Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Healthcare utilization |
Combined number of emergency department visits, outpatient visits, rehabilitation center visits, hospitalizations, and days hospitalized per participant will be compared between the EHP group and control group with data collected by completing the Health Care Utilization and Cost Questionnaire (HCUCQ) at 90 days, 180 days and 365 days. |
Enrollment to 90 days, 180 days and 365 days |
|
| Other |
Incremental cost-effectiveness ratio (for economic evaluation) |
Incremental cost-effectiveness ratio (ICER) calculated with data collected in completing the EQ-5D-5L and the HCUCQ questionnaires at 3 months, 6 months and 12 months. ICER = (Ci - Cc) / (Ei - Ec), where Ci and Ei are the cost and effect in the EHP group and where Cc and Ec are the cost and the effect in the control group. |
Enrollment to 90 days, 180 days and 365 days |
|
| Primary |
Quality of life measured by EuroQol-Five Dimension Questionnaire |
Change in quality of life from baseline to 90 days is measured using the EuroQol-Five Dimension Questionnaire (EQ-5D-5L), a generic health related quality of life instrument. The EuroQol-Five Dimension descriptive system covers five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five response levels; and the responses to 5 dimensions can be combined to provide a 5 digit profile describing the respondent's health state with a single index value. An EQ-5D-5L index score of 1 represents full health. |
Baseline, Day 90 (pre and post-intervention) |
|
| Primary |
Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS) |
Change in quality of life from baseline to 90 days is measured using the EuroQol-Visual Analogue Scale (EQ-VAS). The EQ-VAS records the stroke survivor's self-rated health on a vertical visual analogue scale with end points of 0 (the worst health) and 100 (the best health). |
Baseline, Day 90 (pre and post-intervention) |
|
| Primary |
Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0) |
Change in quality of life from baseline to 90 days is measured using the Stroke Impact Scale 3.0 (SIS3.0), a stroke specific quality of life instrument. The SIS measures self-perceived health within eight domains (strength, hand functionality, activities of daily living, mobility, communication, emotions, memory and thinking, and participation) on a 5-point Likert scale. Scores for each domain are averaged and transformed into a score ranging from 0 to 100, and higher scores denote better health. |
Baseline, Day 90 (pre and post-intervention) |
|
| Primary |
Quality of life measured by Stroke recovery score of the Stroke Impact Scale 3.0 (SIS 3.0) |
Change in quality of life from baseline to 90 days is measured using the Stroke recovery score of the Stroke Impact Scale 3.0 (SIS3.0). The SIS 3.0 also includes a question to assess the patient's global perception of recovery on a visual scale of 0 (no recovery) to 100 (full recovery). |
Baseline, Day 90 (pre and post-intervention) |
|
| Secondary |
Quality of life measured by EuroQol-Five Dimension Questionnaire (EQ-5D-5L) |
Change in quality of life from baseline to 180 days or 365 days is measured using the EuroQol-Five Dimension Questionnaire (EQ-5D-5L), a generic health related quality of life instrument. The EQ-5D-5L descriptive system covers five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five response levels; and the responses to 5 dimensions can be combined to provide a 5 digit profile describing the respondent's health state with a single index value. An EQ-5D-5L index score of 1 represents full health. |
Baseline, Day 180, Day 365 (follow-up) |
|
| Secondary |
Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS) |
Change in quality of life from baseline to 180 days or 365 days is measured using the EuroQol-Visual Analogue Scale (EQ-VAS) , the second part of the EQ-5D-5L. The EQ VAS records the stroke survivor's self-rated health on a vertical visual analogue scale with end points of 0 (the worst health) and 100 (the best health). |
Baseline, Day 180, Day 365 (follow-up) |
|
| Secondary |
Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0) |
Change in quality of life from baseline to 180 days or 365 days is measured using the Stroke Impact Scale 3.0 (SIS3.0), a stroke specific quality of life instrument. The SIS measures self-perceived health within eight domains (strength, hand functionality, activities of daily living, mobility, communication, emotions, memory and thinking, and participation) on a 5-point Likert scale. Scores for each domain are averaged and transformed into a score ranging from 0 to 100, and higher scores denote better health. |
Baseline, Day 180, Day 365 (follow-up) |
|
| Secondary |
Quality of life measured by Stroke recovery score of the Stroke Impact Scale 3.0 (SIS 3.0) |
Change in quality of life from baseline to 180 days or 365 days is measured using the Stroke recovery score of the Stroke Impact Scale 3.0 (SIS3.0). The SIS 3.0 also includes a question to assess the patient's global perception of recovery on a visual scale of 0 (no recovery) to 100 (full recovery). |
Baseline, Day 180, Day 365 (follow-up) |
|
| Secondary |
Self-Efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD-6) |
Change in Self-Efficacy from baseline to 90 days is evaluated by the Managing Chronic Disease 6-item Scale (SEMCD-6). The SEMCD-6 contains six items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). |
Baseline, Day 90 (pre and post-intervention) |
|
| Secondary |
Self-Efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD-6) |
Change in Self-Efficacy from baseline to 180 days or 365 days is evaluated by the Managing Chronic Disease 6-item Scale (SEMCD-6). The SEMCD-6 contains six items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). |
Baseline, Day 180, Day 365 (follow-up) |
|
| Secondary |
Independence of daily activities measured by the Modified Barthel Index (MBI) |
Change in independence of daily activities from baseline to 90 days is evaluated by the Modified Barthel Index (MBI). The MBI is a 10-item, self-report measure to assess level of independence in ability to perform basic activities of daily living. Scale score ranges 0 - 100 with higher scores indicating greater independence in activities of daily living. |
Baseline, Day 90 (pre and post-intervention) |
|
| Secondary |
Independence of daily activities measured by the Modified Barthel Index (MBI) |
Change in independence of daily activities from baseline to 180 days or 365 days is evaluated by the Modified Barthel Index (MBI). The MBI is a 10-item, self-report measure to assess level of independence in ability to perform basic activities of daily living. Scale score ranges 0 - 100 with higher scores indicating greater independence in activities of daily living. |
Baseline, Day 180, Day 365 (follow-up) |
|
| Secondary |
Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS) |
Change in anxiety and depression from baseline to 90 days is evaluated by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of two 7-item subscales measuring depression and anxiety. Items are rated on a four point scale (0-3) and the item scores are summed to give either a depression score or an anxiety score between 0 and 21. Higher score indicates higher levels of disorder. |
Baseline, Day 90 (pre and post-intervention) |
|
| Secondary |
Adherence to medication measured by the Adherence to Refills and Medication Scale (ARMS) |
Change in adherence to medication from baseline to 90 days is assessed by the Adherence to Refills and Medication Scale (ARMS). The ARMS consists of two subscales, an 8- item medication taking subscale and a 4-item prescription refill subscale. Each item is given values from 1 to 4. An overall adherence score ranges from 12-48, with higher scores representing more problems with medication adherence. |
Baseline, Day 90 (pre and post-intervention) |
|
| Secondary |
Satisfaction level measured by the Patient Satisfaction with Care Questionnaire (PSCQ) |
Satisfaction level in the time in completing the Patient Satisfaction Questionnaire at 90 days. |
Day 90 (post-intervention) |
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