Clinical trial NCT04161820: The Effect of Education Based on the Chronic Care Model (StrokeCARE) in Patients With Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Self Efficacy
Keywords: Chronic Care Model
Self-management
Stroke
Quality of Life
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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%. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Diagnosed with psychiatric disease
* Diagnosed with advanced liver or kidney disease
* Malignancy or other neurological disease

Primary outcomes:
measure: Has an effect on improving self-management skills
timeFrame: 3 months
measure: Has an effect on improving quality of life
timeFrame: 3 months
measure: Has an effect on improving patient satisfaction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Simge Kalav
Study officials:
affiliation: Akdeniz University Faculty of Nursing
name: Hicran Bektas, PhD, RN
role: STUDY_CHAIR
References:
citation: 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.