04161820
- Acronym / sponsor ID
- 023
- Conditions
- Stroke, Ischemic, Self Efficacy
- Keywords
- Chronic Care Model, Self-management, Stroke, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 13 Nov 2019 (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 is the third leading cause of death worldwide and is defined as neurological deficit due to ischemic or hemorrhagic causes. The risk of death in the 30 days following recurrent stroke was reported to be between 23% and 41%, and the risk of new disability was between 39% and 53%. Therefore, patient self-management is important in preventing recurrent stroke. The aim of this study was to evaluate the effect of education and telephone follow-up based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke. The study is a randomized controlled experimental study. A total of 68 patients (34 interventions and 34 controls) were randomized into a computer program with 80% power, 95% reliability and 0.05 margin of error. Patients were included in the study according to the inclusion criteria and randomization list. The self-management support component of the Chronic Care Model was implemented using the 5A (ASK, ADVICE, ASSESS, ASSIST, ARRANGE) methodology. The Conceptual-Theoretical-Experimental structure of the research was created. A training booklet for stroke patients was created within the scope of the Chronic Care Model self-management support component. After the pre-tests, the patients who were included in the intervention group were given discharge training with a booklet prepared based on the Chronic Care Model and containing information and recommendations on self-management strategies during their stay in the hospital (0 months). These patients were followed up by telephone on the 7th day, 15th day, 1st month and 2nd month after discharge. No intervention other than routine hospital follow-up was performed for the patients included in the control group.
- The patients who were included in the control and intervention groups were performed to post-tests at the 3rd month outpatient clinic control and metabolic variables of the patients were obtained from the patient clinical information system.
Detailed description
Stroke is the third leading cause of death worldwide and is defined as neurological deficit due to ischemic or hemorrhagic causes. Stroke is an important health problem in Turkey as it is common in society and causes death. Stroke patients are reported to be at risk for secondary stroke. The risk of death in the 30 days following recurrent stroke was reported to be between 23% and 41%, and the risk of new disability was between 39% and 53%. Therefore, patient self-management is important in preventing recurrent stroke. One of the most widely accepted and effective models in the international literature for chronic diseases is the Chronic Care Model. The aim of this study was to evaluate the effect of education and telephone follow-up based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke.
The study is a randomized controlled experimental study. The sample of the study included inpatients with stroke in Akdeniz University Hospital Neurology Clinic. A total of 68 patients (34 interventions and 34 controls) were randomized into a computer program with 80% power, 95% reliability and 0.05 margin of error.
In this study, four components of the Chronic Care Model were applied. These elements are self-management support, delivery system design, decision support and clinical information systems. The self-management support component of the Chronic Care Model was implemented using the 5A (ASK, ADVICE, ASSESS, ASSIST, ARRANGE) methodology. The Conceptual-Theoretical-Experimental structure of the research was created.
According to the intervention protocol of the study:
- A training booklet for Stroke Patients was created within the scope of the Chronic Care Model self-management support component. The quality of the booklet was evaluated by the DISCERN measurement tool by the Nursing Faculty and Neurology specialists. The difficulty level of the training booklet was calculated according to Atesman's Readability Formula.
- Three patients with stroke were applied pilot scheme.
- Patients were included in the study according to the inclusion criteria and randomization list.
- Patients in the control and intervention groups were interviewed before discharge (0 months). Preliminary tests were performed after obtaining informed consent from the patients. For this purpose, Personal Information Form, Modified Barthel Index, Stroke Self-Efficacy Questionnaire, Stroke Specific Quality of Life Scale were applied. Metabolic variables (blood pressure, height / weight assessment and laboratory findings [HDL cholesterol, LDL cholesterol, total cholesterol, triglyceride, HbA1c, APTT, PT and INR]) were obtained from the patient clinical information system.
- After the pre-tests, the patients were given discharge training with a booklet prepared based on the Chronic Care Model and containing information and recommendations on self-management strategies during their stay in the hospital (0 months). Trainings were performed in a single session and in the patient room at the clinic, not to exceed 45-50 minutes.
- The patients who were included in the intervention group were followed up by telephone on the 7th day, 15th day, 1st month and 2nd month after discharge.
- Patients were referred to the hospital in unexpected / unpredictable situations during the three-month period.
- No intervention other than routine hospital follow-up was performed for the patients included in the control group.
- The patients who were included in the control and intervention groups were performed to post-tests at the 3rd month outpatient clinic control and metabolic variables of the patients were obtained from the patient clinical information system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education and telephone follow ups based on the CCM | Experimental | Behavioral: The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic strokeAfter the pre-tests (self-management, quality of life and patient satisfaction were assessed by scales at the first interview), the patients were given discharge training with a booklet prepared based on the Chronic Care Model (CCM) and containing information and recommendations on self-management strategies during their stay in the hospital (0 months). Trainings were performed in a single session and in the patient room at the clinic, not to exceed 45-50 minutes. The patients who were included in the intervention group were followed up by phone on the 7th day, 15th day, 1st month and 2nd month after discharge. Patients were referred to the hospital in unexpected / unpredictable situations during the three-month period. Self-management, quality of life and patient satisfaction were assessed by scales at the first interview and 3 months later. Metabolic variables of the patients were obtained from the patient clinical information system at the first interview and 3 months later. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Matching the TOAST classification criteria
- Place, time, person orientation
- Based on the Modified Rankin Scale "0,1,2,3"
- 18 years and older
- First diagnosis of ischemic stroke by CT and MRI
Key exclusion criteria (3 listed)
- Diagnosed with psychiatric disease
- Diagnosed with advanced liver or kidney disease
- Malignancy or other neurological disease
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 |
|---|---|---|
| The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic strokeThe effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke Self-management, quality of life and patient satisfaction were assessed by scales at the first interview and 3 months later. Metabolic variables of the patients were obtained from the patient clinical information system at the first interview and 3 months later. | Behavioural | Education and telephone follow ups based on the CCM |
Primary outcome
Has an effect on improving self-management skills
Time frame: 3 months
The Stroke Self-Efficacy Questionnaire (SSEQ): In this study, the final 13-item SSEQ was used for collecting data. Each item is scored on a 4-point scale (0 "not at all confident" to 3 "very confident"). The 4-point scale provides a score range 0-39. A higher score indicates a higher self-efficacy. In this study, Turkish Version of the questionnaire was used.
Has an effect on improving quality of life
Time frame: 3 months
Stroke Spesific Quality of Life Scale (SS-QOL) is a disease-specific QOL measure. It consists of 49 items encompassing 12 domains, which include the social role, mobility, energy, language, self-care, mood, personality, thinking, upper extremity function, family role, vision, and work/productivity. Each item is ranked on a five-point Likert scale in which level one means completely agreed while level five means completely disagree. The summary score of this scale is an un-weighted average of the 12 domains. The total score ranges from 49 to 245, with higher scores indicating a better QOL. In this study, Turkish Version of the scale was used.
Has an effect on improving patient satisfaction
Time frame: 3 months
The Patient Assessment of Chronic Illness Care (PACIC) is a relatively brief 20-item questionnaire designed to assess the extent to which care is aligned with the Chronic Care Model. It consists five factors and, 20-item. The increase in the scale scores shows that individuals with chronic disease are highly satisfied with the care they receive. In this study, Turkish Version of the questionnaire was used.
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 13 Nov 2019.
- Derived from this study: PubMed 34264000Kalav S, Bektas H, Unal A. Effects of Chronic Care Model-based interventions on self-management, quality of life and patient satisfaction in patients with ischemic stroke: A single-blinded randomized controlled trial. Jpn J Nurs Sci. 2022 Jan;19(1):e12441. doi: 10.1111/jjns.12441. Epub 2021 Jul 15.
- Individual participant dataSharing planned: No
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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.
Hicran Bektas, PhD, RN study chair
Akdeniz University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke in people with Stroke, Ischemic and Self Efficacy, run by Akdeniz 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 8 inclusion and 3 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 13 Nov 2019. 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?
Has an effect on improving self-management skills (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT04161820, which also lists 1 linked publication.
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 13 Nov 2019.