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The Effect of Education Based on the Chronic Care Model (StrokeCARE) in Patients With Ischemic Stroke

Primary Purpose

Stroke, Ischemic, Self Efficacy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
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
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke, Ischemic focused on measuring Chronic Care Model, Self-management, Stroke, Quality of Life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Simge Kalav

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Education and telephone follow ups based on the CCM

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2019
Last Updated
November 11, 2019
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04161820
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
November 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Self Efficacy
Keywords
Chronic Care Model, Self-management, Stroke, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education and telephone follow ups based on the CCM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
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
Intervention Description
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.
Primary Outcome Measure Information:
Title
Has an effect on improving self-management skills
Description
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.
Time Frame
3 months
Title
Has an effect on improving quality of life
Description
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.
Time Frame
3 months
Title
Has an effect on improving patient satisfaction
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hicran Bektas, PhD, RN
Organizational Affiliation
Akdeniz University Faculty of Nursing
Official's Role
Study Chair
Facility Information:
Facility Name
Simge Kalav
City
Antalya
ZIP/Postal Code
07058
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34264000
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.
Results Reference
derived

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The Effect of Education Based on the Chronic Care Model (StrokeCARE) in Patients With Ischemic Stroke

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