Stroke, Ischemic Clinical Trial
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
NCT number | NCT04161820 |
Other study ID # | 023 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2018 |
Est. completion date | November 5, 2019 |
Verified date | November 2019 |
Source | Akdeniz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- 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.
Status | Completed |
Enrollment | 68 |
Est. completion date | November 5, 2019 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Simge Kalav | Antalya |
Lead Sponsor | Collaborator |
---|---|
Akdeniz University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 months | |
Primary | 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. | 3 months | |
Primary | 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. | 3 months |
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