Patient Experience of Older Adults Living Alone With Injuries
20 de mayo de 2026 actualizado por: Kaohsiung Medical University Chung-Ho Memorial Hospital
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
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
110
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Bih-O Lee, PHD
- Número de teléfono: 2625 886-7-312-1101
- Correo electrónico: biholee@kmu.edu.tw
Ubicaciones de estudio
-
-
-
Kaohsiung City, Taiwán
- Reclutamiento
- Kaohsiung Medical University
-
Contacto:
- Bih-O Lee, PHD
- Número de teléfono: 2625 886-7-312-1101
- Correo electrónico: biholee@kmu.edu.tw
-
-
Kaohsiung
-
Kaohsiung City, Kaohsiung, Taiwán, 807
- Reclutamiento
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Contacto:
- Bih-O BO Lee, Ph.D
- Número de teléfono: 886-7-312-1101 ext 2625
- Correo electrónico: biholee@kmu.edu.tw
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- willing to join this study for 12 weeks
- limb injuries,
- living alone without any family,
- 65 to 74 years old,
- independent before an injury,
- have a smart phone
- be able to communicate in Mandarin
Exclusion Criteria:
- with an ISS greater than 16 (severe injuries)
- severe cognitive impairment
- severe illness such as organ system insufficiency
- diagnosed with depression
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: experimental group
Researchers will conduct the Geriatric Trauma Care Program for the experimental group.
|
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".
|
|
Sin intervención: contrast group
The contrast group will be receiving the routine care only.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Numeric Pain Rating Scale (NPRS)
Periodo de tiempo: 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.
|
at 1 day before hospital discharge
|
|
The Barthel's Index (BI)
Periodo de tiempo: 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.
|
at 1 day before hospital discharge
|
|
The Geriatric Depression Scale Short Form (GDS-SF)
Periodo de tiempo: 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.
|
at 1 day before hospital discharge
|
|
The Elderly Loneliness Scale (ELS)
Periodo de tiempo: 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.
|
at 1 day before hospital discharge
|
|
Taiwanese version of the EuroQol-5D (EQ-5D)
Periodo de tiempo: 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.
|
at 1 day before hospital discharge
|
|
The Numeric Pain Rating Scale (NPRS)
Periodo de tiempo: 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.
|
at 1 months after hospital discharge
|
|
The Barthel's Index (BI)
Periodo de tiempo: 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.
|
at 1 months after hospital discharge
|
|
The Geriatric Depression Scale Short Form (GDS-SF)
Periodo de tiempo: 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.
|
at 1 months after hospital discharge
|
|
The Elderly Loneliness Scale (ELS)
Periodo de tiempo: 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.
|
at 1 months after hospital discharge
|
|
Taiwanese version of the EuroQol-5D (EQ-5D)
Periodo de tiempo: 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.
|
at 1 months after hospital discharge
|
|
The Numeric Pain Rating Scale (NPRS)
Periodo de tiempo: 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.
|
at 3 months after hospital discharge
|
|
The Barthel's Index (BI)
Periodo de tiempo: 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.
|
at 3 months after hospital discharge
|
|
The Geriatric Depression Scale Short Form (GDS-SF)
Periodo de tiempo: 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.
|
at 3 months after hospital discharge
|
|
The Elderly Loneliness Scale (ELS)
Periodo de tiempo: 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.
|
at 3 months after hospital discharge
|
|
Taiwanese version of the EuroQol-5D (EQ-5D)
Periodo de tiempo: 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.
|
at 3 months after hospital discharge
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Bih-O Lee, PHD, Kaohsiung Medical University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de noviembre de 2023
Finalización primaria (Estimado)
31 de julio de 2026
Finalización del estudio (Estimado)
31 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
20 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de mayo de 2026
Publicado por primera vez (Actual)
27 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KMUHIRB-F(I)-20230043
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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