NCT Number: NCT07610161
This study aims to explore the patient experiences of living alone older adults with injuries, and to examine the effects of a "Geriatric Trauma Care Program" in older adults with limb injuries who live alone. A three-year design will be used to reach the purposes of this study. The first stage of this study will use descriptive phenomenology to get patient experiences of living alone older adults with injuries. In the second stage of this study, a two-arm experimental design will be used.
Interested in participating?
Request Info65 year–74 year
All sexes
Interventional
Not applicable
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Kaohsiung, Taiwan
Aim: This study aims to explore patient experience of living alone older adults with injuries, and to examine effects of a "Geriatric Trauma Care Program (GTCP)" in older adults with limb injuries who live alone.
Design: A two-stage design will be used to reach the purposes of this study. The first stage of this study will use descriptive phenomenology to get patient experiences of living alone older adults with injuries. In the second stage, a two-arm experimental design will be used to intervene the "GTCP" and evaluate its outcomes.
Methods: In the first stage, the study settings will be surgical outpatient departments at a university hospital. Purposive sampling will be used to select old adult patients with injury and living alone. Semi-structured and audio-taped interviews will be used as data collection method. About 15 to 20 participants are planned to be interviewed. Colaizzi's (1978) methods will be applied to data analysis. The findings will be used to modify the intervention for the second stage in this study.
In the second stage, a two-arm experimental design will be used. The participants will be older adults with limb injuries. The experiment group will receive the "GTCP" and routine care, and the control group will receive routine care only. The GTCP includes a two-session intervention named "Digital geriatric trauma care" and "Multiple training modalities". The two sessions will use an "age-friendly e-Book" and a "personalized-oriented App" as assistant materials. A three-time point data collection will be used including at hospital discharge, 1 month and 3 months after hospital discharges. The pre -and post- intervention measures will be five structured scales including pain, functional disability, geriatric depression, loneliness, and quality of life. The 2nd stage expects to collect 45 participants in each group. The experimental effects will be examined by the generalized estimating equations (GEEs) model.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention program named GTCP includes two sessions with two digital materials named "Digital geriatric trauma care" (DGTC) and "Multiple training modalities" (MTM). The DGTC has been establishing as an Age-friendly e-Book. It has six units. The MTM has three units including "handwritten wisdom quotes", "6-minute meditation", "inspirational words".
Time frame: at 1 day before hospital discharge
The NPRS is marked with the numbers 0-10 at equal intervals where 0 presents no pain and 10 illustrates the worst pain imaginable. Patients are required to rate the number that represents their current pain intensity. It is well known and broadly used scale in clinical settings. No further reliability and validity tests are needed.
Time frame: at 1 day before hospital discharge
The BI will be used to measure functional disabilities. It is used to assess basic activities of daily living (BADL) in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. The Chinese version has been applied in older population, with Cronbach's alpha ranging from 0.79 to 0.85. The Cronbach's alpha will be retested in this study.
Time frame: at 1 day before hospital discharge
The GDS-SF is a 15-item scale used to identify depression in older adults. It is from the original GDS developed by Sheikh and Yesavage to examine the self-perceived emotions of older adults. The version will be used in this study is a validated Chinese that has been tested its reliability in geriatric older population in Taiwan. The GDS-SF features binary scores for a total score of 0-15. A higher score indicates a more severe of depression. In the GDS-SF, a score of 0 to 5 is normal, a score > 5 suggests depression, and a score ≥ 10 is almost indicative of depression. The Cronbach's alpha for this study will be retested.
Time frame: at 1 day before hospital discharge
Loneliness has been defined as perceptions of being alone and separated from others. This concept has been conceptualized to measure desired social contacts and actual social contacts. Lin and Lin (2013) used 189 older adults to examine the Chinese ELS scale's reliability and validity. The ELS includes 3 items for social loneliness and 5 items for emotional loneliness. It has been scored by a 4 points Likert Scale from 1 to 4 with a higher score indicating more loneliness. The Cronbach's alpha for this will be retested in this study.
Time frame: at 1 day before hospital discharge
The EQ-5D is a scale used to measure the HRQoL developed in Europe, which has been globally tested and used. The EQ-5D has five dimensions including mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. A total of 15 items is included in the EQ-5D. Each dimension has three items assessed by three levels, never, moderate, and severe, of individual quality of life. A participant can only choose one of three levels of their quality of life. It indicates that an assessor only obtains 5 answers from each of 5 domains in the EQ-5D. The hospital discharge EQ-5D will be recalled by participants to report their HRQoL two weeks before admission. The Cronbach's alpha will be retested in this study.
Time frame: at 1 months after hospital discharge
The NPRS is marked with the numbers 0-10 at equal intervals where 0 presents no pain and 10 illustrates the worst pain imaginable. Patients are required to rate the number that represents their current pain intensity. It is well known and broadly used scale in clinical settings. No further reliability and validity tests are needed.
Time frame: at 1 months after hospital discharge
The BI will be used to measure functional disabilities. It is used to assess basic activities of daily living (BADL) in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. The Chinese version has been applied in older population, with Cronbach's alpha ranging from 0.79 to 0.85. The Cronbach's alpha will be retested in this study.
Time frame: at 1 months after hospital discharge
The GDS-SF is a 15-item scale used to identify depression in older adults. It is from the original GDS developed by Sheikh and Yesavage to examine the self-perceived emotions of older adults. The version will be used in this study is a validated Chinese that has been tested its reliability in geriatric older population in Taiwan. The GDS-SF features binary scores for a total score of 0-15. A higher score indicates a more severe of depression. In the GDS-SF, a score of 0 to 5 is normal, a score > 5 suggests depression, and a score ≥ 10 is almost indicative of depression. The Cronbach's alpha for this study will be retested.
Time frame: at 1 months after hospital discharge
Loneliness has been defined as perceptions of being alone and separated from others. This concept has been conceptualized to measure desired social contacts and actual social contacts. Lin and Lin (2013) used 189 older adults to examine the Chinese ELS scale's reliability and validity. The ELS includes 3 items for social loneliness and 5 items for emotional loneliness. It has been scored by a 4 points Likert Scale from 1 to 4 with a higher score indicating more loneliness. The Cronbach's alpha for this will be retested in this study.
Time frame: at 1 months after hospital discharge
The EQ-5D is a scale used to measure the HRQoL developed in Europe, which has been globally tested and used. The EQ-5D has five dimensions including mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. A total of 15 items is included in the EQ-5D. Each dimension has three items assessed by three levels, never, moderate, and severe, of individual quality of life. A participant can only choose one of three levels of their quality of life. It indicates that an assessor only obtains 5 answers from each of 5 domains in the EQ-5D. The hospital discharge EQ-5D will be recalled by participants to report their HRQoL two weeks before admission. The Cronbach's alpha will be retested in this study.
Time frame: at 3 months after hospital discharge
The NPRS is marked with the numbers 0-10 at equal intervals where 0 presents no pain and 10 illustrates the worst pain imaginable. Patients are required to rate the number that represents their current pain intensity. It is well known and broadly used scale in clinical settings. No further reliability and validity tests are needed.
Time frame: at 3 months after hospital discharge
The BI will be used to measure functional disabilities. It is used to assess basic activities of daily living (BADL) in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. The Chinese version has been applied in older population, with Cronbach's alpha ranging from 0.79 to 0.85. The Cronbach's alpha will be retested in this study.
Time frame: at 3 months after hospital discharge
The GDS-SF is a 15-item scale used to identify depression in older adults. It is from the original GDS developed by Sheikh and Yesavage to examine the self-perceived emotions of older adults. The version will be used in this study is a validated Chinese that has been tested its reliability in geriatric older population in Taiwan. The GDS-SF features binary scores for a total score of 0-15. A higher score indicates a more severe of depression. In the GDS-SF, a score of 0 to 5 is normal, a score > 5 suggests depression, and a score ≥ 10 is almost indicative of depression. The Cronbach's alpha for this study will be retested.
Time frame: at 3 months after hospital discharge
Loneliness has been defined as perceptions of being alone and separated from others. This concept has been conceptualized to measure desired social contacts and actual social contacts. Lin and Lin (2013) used 189 older adults to examine the Chinese ELS scale's reliability and validity. The ELS includes 3 items for social loneliness and 5 items for emotional loneliness. It has been scored by a 4 points Likert Scale from 1 to 4 with a higher score indicating more loneliness. The Cronbach's alpha for this will be retested in this study.
Time frame: at 3 months after hospital discharge
The EQ-5D is a scale used to measure the HRQoL developed in Europe, which has been globally tested and used. The EQ-5D has five dimensions including mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. A total of 15 items is included in the EQ-5D. Each dimension has three items assessed by three levels, never, moderate, and severe, of individual quality of life. A participant can only choose one of three levels of their quality of life. It indicates that an assessor only obtains 5 answers from each of 5 domains in the EQ-5D. The hospital discharge EQ-5D will be recalled by participants to report their HRQoL two weeks before admission. The Cronbach's alpha will be retested in this study.
Contact information is provided by the study sponsor or research team.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Other
Patient Experience of Older Adults Living Alone With Injuries and Long-Term Effects of Geriatric Trauma Care Program for Living Alone Older Adults With Injuries
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